Hypnosis and Meditation for Pain Management in Veterans: Efficacy and Mechanisms
Phase: NA
Conditions: Chronic Pain
Sponsor: University of Washington

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Chronic Pain Skills Study Protocol 
CHRONIC PAIN SKILLS STUDY 
A randomized, 3-group parallel design, 240-subject clinical trial to test the efficacy and 
mechanisms of self-hypnosis and mindfulness meditation on chronic pain in Veterans. 
Study Chairman or Principal Investigator: 
Mark P. Jensen, Ph.D., Professor and Vice Chair for Research, University of 
Washington Department of Rehabilitative Medicine 
Rhonda M. Williams, Ph.D., Associate Professor, VA Puget Sound Health Care System 
Supported by: 
The National Center of Complementary and Integrative Health (NCCIH) 
1 R01 AT008336-02 
Study Intervention Provided by: 
University of Washington and VA Puget Sound Health Care System 
VA Puget Sound IRB Approved 
07/09/2020

Contents 
TOOL REVISION HISTORY ..................................................................................................................... 4 
STUDY TEAM ROSTER ......................................................................................................................... 10 
PARTICIPATING STUDY SITES ............................................................................................................ 15 
PRÉCIS ................................................................................................................................................... 16 
A. SPECIFIC AIMS ..................................................................................................................................... 19 
A1. Problem Statement ......................................................................................................................... 19 
A2. Specific Aims and Hypotheses ..................................................................................................... 20 
B. BACKGROUND AND SIGNIFICANCE ................................................................................................. 22 
B1. Significance of Research ............................................................................................................... 22 
B2. Relevance to VA Patient Care Mission ......................................................................................... 22 
C. PRELIMINARY STUDIES ...................................................................................................................... 22 
D. RESEARCH DESIGN AND METHODS ................................................................................................. 25 
D1. Synopsis .......................................................................................................................................... 25 
D2. Study Timeline ................................................................................................................................ 31 
D3. Inter-Site Communication and Coordination ............................................................................... 34 
D5. Participants ..................................................................................................................................... 34 
Eligibility Criteria ............................................................................................................................... 35 
D6. Procedures ...................................................................................................................................... 36 
D6a. Recruitment ................................................................................................................................... 36 
D6b. Screening Procedures: Research Study Participants .............................................................. 40 
D6c. Screening Procedures: Non-Research Participants ................................................................. 44 
D6d. Consent Process .......................................................................................................................... 45 
D6e. Cognitive Assessment ................................................................................................................. 47 
D6f. Hypnotic and Relaxation Exercise ............................................................................................... 47 
D6g. Baseline Data and Demographic Form....................................................................................... 47 
D6h. Personal Contact Information ..................................................................................................... 48 
D6i. Day before Brain Wave Activity (Electroencephalogram or EEG) Assessment...................... 48 
D6j. Brain Wave Activity (or EEG) Assessment ................................................................................. 49 
D6k. Assessment: Pre-Treatment and General Overview ................................................................. 50 
D6l. Randomization ............................................................................................................................... 51 
D6m. Treatment Scheduling: Research and Non-Research Participants ........................................ 52 
D6n. Treatment ...................................................................................................................................... 52 
D6o. Study design enhancements: Missed sessions and study retention strategies ................... 56 
D6p. Optional Assessments ................................................................................................................. 57 
D6q. Study Completion: Main Phase ................................................................................................... 58 
D6r. Open Label Phase ......................................................................................................................... 58 
D6s. Study Data ..................................................................................................................................... 66 
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D6t. Treatment Fidelity Monitoring ...................................................................................................... 71 
D6u. Data Collection and Management ............................................................................................... 72 
D6v. Statistical Analyses ...................................................................................................................... 75 
D6x. Missing Data .................................................................................................................................. 80 
D6w. Power Analyses ............................................................................................................................ 80 
1. Risk to Participants ............................................................................................................................... 82 
1a. Human Participants Involvement and Characteristics ................................................................ 82 
1b. Sources of Materials ....................................................................................................................... 83 
E1c. Potential Risks .............................................................................................................................. 83 
2. Protection Against Risk ........................................................................................................................ 84 
General/Reaction to Assessments ...................................................................................................... 84 
Brain Wave Activity Assessments ....................................................................................................... 85 
Treatment ............................................................................................................................................... 85 
F1d. Privacy and Confidentiality .......................................................................................................... 86 
F1e. Mental Health Issues/ Suicidality ................................................................................................. 87 
3. Data Safety Monitoring ......................................................................................................................... 91 
3a. Adverse Event  and Serious Problem Information: Definition.................................................... 91 
3b. Classification of AE Severity ......................................................................................................... 91 
3c. AE Attribution Scale ........................................................................................................................ 92 
3d. AE Reporting and Follow-up .......................................................................................................... 92 
3e. SAE Reporting ................................................................................................................................. 92 
G1f. Data Quality Assurance and Monitoring ..................................................................................... 93 
3g. Subject Accrual and Compliance .................................................................................................. 94 
G1h. Study Discontinuation ................................................................................................................. 94 
3i. Designation of a Monitoring Committee ........................................................................................ 94 
G1j. Methods and Timing for Assessing Recording, and Analyzing Safety Parameters ............... 95 
3k. Study Report Outline for the Independent Monitors(s) (Interim or Annual Reports) ............... 96 
3l. Reporting Changes in Study Status ............................................................................................... 97 
4. Potential Benefits of Research to Participants and Others .............................................................. 97 
I. Publication of Research Findings ........................................................................................................ 98 
J. Importance of Knowledge to Be Gained ............................................................................................. 98 
K. Appendix 1: Evaluation Timeline ...................................................................................................... 105 
 
 
 
 
 
 
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TOOL REVISION HISTORY  
Version Number: 2.0 
Version Date: 12-08-15 
Summary of Revisions Made:  
1. Eliminated reference of MED exclusion criterion for non-research participants; 
Changed exclusion criterion regarding reported average daily use of morphine 
equivalent dose (MED) from >100mg to >120mg MED; 
2. Eliminated exclusion criterion regarding receipt of services from the VAPSHCS Pain 
Service; 
3. Reference to revision in protocol regarding psychological screening assessment, 
specifically that the psychologist could complete a medical record review or use firsthand 
clinical experience to deem eligibility. The psychologist may call the subject if s/he does 
not feel s/he can make a definitive judgement regarding eligibility following the medical 
record review; 
4. Reference to additional measures (PROMIS Global Health and StarTBack Screening 
Tool); 
5. Minor revisions to Table 1 to include new measure; 
6. Minor revisions to Table 4 to include new measures; 
7. Minor revisions to Table 5 to include new measures, update and correct assessment 
schedule. 
Version Number: 3.1 
Version Date: 01-11-16 
Summary of Revisions Made: 
 
1. Eliminated reference to provision of VAPSHCS research brochure (no longer required); 
2. Revised reference to amount of compensation for EEG assessments (from $50 to $100); 
3. Eliminated reference to having subjects choose to complete the consent session and the 
pre-treatment EEG assessment on the same day at the IBIC (still possible, yet no longer 
offered to subjects). 
4. Updated Study Team Roster; 
5. Updated table showing research staff who are blind or unblind to assignment; 
6. Update language regarding length of optional assessment; 
7. Removed reference to scanning treatment case report forms via Clinical 
Documentations Unit; 
8. Changed a typo ‘unblended’ to ‘unblinded.’ 
 
 
 
 
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Version Number: 4.0 
Version Date: 03-11-16 
Summary of Revisions Made: 
1. Updated description of psychologists who could conduct the psychological screening 
assessments. 
 
Version Number: 5.0 
Version Date: 04-20-16 
Summary of Revisions Made: 
1. Updated team roster; 
2. Update address of secure clinical drives; 
3. Reference to feedback regarding treatment modality; 
4. Protocol change: open-end questions regarding treatment satisfaction and treatment 
modality administered by unblinded staff member; 
5. Removed reference to ITHS as organization for Katherine Davis, now listed as 
independent consultant. 
 
Version Number: 5.1 
Version Date: 05-19-16 
Summary of Revisions Made: 
1. Added language that participants are limited to attend each intervention only once 
 
Version Number: 6 
Version Date: 06-24-2016 
Summary of Revisions Made: 
1. Added language that participants may experience discomfort (numbness, tingling, 
perceived loss of sensation) from sitting still for extended periods of time. 
 
 
 
 
 
 
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Version Number: 7.1 
Version Date: 08-04-16 
Summary of Revisions Made: 
1. Updated protocol to reflect revision in open label phase procedures to minimize chance 
of unblinding.  
2. Revised language regarding the consent process to reflect change to consent via 
telephone and postal mail. 
3. Added language  to define participation in a treatment study group as attending four or 
more treatment sessions for that particular group (e.g. mindfulness meditation).   
4. Clarified that signing the repository consent form gives study researchers permission to 
include data from all study activities as described in the main study consent form, 
including the open label phase. 
5. Updated study roster to reflect staff changes. 
6.   Updated study roster by changing personal email addresses to VA/UW addresses. 
 
 
Version Number: 8 
Version Date: 08-18-16 
Summary of Revisions Made: 
 
1. Updated study roster to reflect staff changes. 
2. Updated protocol to reflect screening, enrollment, baseline data collection and 
randomization relative to onset of treatment intervention. 
3. Updated protocol to allow  study researchers to conduct the medical record review 
(MRR) screening component after receipt of a clinic consult and prior to the mailing of 
the letter of orientation 
4. Updated protocol to reflect that pre-treatment assessments may be repeated if groups 
do not start within 4 weeks of completion of the assessments.  
5. Updated protocol to reflect the addition of 3- and 6- month optional assessments. 
6. Updated protocol to reflect open label screening process. 
7. Updated protocol to reflect that the open label consent process can take place in person 
as well as by phone and postal mail. 
8. Updated protocol to reflect data validation of exploratory treatment data. 
 
 
Version Number: 9 
Version Date: 11-21-16 
Summary of Revisions Made: 
 
1. Updated study protocol to reflect possibility of collecting less than four short 
assessments during each assessment period. 
2. Updated roster to reflect new group leaders added to the study and also group leaders 
that were removed. 
3. Eliminated examples provided for  exclusion criterion regarding psychiatric and 
behavioral conditions with symptoms that are unstable and severe. 
4. Emphasized that clinical discretion may be used to determine eligibility regarding mental 
health exclusion criteria. 
5. Took out reference to attached CVs for DSMC members (accidental inclusion from 
original IRB application). 
 
 
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Version Number: 10 
Version Date: 01-03-17 
Summary of Revisions Made: 
 
1. Added language indicating subjects will not be withdrawn from the study if they present 
unstable and/or severe symptoms related to a psychiatric condition following enrollment 
unless study researchers believe it is in the subject’s best interest to be withdrawn.  
2. Added language indicating subjects will not be withdrawn if deemed at high suicide risk 
following enrollment unless study researchers believe it would be in subject’s best 
interest to be withdrawn 
 
Version Number: 11 
Version Date: 01-06-17 
Summary of Revisions Made: 
 
1. Added a sleep supplement component funded by the sponsor. The procedures for the 
sleep supplement will be treated as an optional sub-study, with subjects going through 
an additional informed consent process if interested in participating. The sleep sub-study 
consists of the following components: 
a) Self-report items administered via telephone during the main pre-treatment, 4 
weeks, post-treatment, and 3 month assessment periods; 
b) Wearing an actigraph device measuring sleep and sleep quality during the main 
pre-treatment, post-treatment, and 3 month assessment periods;  
c) Completing a pencil-and-paper sleep/wake diary during the main pre-treatment, 
post-treatment, and 3 month assessment periods. 
Sleep sub-study subjects will have the opportunity to be compensated up to $150 if they 
participate fully in all three main time points. 
2. Added reference to protocol where a blank medication list is sent to a subject in advance 
of the EEG assessment, along with a revised letter. 
3. Eliminated use of term “proposed” relative to study, as the grant was in fact awarded. 
4. Added PANAS positive affect subscale (10 items) as part of main phase measures. 
5. Added PROMIS Psychosocial Illness Impact Positive measure as part of main phase 
measures. 
6. Updated Blinded/Unblinded Research Staff list to reflect current group leaders. 
 
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Version Number: 12 
Version Date: 03-12-17 
Summary of Revisions Made: 
 
1. Clarified language pertaining to the timing of the formal screening process.  
2. Revised our procedures regarding the timing of the initial telephone call following the 
mailing of the approach letter to prospective subjects. 
3. Clarified language pertaining to the credentialed providers who would be leading the 
groups. There are providers from a variety of disciplines who may lead groups. 
4. Added the option of sending text reminders for  participants who request this type of 
communication rather than a telephone call. 
5. Added a reminder letter that would be mailed prior to follow-up assessments. 
 
 
 
Version Number: 13 
Version Date: 06-21-17 
Summary of Revisions Made: 
 
 
1. Revised wording of sex/gender as a demographic variable collected/ used for 
stratification in randomization from “sex” to “sex/gender” to be more accurate of data 
collected/used. 
2. Revised wording to reflect actual intention of collecting sleep baseline data before 
treatment starts rather than prior to randomization. 
3. Revised wording to reflect actual intention of administering the Modified Stanford 
Hypnotic Clinical Scale (SHCS)  before treatment starts rather than prior to 
randomization. 
4. Updated language  to reflect that  data collected as part of the sleep sub-study will be 
collected up to 7 days during each assessment period.  
5. Update language to indicate clinicians will not have access to the crosswalk between 
study data and participants’ identities.   
6. Deleted incorrect language making reference to the transcription of treatment data on to 
a new CRF with SUBID only; study sponsor gave study researchers permission not to 
transcribe data but rather have only electronic copies of the original forms saved on a 
secure clinical drive.  
7. Add Regan Permito to the list of study staff members. 
8. Remove Julie Bondzie, Kaitlyn Kadel, Emily Koelmel  and  Dustin Logan from study staff 
members.  
9. Eliminated incorrect reference to staff not reviewing treatment data of non-research 
participants; staff may review the form to ensure no adverse events take place that 
would require clinical intervention. 
10. Corrected language in Table 3 regarding timing of pre-treatment brain activity 
assessment. 
11. Revised language to reflect that research staff ideally will attempt to collect each pain 
assessment a minimum of 24 hours between each assessment, but may collect each 
assessment no less than 22 hours between each assessment if necessary. 
12. Removed incorrect reference to scheduling of treatment groups based on enrollment 
numbers. 
13. Revised language regarding number of group leaders per treatment group. 
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14. Removed asterisk indicating exclusion criterion #5 is verified solely by medical record 
review given the redundant nature. 
15. Corrected Table 5, assessment schedule, to indicate Theta, alpha, beta, and gamma 
bandwidth power are only recorded during the pre- and post-treatment assessment 
periods.  
16. Corrected Table 5, assessment schedule, to indicate the Working Alliance Inventory, 
Group Climate Questionnaire, and Treatment Expectancies/Credibility are collected 
during treatment only as part of the two-week assessment period. 
17. Added language indicating ineligible individuals will be provided any relevant clinical 
resources available in addition to the resource list. 
18. Added language regarding possible risk of discomfort and distress upon hearing other 
Veterans discuss their pain or other problems in a group setting. 
19. Added language regarding possible risk of discomfort and distress due to increased 
focus on pain problem during assessments/treatments. 
20. Added language regarding protection against risk of discomfort/distress during treatment 
group settings. 
 
Version Number: 14 
Version Date: 10-23-17 
Summary of Revisions Made: 
 
1. Updated study roster to reflect current staff members. 
2. Clarified language that main phase participants would be approached to participate 
in the Open label phase only after they have completed the 6-month f/u assessment. 
3. Defined a  “study completer” for the main phase of the study and the sub-study. 
4. Added 6 items from the Neurobehavioral Status Inventory to the pre-,post-treatment 
and 3-month main phase assessments, and to the pre- and post-treatment Open 
label assessments. 
5. Clarified language in D6o to state that we will track reasons for treatment withdrawal 
rather than reasons for missed treatment sessions. 
6. Corrected language in D6x to state that participation in less than 50% (rather than 
less than 60%) of treatment sessions would be reported as a protocol deviation. Also 
clarified in section D6n that participation in less than 4 treatment sessions would be 
reported via Note-to-File. 
7. Updated the potential risks of the EEG procedure to include the potential for 
temporary increase in pain and the potential for temporary increase in PTSD 
symptoms. 
8. Clarified in section 3j that we would use the sponsor-recommended Note-to-File 
template rather than reporting via the VA template AND the sponsor template. 
9. Added language to D6t to indicate that data could be shared with study investigators 
at UW via the secure data transfer method – SAFE. 
10. Updated AE reporting in 3d to state that AEs related to the sleep sub-study will also 
be reported to the WSU IRB. 
 
Version Number: 15 
Version Date: 02-16-18 
Summary of Revisions Made: 
 
1. Added language that consent would be obtained using the UW EEG consent document 
prior to the EEG study procedure. 
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2. Added language that investigators expect 10% of the actigraphs from the sleep sub-
study to not be returned due to loss/misplacement by the participant or loss in the mail. 
Participants would have the option of hand delivering the actigraph to a research staff 
member at either the Seattle or American Lake VA campus. 
3. Added language that the EEGs are conducted at the UW IBIC and that informed consent 
would be obtained at IBIC prior to the EEG.  
Dr. Melissa Day was added to the roster 
4. Dr. Pagulayan was removed as the DSM chair.  Tracy Simpson was moved to DSM 
chair. Kendall Browne was added to the DSM committee.  
5. Added language to describe measuring a participants head to ensure that the EEG nets 
would fit their head. 
 
Version Number: 16 
Version Date: 05-07-18 
Summary of Revisions Made: 
 
1. Clarified language that source documents will be stored at either the Seattle or American 
Lake division.  Also clarified that the source documents will be transported between 
Seattle and American Lake sites. 
2. Added Anne Arewasikporn and Kevin Yagle to team roster 
 
Version Number: 17 
Version Date: 07-17-18 
Summary of Revisions Made: 
 
1. Corrected Study Assessment Schedule.  An X was inadvertently removed from Post-
treatment for the working alliance and global climate measures, so the X was added 
back in. 
2. Clarified that the Brain Wave Activity is an Optional study procedure (as it is written 
in the consent document and intended by study investigators. 
3. Increased the enrollment number  for  the Sleep Sub-Study from 135 to 180.  
4. Updated language to show that after cohort 9, new participants would be offered 
treatment materials (workbook and audio recordings) for the intervention that they 
were not randomized to in place of an invitation to participate in the open label 
phase.  
5. Removed David Kearney from Blinded/Unblinded staff list on page 67. 
6. Added Emily Stensland to the list of study staff members. 
7. Defined  lost to follow up and study completers for the main, open label and sleep 
study 
8. Added language to show that optional assessments will stop once there is enough 
data to answer exploratory questions.  
9. Added language that participants enrolled in the Sleep Sub-Study may be asked to 
complete the Pre-Tx assessment period again if they do not begin treatment within 
four weeks of completing the Pre-Tx assessment period.  
 
Version Number: 18 
Version Date: 10-30-18 
Summary of Revisions Made: 
 
1. Update study team roster and Blinded/Unblinded Research Staff table with added and 
removed group leaders 
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2. Added language that participants who were randomized in cohorts 1-9 and are eligible 
for the open label phase will be offered the option of either receiving treatment materials 
in the mail or enrolling in the open label phase.  
 
Version Number: 19 
Version Date: 03-11-19 
Summary of Revisions Made: 
 
1. Increased the enrollment number  for  the Sleep Sub-Study from 180 to 195. 
2. Increased the enrollment number  for  the Main Study from 343 to 355. 
3. Updated team roster and blinded/unblinded table. 
4. Removed language that refers to future groups or cohorts for Non-research participants. 
5. Clarified that the actigraph data will transmitted by WSU staff to VA staff electronically in 
de-identified form to be stored indefinitely on the secure VA server with the rest of the 
study data. 
6. Clarified  that data from the main phase of the study will be shared with WSU study 
investigators for the purposes of data analysis. 
7. Removed references that de-identified data would be shared via the SAFE method.  
 
Version Number: 20 
Version Date: 05-28-19 
Summary of Revisions Made: 
 
1. Clarified that primary analysis will use an Intent to treat approach and not a per protocol 
approach. 
2. Detailed approach to missing data. 
3. Aim I will be tested using Analysis of CO-variance (ANCOVA), rather than Analysis of 
Variance (ANOVA) as originally and erroneously specified.   
4. Removed reference to using repeated measures ANOVAs for the exploratory aim that 
looks at the longer-term effects of the two active treatments relative to the education 
control, added the use of a Generalized Estimating Equations (GEE) approach.  
5. Removed reference to additional exploratory brain activity analyses using the LORETA 
method. 
6.  Added the use of PROCESS, a free downloadable add-on to SAS or SPSS to conduct 
the mediation and moderation analyses, as recommended by Hayes & Rockwood 
(2017).   
7. The analytic procedures for the supplementary study differ slightly from those to be used 
in the parent study. Aim 1 of the parent study uses an ANCOVA to look at between-
group changes in outcomes from pre to posttreatment. The power analyses for the 
parent study were based on estimated effects at posttreatment, not at the later follow-
ups. In contrast, the sleep study supplement Aim 1 proposes to look at differences in 
outcome both at posttreatment and at 3 months posttreatment follow-up, using a 
technique that accounts for repeated measures within subjects. We did not change the 
proposed analyses for the sleep study, but simply are explaining here why the analyses 
look slightly different between the main study and the supplement. We have added some 
minor clarifying remarks in the updated protocol also (shown in track changes). 
8. Updated study staff roster. 
9. Added Group Comfort Questionaire. 
 
 
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Version Number: 21 
Version Date: 02-19-20 
Summary of Revisions Made: 
 
1. Added language to serve as a reminder of why the exclusion criteria of >120mg MED 
was determined.  
 
 
Version Number: 22 
Version Date: 05-26-20 
Summary of Revisions Made: 
 
1. Added language stating that the crosswalk will be destroyed once the study is in data 
analysis and closed to enrollment and determined to do so by the study PIs. 
 
 
 
Version Number: 23 
Version Date: 06-30-20 
Summary of Revisions Made: 
 
1. Updated non-key study staff roster 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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STUDY TEAM ROSTER 
Name 
Role 
Address 
Phone/Fax 
Email 
Mark Jensen, 
Ph.D. 
Principal 
Investigator 
908 Jefferson 
Street, Seattle WA 
98104 
P:206-543-3185 
F:206-897-4881 
mjensen@uw.edu  
Rhonda 
Williams, 
Ph.D. 
Principal 
Investigator 
1600 Columbian 
Way, Seattle WA 
98108 
P: 206-277-6290 
F: 206-716-5978 
Rhonda.Williams1@va.gov  
Aaron Turner, 
Ph.D 
Co-
Investigator 
1600 Columbian 
Way, Seattle WA 
98108 
P: 206-764-2263  
F: 206-716-5978 
Aaron.Turner@va.gov  
Kevin Gertz, 
M.P.A. 
Research 
Manager 
908 Jefferson 
Street, Seattle WA 
98104 
P: 206-616-8630 
F:206-897-4881 
kjgertz@uw.edu  
Dawn Ehde, 
PhD  
Fidelity and 
Education 
supervision 
908 Jefferson 
Street, Seattle WA 
98104 
 P: 206-744-
2811 
 
ehde@uw.edu 
Alisha McCall, 
B.A. 
Research 
Assistant 
9600 Veterans 
Drive, Tacoma WA 
98493 
P:253-583-1891 
Alisha.mccall@va.gov  
Carrie Kincaid, 
B.A. 
Research 
Coordinator 
1600 Columbian 
Way, Seattle WA 
98108 
P:206-277-3959 
Carrie.Kincaid@va.gov 
 
Derek 
Anderson, 
Ph.D. 
Group 
Leader 
9600 Veterans 
Drive, Tacoma WA 
98493 
 
Derek.Anderson2@va.gov 
 
 
Jenny 
Bambara, 
Ph.D. 
Group 
Leader 
1600 Columbian 
Way, Seattle WA 
98108 
P:206-277-4264 
Jennifer.Bambara@va.gov 
 
Amanda 
Wood, PhD 
Data 
Analyst/writer 
1600 Columbian 
Way, Seattle WA 
98108 
 
Amanda.Wood@va.gov 
 
Pradeep Suri, 
MD,MS 
Data 
Analyst/writer 
1600 Columbian 
Way, Seattle WA 
98108 
 
Pradeep.Suri@va.gov 
 
Sarah Noonan 
Ph.D. 
Group 
Leader 
9600 Veterans 
Drive, Tacoma WA 
98493 
P:253-583-1843 
Sarah.Noonan@va.gov 
 
Genevra 
Vanhoozer 
B.A. 
Research 
Assistant 
1600 Columbian 
Way, Seattle WA 
98108 
P:206-277-1041 
genevra.vanhoozer@va.gov 
Kaitlin 
Harding, MS 
Group 
Leader/writer 
1600 Columbian 
Way, Seattle WA 
98108 
 
Kaitlin.Harding@va.gov 
 
Megan Miller 
PHD  
 
Group 
Leader/writer 
1600 Columbian 
Way, Seattle WA 
98108 
 
Megan.Miller@va.gov 
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Moriah Brier, 
MA 
Group 
Leader/Writer 
1600 Columbian 
Way, Seattle WA 
98108 
 
Moriah.Brier@va.gov 
 
Marcia Ciol, 
PhD 
Biostatistician 
908 Jefferson 
Street, Seattle WA 
98104 
 
marciac@uw.edu 
 
 
 
 
 
 
 
 
 
WSU SUB-STUDY TEAM ROSTER 
 
Name 
Role 
Address 
Phone/Fax 
Email 
Marian Wilson, 
Ph.D. 
Sub-Study 
Principal 
Investigator 
WSU Sleep and 
Performance 
Research Center 
PO Box 1495 
Spokane, WA 99210 
509-324-7443 
Marian.wilson@wsu.edu 
Hans van 
Dongen, Ph.D. 
Co-
investigator, 
data 
analysis 
WSU Sleep and 
Performance 
Research Center 
PO Box 1495 
Spokane, WA 99210 
 
hvd@wsu.edu 
Kimberly 
Honn, Ph.D. 
Co-
investigator, 
data 
analysis 
WSU Sleep and 
Performance 
Research Center 
PO Box 1495 
Spokane, WA 99210 
 
kimberly.honn@wsu.edu 
Devon Grant, 
Ph.D. 
Co-
investigator, 
data 
analysis 
WSU Sleep and 
Performance 
Research Center 
PO Box 1495 
Spokane, WA 99210 
 
devongrant@wsu.edu 
Julie Erwin 
Research 
assistant 
WSU Sleep and 
Performance 
Research Center 
PO Box 1495 
Spokane, WA 99210 
 
 
julie.erwin@wsu.edu 
Lillian Skeiky 
Research 
assistant 
WSU Sleep and 
Performance 
Research Center 
PO Box 1495 
Spokane, WA 99210 
 
lillian.skeiky@wsu.edu 
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PARTICIPATING STUDY SITES 
Name 
Role 
Address 
Phone/Fax 
Email 
Mark Jensen, 
Ph.D. 
Principal 
Investigator 
908 Jefferson 
Street, Seattle 
WA 98104 
P:206-543-3185 
F:206-543-3185 
mjensen@uw.edu 
Rhonda 
Williams, Ph.D. 
Principal 
Investigator 
1600 Columbian 
Way, Seattle 
WA 98108 
P:206-277-6290 
F: 206-716-5978 
Rhonda.Williams1@va.gov 
Rhonda 
Williams, Ph.D. 
Principal 
Investigator 
9600 Veterans 
Drive, Tacoma 
WA 98493 
206-277-6290 
F: 206-716-5978 
Rhonda.Williams1@va.gov 
Marian Wilson, 
Ph.D. 
Sub-Study 
Principal 
Investigator 
WSU Sleep and 
Performance 
Research 
Center 
PO Box 1495 
Spokane, WA 
99210 
 
509-324-7443 
Marian.wilson@wsu.edu 
 
*Please note: unless prefaced by the subheader “Main study” or “Sub-study”, 
each section pertains to both the main study and the sleep sub-study. 
 
 
 
 
 
 
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PRÉCIS  
 
Study Title: Chronic Pain Skills Study 
 
Objectives: Main Study 
 
The purpose of this randomized controlled trial is to evaluate the efficacy and mechanisms 
of self-hypnosis (HYP) and mindfulness meditation (MM) as treatments for chronic pain in a 
sample of 240 Veterans. Participants will be randomly assigned to 8 group sessions of (1) HYP, 
(2) MM, or (3) an education control condition (ED). Primary (characteristic pain intensity) and 
secondary outcomes will be assessed at pre-treatment, three times during treatment, post-
treatment, and at 3- and 6-month follow-up. Potential treatment moderators and mediators will 
also be assessed. The study will address two aims. 
 
Aim 1:  Determine the efficacy of 8 sessions of group delivered HYP and MM training for 
reducing characteristic pain intensity in Veterans, relative to 8 sessions of ED.  The 
hypothesis associated with Aim 1 is: 
 
Hypothesis 1: Primary Study Hypothesis.  Veterans receiving 8 sessions of HYP or MM training 
will report significantly greater pre- to post-treatment decreases in average pain intensity than 
Veterans receiving 8 sessions of ED. 
 
Aim 2:  Evaluate the moderation effects of brain states (as measured by EEG) on 
response to HYP and MM, relative to ED.  The hypothesis associated with Aim 2 is: 
 
Hypothesis 2: Brain State Moderating Hypothesis (Secondary).  Pain reduction with HYP and 
MM will be significantly associated with different patterns of baseline brain activity. Specifically, 
participants who report the most pain reduction with HYP will evidence higher levels of global 
theta activity and lower levels of left frontal gamma activity at baseline.  Participants who report 
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the most pain reduction with MM will evidence lower levels of alpha activity at baseline.  
Baseline brain activity will not be significantly associated with pain reduction following ED. 
 
 
Sub-Study Title: Sleep and Pain in Veterans Sub-Study 
 
Objectives: Sleep Sub-Study 
 
The purpose of the sub-study is to examine how sleep relates to chronic pain within the 
context of the randomized controlled trial with a sample of up to 135 180* 195** Veterans. 
Participants in the sub-study will wear an actigraph device and complete sleep/wake diaries to 
assess sleep quality and duration at pre-treatment, post-treatment, and at 3-month follow-up. 
The sub-study will address two aims. 
 
*Due to a higher attrition rate than anticipated, we have increased the enrollment number from 
135 to 180 to ensure the 117 completers needed. 
 
**Enrollment number increased to allow for the recruitment of a full cohort in the final cohort of 
the study.   
 
Aim 1:  Determine the efficacy of 8 sessions of group delivered HYP and MM training for 
improving sleep quality and duration in Veterans, relative to 8 sessions of ED.  The 
hypothesis associated with Aim 1 is: 
 
Hypothesis 1: Participants in the HYP and MM treatment groups will show improvements in self-
reported sleep quality and in actigraphic sleep duration both immediately post-treatment and at 
3-month follow-up, relative to the control group. 
 
Aim 2:  Evaluate the relationships between sleep quality, sleep duration and pain 
intensity.  The hypothesis associated with Aim 2 is: 
 
Hypothesis 2: Changes in sleep quality and duration precede (and thus predict) subsequent 
changes in pain intensity. Secondarily, we will investigate whether associations are moderated 
by treatment group. We hypothesize that larger lagged effects will occur for the two treatment 
conditions, relative to the control condition. 
 
Design and Outcomes   
 
Main Study: 
A randomized, 3-group parallel design, 240-subject clinical trial to test the efficacy and 
mechanisms of self-hypnosis (HYP) and mindfulness meditation (MM) on chronic pain in 
Veterans. 
 
Sub-Study: 
Sleep data collection (quality, duration) on up to 135 180 195 Veterans with chronic pain 
who are enrolled in the main study.  
 
Interventions and Duration  
 
Main Study: 
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Participants will be randomly assigned to 8 group sessions of (1) self-hypnosis (HYP), (2) 
mindfulness meditation (MM), or (3) an education control condition (ED). Treatment groups will 
meet once per week over an 8 week period. Each session will last for duration of about 90 
minutes. Primary (characteristic pain intensity) and secondary outcomes will be assessed at 
pre-treatment, three times during treatment, post-treatment, and at 3- and 6-month follow-up.  
The total time involved in the study is approximately 20-23 hours over a 9-month period. 
 
Once participants complete their involvement in the primary study (i.e., after they have 
received one of the treatments and completed their last follow-up assessment), they may be 
invited to attend either (or ultimately both, if they wish) of the other two group treatments. This is 
called the “open label” phase of the study.  
 
Participants who attend treatment for the first time in cohort 10 and all subsequent cohorts 
will not be offered the open label phase given study researchers intend to stop running 
treatment groups by the time these participants will complete the main phase of the 
study.  Instead, these participants will be offered the treatment materials for the treatment of 
their choice. The treatment materials (workbook and audio recordings) will be mailed via USPS. 
 
 
 
Participants who were randomized in cohorts 1-9 and are eligible to participate in the open 
label phase for cohorts 11 or 12 will be offered the option of either receiving treatment materials 
in the mail for the treatment of their choice or enrolling in the open label phase depending on 
space availability. 
 
Sub-Study: 
All participants enrolled in the sleep sub-study will be asked to wear a wrist actigraph 
(Actiwatch 2, Philips Respironics, Bend, OR) for up to 7 consecutive days, up to 24 hours/day to 
collect objective sleep data at 3 time points: before treatment begins, immediately following the 
end of treatment, and 3 months following the end of treatment. During each one-week 
assessment period they will also be asked to complete a brief questionnaire each morning and 
evening, and fill out a sleep log that includes estimates of time to bed, time to sleep, time awake 
and out of bed, sleep quality, and daytime napping. 
 
 
Sample Size and Population  
 
Main Study: 
We plan to enroll up to 343 355** Veterans with moderate to severe chronic pain to achieve 
a sample size of 240 completers, with 80 completers in each of the treatment groups. 
 
Enrolled participants who complete the required baseline components (cognitive 
assessment, hypnotic and relaxation exercise, baseline data and demographic form, and pre-
treatment assessment period) will be randomized in stratified blocks to ensure that participants 
with each sex/gender and pain type (neuropathic, non-neuropathic, mixed or undetermined) 
have an equal chance of being randomized to one of the 3 conditions. Stratifying in this manner 
will ensure the groups are balanced to reduce variation in outcome that is associated with each 
stratification variable. 
 
Sub-Study: 
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Recruitment will follow the protocol of the main study. We propose to recruit up to 135 180* 
195** of the 343 355** parent grant participants in order to ensure complete data from 117 
participants, assuming a 15% drop-out rate. Based on our experience, we anticipate that at 
least 75% of the parent sample will elect to join the sleep study. 
 
*Due to a higher attrition rate than anticipated, we have increased the enrollment number from 
135 to 180 to ensure the 117 completers needed. A 13% attrition rate was determined based on 
the main study. The actual attrition rate for the sleep study is 27%. 
 
 
** Enrollment number increased to allow for the recruitment of a full cohort in the final cohort of 
the study.  
 
 
 
 
 
 
 
 
 
A. SPECIFIC AIMS 
 
A1. Problem Statement  
Main Study: 
 
As many as 50% of male and 75% of female Veterans presenting to Primary Care report 
chronic pain 1-4, and reporting rates are even higher in specialty clinics.5-7 Among Veterans 
returning from Iraq and Afghanistan, 82% report chronic pain,8 and the prevalence of painful 
musculoskeletal, joint, and back problems tends to increase in the years following deployment.9 
Prevalent co-morbidities among Veterans, such as substance use disorders, sleep 
dysregulation, mood disorders, and Post Traumatic Stress Disorder (PTSD) can amplify the 
experience of pain and complicate treatment.10-12  In Veterans, the presence of co-morbid pain 
and anxiety is associated with increased service utilization,13 while co-morbid pain and 
substance use increases the risk of medication misuse.14 Pain is also associated with greater 
depression and anxiety,15 sleep dysregulation 12, 16, decreased quality of life,17 and lower self-
reported health.18  
 
The most common treatments for chronic pain are analgesics.19-21 However, chronic pain is 
multi-dimensional in nature and is therefore often refractory to these and other biomedical 
interventions.22 Moreover, the most powerful analgesics – opioids – are associated with adverse 
side effects including sedation, constipation, and respiratory depression.  
Opioids are potentially addictive, which can contribute to their misuse, addiction, and diversion 
(e.g., selling, hoarding or non-prescribed use).23 Further, opioid analgesics typically engender 
tolerance effects. In sum, there is a compelling need to identify additional effective treatments 
for Veterans with chronic pain, particularly ones that offer alternatives to pharmacologic agents. 
 
Sub-Study: 
U.S. Veterans commit suicide at a rate of 22 per day.24  Those receiving long-acting opioid 
and sedative co-prescriptions to manage pain and sleep are at much higher risk.25, 26 Chronic 
pain and insomnia independently rank high as risk factors for suicidal ideation and suicide 
attempts.27, 28 Greater understanding of how pain and sleep interact in chronic pain populations 
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is urgently needed in order to develop strategies to improve these distressing symptoms. 
Treating pain and sleep concurrently would seem to be a logical approach.29 However, specific 
recommendations have not yet been proposed or translated into clinical practice. When treated 
concomitantly, pain and sleep treatments often include prescribing both sleep and pain 
medications, which can have deadly synergistic results.  
The co-occurring pain-sleep problem has been called a “vicious cycle” and use of opioids, 
marijuana, alcohol, as well as illicit and prescribed drugs have been used in an attempt to find 
relief.30 
There is a compelling, urgent need to address poorly managed pain and sleep, particularly 
for Veterans, using safe and effective treatment approaches. 
 
 
A2. Specific Aims and Hypotheses 
 
Main Study: 
Several chronic pain self-management approaches have been developed that provide 
patients with a skill-set they can use – anywhere and anytime – to better manage pain and its 
effects on their lives.  Importantly, these treatments encourage individuals to play an active role 
in their healthcare, rather than remain a passive recipient of biomedical interventions.  
 
 
Two such skills-based self-management techniques that may contribute to better pain 
management and improvements in psychological functioning and sleep quality in Veterans are 
self-hypnosis (HYP) and mindfulness meditation (MM). Both HYP and MM are easily taught and 
learned, and therefore could be seamlessly incorporated into clinical practice in VA hospitals 
and clinics across the country.  However, at this point in time, little is known about the efficacy of 
HYP and MM interventions for chronic pain in Veteran populations, their effects on co-morbid 
conditions, and their biological and psychological mechanisms.  Such information is critical to 
the development of strategies to efficiently and cost-effectively maximize their efficacy and to 
ensure optimal implementation.   
 
The purpose of this randomized controlled trial is to test the efficacy and mechanisms of HYP 
and MM on chronic pain in 240 Veterans. Participants will be randomly assigned to 8 group 
sessions of (1) HYP, (2) MM, or (3) an education control condition (ED). Primary (characteristic 
pain intensity) and secondary outcomes will be assessed at pre-treatment, three times during 
treatment, post-treatment, and at 3- and 6-month follow-up. Potential treatment moderators and 
mediators will also be assessed.  
 
The study will address two aims. 
 
Aim 1:  Determine the efficacy of 8 sessions of group delivered HYP and MM training 
for reducing characteristic pain intensity in Veterans, relative to 8 sessions of ED.  The 
hypothesis associated with Aim 1 is: 
 
Hypothesis 1: Primary Study Hypothesis.  Veterans receiving 8 sessions of HYP or MM 
training will report significantly greater pre- to post-treatment decreases in average pain 
intensity than Veterans receiving 8 sessions of ED. 
 
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Aim 2:  Evaluate the moderation effects of brain states (as measured by EEG) on 
response to HYP and MM, relative to ED.  The hypothesis associated with Aim 2 is: 
 
Hypothesis 2: Brain State Moderating Hypothesis (Secondary).  Pain reduction with HYP and 
MM will be significantly associated with different patterns of baseline brain activity. Specifically, 
participants who report the most pain reduction with HYP will evidence higher levels of global 
theta activity and lower levels of left frontal gamma activity at baseline.  Participants who report 
the most pain reduction with MM will evidence lower levels of alpha activity at baseline.  
Baseline brain activity will not be significantly associated with pain reduction following ED. 
In addition to testing the above specific hypotheses, we will use the data obtained in this 
study to further explore (1) the effects of HYP and MM relative to each other and to the ED 
control condition on key co-morbid symptoms and conditions other than pain intensity; (2) the 
longer-term (up to 6 months) effects of HYP and MM, relative to ED; and (3) additional potential 
moderators (e.g., hypnotizability, treatment outcome expectancies, treatment motivation, 
demographic variables, pain type [neuropathic vs. nociceptive], cognitive functioning) and 
mediators (changes in EEG activity, pain acceptance, catastrophizing, mindfulness, therapeutic 
alliance, amount of skill practice between sessions) of treatment outcome. 
 
 
 
Sub-Study: 
 
A significant barrier to advancing science regarding pain and sleep is the lack of precise, 
objective sleep measurements.31, 32 Chronic pain studies reporting on sleep typically rely on self-
report,31 which limits confidence in sleep-related findings due to report and recall bias.33-36 The 
study will increase our understanding by adding wrist actigraphs – small, wrist-watch sized 
activity monitors worn on the wrist – to unobtrusively capture sleep/wake activity data in a trial of 
non-pharmacological pain interventions. Actigraphs are the technology standard for objective, 
naturalistic assessment of sleep.37 
 
Duration of sleep has been linked to improvements in pain reports38 while sleep restriction 
has been found to increase pain perception and decrease ability to disengage from pain.32 
Sleep deprivation reduces the pain threshold and alters levels of interleukins, suggesting an 
inflammatory response to sleep loss39 which potentiates pain.40 However, to what extent such 
potential mechanisms play a role in chronic pain, and whether or not sleep is a viable target for 
interventions to mitigate chronic pain, remains to be investigated. 
 
The purpose of the sub-study is to examine how sleep relates to chronic pain within the 
context of the randomized controlled trial with a sample of up to 135 180 195 Veterans. 
Participants in the sub-study will wear an actigraph device and complete sleep/wake diaries to 
assess sleep quality and duration at pre-treatment, post-treatment, and at 3-month follow-up. 
The sub-study will address two aims. 
 
Aim 1:  Determine the efficacy of 8 sessions of group delivered HYP and MM training for 
improving sleep quality and duration in Veterans, relative to 8 sessions of ED.  The 
hypothesis associated with Aim 1 is: 
 
Hypothesis 1: Participants in the HYP and MM treatment groups will show improvements in self-
reported sleep quality and in actigraphic sleep duration both immediately post-treatment and at 
3-month follow-up, relative to the control group. 
 
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Aim 2:  Evaluate the relationships between sleep quality, sleep duration and pain 
intensity.  The hypothesis associated with Aim 2 is: 
 
Hypothesis 2: Changes in sleep quality and duration precede (and thus predict) subsequent 
changes in pain intensity. Secondarily, we will investigate whether associations are moderated 
by treatment group. We hypothesize that larger lagged effects will occur for the two treatment 
conditions, relative to the control condition. 
 
 
B. BACKGROUND AND SIGNIFICANCE 
 
B1. Significance of Research 
Main Study: 
Results will determine if the preliminary evidence supporting the efficacy of HYP and MM in 
other populations generalizes to a heterogeneous sample of Veterans with chronic pain.  The 
study findings will provide critical information regarding the mechanisms of HYP and MM, 
including potential moderators and mediators of each.  If the primary study hypotheses are 
supported, the findings will provide the evidence needed to allow for greater access to 
treatments that would to reduce the pain and suffering in Veterans living with chronic pain.  
 
 
 
Sub-Study: 
We have a unique opportunity with this sub-study to leverage existing resources, collect high-
quality, objective sleep data using wrist actigraphy, and combine expertise in pain and sleep 
science to disentangle the relationship of pain and sleep symptoms. The knowledge gained can 
be used to develop and test novel solutions for pain treatment that provide safe, effective 
alternatives to pharmacologic agents, and ultimately, reduce suffering of Veterans and others 
living with chronic pain.  
 
 
B2. Relevance to VA Patient Care Mission 
 
We will administer the treatments in group sessions (which are more efficient than individual 
sessions) across multiple clinic settings at VAPSHCS using credentialed providers (e.g. 
psychologists and nurse practitioners) already working in those clinics. The interventions will be 
offered as part of normally available clinic services, and integrated into the administrative and 
clinical infrastructure of these clinics. If, as we anticipate, the efficacy of these interventions is 
supported, the system will already be in place in the VAPSHCS for the treatments to continue. 
Moreover, the interventions will be extremely easy to extend to other VA clinics.   
 
This strategy of designing the interventions in a way that provides for rapid dissemination and 
utilization in the event that the findings support the treatment(s) is another important innovation 
of the current study. 
 
C. PRELIMINARY STUDIES 
 
Our team has been conducting large, nationally funded randomized controlled trials (RCTs) 
on the efficacy of various treatments for chronic pain for over two decades, including clinical 
trials of hypnosis and meditation procedures, demonstrating that (1) we have the expertise to 
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conduct the study and (2) we have experience in recruiting and retaining the participants 
(including Veterans) needed for clinical trials. 
 
Self-Hypnosis training studies. We have successfully completed three RCTs  testing the 
efficacy of HYP training for reducing chronic daily pain in persons with MS,41 SCI,42 and low 
back pain (the latter study was in a sample of Veterans recruited from the Michael E. DeBakey 
VA Medical Center in Houston, Texas; Mark P. Jensen, Co-Investigator).   
 
These studies demonstrate (1) that the HYP procedures we have developed are effective in at 
least three populations of individuals with chronic pain and (2) we have experience in the 
design, conduct, and successful completion of RCTs of CAM interventions.  These studies also 
provide us with critical effect size information needed for the power analyses for testing the 
primary study hypothesis (i.e., differences between HYP and the education control condition) in 
the study. 
 
Mindfulness training studies. Recently we completed a pilot RCT investigating an adapted 
mindfulness-based cognitive therapy (MBCT) for pain protocol compared to a delayed treatment 
control (DT) for headache pain.  
 
 
 
 
Results demonstrated large benefits for pain intensity (d = .80)43 as well as for pain 
interference, pain acceptance, and catastrophizing (ds = 1.29, 1.22, and .94, respectively).   
Characteristics of treatment responders and non-responders in our pilot RCT on pain intensity 
were explored via mixed-methods analyses and showed a medium effect size difference (d 
=.64) in pain acceptance, suggesting that pain acceptance may be critical to the efficacy of MM 
for improving pain intensity.  Pain acceptance is one of the mediators we propose to examine in 
this study.  
 
Recruitment of Veterans into clinical trials. For the past 10 years, members of our 
research team have gained considerable experience recruiting Veterans from the VA Puget 
Sound Health Care System (VAPSHCS) into numerous studies, including RCTs.  We have in 
place proven recruitment and retention methodologies.  Collapsing across three recent studies, 
we were able to identify 355 eligible participants, enroll 203 (57% of those eligible) and retain 
179 (88% of those enrolled).  These studies are particularly pertinent to this study as they 
entailed similar participant burdens and recruitment challenges, and we recruited from the 
clinics proposed for inclusion in this study.  In sum, we have extensive experience in 
successfully enrolling Veterans from the clinical settings of this project.  Based on this 
experience, we estimate that over the 45 months of participant recruitment, we could potentially 
recruit up 650 (50% of those eligible) participants who meet the eligibility criteria for the current 
study, and retain as many as 572 (88%) of these in the trial.  These numbers far exceed those 
needed for the current study (i.e., 343355 recruited, 240 retained).  
 
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EEG and pain study. We have recently completed a NIH-funded R21 pilot study to examine 
the effects of a single session of four pain treatments and a sham (placebo) intervention on pain 
and EEG.  In this study, 30 individuals with SCI and chronic pain were given an EEG and 
measures of pain before and after a single session of HYP, a focused awareness meditation 
procedure, transcranial direct 
current stimulation (tDCS), 
neurofeedback to reinforce 
more alpha and less beta 
activity, and a sham tDCS 
control procedure.   
We found that (1) each of 
the active procedures 
influenced EEG activity in 
different ways, and that (2) 
EEG at baseline predicted 
treatment response. Our 
findings regarding baseline 
EEG as an outcome 
predictor are quite striking, 
especially those that predict 
pain reduction with HYP and 
meditation (see Figure 2).  
They indicate that HYP and 
meditation operate via 
different mechanisms (and 
that these differences can be 
assessed using spectral 
analysis of EEG data); that is, “different brains” respond to each treatment.  
 
If these findings are replicated in future studies, they would provide strong support that not 
only do HYP and MM operate via different mechanisms, but that individuals who do not respond 
to one could very well respond to the other; therefore both treatments should be offered.  
 
With respect to this latter finding, we found that patients who responded more to HYP had 
more theta activity overall and less left frontal gamma at baseline, while those who responded to 
meditation had less alpha at baseline (see Figure 2).  Interestingly, these differences are 
consistent with our hypotheses about the mechanisms of HYP and mediation.  That is, higher 
levels of theta are found in individuals who have more trait hypnotizability (tendency to respond 
to hypnotic suggestions in general).44  This brain oscillation is associated with higher levels of 
focused attention44-46 thought to be a critical aspect of hypnosis.47 Moreover, there is growing 
evidence that individuals with more trait hypnotizability also respond to hypnosis and hypnotic 
suggestions by inhibiting activity in frontal regions involved in executive functioning,48-50 
consistent with our finding of decreased left-frontal gamma (see Figure 2).  
 
With respect to the findings regarding pre-treatment alpha predicting response to meditation, 
we know that meditation increases alpha activity, so it is reasonable that those “lacking” in alpha 
activity would be those most likely to respond to meditation.  Continued examination of the 
impact of HYP and meditation techniques on brain states – and the ability of brain states at 
baseline to predict treatment response– represents an exciting and innovative area of study for 
the field.  Hence, we focus on this as our second study aim. 
Figure 1.  Associations between baseline EEG and response to 
treatment.  Red = moderate (> .30) positive association (more of 
this = more response);  Blue = moderate (< -.30) negative 
association (less of this = more response); bold lines = significant 
(p < .05) association.
 
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D. RESEARCH DESIGN AND METHODS 
 
D1. Synopsis 
Main Study: 
The sample will include up to 343 355 Veterans with chronic pain. Inclusion criteria include: 
(1) Veteran status (defined as prior service in the US Armed Forces and eligible to receive 
health care services through Veterans Health Affairs); (2) 18 years of age or older;  
(3) self-reported presence of chronic physical pain; (4) average pain intensity rating of ≥ 3 on a 
0-10 Numerical Rating Scale (NRS) of pain intensity in the last week; (5) worst pain intensity 
rating of ≥ 5 on a 0-10 Numerical Rating Scale (NRS) of pain intensity in the last week;  
(6) duration of chronic pain 3 months or more; (7) Experiences pain at least 75% of the time in 
the past 3 months; (8) able to read, speak, and understand English. Exclusion criteria include: 
(9) severe cognitive impairment defined as two or more errors on the Six-Item Screener;51  
(10) Current or history of diagnosis of primary psychotic or major thought disorder as listed in 
participant’s medical record or self-reported within the past five years; (11) Hospitalization for 
psychiatric reasons other than suicidal ideation, homicidal ideation, and/or PTSD self-reported 
or noted in chart (within the past 5 years); (12)  psychiatric or behavioral conditions in which 
symptoms were unstable or severe  as listed in participant’s medical record or self-reported 
within the past six months; (13) any behavioral issues as noted in the medical record that would 
indicate the participant may be inappropriate in a group setting;  
(14) presenting symptoms at time of screening that would interfere with participation, specifically 
active suicidal ideation with intent to harm oneself or active delusional or psychotic thinking; (15) 
Difficulties or limitations communicating over the telephone; (16) any planned life events that 
would interfere with participating in the key elements of the study; and (17) reported average 
daily use of >120mg morphine equivalent dose (MED).  
 
 
 
Study participants who complete all baseline assessments will then be randomly assigned to 
eight group sessions of one of three manualized treatments: (1) pain education  (ED), (2) self-
hypnosis training (HYP), or (3) mindfulness meditation training (MM).  Inclusion of the face-valid 
pain education  condition will allow us to control for many of the non-specific effects of HYP and 
MM treatments, including time, therapist attention, and treatment outcome expectancy.52, 53 
Moreover, this condition is expected to be beneficial in ways that are not reflected in our 
outcome measures (e.g., improved knowledge/understanding of chronic pain, improved 
communication skills). 
 
This RCT will examine the immediate post-treatment and long-term (3- and 6-months from 
end of treatment) efficacy and mechanisms of HYP and MM on average pain intensity (primary 
outcome), worst pain intensity, depression, anxiety, sleep disturbance, pain interference, 
medication use, post-traumatic stress, thoughts about pain, mindfulness and global satisfaction 
relative to the ED intervention designed to control for time, dose, attention, and other 
nonspecific therapeutic effects such as therapeutic alliance. Self-report data will be collected 
primarily via telephone excluding the cognitive assessment and hypnotic and relaxation 
exercise.  
 
This RCT will also examine whether pain reduction with HYP and MM will be significantly 
associated with different patterns of baseline brain activity. Brain activity data will be collected 
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via electroencephalogram (EEG) once before and once after treatment to test the second aim of 
this study. 
 
The study uses a 3-group parallel design. During their study participation, all participants will 
continue to receive their usual medical, psychiatric, and psychotherapeutic care.  Participants 
will also be offered to participate in one or both treatments they did not receive following end of 
participation in the main phase. 
 
Sub-Study: 
The sample for the sub-study will include up to 135 180 195 Veterans with chronic pain who 
are enrolled in an existing 3-arm RCT examining the efficacy and mechanisms of two active 
treatments (mindfulness meditation and self-hypnosis training), relative to a pain education 
control condition. At the time of recruitment into the parent study, all participants will receive 
information on the supplemental sleep study and be invited to join. If they agree, after 
consenting to the parent study, a research staff member (trained by Dr. Wilson, the lead on the 
supplemental study) will explain the sleep study and review the eligibility criteria and consent 
form specific to this study. Use of wrist actigraphy will be demonstrated and the additional sleep 
data collection will be explained. Once consented, participants who have agreed to participate 
will have additional self-reported sleep data collected along with the original RCT’s planned pre-
treatment assessments. As a condition of the parent grant, study participants will then be 
randomly assigned to eight group sessions of one of three standardized treatment conditions.    
 
All participants enrolled in the sleep study will be asked to wear a wrist actigraph (Actiwatch 
2, Philips Respironics, Bend, OR) for up to 7 consecutive days, up to 24 hours/day to collect 
objective sleep data at 3 time points, following study enrollment. During that one-week period 
they will also be asked to complete a brief questionnaire each morning and evening, and fill out 
a sleep log that includes estimates of time to bed, time to sleep, time awake and out of bed, 
sleep quality, and daytime napping. Participants will also call in to a voice mail system daily for 
up to 7 days to report their sleep and wake times.  
These data (sleep/wake diary, sleep calls) will help validate the actigraph objective sleep 
data, assure participant engagement with sleep data collection, and serve as additional 
covariate and mechanism variables to explain sleep findings more completely.   
 
These additional sleep data (self-reported sleep data via telephone, objective actigraph data,  
sleep/wake diary, sleep calls) will be collected at time points that align with significant data 
collection time points from the parent grant: immediately pre-treatment, treatment mid-point at 
week 4 (self-report data via telephone only), post-treatment at week 8 for assessment of post-
treatment effect, and again at month 3 for a long-term measurement.  
 
 
 
 
 
 
 
 
 
 
 
 
 
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Table 1. Study Design: Main Phase 
Step 
Data Collected 
How Often/When 
Cognitive 
Assessment 
Cognitive functioning  
Once following consent, 
before treatment begins 
Relaxation and 
Hypnotic 
Exercise 
Hypnotic responsivity 
Once following consent, 
before treatment begins 
Baseline Data 
and 
Demographic 
Form 
Demographic and general health information, pain type 
Once following consent, 
before treatment begins 
Pre-Treatment 
Telephone 
Assessments  
average pain intensity (primary outcome), worst pain 
intensity, depression, anxiety, sleep disturbance, pain 
interference, global health, medication use, post-traumatic 
stress, thoughts about pain, mindfulness, treatment 
motivation and expectancy, cognition 
Once following consent, 
before treatment begins 
Pre-Treatment 
EEG Brain 
Activity 
Delta, theta, alpha, beta, and gamma power 
 
Once following consent, 
before treatment begins 
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Table 2. Study Design: Open Label Phase (for participants enrolled in cohorts 1-9) 
Randomization 
No data collected 
Once following completion 
of all baseline study 
procedures 
Treatment 
Homework completed between sessions, pain and comfort 
levels pre- and post-session, participant engagement as per 
clinician 
Eight sessions avg. once 
per week 
During 
Treatment 
Assessments 
Average pain intensity (primary outcome), depression, 
anxiety, sleep disturbance, pain interference, global health, 
medication use, post-traumatic stress, thoughts about pain, 
mindfulness, group climate, therapeutic alliance,  
After sessions 2, 4 and 6 
Post-Treatment 
Telephone 
Assessment 
average pain intensity (primary outcome), depression, 
anxiety, sleep disturbance, pain interference, global health,  
medication use, post-traumatic stress, thoughts about pain, 
mindfulness, global satisfaction, therapeutic alliance, 
treatment satisfaction, treatment modality and feedback, 
cognition  
Once following end of 
treatment 
Post-Treatment 
EEG Activity 
Assessment 
Delta, theta, alpha, beta, and gamma power 
 
Once following end of 
treatment 
3 Month 
Telephone 
Assessments 
Average pain intensity (primary outcome), depression, 
anxiety, sleep disturbance, pain interference,  global health, 
medication use, post-traumatic stress, thoughts about pain, 
mindfulness and global satisfaction, cognition 
Three months following end 
of treatment 
6 Month 
Telephone 
Assessments 
Average pain intensity (primary outcome), depression, 
anxiety, sleep disturbance, pain interference,  global health, 
medication use, post-traumatic stress, thoughts about pain, 
mindfulness 
Six months following end of 
treatment 
Step 
Data Collected 
How Often/When 
Pre-Treatment 
Telephone 
Assessments  
Average pain intensity (primary outcome), depression, 
anxiety, sleep disturbance, pain interference, global health, 
post-traumatic stress, and medication use, cognition 
After completion of 6 month 
assessment of main phase, 
before treatment begins 
Treatment 
Intervention 
Selection 
No data collected 
Once following completion 
of pre-treatment 
assessments 
Treatment 
Homework completed between sessions, pain and comfort 
levels pre- and post-session, participant engagement as per 
clinician 
Eight sessions avg. once 
per week 
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Table 3. Study Design: Sleep Sub-Study 
Post-Treatment 
Telephone 
Assessment 
Average pain intensity (primary outcome), depression, 
anxiety, sleep disturbance, global health, pain interference, 
post-traumatic stress, medication use, global satisfaction, 
and treatment satisfaction, cognition 
Once following end of 
treatment 
Step 
Data Collected 
How Often/When 
Pre-Treatment 
Telephone 
Assessments  
Two questions about how much the subject agrees with 
certain statements about his/her sleep, as well as two 
questions about how confident the subject is about carrying 
our certain sleep behaviors 
Once following consent, 
before treatment begins 
Pre-Treatment 
Actigraph 
Device and 
Sleep/Wake 
Diary 
Sleep duration and quality (objective and self-report), 
wake/ sleep times (self-report),  how the subject felt that 
day, any problems s/he experienced such as illness or 
discomfort, and basic activities s/he participated in like 
going to work, napping, drinking caffeinated beverages, 
etc. (self-report) 
One-week period following 
consent, before treatment 
begins 
4 Week 
Telephone 
Assessments  
Two questions about how much the subject agrees with 
certain statements about his/her sleep, as well as two 
questions about how confident the subject is about carrying 
our certain sleep behaviors 
One-week period following  
treatment session #4 
Post-Treatment 
Telephone 
Assessment 
Two questions about how much the subject agrees with 
certain statements about his/her sleep, as well as two 
questions about how confident the subject is about carrying 
our certain sleep behaviors 
Once after the end of 
treatment 
Post-Treatment 
Actigraph 
Device and 
Sleep/Wake 
Diary 
Sleep duration and quality (objective and self-report), 
wake/ sleep times (self-report),  how the subject felt that 
day, any problems s/he experienced such as illness or 
discomfort, and basic activities s/he participated in like 
going to work, napping, drinking caffeinated beverages, 
etc. (self-report) 
One-week period following  
the end of treatment 
3 Month 
Telephone 
Assessment 
Two questions about how much the subject agrees with 
certain statements about his/her sleep, as well as two 
questions about how confident the subject is about 
carrying our certain sleep behaviors 
Once three months after 
the end of treatment 
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3 Month 
Actigraph 
Device and 
Sleep/Wake 
Diary 
Sleep duration and quality (objective and self-report), 
wake/ sleep times (self-report),  how the subject felt that 
day, any problems s/he experienced such as illness or 
discomfort, and basic activities s/he participated in like 
going to work, napping, drinking caffeinated beverages, 
etc. (self-report) 
One-week period  three 
months after the end of 
treatment 
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D2. Study Timeline 
Main Study: 
We designed a five-year study plan and timeline for achieving short-term study objectives. 
There will be 36 months available to enroll up to  355 participants, with 240 participants 
projected to complete all study elements. Please note that the researchers received funding for 
58 months instead of 60 months (i.e. five years), which is reflected in the timeline below. 
 
Months 01-09 in Year 01 will be spent hiring staff, obtaining IRB and sponsor approval, 
finalizing treatment manuals, and creating databases. Subject enrollment will require 3.17 years 
(Months 10 through 48). Data collection and cleaning will be ongoing and will continue through 
Months 10-56. Months 53-58 will be devoted to data analysis and dissemination activities. 
 
Sub-Study: 
Months 01-05 in Year 01 of the supplement will be spent training Seattle-based personnel, 
finalizing data collection procedures, and securing IRB agreements and approvals between 
sites. Participant enrollment and data collection will require 1.5 years (Month 06 in Year 01 to 
Month 12 in Year 02).  
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 Q1                 
09/01/14-11/30/14
 Q2                       
12/01/14-2/28/15
 Q3                 
03/01/15-05/31/15
 Q4                     
06/01/15-06/30/15
 Q1                 
07/01/15-09/30/15
 Q2                       
10/01/15-12/31/15
 Q3                 
01/01/16-3/31/16
 Q4                     
04/01/16-06/30/16
 Q1                 
07/01/16-09/30/16
 Q2                       
10/01/16-12/31/16
 Q3                 
01/01/17-3/31/17
 Q4                     
04/01/17-06/30/17
 Q1                 
07/01/17-09/30/17
 Q2                       
10/01/17-12/31/17
 Q3                 
01/01/18-3/31/18
 Q4                     
04/01/18-06/30/18
 Q1                 
07/01/18-09/30/18
 Q2                       
10/01/18-12/31/18
 Q3                 
01/01/19-3/31/19
 Q4                     
04/01/19-06/30/19
Start
End
Development  (Months 1-9)
Sep-14 May-15
Prepare recruitment, enrollment, randomization and retention procedures
Implement meetings with investigators and staff from all sites
Obtain Veterans Affairs Puget Sound Health Care System (VAPSHCS) IRB approval including 
submission of application
Obtain approval by NCCIH
Construct and test databases for measures, session data, and tracking 
Obtain University of Washington (UW) Institutional Review Board (IRB) approval including 
submission of application 
Preparation  (Months 1-9)
Sep-14 May-15
Hire research staff
Train research staff 
Register with clinicaltrials.gov 
Obtain Certificate of Confidentiality
Purchase supplies 
Create and organize filing system 
Open checking accounts, subject payments 
Order participant workbooks 
Accommodate Sponsor Site Visit
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 Q1                 
09/01/14-11/30/14
 Q2                       
12/01/14-2/28/15
 Q3                 
03/01/15-05/31/15
 Q4                     
06/01/15-06/30/15
 Q1                 
07/01/15-09/30/15
 Q2                       
10/01/15-12/31/15
 Q3                 
01/01/16-3/31/16
 Q4                     
04/01/16-06/30/16
 Q1                 
07/01/16-09/30/16
 Q2                       
10/01/16-12/31/16
 Q3                 
01/01/17-3/31/17
 Q4                     
04/01/17-06/30/17
 Q1                 
07/01/17-09/30/17
 Q2                       
10/01/17-12/31/17
 Q3                 
01/01/18-3/31/18
 Q4                     
04/01/18-06/30/18
 Q1                 
07/01/18-09/30/18
 Q2                       
10/01/18-12/31/18
 Q3                 
01/01/19-3/31/19
 Q4                     
04/01/19-06/30/19
Start
End
Participant Enrollment/ Data Acquisition (Months 10-56)
Jun-15 Apr-19
Enroll an average of approximately 8-9 participants per month (Months 10-48)
9
36
63
90
117
144
171
198
225
252
279
306
333
343
Assign participants to treatment intervention 
6
25
44
63
82
101
120
139
158
176
195
214
233
240
Conduct treatment with participants
6
25
44
63
82
101
120
139
158
176
195
214
233
240
Acquire pertinent data from enrolled participants
Provide ongoing supervision to research and clinical staff 
Conduct weekly meetings with research staff to address enrollment 
Operations and Maintenance  (Months 10-56)
Apr-15 Apr-19
Submit annual reports to Sponsor
Submit IRB continuing review reports (annually)
Maintain personnel training files
Monitor and supervise staff to ensure adherence to procedures 
Conduct regular meetings with clinical staff
Data and Safety Management  (Months 10-56)
Jun-15 Apr-19
Conduct data entry 
Conduct data checking/cleaning ongoing throughout
Review monthly progress reports (Co-PIs)
Review quarterly progress reports to (DSMC Chair and Co-PIs)
Review Data and Safety Management Annual Report (DSMC)
Publication/ Disseminaton (Months 9-58)
May-15 Jun-19
Attend annual scientific meetings to report on progress and findings
Prepare papers for publication (Months 53-58) 
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D3. Inter-Site Communication and Coordination 
Main Study: 
Routine communication and coordination between the investigators of the two study sites 
(UW and VAPSHCS) will occur primarily through via joint teleconferenced executive meetings. 
These meetings will be scheduled once every two weeks through month 7 in Year 1, and then 
on an as-needed basis during the publication/dissemination period. Research staff from both 
sites will also meet either in-person or via telephone with the research manager on a weekly 
basis to address recruitment and enrollment and general workload strategies. Additionally, the 
research manager will visit each site on a regular basis to monitor and review each site’s study 
activities.  
 
Sub-Study: 
Routine communication and coordination between the investigators of the three study sites 
(UW, VAPSHCS, and WSU) will occur primarily through via joint teleconferenced executive 
meetings on an as-needed basis throughout the sub-study. Research staff from all three sites 
will also meet via telephone on a regular basis to address recruitment and enrollment and 
general workload strategies.  
 
 
D4. Participant Recruitment and Feasibility 
 
Veterans will be recruited from several clinics and service lines at VAPSHCS: the 
Rehabilitation Care Service (which includes the Polytrauma Network Site for the northwest four 
states, the Multiple Sclerosis Clinic/Center of Excellence, Prosthetic/Limb Loss Clinic, and 
Musculoskeletal Clinic), and the Spinal Cord Injury Service. Each of these clinics sees 200-500 
new Veteran patients per year and carries an ongoing patient load of 200 – 400 patients. We 
will also recruit patients from Primary Care as needed, which carries an ongoing patient load of 
19,000 patients per year.  Last, Veterans may be referred to the study by clinicians in other 
service lines or from VA community-based outpatient clinics (CBOC) , but we will not actively 
recruit Veterans from other service lines. 
 
The recruitment sources described above will provide participants who are representative of 
the general Veteran population with a history of chronic pain, and enhance the generalizability 
of the study results. 
 
 
D5. Participants  
Main Study: 
We propose to enroll up to 343 355* participants in order to ensure complete data from 240 
randomized participants, assuming a very conservative 30% drop-out rate (the dropout rate in 
our other studies has averaged 12%).  We will monitor the dropout rate on an ongoing basis, 
and modify the number of participants recruited as needed to ensure a final sample of N = 240 
study completers. 
*Enrollment number increased to allow for the recruitment of a full cohort in the final cohort of 
the study.  
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A completer is someone who is enrolled, randomized and participated in at least one data 
assessment point following randomization. 
If someone is enrolled and not a completer, they would be defined as either 1.) Enrolled, not 
randomized or 2.) Enrolled, randomized, did not provide any data after randomization  
For Open Label: A completer is someone who is enrolled, selects treatment and participates in 
the post-treatment assessment point. 
If someone is enrolled and not a completer, they would be defined as either 1.) Enrolled, did not 
select treatment or 2.) Enrolled, selected treatment, did not participate in the post-treatment 
assessment. 
 
Sub-Study: 
We propose to enroll up to up to 135 180 195 participants in the sub-study to ensure complete 
data from 117 randomized participants, assuming a 25 - 30% drop-out rate. We will monitor the 
dropout rate on an ongoing basis, and modify the number of participants recruited as needed to 
ensure a final sample of N = 117 sub-study completers.  
A completer is someone who is enrolled, randomized and participated in at least one data 
assessment point following randomization. 
If someone is enrolled and not a completer, they would be defined as either 1.) Enrolled, not 
randomized or 2.) Enrolled, randomized, did not provide any data after randomization  
 
Eligibility Criteria 
 
Inclusion criteria:  
 
(1) Veteran status (defined as prior service in the US Armed Forces and eligible to receive 
health care services through Veterans Health Affairs);* 
(2) 18 years of age or older; * 
(3) Self-reported presence of chronic pain;**  
(4) Average pain intensity rating of ≥ 3 on a 0-10 Numerical Rating Scale (NRS) of pain 
intensity in the last week; ** 
(5) Worst pain intensity rating of ≥ 5 on a 0-10 Numerical Rating Scale (NRS) of pain intensity 
in the last week;** 
(6) Duration of chronic pain 3 months or more; ** 
(7) Experiences pain at least 75% of the time in the past 3 months; Those who have a hard 
time answering this question will be asked the following question:  “Which statement 
best describes your pain?” 
(a) Pain all the time, but the pain intensity varies; 
(b) Pain most of the time with only occasional periods of  being pain-free; 
(c) Pain that comes and goes; 
(d) Occasional pain; 
Participants must report experiencing pain that matches one of the first two options;** 
(8) Able to read, speak, and understand English.**  
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Exclusion criteria:  
 
(1) severe cognitive impairment defined as two or more errors on the Six-Item Screener;51 ** 
(2) Current or history of diagnosis of primary psychotic or major thought disorder as listed in 
participant’s medical record or self-reported within the past five years;* 
(3) Hospitalization for psychiatric reasons other than suicidal ideation, homicidal ideation, 
and/or PTSD self-reported or noted in chart (within the past 5 years);* 
(4) Psychiatric or behavioral conditions in which symptoms are unstable or severe as listed in 
participant’s medical record or self-reported within the past six months;*  
(5) Any behavioral issues as noted in the medical record that would indicate the participant 
may be inappropriate in a group setting; 
(6) Presenting symptoms at time of screening that would interfere with participation, 
specifically active suicidal ideation with intent to harm oneself or active delusional or 
psychotic thinking;** 
(7) Difficulties or limitations communicating over the telephone;** 
(8) Any planned life events that would interfere with participating in the key elements of the 
study.** 
 (9) Reported average daily use of >120mg morphine equivalent dose (MED). ** (see notes 
below regarding the >120mg cut off 
 
*also verified via medical record review in CPRS, as described below in section D6b. 
**verified solely via self-report, as described below in section D6b; there is no medical record 
review component. 
 
Veterans above 120 MED are typically better served by the Opioid Safety Program in which 
medication concerns are addressed first, typically through Pain Clinic taper, suboxone 
prescription, or even referral to the Addiction Treatment Center (ATC).  
 
Per the VA/DoD Opioid Safety CPG (2017): 
“The risk of prescription opioid overdose and overdose death exists even at low opioid dosage 
levels and increases as dosage increases. Significant risk (approximately 1.5 times) exists at a 
daily dosage range of 20 to <50 mg morphine equivalent daily dose (MEDD) and further 
increases (approximately 2.6 times) at a range of 50 to <100 mg MEDD compared to risk at <20 
mg MEDD. Risk continues to increase at higher dosage ranges (≥100 mg MEDD).” 
 
Clinical discretion may be exercised as needed regarding mental health exclusion criteria above 
to determine appropriateness in a group setting. 
 
We will not have an upper age cutoff for study participation because we have successfully 
treated individuals at all ages, including those over 80 years old.  Moreover, age is one of the 
potential moderator variables we propose to study, so we will be better able to evaluate age 
effects with greater age variability in the sample. 
 
 
D6. Procedures 
 
D6a. Recruitment 
 
Prospective participants will be identified via several mechanisms: 
 
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Chronic Pain Skills Program Consult 
 
Any clinical provider at VA Puget Sound or an affiliated  community-based outpatient clinic 
(CBOC) can refer a Veteran for participation. The consult will contain information about eligibility 
and research vs. non-research options.  
 
We will offer regular in-services and study information to providers who staff the 
clinics/service lines described above so they will be familiar with the study and clinic inclusion 
and exclusion criteria and basic intervention components. 
 
As part of this research study, researchers will develop a clinic (known as the ‘Chronic Pain 
Skills Program’) that offers the three types of group treatment to both research participants as 
well as non-research participants.  
 
A provider may refer to the Chronic Pain Skills Program any Veteran with chronic pain the 
provider believes would benefit from learning pain management skills. The provider would make 
the referral by selecting the program from a menu in CPRS as a consult. There will be 
instructions on the consult that remind the referring provider of the eligibility criteria.  
 
Research staff will monitor the incoming consults through automatic notifications. Staff will 
then review the medical records of each Veteran in CPRS. Research staff will contact ineligible 
patients to inform them of their ineligibility with the assistance of a script. Research staff will 
send a letter of orientation to all eligible Veterans who are referred to the program. The letter will 
be accompanied by a document explaining the difference between attending the program as a 
research participant versus a non-research participant.   
 
Research participants, in addition to the attendance of treatment sessions, would (1) 
participate in all of the study assessments including the brain activity assessments, (2) be 
compensated for completion of these assessments, and (3) be randomized to one of the three 
interventions following informed consent. Non-research participants would simply participate in 
the treatment intervention of their choice (i.e. would not be randomized), and would not receive 
any compensation beyond travel reimbursement the VA may offer.  
 
Veterans referred to the Chronic Pain Skills Program can contact research staff via 
telephone if interested in participating in the research. Research staff would also call Veterans 
in 1-2 weeks following the mailing if there is no response to make sure the Veteran received the 
letter. Research staff would use a script to inquire whether the Veteran is interested 1) in 
participating in the program at all, and 2) if yes, whether the Veterans would like to participate in 
the program as a research participant or non-research participant.  
 
Research staff would initiate the study screening process using the research recruitment 
script and screening case report form if the Veteran is interested in participating in the program 
as a research participant. Research staff would initiate the non-research screening process 
using the non-research screening checklist and recruitment script.   
 
The basic outcome of the screening for non-research participants will be stored 
electronically in aggregate form in de-identified form to help discern the feasibility of 
implementing this type of program in the future in VA medical centers. Research staff will inform 
eligible individuals of the three different group treatments if the Veteran wants to participate in 
the clinic as a non-research participant.  
 
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The research staff member would then convey both treatment group selection and preferred 
location (Seattle or American Lake Division) of this non-research participant either in person, via 
telephone or via PKI encrypted email to Dr. Williams.  Dr. Williams would then add the 
participant to the appropriate clinic list. 
  
Number of Contacts: Research staff would send one letter of orientation, leave up to three 
successive unanswered voicemails, and send a final letter indicating research staff will no 
longer be attempting to contact the participant unless notified otherwise before terminating 
attempts. 
 
Provider Referral 
 
a) Health care providers from the clinics/services listed above may also provide research staff 
members via CPRS or encrypted VA email the contact information of potential participants who 
expressed interest in participating in the research study following a discussion during a medical 
appointment.  Staff would then review the medical records of the Veterans in CPRS. Research 
staff would contact ineligible patients to inform them of their ineligibility with the assistance of a 
script. Research staff would use a script to contact eligible Veterans via telephone to help 
describe the study in more detail. Research staff would initiate the study screening process if a 
Veteran is interested in participating using the research recruitment script and screening case 
report form (self-report screening protocol described in detail below). 
 
Number of Contacts: Research staff would leave up to three successive unanswered 
voicemails and then send a final letter indicating research staff will no longer be attempting to 
contact the Veteran unless notified otherwise before terminating attempts. 
 
b) Providers can also refer Veterans to the study by providing the Veteran with a brochure and 
inviting them to follow-up independently. The Veteran would then contact research staff via 
telephone if interested in participating in the study.  
 
 
Number of Contacts: Following initial contact by Veteran, research staff would leave up to 
three successive unanswered voicemails and then send a letter indicating research staff will no 
longer be attempting to contact the Veteran unless notified otherwise before terminating 
attempts. 
 
c) In addition, CPRS records will be reviewed for Veterans with upcoming visits to certain clinics 
(e.g., various Rehabilitation Care Service clinics) where we expect a high rate of interest, 
relevance, and eligibility.  
Specifically, staff would review the medical records in CPRS of these Veterans as per medical 
record screening protocol to determine initial eligibility (see detailed description below).  
 
Research staff would contact a provider via encrypted email to inform them when a 
particular Veteran who appears to be eligible for the study based on the medical record 
screening protocol will be attending an upcoming appointment, and that staff would like the 
provider to mention the study to the Veteran. Ideally this would then result in scenario ‘a’ 
described above.  
 
d) Finally, research staff will contact on a regular basis clinical providers within the 
clinics/service lines described above to inquire whether any recent patients seen by the 
providers who were not referred to the study may be a good fit for the study.  The clinical 
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providers would then provide via encrypted email names of Veterans to research staff members 
who they deem might be a good fit.  Staff would review the medical records in CPRS of these 
Veterans as per medical record screening protocol to determine initial eligibility (see detailed 
description of medical record screening below). Research staff will send eligible Veterans an 
approach letter along with an information sheet about the study if s/he is deemed eligible. The 
Veteran would then contact research staff via telephone if interested in participating in the study. 
Research staff would call Veterans in 1-2 weeks following the mailing if there is no response to 
make sure the participant received the letter. Research staff would use a script to inquire 
whether the Veteran is interested in participating in the research study or not.  
Research staff would initiate the study self-report screening process if the Veteran is interested 
in participating using the research recruitment script and screening case report form (self-report 
screening protocol described in detail below). 
 
Number of Contacts: Research staff would send one approach letter, leave up to three 
successive unanswered voicemails, and then send a final letter indicating research staff will no 
longer be attempting to contact the Veteran unless notified otherwise before terminating 
attempts. 
 
 
Select Medical Record Review 
CPRS records will be reviewed for Veterans seen in several Rehabilitation Care Service 
(RCS), Spinal Cord Injury Service (SCI), and some primary care clinics up to three years prior to 
beginning recruitment. This strategy will be used to augment current provider and self-referrals, 
and will be done in reverse chronological order, month by month, until recruitment goals are 
met. Specifically, staff would review the medical records in CPRS of these Veterans as per 
medical record screening protocol to determine initial eligibility (see detailed description below). 
Research staff would send eligible Veterans an approach letter along with an information sheet 
about the study if s/he is deemed eligible. The Veteran would then contact research staff via 
telephone if interested in participating in the study.  
 
Research staff would call Veterans in 1-2 weeks following the mailing if there is no response to 
make sure the Veteran received the letter. Research staff would use a script to inquire whether 
the Veteran is interested in participating in the research study or not. Research staff would 
initiate the study self-report screening process if the Veteran is interested in participating using 
the research recruitment script and screening case report form (self-report screening protocol 
described in detail below). 
 
Number of Attempts: Research staff would send one approach letter, leave three successive 
unanswered voicemails, and then send a final letter indicating research staff will no longer be 
attempting to contact the Veteran unless notified otherwise before terminating attempts. 
 
Self-Referral 
 
Flyers and brochures describing the study will be available throughout both VAPSHCS 
divisions. Interested Veterans would then contact research staff via telephone. Research staff 
would initiate the study self-report screening process if the Veteran is interested in participating 
in the study using the research recruitment script and screening case report form (self-report 
screening protocol described in detail below).  
Staff would review the medical records in CPRS of Veterans deemed initially eligible as per 
medical record screening protocol to determine final eligibility (see detailed description of 
medical record screening below). Research staff would contact ineligible Veterans to inform 
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them of their ineligibility with the assistance of a script. Research staff would begin scheduling 
the informed consent process with eligible Veterans. 
 
Number of Contacts: Following initial contact by Veteran, research staff would leave up to  
three successive unanswered voicemails and then send a letter indicating research staff will no 
longer be attempting to contact the Veteran unless notified otherwise before terminating 
attempts. 
 
The recruitment approaches described above will provide participants who are representative of 
the general Veteran population with chronic pain, and enhance the generalizability of the study 
results. 
 
Please note that only research staff members will screen, consent or perform study procedures 
with potential participants. 
 
D6b. Screening Procedures: Research Study Participants 
 
The study screening procedures for research participants will consist of the following three 
steps: 
 
Component 1: Medical Record Screening 
Each potential participant’s medical records in CPRS will be reviewed to confirm the following 
inclusion criteria: 
 
• 
Veteran status (defined as prior service in the US Armed Forces and eligible to receive 
health care services through Veterans Health Affairs); 
• 
18 years of age or older.  
 
 
In addition, each potential participant’s medical records in CPRS will be reviewed to rule out the 
following exclusion criteria: 
 
• 
Current or history of diagnosis of primary psychotic or major thought disorder as listed in 
participant’s medical record or self-reported within the past five years; 
• 
Hospitalization for psychiatric reasons other than suicidal ideation, homicidal ideation, 
and/or PTSD self-reported or noted in chart (within the past 5 years); 
• 
Psychiatric or behavioral conditions in which symptoms were unstable or severe as 
listed in participant’s medical record or self-reported within the past six months; 
• 
Any behavioral issues as noted in the medical record that would indicate the subject may 
be inappropriate in a group setting; 
 
A staff member will record the findings of the medical record review using the screening 
case report form. 
 
The medical record screening may be reviewed either before or after the self-report 
screening component depending on recruitment source. 
 
Clinical discretion may be exercised as needed regarding mental health exclusion criteria above 
to determine appropriateness in a group setting. 
 
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Component 2: Self-Report Screening 
Research staff will ask potential participants a set of formalized IRB-approved questions to 
determine eligibility based on all of the study inclusion/exclusion criteria listed below with the 
assistance of the screening case report form. 
 
The self-report screening may take place either before or after the medical record review 
depending on recruitment source. Please note that several criteria will be confirmed twice by 
both initial steps (medical record and self-report screening). 
 
Self-reported inclusion criteria include the presence of chronic pain, operationalized as follows: 
 
• 
Self-reported presence of chronic pain;  
• 
Average pain intensity rating of ≥ 3 on a 0-10 Numerical Rating Scale (NRS) of pain 
intensity in the last week;  
• 
Worst pain intensity rating of ≥ 5 on a 0-10 Numerical Rating Scale (NRS) of pain 
intensity in the last week; 
• 
Duration of chronic pain 3 months or more;  
• 
Experiences pain at least 75% of the time in the past 3 months; Those who have a hard 
time answering this question will be asked the following question:  “Which statement 
best describes your pain?” 
a) Pain all the time  but the pain intensity varies; 
b) Pain most of the time with only occasional periods of  being pain-free; 
c) Pain that comes and goes; 
d) Occasional pain. 
 
Subjects must report experiencing pain that matches one of the first two options. 
 
 
An additional self-report inclusion criterion includes: 
 
• 
Able to read, speak, and understand English.  
 
Self-reported exclusion criteria also include presence of psychiatric disorders that would 
interfere with ability to participate, as operationalized below: 
• 
Current or history of diagnosis of primary psychotic or major thought disorder as self-
reported within the past five years; 
• 
Hospitalization for psychiatric reasons other than suicidal ideation, homicidal ideation, 
and/or PTSD self-reported (within the past 5 years); 
• 
Psychiatric or behavioral conditions in which symptoms were unstable or severe  as self-
reported within the past six months. 
 
Clinical discretion may be exercised as needed regarding mental health exclusion criteria above 
to determine appropriateness in a group setting. 
 
Additional self-report exclusion criteria include: 
• 
Difficulties or limitations communicating over the telephone; 
• 
Any planned life events that would interfere with participating in the key elements of the 
study. 
• 
Reported average daily use of >120mg morphine equivalent dose (MED).  
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A staff member will record the findings of the self-report screening using the screening case 
report form. 
 
 
 
Component 3: Psychological Screening Assessment 
 
Once a prospective participant has been screened and deemed eligible to participate in the 
research study based on the self-report screening and medical record review,  one of the 
study’s credentialed VA psychologists will conduct a review of the subject’s medical record or 
use firsthand clinical experience to discern whether a subject has experienced active suicidal 
ideation or delusional thoughts in the recent past, or if review of the chart provides sufficient 
information to make a clinically informed determination that risk is low or minimal. 
 
The credentialed psychologist will call the subject if s/he does not feel s/he can make a 
definitive judgment regarding eligibility based on the medical record review. The psychologist 
will ask the participant some questions to assess the presence of active suicidal ideation or 
paranoid thoughts using an assessment sheet. Individuals who do have these types of thoughts 
will not be eligible for the study. Individuals will be referred to a mental health professional if he 
or she needs immediate attention following the study’s suicide risk reduction protocol (described 
below).  
 
A staff member will record the findings of the psychological screening assessment using the 
screening case report form. 
 
Clinical discretion may be exercised as needed regarding this exclusion criterion. 
 
 
Ineligible Veterans 
Research staff will offer all ineligible Veterans a list of resources with information about 
treatment of pain (e.g. books, internet resources, etc.) and any relevant clinical resources 
available. This resource list will also be available to enrolled participants who inquire about 
additional resources. The resource list will be accompanied with a cover letter if sent via mail.  
 
In general, Veterans deemed ineligible for the study for reasons related to their 
appropriateness in group will also be ineligible for participation in the classes as a non-research 
participant.  
 
However, Veterans deemed ineligible based on pain inclusion criteria may be offered the 
opportunity to participate in the Chronic Pain Skills Program as a non-research participant, i.e. 
only attend the treatment portion of the program without any research procedures involved, if 
space is available. The screening procedures for non-research participants including eligibility 
criteria are listed below. 
 
Veterans who Decline 
Research staff will collect basic demographic information using the demographic information 
form from all participants who are deemed eligible to participate (following self-report and 
medical record screening) yet decline to participate.  These data will be collected to determine if 
there are significant differences between eligible participants who enroll and those who do not. 
 
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Veterans who decline but meet eligibility criteria will be offered the opportunity to participate 
in the Chronic Pain Skills Program as a non-research participant, i.e. only attend the treatment 
portion of the program without any research procedures involved, if space is available. The 
screening procedures for non-research participants including eligibility criteria are listed below. 
 
 
Re-Screening 
Research staff will re-screen participants (both via self-report and medical record review) 
with the use of a re-screening script on the following mutable inclusion criteria if 3 months or 
more have elapsed between the initial screening and consent process: 
 
(1) Self-reported presence of chronic pain;  
(2) Average pain intensity rating of ≥ 3 on a 0-10 Numerical Rating Scale (NRS) of pain 
intensity in the last week;  
(3) Worst pain intensity rating of ≥ 5 on a 0-10 Numerical Rating Scale (NRS) of pain 
intensity in the last week; 
(4) Duration of chronic pain 3 months or more;  
(5) Experiences pain at least 75% of the time in the past 3 months; those who have a hard 
time answering this question will be asked the following question:  “Which statement 
best describes your pain?” 
 
(a) Pain all the time  but the pain intensity varies; 
(b) Pain most of the time with only occasional periods of  being pain-free; 
(c) Pain that comes and goes; 
(d) Occasional pain. 
 
Participants must report experiencing pain that matches one of the first two options; 
 
 
In addition, research staff will re-screen participants on the following mutable exclusion 
criteria if 3 months or more have elapsed between the initial screening and consent process: 
 
(1) Current or history of diagnosis of primary psychotic or major thought disorder as listed in 
participant’s medical record or self-reported within the past five years; 
(2) Hospitalization for psychiatric reasons other than suicidal ideation, homicidal ideation, 
and/or PTSD self-reported or noted in chart (within the past 5 years); 
(3) Psychiatric or behavioral conditions in which symptoms were unstable or severe (within 
the past six months; 
(4) Any behavioral issues as noted in the medical record that would indicate the subject may 
be inappropriate in a group setting; 
 (5) Reported average daily use of >120mg morphine equivalent dose (MED).  
 
A staff member will record the findings of the re- screening using the re-screening case 
report form. 
 
Clinical discretion may be exercised as needed regarding mental health exclusion criteria above 
to determine appropriateness in a group setting. 
 
Screening procedures for this study will not require a physical examination or laboratory 
procedures.  
 
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The recruitment outcome for each participant will be captured using a recruitment outcome 
case report form.  The data collected via this case report form will be entered into a Microsoft 
Access database to help ensure accurate reporting of recruitment and enrollment efforts in 
future publications. 
 
All participants who meet eligibility criteria following all three components of the screening 
procedures will then undergo the informed consent process if they wish to participate. 
Prospective participants will be sent directions on how to get to the VAPSHCS campuses 
(Seattle and American Lake) or the Integrated Brain Imaging Center (IBIC) at the University of 
Washington (UW) prior to the consent process. The directions will be accompanied by a cover 
letter and the study consent form. 
 
The self-report screening and psychological assessment screening components may take place 
up to eight weeks prior to the start of the treatment groups for that particular cohort.  
 
 
D6c. Screening Procedures: Non-Research Participants 
All participants that either (1) decide to participate in the Chronic Pain Skills Program as a non-
research participant or (2) are deemed ineligible to participate as a research participant based 
on pain inclusion criteria but would like to participate in the Program as a non-research 
participant will be screened by research staff to deem appropriateness for participating in the 
program as a non-research participant. Research staff would initiate the non-research screening 
process using the non-research screening script and case report form.   
 
Inclusion Criteria (to be assessed via medical record and/or self-report screening components) 
for participation as a non-research participant include:  
(1) Veteran status (defined as prior service in the US Armed Forces and eligible to receive 
health care services through Veterans Health Affairs); 
(2) 18 years of age or older;  
(3) Able to read, speak, and understand English. 
(4) Self-reported presence of chronic pain; 
(5) Duration of chronic pain 3 months or more;  
(6) Chronic pain deemed bothersome by participant. 
 
Exclusion Criteria (to be assessed via medical record and/or self-report screening components):  
(1) severe cognitive impairment defined as two or more errors on the Six-Item Screener;51  
(2) Current or history of diagnosis of primary psychotic or major thought disorder as listed in 
participant’s medical record or self-reported within the past five years; 
(3) Hospitalization for psychiatric reasons other than suicidal ideation, homicidal ideation, 
and/or PTSD self-reported or noted in chart (within the past 5 years); 
(4) Psychiatric or behavioral conditions in which symptoms were unstable or severe  as listed 
in participant’s medical record or self-reported within the past six months; 
(5) Any behavioral issues as noted in the medical record that would indicate the subject may 
be inappropriate in a group setting; 
 
Clinical discretion may be exercised as needed regarding mental health exclusion criteria above 
to determine appropriateness in a group setting. 
 
The following inclusion criteria for research eligibility are not required for participation in the 
classes: 
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(1) average pain intensity rating of ≥ 3 on a 0-10 Numerical Rating Scale (NRS) of pain 
intensity in the last week;  
(2) worst pain intensity rating of ≥ 5 on a 0-10 Numerical Rating Scale (NRS) of pain intensity 
in the last week; 
(3) duration of chronic pain 3 months or more;    
 
  (4) Experiences pain at least 75% of the time in the past 3 months; Those who have a hard 
time answering this question will be asked the following question:  “Which statement best 
describes your pain?” 
(a) Pain all the time but the pain intensity varies; 
(b) Pain most of the time with only occasional periods of being pain-free; 
(c) Pain that comes and goes; 
(d) Occasional pain; 
 
Veterans with evidence of a potential mental health condition or those who have never been 
seen in Mental Health will need to participate in the same telephone psychological screening 
assessment described above.  Specifically, research staff will arrange a time and date for the 
Veteran to participate in a telephone psychological screening assessment with a credentialed 
psychologist affiliated with the Chronic Pain Skills Program. The psychologist will ask the 
Veteran some questions to assess the presence of active suicidal ideation or paranoid thoughts 
using an assessment sheet. Individuals who do have these types of thoughts will be deemed 
inappropriate to participate in the program. Individuals will be referred to a mental health 
professional if he or she needs immediate attention following the study’s suicide risk reduction 
protocol.  
 
The basic outcome of the screening for non-research participants will be captured using the 
non-research participant recruitment outcome case report form and stored electronically in de-
identified form to help discern the feasibility of implementing this type of program in the future in 
VA medical centers. Research staff will then describe each treatment group to non-research 
participants using a formalized script. 
 
The research staff member would then convey both treatment group selection and preferred 
location (Seattle or American Lake Division) of this non-research participant either in person, via 
telephone or via PKI encrypted email to Drs. Williams.  Drs. Williams would then add the 
participant to the appropriate clinic list. 
 
Non-research participants are limited to participating in each treatment intervention only once.  
Participation is defined as attending four or more treatment sessions for that particular 
intervention. Non-research participants may attend each treatment intervention more than once 
if they in fact attend three or fewer sessions.   
 
Non-research participants who attend treatment in cohort 12 will not be offered the option of 
participating in another treatment intervention given study researchers intend to stop running 
treatment groups after this cohort.  
 
 
D6d. Consent Process  
 
Research staff will participate in and obtain informed consent from research participants 
after screening but prior to commencement of any further study procedures. The informed 
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consent process may take place at one of the following locations: (1) the VAPSHCS Seattle 
Campus; (2) VAPSHCS American Lake Campus or (3) IBIC at the UW.   
The consent process will occur at a time deemed mutually feasible for the Veteran and staff 
member and coordinated on a case-by-case basis.  The consent process will take place in a 
private location (e.g., a medical exam room or private conference room).  
 
A research staff member will review each section of the informed consent form (ICF) 
approved by all regulatory institutions, inviting discussion to ensure comprehension.  
Staff will be trained by study investigators to ensure competency to discuss informed 
consent and strategies to ensure there is no coercion.  
 
Participants will be provided with as much time as needed to review the ICF and ask the 
research staff member questions about the ICF, their rights as human participants, and 
participation in the study. Potential participants will be fully informed of all risks and benefits 
prior to giving their written informed consent and prior to enrollment in the study.  
 
If during the course of this contact the potential participant has questions that cannot be 
addressed by research staff, one of the study investigators or the research manager (depending 
on the nature of the questions) will follow up with the potential participant to answer the 
questions. Participants may take time to think about participating and render a decision in a 
subsequent visit.  
 
Potential participants will be asked to repeat back understanding of this material as 
necessary. Individuals will not be permitted to participate if there is any question as to whether a 
person is able to provide informed consent. 
 
The participant will then be asked to sign and date the ICF. Research staff will also date and 
sign the ICF. All participants will be offered a copy of the signed ICF for their records. A 
scanned copy of the consent form and an enrollment note template will be sent to the 
VAPSHCS Research Compliance Officer (RCO) as per VAPSHCS guidelines. In addition, a 
note of enrollment will be made in CPRS. 
 
Research staff will also review a HIPAA authorization form with the participant that permits 
research staff to review in CPRS encounters of providers running the treatment groups to 
confirm attendance of said groups and extract data collected during treatment. 
 
Finally, research staff will review with the participant a consent form for the data repository 
entitled “Rehabilitation Collaborative Repository”.  By enrolling in this repository, the participant 
gives the researchers permission to retain their de-identified study (both main and open label 
phases) data indefinitely, combine data from this project with data from other projects, and 
conduct analyses/address scientific questions not described in this protocol. The participant will 
sign the separate repository consent form if they wish to participate in the repository. 
Participants may refuse to participate in the repository and still participate in the research study. 
 
Research staff will file original copies of both the consent and HIPAA forms in Dr. Williams’ 
office, separate from data collected during screening and subsequent data collected during 
participation in the study. 
 
Research staff will provide participants with staff business cards after the consent process. 
Participants will also be provided a response key to help answer questions asked during the 
telephone assessment periods.  
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Research staff will complete an enrollment case report form as well as documenting the 
consent process form for each enrolled subject that will be filed with study data. 
 
 
D6e. Cognitive Assessment 
 
Research staff will administer a battery of five neuropsychological measures assessing 
memory, information processing, and executive functioning.  These measures, henceforth 
described as the cognitive assessment, take approximately 20-30 minutes to complete.  
 
The cognitive assessment may be completed immediately following the consent process or 
at a later, mutually agreed upon time in person. Participants will be compensated $10 for 
completion of the cognitive assessment via a check written from the Seattle Institute for 
Biomedical and Clinical Research (SIBCR), the nonprofit institute that works with the VA to 
conduct research. 
 
 
D6f. Hypnotic and Relaxation Exercise  
 
A research staff member will administer in person the Modified Stanford Hypnotic Clinical 
Scale (SHCS) to assess hypnotizability for all participants following enrollment but prior to the 
start of treatment.  Research staff will read a brief introduction about the hypnosis scale before it 
is administered, as well as provide participants with a brochure about hypnosis published by the 
APA if the participant has reservations or additional questions about hypnosis. This measure 
takes approximately 15-20 minutes to complete. 
 
Participants will be compensated $5 for completion of the hypnotic and relaxation exercise 
via a check written from the Seattle Institute for Biomedical and Clinical Research (SIBCR), the 
nonprofit institute that works with the VA to conduct research. 
 
 
D6g. Baseline Data and Demographic Form 
 
A research staff member will then ask the participant to provide demographic data (age, 
sex/gender, marital status, income, education level, employment status) and deployment history 
(number and month of deployments, whether deployment involved hostile duty) for descriptive 
purposes.  We will also ask participants their history of HYP, MM and ED treatment and 
practice, and the presence of history of military sexual trauma (using the 2-item clinical reminder 
screen by VHA) as trauma history has been associated with different pain experiences. 
 
The baseline data and demographic form will take approximately 20-30 minutes to 
complete, and may be completed following enrollment either in person or over the telephone at 
a later time if more convenient for the participant. Participants will be compensated $10 for 
completion of the baseline data and demographic form via a check written from the Seattle 
Institute for Biomedical and Clinical Research (SIBCR), the nonprofit institute that works with the 
VA to conduct research. 
 
The informed consent process, including collection of data during the initial intake as outlined in 
our protocol, may take place up to six weeks prior to the start of the treatment groups for that 
particular cohort. 
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D6h. Personal Contact Information 
 
Research staff will collect the following information from participants: (1) contact information; 
(2) preferred telephone number to reach an individual if they have more than one line; (3) 
permission to leave message on mobile/landline phones; (4) permission to send a text message 
and, if yes, cell phone carrier; (5) best times/days to reach participant; and (6) names and 
contact information of people staff are allowed to contact if participant is lost to follow-up or 
otherwise cannot be contacted (i.e. collateral contacts). The purpose of this is to maximize the 
likelihood of reaching a participant to complete the study procedures. Furthermore, asking 
permission to leave a voicemail on at a specified contact number ensures a greater level of 
privacy for the participant.  
 
The information may be completed following enrollment either in person or over the 
telephone at a later time if more convenient for the participant. 
 
 
D6i. Preparation for Brain Wave Activity (Electroencephalogram or EEG) Assessment 
 
Research staff may ensure that the EEG net (device worn on the head that  holds the EEG 
electrodes) will fit a participant’s head prior to the EEG assessment.  Research staff will cut a 
piece of string that is about 70 cm long, make two marks 62 cm apart, leaving a little on either 
end to hold on to. Research staff will wrap the string around participants’ head in a circular loop 
that includes the following landmarks: 1) the point between the eyebrows above the nose (the 
glabella); 2) the point farthest back on the back of the head (the occipital protuberance); and 3) 
the sides of the head even with the tops of the ears. If the head circumference is greater than 62 
cm, the staff member will inform the participant that the EEG equipment would not 
accommodate them and therefore they would not be able to participate in this study procedure.  
 
Time permitting, research staff will send a letter to each participant that provides simple 
instructions to ensure quality data is collected from the participant during the assessment, e.g. 
requesting the participant clean his/her hair the day of the assessment, not wear jewelry, refrain 
from as needed medications, etc. 
In addition, the letter will instruct the participant to write down the name and dosage of 
medications they may use within 24 hours of the EEG assessment on an enclosed worksheet, 
and bring the completed worksheet to the appointment to serve as reference.  The participant 
will be instructed not to write any identifying information on the worksheet.  In addition, the 
participant will keep the worksheet after the appointment; research staff will not collect the 
worksheet. 
 
Research staff will call the participant to remind him/her of the electroencephalogram or 
EEG assessment appointment, as well as provide simple instructions for the participant to 
ensure quality data is collected from the participant during the assessment, e.g. requesting the 
participant clean his/her hair the day of the assessment, not wear jewelry, refrain from as 
needed medications, etc. During this call research staff will use a script designed for this 
purpose. 
 
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Research staff will also call female participants the morning the EEG assessment is scheduled 
to determine if they are experiencing their menses or not. Research staff will use a telephone 
script designed for this purpose during the call.  The EEG assessment will be re-scheduled if 
that is the case. 
 
 
D6j. Brain Wave Activity (or EEG) Assessment 
 
Brain wave activity will be assessed following enrollment by conducting a brain wave activity 
or EEG assessment. The brain wave activity assessment will take place at the Integrated Brain 
Imaging Center (IBIC) at the University of Washington main campus.   
The IBIC is a research-dedicated technology center organized under the department of 
Radiology.  EEG will be sampled with an electrode array using an electrode net dipped in a 
saline solution.   
 
The research staff member, a UW IBIC employee with a Without Compensation (WOC) 
appointment at the VA, will obtain consent at the IBIC using the UW EEG consent document. 
They would then collect the EEG activity data, and ask the participant to remain as still as 
possible during portions of the assessment.  The EEG technician will collect from the participant 
data regarding medication used within 24 hours of assessment. S/he will also ask the participant 
to rate the intensity of his or her pain just before the assessment (current pain), after a few 
minutes of the assessment (current pain and worst, least, and average pain over the past few 
minutes), and at the end of the EEG session (current pain, and worst, least, and average pain 
over the past few minutes), using 0-10 Numerical Rating Scales.  Finally, the technician will ask 
the participant to think about their chronic pain in general or a particularly painful event for a 
period of two minutes. The technician will then ask the participant to rate his/her pain intensity, 
as well as answer some questions about how s/he thought about his/her pain during the two-
minute period. The EEG technician then will ask each participant whether they experienced any 
negative effects they associate with study procedures to make certain all adverse events related 
to the study are recorded.  
 
The entire brain wave activity assessment will take approximately 45-60 minutes to 
complete.  Participants will be compensated $100 for completion of the brain wave activity 
assessment via a check written from the Seattle Institute for Biomedical and Clinical Research 
(SIBCR). The check will be sent via USPS mail and accompanied by a payment cover letter. 
 
The brain wave activity assessment must be administered at IBIC, and only after completion 
of the informed consent process. All other assessment activities may be administered at IBIC or 
a VA site. So, participants have some options around where they do their baseline assessments 
and in what combination.  
 
Subjects will be asked to complete the same brain activity assessment following completion 
of treatment following the same procedures above.  
 
The one difference will be, during the post-treatment assessment, participants will complete 
an additional 10-minute assessment portion in which they think about the skills they learned 
during the treatment sessions.  
 
Participants will report the skills s/he used during this assessment portion, as well as general 
experience during this portion. Participants will be compensated $100 for completion of the 
brain wave activity assessment via a check written from the Seattle Institute for Biomedical and 
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Clinical Research (SIBCR). The check will be sent via USPS mail and accompanied by a 
payment cover letter. 
 
Participants may still participate in the study if they decline to participate in the EEG 
assessments. The EEG assessment is optional. 
 
 
D6k. Assessment: Pre-Treatment and General Overview 
 
Subjective reports of pain intensity vary over time, and to most accurately measure pain 
intensity (our primary outcome), it is most valid to assess multiple times and take an average. 
Hence, we have developed a method of assessment that will seek to obtain up to four telephone 
assessments over a period of one week or 7 days. In addition, research staff will seek to 
administer these assessments ideally with a minimum of 24 hours between each assessment. 
Given scheduling confilicts, research staff may collect each assessment no less than 22 hours 
between each assessment if necessary. 
  
During each telephone contact, research staff will ask participants, at minimum, to rate their 
current, average, worst and least pain intensity over the past 24 hours, as well as their average 
pain intensity over the past week. 
 
 In addition, if possible, research staff will ask the participant to rate their current, average, 
worst and least pain intensity over the past week during the final telephone contact. These 
assessments will be referred to as “short assessments.” The primary outcome will be an 
average of all of the 24-hour ratings (range=1-4 ratings) of average pain intensity obtained over 
a period of one week during each assessment period. 
 
In addition, sometime during this assessment period researchers will ask questions 
regarding pain interference, depression, anxiety, sleep disturbance, post-traumatic stress 
disorder (PTSD) symptoms, medication use, medical services utilization, thoughts about pain 
and treatment motivation. This latter set of questions will only be asked once during the 
assessment period, and will be referred to as “the long assessment.”  
 
Research staff will give participants the option to: 1) complete the long assessment during 
one of the four short telephone assessments described above; or 2) spread the long 
assessment across several days during the assessment period.  
The entire long assessment or portions thereof may fall up to two days outside the 7-day period 
for the four short assessments. The entire time required to answer questions during the 
assessment period is 45-60 minutes. 
 
Research staff may complete additional short assessments per assessment period with the 
participant if research staff is unable to complete up to four assessments within a span of one 
week. For example if a participant completes short assessment #1 on 11/1, Short assessment 
#2 on 11/6, short assessment #3 and long assessment on 11/08, and short assessment #4 on 
11/10, research staff would attempt to complete one more short assessment by 11/13 and 
discard the data from short assessment #1 so that all short assessments are completed in a 
period of seven days (11/6-11/13). Participants will not be compensated additionally for 
completing these assessments.  Participants may refuse to complete additional assessments 
and will remain in the study regardless. 
 
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In addition, the entire assessment period (up to 4 short assessments and the long 
assessment within a period of one week) may be repeated if the treatment groups the 
participant has been assigned to does not start within four weeks of completing the original pre-
treatment assessment period. Participants will be compensated for completing this additional 
assessment period. 
 
The assessment period described above will be completed prior to initiating treatment, and 
then after completion of treatment sessions #2, 4 and 6 and 8 (i.e. post-treatment), and 3 and 6 
months following the end of treatment for a total of seven times. These assessment periods that 
occur following the start of treatment will also include questions about group climate, therapeutic 
alliance with the group clinician, treatment satisfaction, feedback about the treatment modality, 
and overall improvement since the participant began the pain program. The open-ended 
questions regarding treatment satisfaction and feedback on treatment modality will be collected 
by an unblinded staff member. Group Comfort Questions will be administered by an unblinded 
staff member at any time after session 8 (final group session). This assessment is optional.  The 
window is from post-treatment until the participant is disenrolled.  
 
Staff will send via USPS mail a reminder letter prior to the 3- and 6-month assessment periods.  
 
As mentioned above, during the consent process research staff will provide participants with 
a response key to help answer questions asked during the telephone assessment periods.  
Participants may request research staff send another response key to them if they lose the key 
during study participation. Research staff will send the response key along with a cover letter via 
USPS mail.   
 
Participants will be compensated $25 for the completion of each assessment period via a 
check written from the Seattle Institute for Biomedical and Clinical Research (SIBCR). The 
check will be sent via USPS mail and accompanied by a payment cover letter. 
 
The pre-treatment assessment period may take place up to four weeks prior to the start of the 
treatment groups for that particular cohort. 
 
 
D6l. Randomization 
 
Enrolled participants who complete the required baseline components (cognitive 
assessment, hypnotic and relaxation exercise, baseline data form, and pre-treatment 
assessment period) will be randomized in stratified blocks to ensure that participants with each 
sex/gender and pain type (neuropathic, non-neuropathic, mixed or undetermined) have an equal 
chance of being randomized to one of the 3 conditions. Stratification will assure that the 
treatment groups are balanced regarding each stratification variable, so that the estimated effect 
of the treatment is not biased due to differences in distribution of sex/gender or type of pain.  
 
Assignment to one of the 3 groups will be accomplished with a Microsoft Excel spreadsheet 
with random numbers created by the research manager with the guidance of the biostatistician. 
Only a research staff member who does not have access to study data during subject 
enrollment will conduct the randomization procedures. This randomization assignment will be 
entered into a password-protected database located on a VA secure drive. Research staff will 
complete a randomization case report form for each randomized subject that will be filed with 
study data. 
  
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The staff randomizing subjects will convey assignment to Dr. Williams via email with only a 
code number used i.e. no identifying information to identify the participant. Dr. Williams will then 
update the master list of participants, both research and non-research, of the clinic portion of the 
program.   
 
Subjects will be sent a letter that outlines the schedule of treatment sessions they will 
attend. 
 
Research staff will re-screen participants on approved mutable eligibility criteria (e.g. pain 
intensity, frequency, etc.) if 6 months or more has elapsed between the consent process and 
randomization. 
 
Randomization may take place up to four weeks prior to the start of the treatment groups for 
that particular cohort. 
 
D6m. Treatment Scheduling: Research and Non-Research Participants 
 
Cohorts of study treatment groups will be offered beginning every four months.  In each 4-
month period, there will be two class options for each condition, one based in Seattle and one at 
American Lake. Thus, there will be six classes offered per four month period, or a total of 18 
classes per year.  
 
Trained instructors will commit to offering three groups per year: one of each treatment type. 
This will reduce the potential for therapist bias in on the outcomes. Up to 15 participants can be 
enrolled in each group treatment class. 
 
Dr. Williams will maintain lists of group assignments (for both research and non-research 
participants) and coordinate the scheduling of group class appointments.  
Both Dr. Turner and the unblinded research staff member responsible for randomization will 
have access to this information and be available to provide back-up if Dr. Williams is absent or 
preoccupied.  
 
As aforementioned, the research staff conducting randomization procedures will alert Dr. 
Williams that a research participant has been randomized.  
 
Research staff will also alert Dr. Williams of non-research participants who are eligible to 
participate, and of their intervention preference. These master schedule/lists will not contain any 
study data or links to study data (i.e., no subject identification numbers). Rather the lists will only 
include the participant’s name, CPRS ID, tract of participation in the program (i.e. research or 
non-research participant), and general status in the program (on hold, active, pending). These 
master lists will be stored on a secure VA drive in a password-protected file. It will contain the 
minimal amount of information necessary to manage properly treatment group scheduling.  
 
D6n. Treatment 
 
In all three treatment conditions, intervention appointments will be scheduled in regular 
group clinics at the VA facility (American Lake or Seattle). This means that treatment sessions 
will appear on the Veterans’ lists of regular clinical appointments. Although the appointments 
are scheduled for 90 minutes, in practice they will last 60-80 minutes, with a 10 minute time 
cushion built in to allow for participants who may have mobility limitations to arrive, settle, and 
then vacate the group rooms without hurrying.  
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The reason that there is variation in the amount of time planned for each group (60-80 minutes) 
is that some of the sessions may require more time than others; for example, the first session 
will take more time than the others because it will include time for introductions and reviewing 
the format of the treatment, as well as for answering questions about treatment. Some groups 
may have participants with mobility limitations who require a little longer than others to get 
physically settled into the room, some may require a 5-10 minute break during the session, and 
some groups- especially those with higher numbers of participants- may require a little more 
time than others to ensure each participant has an opportunity to actively participate and 
discuss.  
 
Group clinicians will be asked to report how much time was spent in each group so we can 
control for possible differences in this variable between treatment conditions. 
 
The group sessions will be conducted by VAPSHCS providers who have undergone a 
formal two-day training process that prepares clinicians to conduct each of the three treatment 
interventions in a group setting.   
 
Providers will be licensed/credentialed/privileged allied health professionals at the 
VAPSHCS. Providers will represent a variety of disciplines, including but not exclusive to the 
following: Ph.D. licensed Psychologists, Pre-doctoral Clinical Psychology Interns (i.e., who are 
in their final year of a doctoral degree program and supervised by a licensed Clinical 
Psychologist) and Psychology Post-doctoral F(who have completed a Ph.D.), Occupational 
Therapists (MOTR/L), Speech-Language Pathologists (MS CCC-SLP), Social Workers 
(LICSW), Recreational Therapists (RT), Physical Therapists (PT, DPT), or Nurses (RN). Each 
provider will participate in a two-day training, which will cover group instruction for mindfulness 
meditation, self-hypnosis and pain education. 
 
 All study clinicians will also be given regular feedback by Drs. Jensen and/or Williams on 
their performance. In addition, ongoing consultation will be offered to providers leading 
mindfulness meditation and self-hypnosis interventions by Drs. Jensen and Day to ensure that 
any questions that in real time can be answered. 
 
We will have a goal of having each group led by two providers allowing for groups to 
continue as scheduled in the event one of the providers is unable to attend a particular group.  
 
Additional participants will be scheduled for the groups until they reach the maximum size of 
fifteen. Providers will be expected to  follow closely the treatment manuals to ensure all 
scheduled material is covered, and to ensure the consistency and replicability of treatment. 
 
In all conditions, home practice activities will be assigned to increase engagement in the 
treatment. Participants will be asked to record the extent of engagement in these activities using 
a form provided to them by the clinician. We realize that adherence to interventions assigned 
outside of treatment sessions may influence study outcomes so will utilize data collected by the 
clinicians about homework compliance. In addition, all participants in all interventions will be 
given a treatment workbook with materials to refer to and discuss during the group sessions as 
well as additional materials to read between sessions. 
 
Education (ED) condition.  The pain education control condition will include 8 informational 
90-minute group sessions that are compelling and informative, but are designed not to be 
effective for pain reduction, our primary outcome measure.  
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However, it is expected that participants in this treatment condition will experience improvement 
in other outcomes, such as coping skills, knowledge, and reduced distress. Hence, we describe 
this in our ICF as one of three treatment conditions, rather than as an inert control condition. 
Participants in this condition will be given pre-recorded audio recordings of the content of the 
sessions to listen to, to control for the between-session practice that will be encouraged in the 
HYP and MM groups (see below).  We have used this condition successfully in past and current 
trials.  Participants have rated it as helpful and credible, yet have not shown changes in pain 
intensity.52, 53 Thus, it will control for non-specific factors related to the active interventions, 
including therapist attention, participation in a group, and time, but will not impact the primary 
outcome measure (pain intensity).  
 
HYP condition.  In the HYP condition, each group session will be highly structured. Group 
sessions will begin with a review and discussion of the home practice assignments and goals for 
the session. The facilitator will perform a standard hypnotic short induction followed by 
therapeutic suggestions, including post-hypnotic suggestions.  
 
Participants will relax in a comfortable position with their eyes closed and will simply listen to 
the clinician read a standardized hypnotic script that will include an induction followed by 
suggestions for decreased pain and improvement in co-morbid symptoms (e.g., improved mood 
and optimism, relaxation, sleep quality). Sessions will also include discussion post-exercise. 
The sessions will end with recommendations for home practice. Participants will be given pre-
recorded recordings of the hypnotic inductions and suggestions provided in each session and 
encouraged to practice self-hypnosis (first, using recordings, but over time and as they gain 
more confidence, on their own without the recordings), and time will be devoted to problem 
solving around any difficulties with self-hypnosis practice.  We have a great deal of experience 
with this intervention.41, 42, 54  
 
MM condition.  The MM group interventions will teach participants Vipassana meditation, which 
is the specific form of MM typically implemented in mindfulness research. The emphasis is 
placed upon developing focused attention on an object of awareness, such as the breath.  
This focus is then expanded to include a more open, non-judgmental monitoring of any sensory, 
emotional, or cognitive events. As with the HYP intervention, a standard script will be read by 
the clinician to the participants, who will be seated in a comfortable yet alert position.  
 
In addition, participants will be given pre-recorded recordings of the meditation technique 
taught in the sessions and encouraged to practice MM daily (first using the recordings, and then 
later, as with HYP, on their own without recordings).  Time will also be devoted to problem 
solving around any difficulties with MM practice. 
 
Please note that the overall content of the treatment interventions as described above will 
not change during the course of the study.  However, minor revisions of the actual therapist 
manual and participant workbook, such as minor changes to formatting and specific language 
(i.e. revisions that do NOT result in a change in the risk/benefit ratio or to the substance of the 
material covered), are anticipated throughout the study due to the iterative process of 
developing a psychotherapeutic treatment intervention.   
The researchers will submit a modification request to both the VAPSHCS and UW IRBs  should 
there be any change to study procedures or a substantive change in content based on new 
information that becomes available during the course of the study.  
 
 
 
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Attendance Records 
Group leaders (clinicians) will be given an attendance record of the anticipated participants 
in their group and will be responsible for ensuring scheduling and other clinical matters are 
managed once the groups start.  The attendance record will only include a participant’s name 
and CPRS ID. The clinician will record the subject’s absence or presence for each session on 
the record. Completed attendance records will be uploaded and stored on a limited access 
folder on the secure VA network drive. Only Dr. Williams, Dr. Turner, and the unblind staff 
member responsible for randomization will have access to these forms. The hard copies of 
these attendance records will be destroyed once they are uploaded to the drive at the end of 
each treatment group.  
 
Participation in less than 4 treatment sessions will be considered a protocol deviation.  A 
Note-to-file will be drafted at the end of each cohort to report research participants that 
completed less than 4 treatment sessions. 
 
Data Collected during Treatment Sessions 
Participants will complete and hand in a form regarding their completion of tasks or 
“homework” assigned by the clinician from the previous session.  
 
In addition, participants will complete  and hand in forms before and after each session that 
include questions regarding pain intensity and comfort level, as well as questions about what 
the participants have found helpful or non-helpful about the treatment.  
 
Finally, study clinicians will complete a form each session that captures information 
regarding the perceived engagement of each participant in that particular session. All of these 
forms will be labeled with a subject’s name. 
 
Information will be gathered during the group interventions as per standard of care 
procedures that all attendees will do regardless of their participation in the study. The clinicians 
running the groups will not have access to the crosswalk between study data and participants’ 
identities.   
 
Following each session, per usual care the clinician will enter a progress note in CPRS for 
each participant, indicating attendance or absence for that particular session. The note will also 
include the length of the group session, as well as basic content covered during the session. 
Information gathered during the group sessions (e.g., homework logs, pre- and post-class 
pain ratings, patient engagement) will be used for clinical supervision and treatment planning. 
This clinical information will be scanned and stored on a secure drive (PUG_Services 
(\\RO1PUGHSM03.r01.med.va.gov\RCS\Psychology\SKILLS CLINICAL GROUPS) within the 
Rehabilitation Care Service. Access to this drive will be limited to clinicians who are running the 
classes and their clinical supervisor, and unblinded staff members.  
 
Unblinded staff members will extract these data associated with the main RCT as well as 
with the open-label phase (since all group participants will be completing the forms regardless of 
study status). These staff members will have access to this secure limited-access drive, and to 
the cross walk linking names/study IDs. These two staff members would identify the veterans 
who are study subjects and access the PDFs of the scanned information in this clinical drive, 
and enter the data directly into a secure database with the participant’s code number (study id). 
 
 
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 In this way, we leverage existing clinical data to address an important scientific question 
(i.e., whether engagement in homework and experience within sessions is associated with 
outcomes), but none of the clinicians are engaged in research activities, and there is no 
additional burden to the subjects. 
 
The staff member will enter the data labeled with only the participant’s code number into a 
password-protected database separate from all non-treatment study data. The staff member will 
not enter the data collected from non-research participants.   
 
Audio Recordings 
All group treatment sessions will be audio recorded to ensure compliance to treatment 
procedures.   A portion of treatment sessions will be randomly selected to be reviewed by study 
researchers to ascertain fidelity to protocol. Study clinicians will receive feedback as needed if 
they diverge from protocol. 
 
The study clinicians will notify participants before the start of the session that s/he will be 
recording the session, and all participants in the group (including non-research participants) will 
be asked to complete requisite consent forms to record voice.    The audio recordings will be 
collected using a VA approved encrypted device.   
 
The recordings will be stored on a secure server at the VA (V:\Chronic Pain Skills 
group\Fidelity Recordings). Audio recordings will only be reviewed by study personnel and used 
for assessing consistency between study clinicians.  The audio recordings will not be labeled 
with any identifying information.   
 
The only identifying information that will be contained within the recordings will be 
participants’ voices and if the study clinician or group members state participants’ names during 
the discussion. 
 
Treatment Intervention Discontinuation 
A participant will be withdrawn from the treatment intervention if s/he (1) engages in 
behavior that is disruptive to the group, and/or (2) engages in behavior that interferes with the 
appropriate administration of the group treatment.  
 
However, participants who are withdrawn from the study treatment intervention will be 
invited to complete study assessments during treatment at (2, 4 and 6 weeks), post-treatment, 
3-month and 6-month follow-up in order to allow for complete data for the planned intent-to-treat 
analyses. Participants will receive payment for the time it takes to provide outcome data at each 
assessment point. 
 
 
D6o. Study design enhancements: Missed sessions and study retention strategies 
 
We will monitor session attendance and session dates to track attendance. We will also track 
treatment withdrawal and the reason for withdrawal via the 'Treatment Withdrawal Form'.  We 
will then enter the data into the unblinded Treatment Database. 
 
We will make efforts to deliver the full treatment to every participant, but we expect some 
variation in treatment delivery dose as well as treatment drop-out. Reasons for attrition will be 
assessed for enrolled participants who withdraw from treatment.  
 
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We will use a number of strategies to maximize study retention. For example, treatment 
sessions will be offered at different times, on a recurrent basis, giving study participants a great 
deal of flexibility for scheduling.   
 
Data collection staff will be taught listening skills and encouraged to be warm in all 
interactions in order to enhance rapport. Also, the Co-PIs will receive weekly reports from the 
staff so that the study investigators can discuss recruitment and retention during the weekly 
research meetings.  
 
Finally, participants will receive remuneration for completion of the following study components: 
 
Baseline components (hypnotic and relaxation exercise, cognitive assessment, baseline data 
and demographic form-$25 total);  
Each of the seven assessment points ($25 each, $175 total);  
Brain wave activity or EEG assessments ($100 per assessment, $200 total).  
 
In addition, we plan to offer a $50 bonus for participants who complete all seven of the 
telephone assessments (up to $450 total). We have successfully used these and other 
strategies in our past trials, with a retention rate of 80% to 92% across similar studies. 41, 42, 53 
 
 
Replacement Check Protocol 
 
VA research staff will send participants with a check that is outstanding 180 days after issuance 
a letter that: 
  
• 
Notifies the participant that the check remains uncashed; 
• 
Requests the participant indicate whether they would like a new check(s) or decline 
payment; and 
• 
Instructs the participant to sign the reissuance form and send it back to research staff 
in the included self-addressed envelope.   
Research staff will then forward the signed and completed letter to SIBCR, who will then 
issue a new check to participants. Research staff will contact participants who have not returned 
the signed form within 2-3 weeks of mailing. Research staff will send out the same letter again if 
requested by participants. 
 
Research staff will send the same letter described above to participants who notify VA staff 
that they did not receive the check/lost it, and request a replacement check.   
 
 
D6p. Optional Assessments 
Pre- and Post-Treatment Assessment Periods: 
For the pre-treatment and post-treatment telephone assessment periods, research staff will 
use a script to invite participants upon completing the assessment period to participate in an 
optional assessment consisting of two measures developed by study researchers. The optional 
assessment should take approximately 25-30 minutes to complete, and consists of questions 
about how participants feel when they feel pain or think about their pain problem, and how 
participants respond to their pain.   
 
The collection of Optional assessments will stop once there is enough data to answer 
exploratory questions. 
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3- and 6-Month Assessment Periods: 
In addition, research staff will invite research participants to participate in an additional 
optional telephone assessment after they complete the 3- and 6-month assessment periods.  
This optional assessment should take approximately 10-15 minutes to complete and will 
include questions about activity management, flourishing, and sense of humor. 
 
 
Participants are informed all optional assessments are completely voluntary, and that they 
may refuse to complete the optional assessments with no effect on their medical care or their 
payment for their completion of that particular assessment period.  Participants will be informed 
they will not be compensated for completing the optional assessments.  
 
The collection of Optional assessments will stop once there is enough data to answer 
exploratory questions.  
 
D6q. Study Completion: Main Phase 
 
Research staff will complete a study completion form when either a) a subject completes the 
6 month assessment period, or b) withdraws or is withdrawn from the study. Subjects who 
complete the 6 month assessment period will be sent a cover letter along with their final 
remuneration with language indicating completion of the main phase.  Subjects who fail to 
complete the 6 month assessment period will be sent a letter informing the subject that his/her 
participation in the main phase has ended.  
 
Research staff will also note dis-enrollment in CPRS as per VAPSHCS regulatory protocol. 
 
D6r. Open Label Phase (see updates below for cohorts after 9) 
 
Following the completion of the main phase of the study ( i.e. completion of 6-month 
assessment period, research staff will invite participants to complete in one or both of the 
treatment groups they did not attend during participation in the main phase if deemed eligible. 
Specifically, research staff would conduct a simple review of a subjects’ medical record using a 
case report form to detect the presence or absence of a behavioral or suicide risk flag in CPRS.  
In addition, staff will answer two items regarding any observed behaviors that may make a 
subject for a poor candidate for the open label phase.  Participants are limited to participating in 
each treatment intervention only once.  Participation is defined as attending four or more 
treatment sessions for that particular intervention. Participants may attend each treatment 
intervention more than once if they in fact attend three or fewer sessions.  Participants would 
only participate in one treatment group at a time.   
 
Following the completion of the 6 month assessment period, the blinded assessor will 
inquire briefly into the subject’s interest in participating in the open label phase of the study.  If 
the subject is interested, the blinded research staff will inform the subject that an unblinded 
research staff member will call to give him/her more information about the open label phase.  
 
An unblinded research staff member will then call the subject to describe the open label 
phase in more detail, including dates and times for particular interventions (e.g. mindfulness 
meditation) at each division. If the subject is still interested in participating, the unblinded 
research staff member will inform the subject that staff will call him/her to schedule the consent 
process. An unblinded research staff member will conduct the scheduling process to avoid 
unblinding blinded assessors.  
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Updated Open Label study procedures after cohort 9.  
Participants who attend treatment for the first time in cohort 10 and all subsequent cohorts 
will not be offered the open label phase given study researchers intend to stop running 
treatment groups by the time these participants will complete the main phase of the 
study.  Instead, these participants will be offered the treatment materials for the treatment of 
their choice. The treatment materials (workbook and audio recordings) will be mailed via USPS. 
 
Participants who were randomized in cohorts 1-9 and are eligible to participate in the open 
label phase for cohorts 11 or 12 will be offered the option of either receiving treatment materials 
in the mail for the treatment of their choice or enrolling in the open label phase depending on 
space availability. 
 
Consent Session (for cohorts 1-9) 
Research staff will participate in and obtain informed consent from research participants 
prior to commencement of any further study procedures for the open label phase. The informed 
consent process may  take place either via telephone and postal mail, or in person. The consent 
process will occur at a time deemed mutually feasible for the Veteran and staff member and 
coordinated on a case-by-case basis.   
 
A research staff member will review each section of the informed consent form (ICF) 
approved by all regulatory institutions, inviting discussion to ensure comprehension. Staff will be 
trained by study investigators to ensure competency to discuss informed consent and strategies 
to ensure there is no coercion.  
 
Participants will be provided with as much time as needed to review the ICF and ask the 
research staff member questions about the ICF, their rights as human participants, and 
participation in the study. Potential participants will be fully informed of all risks and benefits 
prior to giving their written informed consent and prior to enrollment in the study.  
 
If during the course of this contact the potential participant has questions that cannot be 
addressed by research staff, one of the study investigators or the research manager (depending 
on the nature of the questions) will follow up with the potential participant to answer the 
questions. Participants may take time to think about participating and render a decision at a 
later time.   
 
Potential participants will be asked to repeat back understanding of this material as 
necessary.  
Individuals will not be permitted to participate if there is any question as to whether a person is 
able to provide informed consent. The participant will then be asked to sign and date the ICF. 
Research staff will also date and sign the ICF. All participants will be offered a copy of the 
signed ICF for their records.  
 
A scanned copy of the consent form will be sent to the VAPSHCS Research Compliance 
Officer (RCO) as per VAPSHCS guidelines.  
 
In addition, a note of enrollment will be made in CPRS. Research staff will also review a 
HIPAA authorization form with the participant that permits research staff to review in CPRS 
encounters of clinicians running the treatment groups to confirm attendance of said groups and 
extract data collected during treatment.  
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Research staff will file original copies of both the consent and HIPAA forms in the Dr. Williams’ 
office, separate from data collected during both the main and open label phases of the study. 
 
Research staff will provide participants with staff business cards after the consent process. 
Participants will also be provided a response key to help answer questions asked during the 
telephone assessment periods.  
 
 
Informed Consent Process via Telephone and Postal Mail 
A blinded staff member would arrange a time to conduct the informed consent process via 
telephone if the individual is interested in participating via the recruitment script. The research 
staff member will then send a self-addressed, stamped envelope along with two copies of the 
approved consent form, the approved HIPAA authorization form, and a new cover letter. The 
approach letter will specify that, although individuals may review the forms in advance, they 
should not complete the forms until they have reviewed the forms with research staff at the 
scheduled informed consent session via telephone.   
 
Informed Consent Process in Person 
The informed consent process may take place at one of the following locations: (1) the 
VAPSHCS Seattle Campus; (2) VAPSHCS American Lake Campus or (3) IBIC at the UW.  The 
consent process will occur at a time deemed mutually feasible for the Veteran and staff member 
and coordinated on a case-by-case basis.  The consent process will take place in a private 
location (e.g., a medical exam room or private conference room). 
 
Open Label Phase Assessments (for cohorts 1-9) 
Research participants enrolled in the open label phase will complete telephone 
assessments twice with research staff: once before treatment, and once after treatment has 
ended.  Each assessment will consist of questions regarding pain intensity, post-traumatic 
stress disorder, depression, anxiety, sleep disturbance, pain interference, and medication use. 
The post-treatment assessment will also include questions about treatment satisfaction and 
overall improvement since the participant began the open label phase. The entire time required 
to answer questions during the assessment is about 15-20 minutes. 
 
Research participants will be compensated $10 for the completion of each assessment 
period via a check written from the Seattle Institute for Biomedical and Clinical Research 
(SIBCR). The check will be sent via USPS mail and accompanied by a payment cover letter. 
 
 
Treatment (for cohorts 1-9) 
An unblinded research staff member will notify Dr. Williams when an open label participant 
has completed the pre-treatment assessment, and inform her of the participant’s intervention 
preference. This process will help avoid unblinding blinded assessors. Dr. Williams will add the 
participant to the clinic list described in section D6m. above. Treatment procedures for open 
label phase participants will be the exact same as described in section D6n. above 
 
Research staff will complete an open label phase study completion case report form once 
the participant has completed participation in the open label phase. Research staff will also note 
dis-enrollment in CPRS as per VAPSHCS regulatory protocol. 
 
 
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D6s. Sleep Sub-Study 
 
Recruitment 
 
During the recruitment process for the main phase of the study, all prospective research 
participants will be informed briefly about the possibility of participating in the sleep “sub-study” 
following enrollment into the main phase via a research recruitment script.  
 
 
Following completion of the informed consent process for the main phase, research staff 
members will inform prospective participants about the opportunity to participate in the sub-
study with the assistance of a talking points script. All participants who enroll in the main phase 
of the study will be eligible to participate in the sub-study. Subsequently there is no separate 
screening process for the sub-study. Participants will only be approached about participating in 
the sub-study at the time of enrollment in the main phase; participants who have been enrolled 
and participated in a previous cohort may not participate. 
 
Informed Consent Process 
 
All participants interested in participating in the sub-study will participate in a separate 
informed consent process specific to the sub-study following enrollment into the main study. The 
informed consent process for the sub-study may take place at one of the following locations: (1) 
the VAPSHCS Seattle Campus; (2) VAPSHCS American Lake Campus or (3) IBIC at the UW.  
The consent process will occur at a time deemed mutually feasible for the Veteran and staff 
member and coordinated on a case-by-case basis.  The consent process will take place in a 
private location (e.g., a medical exam room or private conference room).  
 
A research staff member will review each section of the informed consent form (ICF) 
approved by all regulatory institutions, inviting discussion to ensure comprehension. Staff will be 
trained by study investigators to ensure competency to discuss informed consent and strategies 
to ensure there is no coercion.  
 
Participants will be provided with as much time as needed to review the ICF and ask the 
research staff member questions about the ICF, their rights as human participants, and 
participation in the sub-study. Potential participants will be fully informed of all risks and benefits 
prior to giving their written informed consent and prior to enrollment in the sub-study.  
 
If during the course of this contact the potential participant has questions that cannot be 
addressed by research staff, Dr. Williams or the research manager (depending on the nature of 
the questions) will follow up with the potential participant to answer the questions. Participants 
may take time to think about participating and render a decision in a subsequent visit.  
 
Potential participants will be asked to repeat back understanding of this material as 
necessary. Individuals will not be permitted to participate if there is any question as to whether 
s/he is able to provide informed consent. 
 
The participant will then be asked to sign and date the ICF. Research staff will also date and 
sign the ICF. All participants will be offered a copy of the signed ICF for their records.  
 
 
A scanned copy of the consent form and an enrollment note template will be sent to the 
VAPSHCS Research Compliance Officer (RCO) as per VAPSHCS guidelines. In addition, a 
note of enrollment will be made in CPRS. 
 
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Research staff will file the original copy of the consent form in Dr. Williams’ office, separate 
from data collected during screening and subsequent data collected during participation in the 
study. 
 
Participants will also be provided a revised response key to help answer questions asked 
during the telephone assessment periods for the sub-study.  
 
Research staff will complete a sub-study specific enrollment case report form that will be 
filed with study data. In addition, research staff will complete a revised “documenting the 
consent process” form for each enrolled participant that will be filed with the signed consent 
form. 
 
Telephone Assessment   
A research staff member will ask each participant two questions about how much the 
participant agrees with certain statements about his/her sleep, as well as two questions about 
how confident the participant is about carrying our certain sleep behaviors. These questions 
will be asked during the pre-treatment assessment period, 4-week assessment period, post-
treatment assessment period, and the assessment period that takes place 3 months following 
the end of treatment. The questions will take about 5 minutes to complete. The pre-treatment 
assessment period may be repeated if the participant does not start treatment within four 
weeks of completing the original pre-treatment assessment period.  
 
Sleep/Wake Diary  
Three times during his/her participation in the sub-study, we will ask the participant to 
keep what we call a sleep/wake diary: once following enrollment but prior to the start of 
treatment, once following the end of treatment, and once three months following the end of 
treatment.  The sleep/wake diary will either be given to the participant in person or sent via 
postal mail.  If sent via postal mail, the sleep/wake diary will be accompanied by a cover letter. 
Research participants will complete the sleep diary using pen and paper.  The participant will 
complete a diary entry twice a day (morning and night) for up to seven days.  In the morning, 
the participant would answer basic questions about his/her sleep during the previous night, 
including time the participant thinks s/he fell asleep, the quality of his/her sleep, and any other 
experiences that might have affected his/her sleep.  In the evening, the participant will answer 
questions about how the participant felt that day, any problems s/he experienced such as 
illness or discomfort, and basic activities s/he participated in like going to work, napping, 
drinking caffeinated beverages, etc. 
 
Also, the participant will be instructed to call a toll free number twice a day to report when 
s/he woke up in the morning, and when s/he is going to sleep in the evening.  The number will 
be housed at the VAPSHCS, and only accessible to study staff.  If a voicemail is left by the 
participant: staff will delete the voicemail after research staff record the data provided using 
the case report form.   
 
Participants will be advised to leave his/her study ID only without any identifiers. These 
instructions will be given to the participant either in person or via postal mail. 
 
Finally, the participant will be instructed to send back the completed sleep diary to WSU study 
researchers at the Spokane Sleep and Performance Research Center in a provided self-
addressed stamped envelope along with the actigraph device (see description below). WSU 
research staff will use the sleep diary as a reference only for the data downloaded from the 
actigraph device; no data from the sleep diary will be entered into a database at that time.  
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Study investigators expect that 10% of the actigraphs will not be returned by study participants 
due to them being misplaced or lost in the mailing process. The actigraphs and sleep diaries do 
not contain any identifiers, so there would not be a risk of privacy breach. Participants would 
have the option of hand delivering the actigraph to study staff if they are on Seattle or American 
Lake VA campus. 
 
WSU research staff will then send the completed sleep diaries in de-identified form to 
VAPSHCS staff via postal mail, who will then enter the data into the secure database.   
 
The original hard copies will be filed at the VAPSHCS in a locked office separate from 
participant identifiers.  
 
The sleep diary will take approximately two hours to complete over the 7-day period.  
 
The pre-treatment assessment period may be repeated if the participant does not start 
treatment within four weeks of completing the original pre-treatment assessment period.  
 
Actigraphy Device   
Three times during his/her participation in the sub-study, we will ask the participant to 
wear a sleep monitor device called an Actigraph: once following enrollment but prior to the 
start of treatment, once following the end of treatment, and once three months following the 
end of treatment.   The participant would wear the actigraph (Actiwatch , Philips Respironics, 
Bend, OR) like a wrist watch on his/her non-dominant arm.  There is no risk of electric shock 
with this device. The device will measure how long the participant sleeps, as well as the 
overall quality of his/her sleep. The participant will wear the actigraph for up to seven days 
during the same period s/he is completing the sleep diary except for when the participant is 
participating in activities that might get the actigraph wet like swimming, showering, or 
bathing.   
 
The participant will be instructed to send back the actigraph to WSU study researchers in 
a provided self-addressed stamped envelope at the end of the assessment period along with 
the sleep diary. The actigraph device will not be labeled with any identifying information. WSU 
research staff will download the data collected by the actigraph device.  The data will be 
stored on a secure WSU server in de-identified form indefinitely.  Data may be downloaded 
from the Actigraph only with the assistance of  Actigraph software unavailable to the general 
population. The actigraph data will transmitted by WSU staff to VA staff electronically in de-
identified form to be stored indefinitely on the secure VA server with the rest of the study data. 
  
In addition, WSU research staff will complete a data cover page that records basic 
information regarding receipt of the actigraph, date data was downloaded, any comments 
regarding the data, etc. WSU research staff will then send the data cover page along with the 
daily diary of each participant to VAPSHCS research via postal mail in de-identified form.  
VAPSHCS will enter the data recorded on the actigraph data cover page into the secure 
database.  The original hard copies will be filed at the VAPSHCS in a locked office separate 
from participant identifiers. 
 
The sleep data temporarily stored on the actigraphy device will be deleted once the data 
are downloaded by the WSU study researchers.  
 
 
 
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Participants may be asked to wear the actigraph again for pre-treatment if the participant 
does not start treatment within four weeks of completing the original pre-treatment 
assessment period. Participants will be compensated for completing this additional 
assessment period. 
 
Compensation 
     A participant will be compensated $40 each time s/he returns the actigraph device via 
postal mail. An additional $30 will be provided as compensation at the end of the study if a 
participant completes 100% of the sleep diaries and actigraph data collection.  
A partial payment of $15 will be given if less than 100% of sleep diaries or actigraph data 
collection is completed. Compensation will be by check, which will be sent via postal mail 
along with a cover letter by the SIBCR: one version for pre-treatment and post-treatment, and 
one version for the three-month assessment period indicating the participant has completed 
the sleep sub-study. 
 
Sub-Study Completion  
     Research staff will complete a sub-study completion form when a participant a) withdraws 
or is withdrawn from the sleep sub-study; b) completes the three month assessment periodor 
c) does not complete the three month assessment period.   
Research staff will send a letter explaining the participant is no longer enrolled in the sleep sub-
study if s/he fails to complete the three month assessment period. 
 
 
Table 3. Participant Involvement 
 
Procedure 
Number of Visits 
or Assessments  
How Often / When 
Time Required   
for Participants 
Compensation 
Cognitive 
Assessment 
One in-person session at VA 
Seattle or American Lake 
Divisions) or Integrated Brain 
Imaging Center (IBIC) at the 
UW 
Once, following 
informed consent 
process; before 
treatment begins 
About  20-30 
minutes 
$10 
Hypnotic and 
Relaxation 
Exercise 
One in-person session at VA 
Seattle or American Lake 
Divisions) or Integrated Brain 
Imaging Center (IBIC) at the 
UW 
Once, following 
informed consent 
process; before 
treatment begins 
About 15-20 
minutes 
$5 
Baseline 
Data and 
Demographic 
Form 
One session either (1) at VA 
Seattle or American Lake 
Divisions or Integrated Brain 
Imaging Center (IBIC) at the 
UW OR (2) via telephone 
 
 
 
 
 
 
 
Once, following 
informed consent 
process; before 
treatment begins 
About 20-30 
minutes 
$10 
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Procedure 
Number of Visits 
or Assessments 
How Often / When 
Time Required    
for Participants 
Compensation 
Pre-
Treatment 
Telephone 
Assessment 
Period 
Up to 4  telephone 
assessments conducted 
within a one-week period 
Once, following 
informed consent 
process; before 
treatment begins 
About  45-60 
minutes total 
$25 
Pre-
Treatment 
Brain Activity 
Assessment 
One in-person assessment at 
the UW Integrated Brain 
Imaging Center (IBIC) at the 
UW 
Once  following 
informed consent 
process, before 
treatment begins 
About  45-60 
minutes 
$100 
Pre-
Treatment 
Sleep Sub-
Study 
Procedures 
Wear actigraph on wrist, 
complete sleep/wake diary 
twice a day, call in 
wake/bedtimes twice in a day 
during a one-week period 
Once, following 
informed consent 
process; before 
treatment begins 
2 hours for 
sleep/wake 
diary, continuous 
for actigraph 
device 
$40 
During 
Treatment  
Telephone 
Assessment 
Periods 
Up to 4  telephone 
assessments conducted 
within a one-week period 
Following sessions 2, 
4 and 6 
45-60 minutes 
per assessment 
period, 2.25-3.0 
hours total 
$25 per 
assessment 
period, $75 total 
Treatment 
 8 group treatment sessions 
that takes place at the 
VAPSHCS Seattle or 
American Lake Campus 
Average of once per 
week for eight weeks 
up to 12 hours 
total 
$0 
Post-
Treatment 
Telephone 
Assessment 
Period 
Up to 4  telephone 
assessments conducted 
within a one-week period 
Once following end 
of treatment 
About  45-60 
minutes total 
$25 
Post-
Treatment 
Brain Activity 
Assessment 
One in-person assessment at 
the UW Integrated Brain 
Imaging Center (IBIC) at the 
UW 
Once following end 
of treatment 
About 45-60 
minutes 
$100 
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D6t. Study Data 
Main Study: 
The following is a list and description of the data measures included in the study.  
We list the demographic and descriptive information we propose to collect from the study 
participants in the next paragraph. The primary outcome, secondary outcome, covariates 
(variables to control for in planned analyses if needed), and mechanism (mediator and 
moderator) variables for this study are listed in Table 4 (page 33).  
Details regarding a subset of the key measures are provided below. All outcome measures will 
be administered by research staff members blind to group allocation. 
 
Data will be shared with UW study investigators for the purposes of data analysis. All data 
will be de-identified and linked only by a participant ID code. All data sharing will be done in 
accordance with the collaborating institutional human participants’ committees.  
Post-
Treatment 
Sleep Sub-
Study 
Procedures 
Wear actigraph on wrist, 
complete sleep/wake diary 
twice a day, call in 
wake/bedtimes twice in a day 
during a one-week period 
Once following end 
of treatment 
2 hours for 
sleep/wake diary, 
continuous for 
actigraph device 
$40 
3 Month 
Telephone 
Assessments 
Up to 4  telephone 
assessments conducted 
within a one-week period 
Three months 
following end of 
treatment 
About  45-60 
minutes total 
$25 
3 Month 
Sleep Sub-
Study 
Procedures 
Wear actigraph on wrist, 
complete sleep/wake diary 
twice a day, call in 
wake/bedtimes twice in a day 
during a one-week period 
Three months 
following end of 
treatment 
2 hours for 
sleep/wake diary, 
continuous for 
actigraph device 
$40, plus $15-
30 bonus as 
applicable 
6 Month 
Telephone 
Assessments 
Up to 4  telephone 
assessments conducted 
within a one-week period 
Six months following 
end of treatment 
About  45-60 
minutes total 
$25 
Bonus 
Payment: All 
telephone 
assessments 
completed 
All seven telephone 
assessment periods are 
completed  
Over 9-month period 
(see timeline listed 
above) 
Totaling about 5-7 
hours total over a 
9-month period 
$50 
Open Label 
Phase Study 
(cohorts 1-9) 
Two telephone assessments, 
8 treatment sessions 
Following completion 
of the main phase of 
the study 
About 13 hours 
over a 3-month 
period 
(assessments and 
treatment 
sessions 
included) 
$10 per 
assessment 
completed 
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Data will be shared with WSU study investigators for the purposes of data analysis. All data 
will be de-identified and linked only by a participant ID code. All data sharing will be done in 
accordance with the collaborating institutional human participants’ committees. 
Study investigators will destroy the crosswalk which connects study participants to their study 
data once it is deemed no longer necessary. Based on information that we received regarding 
RCS 10-1, the crosswalk is considered a temporary document.  The study will no longer need 
the crosswalk once the study is in data analysis and the PIs determine that the crosswalk is no 
longer needed.  Destroying the crosswalk will further protect study participants. 
 
Descriptive/Demographic variables.  All participants will be asked to provide demographic 
data (age, sex/gender, marital status, income, education level, employment status) and 
deployment history (number and month of deployments, whether deployment involved hostile 
duty) for descriptive purposes.   
 
We will also ask about their history of HYP,MM and ED treatment and practice, and the 
presence of history of military sexual trauma (using the 2-item clinical reminder screen by VHA) 
as trauma history has been associated with different pain experiences. We will also ask 
questions regarding substance dependence as well as co-morbid conditions. 
 
Primary outcome variable: Average daily pain intensity. Average pain intensity will be 
assessed via telephone interviews using a 0-10 numerical rating scale (NRS) of average pain in 
the past 24 hours, up to four times within a 1-week period at each assessment point. The mean 
of these ratings will be used as the primary outcome measure of average daily pain intensity. 
Psychometric theory and research support composite pain measures as more reliable, valid, 
and sensitive to treatment effects than single ratings.55, 56 The 0-10 NRS has demonstrated its 
validity as a measure of pain intensity through its strong association with other pain measures 
as well as its ability to detect changes in pain with pain treatment.57 A consensus panel has also 
recommended the 0-10 as a core outcome measure of pain intensity in clinical trials of pain 
treatments.58 
 
Covariates. All participants will be asked to maintain the same level(s) of analgesic intake 
and not seek additional pain treatments throughout participation. For example, if they are taking 
two ibuprofen/day for pain management, they will be asked to maintain this same dose 
throughout the study. This will help limit the potential confounding effect of changes in pain 
treatment on outcome. However, for ethical reasons, we will not require participants to maintain 
the same analgesics or to not receive additional treatments as a condition of the study. 
Medication use will be assessed via self-report including prescription medications, illicit 
substances (e.g., cannabis, alcohol; we will have in place a Federal Certificate of Confidentiality, 
so that all information provided can remain confidential), and  non-prescribed medications (e.g., 
over-the-counter). To facilitate recall for these, we will ask participants to have their medications 
physically available at the time of assessment.  
 
To ensure similar levels of medical services utilization and pain treatment between groups, 
we will ask participants to report any professional care for pain and analgesic use at each 
assessment point. Research consistently supports the validity of recall for medically related 
variables such as medical number of health care visits 59, 60 and these can also be verified in the 
medical record to ensure reliable reporting. Analgesic medication data will be converted to 
standard equivalencies using the formulas developed at the UW Pain relief Center (methadone 
for opioids, ibuprofen for NSAIDS, and phenobarbital for sedative-hypnotics). This procedure 
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will provide data for both usual and rescue analgesics.61  Note that medication use is also being 
proposed as a secondary outcome measure. 
 
 
 
Table 4. Primary, secondary, co-variate, and mechanism variables. 
Variable Type 
Domain 
Measure 
Primary 
outcome 
Average daily pain 
intensity 
Average of up to 4, 0-10 recall NRS of  average pain intensity 
Secondary 
outcomes 
Worst daily pain 
intensity 
Depression 
Anxiety 
Sleep Disturbance 
Pain interference 
PTSD Symptoms 
Medication use 
Global improv.  
Tx. Satisfaction 
Global Health 
Positive Affect 
Positive 
Psychosocial 
Outcomes 
Average of up to  4, 0-10 recall NRS of  worst pain intensity 
 
PROMIS Depression SF62 
PROMIS Anxiety SF62, suppl. questions 
PROMIS Sleep Disturbance SF62, suppl. questions 
PROMIS Pain Interference SF62 
PTSD Checklist-Civilian version 63 
participant report (see text) 
5-point Likert scale 58 
PGATS64 
Single Item, SF-36 PROMIS Global Health v1.1.65 
PANAS Positive Subscale66 
PROMIS Psychosocial Illness Impact-Positive67, 68 
Co-variates 
Med serv utilization 
Medication use 
# visits in the last week (during Tx) or last month (all others) 
participant report  
Mediators: 
Biological 
Change in EEG 
Theta, alpha, beta, and gamma bandwidth power  
Mediators: 
Psychological 
Pain acceptance 
Catastrophizing 
Mindfulness 
Therapeutic Alliance 
Motivational 
Systems 
Happiness 
Practice 
Chronic Pain Acceptance Ques. 69 
Pain Catastrophizing Scale 70 
Five Facet Mindfulness Questionnaire- Short Form71 
Working Alliance-Short Form 72 
BIS/BAS73 
 
Subjective Happiness Scale74 
Self-report of between-session skill practice 
Moderators 
Baseline EEG 
Hypnotizability 
Tx outcm  expec 
Tx motivation 
Age, sex/gender, 
race/ethnicity 
Pain type 
5 cog functioning 
domains 
Functional 
Comorbidity 
Back Pain 
Theta, alpha, beta, and gamma power 
Stanford Clin Hypno Scale 75-77 
Treatment Eff Scale 78-80 
5-point Likert scale 
Demographic questionnaire 
 
LANSS81 and PainDETECT82 
RAVLT, SDMT, Digit Spain, Trail Making A&B, WRAT 4 
 
Functional Comorbidity Index (FCI)83 
 
STarTback84 
 
 
Brain state will be assessed using standard practices for ensuring valid and reliable EEG 
measures (e.g., careful training and supervision of research assistants in Brain wave activity 
assessment procedures, checking impedance of all sites, not assessing women during menses, 
instructing participants to avoid muscle activity during the assessment). EEG will be recorded 
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with a dense array (128 electrodes) using an electrode cap. EEG analysis will be from a 
weighted average reference montage. During each assessment, EEG will be collected at a 
sample rate of 500 Hz over at least 10 minutes of an eyes-closed condition.   
To ensure that participants do not sleep during the assessments, we will monitor participant 
alertness and include occasional verbal reminders to stay awake.   
 
The primary EEG analysis will measure ratios of theta (4-7.5 Hz), alpha (8-12 Hz), beta (12-
32 Hz), and gamma (38-42 Hz) frequency ranges over the whole brain from artifact free 
segments. Power ratios will be computed for each individual bandwidth (e.g., delta/total power). 
The final EEG measures will consist of composite scores of EEG activity averaged from 60 sec 
epochs (after excluding epochs with artifacts). 
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Table 5. Study Assessment Schedule, Main Phase 
Measures 
Screening 
Pre-
Treatment 
Treatment 
During 
Treatment 
Post-
Treatment 
3 Month 
6 Month 
6-Item Screener51 
X 
 
 
 
 
 
 
Stanford Clin Hypno Scale 75-77 
 
X 
 
 
 
 
 
Treatment Expectancies/Credibility78-80 
 
X 
 
X* 
 
 
 
Treatment Motivation 
 
X 
 
 
 
 
 
Demographic Information 
 
X 
 
 
 
 
 
LANSS81 and PainDETECT82 
 
X 
 
 
 
 
 
SDMT, Digit Span, RAVLT, Trail Making, WRAT 
 
X 
 
 
 
 
 
Deployment History 
 
X 
 
 
 
 
 
History Sexual Trauma 
 
X 
 
 
 
 
 
Use of HYP or MM in the past 
 
X 
 
 
 
 
 
Substance Dependence or Abuse( WHO ASSIST)85 
 
X 
 
 
 
X 
X 
Two- Item Conjoint Screening (TICS)86 
 
X 
 
 
 
X 
X 
Functional Co-Morbidity83 
 
X 
 
 
 
 
 
StarT Back Screening Tool84 
 
X 
 
 
 
 
 
Average of up to 4, 0-10 recall NRS of average pain intensity 
 
X 
 
X 
X 
X 
X 
Average of up to 4, 0-10 recall NRS of  worst pain intensity 
 
X 
 
X 
X 
X 
X 
PROMIS Depression SF62 
 
X 
 
X 
X 
X 
X 
PROMIS Anxiety SF62 
 
X 
 
X 
X 
X 
X 
Depression, Anxiety, Stress Scales 21-item (DASS-21) 
 
X 
 
 
 
 
 
Unvalidated Sleep Questions 
 
X 
 
 
 
 
 
PROMIS Sleep Disturbance SF62 
 
X 
 
X 
X 
X 
X 
PROMIS Pain Interference SF62 
 
X 
 
X 
X 
X 
X 
PROMIS Global Health65 
 
X 
 
X 
X 
X 
X 
PTSD Checklist-Civilian version 63 
 
X 
 
X 
X 
X 
X 
Medication Use 
 
X 
 
X 
X 
X 
X 
Medical Services Utilization 
 
X 
 
 
X 
X 
X 
Theta, alpha, beta, and gamma bandwidth power 
 
X 
 
 
X 
 
 
Chronic Pain Acceptance Ques. 69 
 
X 
 
X 
X 
X 
X 
Pain Catastrophizing Scale 70 
 
X 
 
X 
X 
X 
X 
Five Facet Mindfulness Questionnaire- Short Form 
 
X 
 
X 
X 
X 
X 
Subjective Happiness Scale74 
 
X 
 
X 
X 
X 
X 
BIS/BAS73 
 
X 
 
X 
X 
X 
X 
Working Alliance-Short Form 72 
 
 
 
 X* 
X 
 
 
Self-report of between-session skill practice 
 
 
X 
X 
X 
X 
X 
Pain intensity, comfort, pre- and post- treatment session 
 
 
X 
 
 
 
 
Group Climate Measure87 
 
 
 
X* 
X 
 
 
Participant Engagement, Treatment 
 
 
X 
 
 
 
 
Treatment Satisfaction(PGATS)64, Tx Modality 
 
 
 
 
X 
 
 
Global Improvement58  
 
 
 
 
X 
 
 
Situational Catastrophizing Questionnaire88 
 
X 
 
 
X 
 
 
Relaxation Experience- Brief Scale 
 
 
 
 
X 
 
 
PANAS Positive Affect Subscale66 
 
X 
 
 
X 
X 
X 
PROMIS Psychosocial Illness Impact Positive67 
 
X 
 
 
X 
X 
X 
Neurobehavioral Status Inventory 
 
X 
 
 
X 
X 
 
Group Comfort Questions 
 
 
 
 
X** 
 
 
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*Administered during the treatment phase of the study only at the two-week assessment timepoint. 
** Administered anytime after session 8 (final group session). Late measure: Administered only to 
Cohorts 11,12. Measure is optional. 
 
Sub-Study: 
We will pair sleep data with the data ( demographic, descriptive, outcome, covariate, 
mechanism, etc.) that are collected as part of the main study. 
 
Primary outcome variable: Sleep Quality and Duration. 
Three times during his/her participation in the sub-study, we will ask the participant to wear 
the actigraph (Actiwatch , Philips Respironics, Bend, OR) like a wrist watch on his/her non-
dominant arm.  The device will measure how long the participant sleeps, as well as the overall 
quality of his/her sleep. 
 
In addition, we will ask the participant to keep what we call a sleep diary while wearing the 
actigraph, as well as call a toll free number twice a day to report when s/he woke up in the 
morning, and when s/he is going to sleep in the evening.  These data will be used to validate 
the objective sleep data collected by the actigraph. 
 
Mediator variable: Sleep Self-Efficacy 
In addition to the mediators already examined within the main study, sleep self-efficacy will 
be explored using a 4-item Sleep Self-Efficacy and Control Scale.89 This measurement is 
relevant with regard to whether the adoption of new skills increases participants’ confidence that 
they can self-manage their sleep habits.89 Gains in self-efficacy have been linked to significant 
reductions in chronic disease burden, affective symptoms and disability90, 91 and are relevant to 
future planned work to maximize the effects of sleep and pain self-management. 
 
Additional covariate and mechanism variables will be captured to explain sleep findings more 
completely. Routine and “as required” (PRN) medications for each participant will be recorded 
on the 7-day sleep log to aid in understanding how sleep or pain medicines relate to sleep 
measurements. 
 
D6u. Treatment Fidelity Monitoring  
 
Main Study: 
We will take a number of steps to ensure that the treatment protocols are delivered 
uniformly. First, all treatments will be provided by clinicians who will be trained and supervised 
by the study investigators with a great deal of experience in providing such interventions. 
Second, all of the study clinicians will be provided with detailed treatment manuals. Third, 
adherence and fidelity will be monitored using audio recordings of the treatment sessions. The 
study investigators will review a random selection of these recordings throughout the study to 
ensure that procedures are followed. Corrective feedback will be provided to all clinicians 
regarding their adherence to the established protocols. 
 
 
 
 
 
 
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D6v. Data Collection and Management  
Main Study and Sub-Study: 
Data will be collected at the Seattle and American Lake divisions of the VAPSHCS, and the 
Integrated Brain Imaging Center (IBIC) at the University of Washington. The UW Principal 
Investigator (PI; Dr. Mark Jensen) and the research manager will be located at the University of 
Washington, whereas the VA PI (Dr. Rhonda Williams) and VA coordinator will be located at the 
Seattle VAPSHCS division. Data will be obtained from participants either via telephone or in 
person in an outpatient setting using the approved study case report forms.  
Trained study personnel will conduct the screening interview either in person or via 
telephone at the VAPSHCS using a structured format in which the interviewer asks questions 
from a script and also notes the answers on a case report form. The same case report form will 
be used to guide the medical record review to ensure that the same historical information is 
gathered and coded for all participants.  
 
The self-report assessments and psychological and cognitive assessment consist of 
standardized protocols with specific/scripted questions and scoring systems that quantify 
answers. All study personnel from all study sites who will be gathering data from these sources 
will be trained by the PI regarding the collection of data and will have professional education 
and training as required by these instruments. 
 
Data will be de-identified and labeled with a code number that is unique to each participant 
in the study. The participant code numbers will consist of an arbitrary number consecutively 
numbered in order of screening/medical record review/approach (e.g., 1001, 1002, etc.). All 
hard copy data will be stored in locked filing cabinets in locked rooms at the VAPSHCS, while all 
electronic data will be stored in password-protected files in a limited access folder on the secure 
VA network drive. Study researchers will maintain a key code that links that study participants 
with their coded identifier. This key code will be stored separately from all other study data. Any 
materials with protected health information (e.g., Informed Consents) will be stored in separate 
locked filing cabinets from de-identified, coded materials to ensure the security of participant 
privacy. Special multilevel data security programs have been written into the network operating 
system to ensure that only authorized research personnel have access to the Center Network. A 
computer log is maintained of all system login attempts.  
 
A database will be developed using Microsoft Access by the UW team. Once created, the 
database will be tested, any flaws fixed, and then the final version will be uploaded to the VA 
secure network drive. This database will be supported throughout the study by the UW study 
team.  
 
Two separate study support persons will enter data from the hard copy forms into the 
database to ensure accuracy of data entry. All data entry discrepancies between these two data 
entries will be solved locally by the research manager.  
 
‘Hard copy source documents will be stored at either the American Lake or Seattle VA 
site.  If source documents need to be transported from one site to the other, they will be 
transported by a research staff member via VA shuttle transportation.  The source documents 
will have only the 4-digit sub ID to identify subjects.  The source documents will not contain 
PII.  The source documents will be transported using either a standard briefcase or a packing 
box. All data entry will take place within five business days of collection.’ 
 
 
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In addition, any source documents completed at the UW site will be sent using a delivery 
service that provides shipment tracking and delivery confirmation (e.g., Federal Express) to the 
VAPSHCS Seattle division site. Only approved study personnel will be able to access the 
databases and digital audio files. 
 
All study data will be recorded directly on the CRFs except for the following data: 
 
1) Inclusion and exclusion criteria extracted from Veterans’ medical records during the  
screening process; 
2) data collected during treatment that will be extracted from participants’ medical records;  
and 
3) brain wave activity data collected during the EEG assessment.   
4) Sleep quality and duration data from the actigraphy device (sub-study only). 
 
Sub-Study Only: 
 
Sleep/Wake Diary  
The participant will send back the completed sleep/wake diary to WSU study researchers 
at the Spokane Sleep and Performance Research Center in a provided self-addressed 
stamped envelope along with the actigraph device. WSU research staff will use the sleep 
diary as a reference only for the data downloaded from the actigraph device; no data from the 
sleep diary will be entered into a database at that time.  WSU research staff will then send the 
completed sleep diaries in de-identified form to VAPSHCS staff via postal mail, who will then 
enter the data into the secure database with all other main study data.  The original hard 
copies will be filed at the VAPSHCS in a locked office separate from participant identifiers.  
 
 
Also, the participant will be instructed to call a toll free number twice a day to report when 
s/he woke up in the morning, and when s/he is going to sleep in the evening.  The number will 
be housed at the VAPSHCS, and only accessible to study staff.  If a voicemail is left by the 
participant: staff will delete the voicemail after research staff record the data provided using 
the case report form.  Participants will be advised to leave his/her study ID only without any 
identifiers. These instructions will be given to the participant either in person or via postal mail. 
 
Actigraphy Device   
The participant will be instructed to send back the actigraph to WSU study researchers in 
a provided self-addressed stamped envelope at the end of the three data periods along with 
the sleep diary. WSU research staff will download the data collected by the actigraph device.  
The data will be stored on a secure WSU server in de-identified form indefinitely.  Data may 
be downloaded from the Actigraph only with the assistance of  Actigraph software unavailable 
to the general population. 
  
WSU research staff will send the aforementioned Actigraph data cover page along with the 
daily diary of each participant to VAPSHCS research via postal mail in de-identified form.  
VAPSHCS will enter the data recorded on the actigraph data cover page into the secure 
database with the main study data.  The original hard copies will be filed at the VAPSHCS in a 
locked office separate from participant identifiers.  
WSU research staff will not have access to any identifying information of research 
participants collected and stored by VAPSHCS research staff. 
 
Blinded/Unblinded Research Staff 
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The following table describes details regarding who among the study investigators and research 
staff will be blinded and when they will be blinded. 
 
Study Researcher 
Blinded/Unblinded and  
Reason 
When Blinded 
Mark P. Jensen, Ph.D. 
Blinded (will oversee data  
fidelity) 
Blind during data  
collection  
phase of study. 
Rhonda M. Williams, Ph.D. Unblinded (Dr. Williams will  
be responsible for group  
roster collection and addressing  
clinical issues) 
N/A 
Marcia Ciol, Ph.D. 
Blinded (will help manage  
outcome data) 
Entire study. 
Dawn M. Ehde, Ph.D. 
Blinded  (no opportunity for unblinding) 
Entire study. 
Kevin Gertz, M.P.A. 
Blinded (will help manage  
outcome data) 
Blind during data  
collection phase of  
study. 
Shahin Hakimian, M.D. 
Blinded  (no opportunity for unblinding) 
Entire study. 
Dave Patterson, Ph.D. 
Blinded  (no opportunity for unblinding) 
Entire study. 
Melissa Day 
Blinded  (no opportunity for unblinding) 
Entire study. 
Aaron Turner, Ph.D. 
Unblinded (Dr. Turner will  
serve as back up for  
Dr. Williams for group  
roster collection 
and addressing clinical  
issues.) 
N/A 
Carrie Kincaid, B.A. 
Unblinded (Assist with coordination of  
collection and entry of treatment data, assist w
treatment fidelity) 
N/A 
Alisha McCall, B.A. 
Blinded (will collect outcome 
data) 
Blind during data  
collection  
phase of study. 
Genevra Vanhoozer, B.A. 
Blinded (will collect outcome 
data) 
Blind during data  
collection  
phase of study. 
Derek Anderson, Ph.D. 
Unblinded (will be leading treatment 
groups) 
N/A 
Jenny Bambara, Ph.D. 
Unblinded (will be leading treatment 
groups) 
 
N/A 
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Megan Miller, Ph.D. 
Unblinded (will be leading treatment 
groups) 
 
N/A 
Moriah Brier, MA 
Unblinded (will be leading treatment 
groups) 
 
N/A 
Sarah Noonan, Ph.D. 
Unblinded (will be leading treatment 
groups) 
 
N/A 
Kaitlin Harding, MS 
Unblinded (will be leading treatment 
groups) 
 
N/A 
 
 
 
WSU Sub-Study Researchers 
 
Study Researcher 
Blinded/Unblinded and  
Reason 
When Blinded 
Marian Wilson, Ph.D. 
Blinded  (no opportunity for unblinding) 
N/A 
Hans van Dongen, Ph.D. 
Blinded  (no opportunity for unblinding) 
N/A 
Kimberly Honn, Ph.D. 
Blinded  (no opportunity for unblinding) 
N/A 
Devon Grant, Ph.D. 
Blinded  (no opportunity for unblinding) 
N/A 
Julie Erwin 
Blinded  (no opportunity for unblinding) 
N/A 
Lillian Skeily 
Blinded  (no opportunity for unblinding) 
N/A 
 
 
 
D6x. Statistical Analyses 
 
 
Main Study: 
 
Addressing Aim 1 by testing Hypothesis 1.General Approach to Analyses.  
For the primary analyses addressing Aim 1, we will use an intent-to-treat (ITT) approach, 
which analyzes all participants who were randomized in their respective assigned treatment, 
regardless of how much they actually received of that treatment.   
 
 
Missing Data. Analyses to identify potential patterns in missing outcome data will be 
conducted to determine if they are missing at random (“ignorable”).  Missingness at random is 
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not testable, but we can look at the variables that were observed in groups with and without 
missing outcomes data. No association between observed variables and the group (missing vs. 
no missing) will be considered an indication that the data are missing at random.  In addition, we 
will look at the reported reasons for missing values when available.  If we can assume data are 
missing at random, we will use multiple imputation procedures.  If there appear to be non-
random missing outcomes data, we will use two methods designed to account for this: 
Heckman’s selection models and pattern-mixture models, both of which model the joint 
distribution of the outcome and the missing mechanism. In the case of non-ignorable missing 
data, we will use both methods as a sensitivity analysis.   If less than 5% of the data is missing 
and we can assume ignorable missing data, the following analysis will be performed. 
 
 
 Hypothesis 1 states that Veterans randomly assigned to receive eight group sessions of 
HYP or MM will report significantly greater pre- to post-treatment decreases in average pain 
than Veterans receiving eight sessions of ED.  The response variable will be change in average 
pain intensity score from pre- to post-treatment (Pre-treatment score – Post-treatment score).  
This response variable will be analyzed using an analysis of covariance (ANCOVA) with 
treatment condition (HYP, MM, ED) as the explanatory variable and the baseline pain as a 
covariate.  
 
Support for Hypothesis 1 would emerge if a significant treatment main effect is present after 
adjusting for the baseline covariate, and subsequent post-hoc analyses indicate larger baseline 
to post-treatment decreases in pain intensity in the HYP and MM conditions, relative to the ED 
condition.  The overall significance level for the test of the null hypothesis that all three 
treatments have equal effect will be set to 0.05.   
 
Although we anticipate that HYP and MM will have similar effects on the primary outcome 
variable, these analyses will also allow us to compare the relative effects of HYP and MM with 
each other, as part of the exploratory aims/analyses. 
 
Pairwise comparisons of the treatment groups will be performed using Tukey method (see 
for example, Analysis of Messy Data Volume 1: Designed Experiments, Second Edition, by GA 
Milliken and DE Johnson. 2009, chapter 3).   
Addressing Aim 2 by testing Hypothesis 2. Hypothesis 2 states that baseline EEG 
activity will predict differential response to HYP and MM, such that those participants who have 
higher baseline levels of global theta, and lower baseline levels of left frontal gamma will 
respond to HYP, while participants with lower baseline levels of global alpha will respond to MM.  
We will test for this moderator using a linear regression analysis, with pre- to post-treatment 
change in pain intensity as the response (criterion) variable.   
Treatment Condition, absolute power of baseline theta, alpha, and (left frontal) gamma, and 
terms representing the interaction between treatment condition and each EEG bandwidth will be 
the explanatory variables.  Significant Treatment Condition X Theta, Alpha, and Gamma 
interactions, with higher coefficients for baseline theta and lower coefficients for baseline 
gamma in the HYP group, and lower coefficient for baseline alpha in the MM group would 
support Hypothesis 2. 
 
Additional exploratory analyses.  In addition to testing the two study hypotheses, we 
propose a series of exploratory analyses (explained below) to take full advantage of the data 
collected to better understand the effects and potential mechanisms of HYP and MM.  However, 
because these analyses are exploratory, we will report them as such.  Any statistically 
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significant findings will be viewed as providing support for further, more definitive, testing in the 
future. 
 
Effects of HYP and MM on secondary outcomes.  To examine the potential effects of 
HYP and MM, relative to ED, on co-morbid conditions, we will repeat the ANCOVA analyses 
planned to test Hypothesis 1 for the secondary outcome variables (assessing pre- to post-
treatment decreases in depression, anxiety, sleep disturbance, pain interference, PTSD 
symptoms) as the response variables,  controlling for the respective baseline measures of these 
secondary outcomes.   The response variable will be change in each outcome measure score 
from pre- to post-treatment (Pre-treatment score – Post-treatment score).  This response 
variable will be analyzed using an analysis of covariance (ANCOVA) with treatment condition 
(HYP, MM, ED) as the explanatory variable and the corresponding baseline value for each 
secondary outcome measure as a covariate.   
 
Perceived global improvement is a secondary outcome measure but unlike the other 
secondary outcome measures it was not measured at baseline, hence a slightly different 
approach will be used for this secondary outcome measure. Instead of a change score, we will 
simply use ANOVA to compare perceived global improvement with treatment condition as the 
independent variable. 
 
To assess the effect of each treatment on post-treatment ratings of global satisfaction(which 
has only 5 categories), we will use  an ordinal polytomous logistic regression.  Because we 
anticipate that both HYP and MM will have significant beneficial effects on outcomes, we do not 
anticipate large differences between these two interventions in the outcome measures. 
However, we think that it would be important to estimate differences in outcome between the 
two active treatments for descriptive purposes. To do so, we will perform pairwise post-hoc tests 
to compare the means of the three groups. 
 
We will report both the p-value and effect sizes for the tests  between the two conditions 
(HYP and MM) on outcomes.  While the study was not powered to simultaneously test for the 
primary and secondary outcomes, it is reasonable to assume that the sample size of 80 
participants per condition (determined to adequately power the primary hypotheses) will allow 
for reliable estimates of the effect sizes for secondary outcomes as well. 
 
Longer-term effects of HYP and MM, relative to ED.   
As part of our exploratory aims, we plan to assess the extent to which change in pain 
intensity, the primary outcome, is maintained at 3 and 6 months post-treamtent, and to see if 
longer term changes in pain intensity differ between HYP and MM compared to ED. To assess 
this, we propose to use a Generalized Estimating Equations (GEE) approach, which accounts 
for the correlated nature of the data due to multiple observations of the same person over time. 
Response variables over time will be the change from pre-treatment to post-treatment, and pre-
treatment to 3- and 6- months follow-ups, with intervention group and follow-up time as the main 
factors of interest (including a Group X Time interaction), and the pre-treatment value as the 
covariate.  For the correlation matrix, we will assume an unstructured format, since there was no 
a priori reason to use a more structured matrix format.  We will repeat these analyses for the 
secondary outcome measures mentioned above.   
 
Mediation analyses.  
The goal of  mediation analyses is to examine whether group assignment (determined by 
randomization at baseline) impacts the change in pain intensity (primary outcome) from baseline 
to post-treatment through indirect effects on the hypothesized mediators (measured midway 
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between baseline and post-treatment). Our potential mediators have been identified a priori and 
are shown in the table of measures (Table 4).  
To evaluate the association between intervention type, potential mediating factors, and 
change in pain intensity, we will first run models with individual mediators to get unadjusted 
estimates and to estimate the degree of confuouding in subsequent multivariate models. Per 
Hayes & Rockwood’s 2017 recommendations, we will test multiple mediators in the same 
model, to more accurately reflect our theoretical understanding of parallel biological and 
psychological mediating processes, and to facilitate comparison of the size of indirect effects 
through different mediators. Mediators to be included in the model include change in EEG 
composite scores for theta, alpha, beta, and gamma bandwidths, pain acceptance, 
catastrophizing, mindfulness, therapeutic alliance, and skill practice.   Also per the 
recommendations of Hayes and Rockwood (2017), we will compute bootstrap confidence 
intervals for the indirect effects.  All mediation analyses will be done using PROCESS, a free 
downloadable add-on available for SPSS and SAS (the analysis packages we will use for the 
study’s data analysis). PROCESS includes the computational code to generate a primary 
estimate for the mediation model which represents the indirect, or mediated effect, and allows 
for inclusion of moderator variables.   
 
Our study is longitudinal and, in addition to posttreatment assessments, we have collected 
data at 3- and 6-months post-treatment on outcomes and all other variables (mediators and 
moderators).  While the approach used in the PROCESS software can be somewhat adapted 
for longitudinal analysis, the most appropriate analysis would be longitudinal structural 
equations models, particularly latent growth models (e.g., Goldsmith et al. 2018).  These models 
require specialized software such as AMOS or LISREL and are beyond the scope of our 
exploratory aims.  If we are able to access such statistical resources in the future, however, we 
would like to leverage this dataset for these exploratory purposes.   
 
Additional moderator analyses. As in any study, we are interested in exploring whether 
the treatments have different effects at different levels of other variables, that is, if there are 
interactions between treatments and those variables (which then would be called moderators). 
In our study, we have 16 potential moderators (e.g., demographic variables, baseline beta 
activity, etc., see Table 4).   Given the large number of potential moderators and their 
interactions with treatment, it would not be adequately statistically powerful nor easily 
interpretable to include all of them in a single model at once.  On the other hand, 16 models with 
a single potential moderator would not give a realistic picture of how the moderation effects 
were acting in the population of interest.  To address these concerns, we propose to first  
assess the correlations between the potential moderators.  If two or more potential moderators 
are highly correlated, we are unlikely to enter them in the same model (due to collinearity) and if 
necessary will  choose one of them (based on what is know about the variable, such as how 
reliable it is) to continue as a candidate.   
This process might reduce the number of potential moderators in a way that uses both empirical 
support (correlations) and integrates our theoretical knowledge about the variables.  Once the 
potential moderators have been winnowed to a smaller number,  we will construct the models 
gradually, by including potential moderators and their interaction with treatment in a forward 
fashion (in the order of statistical signifcance).  Hayes and Rockwood (2017) recommend use of 
the macro PROCESS for this, which writes the SPSS syntax for a specified model. Statistically 
significant Treatment Condition X Moderator interactions would suggest that the impact of the 
moderator variable on outcome differs as a function of treatment condition. In the absence of 
interaction, statistically significant main effects for the potential moderators would suggest that 
they might be associated with the outcome.  Given the very large number of exploratory 
moderator analyses proposed, we will be very cautious in interpreting the results, and will use 
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these analyses only as a way of identifying potential moderators to examine more closely in 
future research.  
 
The moderation/mediation analyses described above are exploratory in nature.  As a result 
we will not implement a multiplicity adjustment for these analyses. Study researchers will ensure 
that publications report all the analysis results and specify the total number of exploratory 
analyses that were conducted. 
 
Sub-Study: 
We will pair sleep data with the demographic and descriptive information as well as the pain 
outcomes that are collected as part of the main study. All data will be de-identified and linked 
only by a participant ID code and all data sharing will be done in accordance with the 
collaborating institutional human participants’ committees.  
 
For aim 1 of this supplemental study, the primary outcome measures are (1) self-reported 
sleep quality (subjective sleep assessment on the continuum from “good” to “poor” sleep), and 
(2) actigraphic sleep duration (the total amount of sleep per 24 hours measured objectively with 
wrist actigraphy). Secondary outcomes include self-reported and actigraphy-based sleep timing 
and continuity.  
 
For the statistical analyses in support of aim 1, we will compare sleep quality and duration in 
self-hypnosis and mindfulness meditation treatment groups as measured by self-report and 
through wrist actigraphy from pre-treatment to immediate post-treatment, and at 3-month follow-
up, relative to sleep quality and duration at the same time points in the education control group. 
We hypothesize that participants in the two treatment groups will show improvements in self-
reported sleep quality and in actigraphic sleep duration both immediately post-treatment and at 
3-month follow-up, relative to the control group. We will test this hypothesis, for each of the two 
primary outcome measures, by means of mixed-effects analysis of variance (ANOVA), where a 
random effect will be placed on the intercept, and the hypothesis tested with planned contrasts 
between conditions, at each time point, embedded in the mixed-effects ANOVA framework.92 
Secondary analyses will use additional key demographic variables (age, sex/gender, 
race/ethnicity, medications) as covariates.  
 
For aim 2 of this supplemental study, the primary outcome measures will be paired with the 
primary pain  outcome from the parent grant as measured with a 0–10 numeric pain intensity 
scale.41  
 
 
 
As a secondary sleep outcome, for this aim we will add the PROMIS Sleep Disturbance Short 
Form, which is already being administered as a self-report measure of sleep quality within the 
parent project. This will allow us to evaluate the level of congruence between the parent grant 
and the subsample studied in the supplement.   
 
For the statistical analyses in support of aim 2, we will determine whether changes in self-
reported sleep quality and in actigraphic sleep duration in the hypnosis and mindfulness 
meditation treatment groups and the control group precede changes in pain, or vice versa, from 
pre-treatment to mid-treatment to immediate post-treatment to 3-month follow-up. Specifically, 
we will evaluate the association between early treatment changes in self-reported sleep quality 
(from pre-treatment to mid-treatment) and late treatment changes in pain (from mid-treatment to 
post-treatment), and vice versa.  
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We will also evaluate the association between treatment-related changes in objective sleep 
duration (from pre-treatment to post-treatment) and post-treatment changes in pain (from post-
treatment to 3-month follow-up), and vice versa. We hypothesize that changes in sleep quality 
and duration precede (and thus predict) subsequent changes in pain intensity. Secondarily, we 
will investigate whether associations are moderated by treatment group. We hypothesize that 
larger lagged effects will occur for the two treatment conditions, relative to the control condition. 
Our hypothesis testing for aim 2 will be based on cross-lagged regression analysis.103, 104  
 
Additional covariate and mechanism variables will be captured to explain sleep findings more 
completely. Routine and “as required” (PRN) medications for each participant will be recorded 
on the 7-day sleep log to aid in understanding how sleep or pain medicines relate to sleep 
measurements. Sleep data will be analyzed for relationships with data already collected within 
the parent grant, including depression scores and self-report of new self-hypnosis and 
mindfulness meditation skills practiced. In addition to the mediators already examined within the 
parent grant, sleep self-efficacy will be explored using a 4-item Sleep Self-Efficacy and Control 
Scale.89 These mediator variables will be related to the sleep outcomes (not the pain outcomes 
as those are already analyzed for covariates in the parent grant) by including them as 
covariates in mixed-effects ANOVA, controlling for condition and time point. These will be 
exploratory analyses where type II error is more problematic than type I error; therefore no type 
I error threshold correction is envisioned. Mediator analysis results will be explicitly reported as 
exploratory. 
 
 
D6y. Missing Data 
 
Analyses to identify potential patterns in missing outcome data will be conducted to 
determine if they are missing at random (“ignorable”).  Missingness at random is not testable, 
but we can look at the variables that were observed in both, group with missing and without 
missing outcomes data. No association between observed variables and the group (missing vs. 
no missing) will be considered an indication that the data is missing at random.  In addition, we 
will also look at the reported reasons for missing values (when available).  If we can assume 
missing at random data, we will use multiple imputation procedures.  Currently, two methods are 
used when the data is considered not missing at random: Heckman’s selection models and 
pattern-mixture models, both of which model the joint distribution of the outcome and the 
missing mechanism. In the case of non-ignorable missing data, we will use both methods as a 
sensitivity analysis. If less than 5% of the data is missing and we can assume ignoble missing 
data, the following analysis will be performed. 
 
D6z. Power Analyses 
 
We performed power analyses, reported below, to ensure that the study had more than 
adequate power to test the hypothesis related to the effects of the treatments on the primary 
outcome (average pain intensity).   
 
Power to test the primary study hypothesis. The primary study outcome variable is 
change in average pain intensity, as represented by the difference between the baseline and 
post-treatment average pain intensity measures.   
We have used this measure successfully in numerous previous trials.41, 42, 52, 105, 106 Anticipated 
effects for HYP are based on the changes observed in our previous HYP trials using the 0-10 
NRS measure, plus our pilot study of HYP for low back pain treatment, reported in the 
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‘Preliminary findings’ section.   
 
Anticipated effect sizes for MM are based on published studies of the effects of treatments 
that involve mindfulness that used 0-10 NRS measures.   
 
Assuming a decrease in pain score of 0.3 points for the education group, 0.8, 1 and 1.4 for the 
HYP, and 0.6, 0.8 and 1 for MM, we calculated the sample size to find differences between pre-
post treatment difference scores, with an alpha of 0.05, power of 0.80, and varying the standard 
deviation (SD) from 0.15 to 1 (to cover values observed) when using an ANOVA. Sample sizes 
of 80 completers per condition (total = 240) will have at least 80% power, even at the largest 
standard deviation.   
 
Power for secondary and exploratory analyses.   
The sample size calculations above take into consideration only the primary hypothesis of 
interest (that different treatment have different effects in changing pain intensity), which is the 
most important result this study can provide for the person affected with chronic pain.  However, 
the sample size of this study is relatively large and will provide extremely useful and important 
information regarding secondary outcomes, mediators and moderators associated with pain 
intensity and EEG.  The results will form the basis for continuing research not only to find 
treatments that are efficacious, but also to hypothesize mechanisms of action, which will be 
crucial in designing future studies.   
 
Power Calculations (Sub-Study) 
We focus our power calculations on the most innovative aspect of the supplemental study, 
that is, the objective measurement of sleep by means of wrist actigraphy in the context of non-
pharmacological pain treatments.  
 
We base our power calculation on a previous study that is informative of the statistical power 
found in sleep duration data from wrist actigraphy as collected in naturalistic repeated-measures 
settings. In this previous study, 24 regional airline pilots participated in a two-day flight simulator 
study.107 In the day before the study, they flew into the airport where the flight simulator center 
was located, and that night they planned their sleep naturalistically. As the pilots discovered that 
the workload during the study was high, they extended their sleep in the night between the two 
study days in order to recuperate. As measured by wrist actigraphy (same type as will be used 
in the supplement), the sleep duration in the night prior to the second study day was significantly 
greater than the sleep duration in the night prior to the first study day, by a difference of 1.35 
hours (t23=3.97, P<0.001). The correlation of sleep duration between nights was ρ=0.122. 
Relevant for our power calculation is also the systematic between-subjects standard deviation, 
which was SD=26.3 minutes. 
 
In aim 1 of the supplemental study, we will use wrist actigraphy to compare sleep pre-treatment 
to immediately post-treatment (8 weeks) and to 3-month follow-up, relative to sleep at the same 
time points in the control group. Thus, we will make two repeated-measures comparisons: pre-
treatment to post-treatment in the intervention group relative to the control group, and pre-
treatment to 3-month follow-up in the intervention group relative to the control group. Because 
each of these two comparisons defines an interaction effect, which is inherently low on 
statistical power, we set the a-priori type I error threshold to α=0.1.108 However, because we will 
do two comparisons using the same pre-treatment data, we must also control for multiple 
comparisons. Therefore, after applying Bonferroni correction, we end up with a type I error 
threshold of α=0.05.  
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To make use of the statistical power conferred by systematic between-subjects variability,102 
we will employ mixed-effects ANOVA to implement the test (which then again takes the form of 
an interaction effect).  
For power calculation purposes this is relevant in that the standard deviation of interest is 
therefore the systematic between-subjects standard deviation provided above (which, in a 
comparison between independent samples, serves as the estimated pooled standard deviation).  
 
Also, as we expect that treatment will improve sleep and we will only consider the effect 
beneficial if it involves extension of sleep duration, one-sided testing will be used. We will 
consider a mean increase in sleep duration of M=15 minutes or more to be clinically relevant.109 
Thus, we seek to demonstrate an effect size of Cohen’s d=M/SD=15/26.3=0.57. To achieve 
80% statistical power at a type I error threshold of α=0.05, we will need to study 39 participants 
per group (nQuery 7.0, Elashoff, 2007). Thus, we will need to study 39 participants in each of 
the two treatment groups and 39 participants in the control group. As such, our target sample 
size for the supplemental study is N=117.  
 
For aim 2 of the supplemental study, with 39 subjects in each treatment group we will have 
the ability to investigate the relationship between actigraphically measured sleep duration and 
pain outcomes from the parent project. For each of the two intervention groups, we will first use 
a regression model on subjective pain with sleep duration as the covariate of interest, and our 
objective will be to test the regression coefficient for this covariate against zero (two-tailed). With 
39 subjects, we will have 80% statistical power, at a type I error threshold of α=0.05, to detect a 
relationship between sleep duration and subjective pain if this relationship explains at least 
17.5% of the variance (nQuery 7.0, Elashoff, 2007). 
 
We will then apply an autoregressive cross-lagged model to investigate the cross-lagged 
relationship between actigraphically measured sleep duration and pain outcomes from the 
parent project. For each of the two intervention groups, we will use an autoregressive 
regression model on sleep duration with subjective pain as the covariate of interest, and our 
objective will be to test the regression coefficient for this covariate against zero (two-tailed). We 
will account for the variance in sleep duration at the post-intervention and follow-up time points 
that is explained by sleep duration at the respective immediately preceding time point, ρ2, where 
the estimated value for ρ is drawn from our previous data set described above (ρ=0.122). With 
39 subjects, we will have 80% statistical power, at a type I error threshold of α=0.05, to detect a 
cross-lagged relationship between sleep duration and subjective pain at the immediately 
preceding time point if this relationship explains at least 17.3% of the variance (nQuery 7.0, 
Elashoff, 2007).   
HUMAN PARTICIPANTS SECTION 
 
1. Risk to Participants 
 
1a. Human Participants Involvement and Characteristics 
 
We plan to enroll up to 343 355 participants into the study.  Male and female participants 18 
years of age or older who have chronic pain will be approached to participate in the study. 
Participants will be recruited from clinics at the Seattle and American Lake Campuses of 
VAPSHCS, as well as community-based outpatient clinics (CBOC). 
 
Veterans will be recruited from several clinics and service lines at VAPSHCS: the 
Rehabilitation Care Service (which includes the Polytrauma Network Site for the northwest four 
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states, the Multiple Sclerosis Clinic/Center of Excellence, Prosthetic/Limb Loss Clinic, and 
Musculoskeletal Clinic), and the Spinal Cord Injury Service. Each of these clinics sees 200-500 
new Veteran patients per year and carries an ongoing patient load of 200 – 400 patients. We 
will also recruit patients from Primary Care as needed, which carries an ongoing patient load of 
19,000 patients per year. 
 
Participants will also be recruited from VA community-based outpatient clinics (CBOC). 
 
1b. Sources of Materials 
 
Several sources of information will serve as data for the study, including medical record 
reviews, self-report assessments, cognitive tests, brain activity assessments, and audio-
recorded treatment sessions (to be used for supervision and determination of adherence and 
fidelity). The study design involves non-invasive procedures.  
 
The data described other than the data collected during the group treatment sessions will be 
collected solely for research purposes. Participants will be informed that  data collected before 
and after treatment sessions, i.e. data regarding homework practice, pain intensity and comfort 
before and after each treatment session, and participant engagement as per the study clinician, 
will be reported in their medical record, as clinically indicated. Research participation will not 
influence any part of a patient’s medical treatment. 
 
E1c. Potential Risks 
 
General/Reaction to Assessments 
Regarding research risks, participants may experience fatigue and/or boredom while 
completing the telephone assessments, cognitive assessment and the treatment sessions. 
Some participants may also experience mild anxiety, frustration, and/or stress while answering 
questions about depression, anxiety and PTSD symptoms.  As  result of answering questions 
regarding pain and other symptoms, participants may experience a temporary increase in 
intensity and/or distress of symptoms. 
 
Some participants may also experience mild anxiety, frustration, and/or stress if the 
cognitive assessment proves difficult for them, and/or during the course of treatment.  
 
 
 
 
Brain Wave Activity Assessments 
Some participants may find sitting still for up to one hour (including prep time, adjustment 
period and actual assessment) and/or wearing an electrode net on their head to be 
uncomfortable during the EEG assessment. Some participatns may also find a temporary 
increase in their overall pain. Some particpants may find the EEG assessment, including 
questions asked during the EEG, may cause a temporary increase in PTSD symptoms. 
 
Treatment 
The three types of treatment involve discussions and/or exercises about pain and related 
topics in a group setting that may make some individuals feel uncomfortable. In addition, some 
individuals may find it uncomfortable or distressing to hear other Veterans discuss their pain or 
other problems in a group setting.  As  result of group discussions or exercises, participants may 
focus more on their pain, which may lead to a temporary increase in pain intensity and/or 
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distress regarding their pain problem. Some individuals may also experience discomfort 
(numbness, tingling, perceived loss of sensation) from sitting still for extended periods of time. 
 
Regarding the self-hypnosis training, some individuals may find the state of deep relaxation 
associated with hypnosis uncomfortable. Also, some individuals under hypnosis may remember 
past experiences that are uncomfortable and/or cause distress, even after the session has 
ended. In addition, some individuals under hypnosis or practicing mindfulness may also 
experience mild disorientation or grogginess during or after the session has ended. No stress or 
discomfort is anticipated to be associated with the education control intervention, and there is 
little chance of physical injury from the treatment procedures described above.  
 
Sub-Study: Sleep/Wake Diary 
Participants may experience fatigue and/or boredom while completing the sleep/wake diary. 
Some participants may also experience mild anxiety, frustration, and/or stress while answering 
questions about sleep and activities during the day.   
 
Sub-Study: Actigraphy Device 
Participants may find it uncomfortable or inconvenient in general to wear a device like an 
actigraph both during the day and while sleeping.  There is no risk of electrical shock while 
wearing the actigraph and it cannot track where participants are or what they are doing.  
Participants  may experience sweating or skin irritation while wearing the actigraph if they 
have sensitive skin. 
 
Privacy and Confidentiality 
Participants may also worry about the confidentiality of their responses during the 
assessments. There is a risk of invasion of privacy in that the research staff directly involved 
with data collection will need to keep participants’ names, addresses, and phone numbers for 
the duration of the study in order to contact them for the follow-up assessments. There is also a 
chance that a participant’s identity and participation in the study may be discovered by an 
outside party given the group intervention dynamic. 
 
Mental Health Issues/ Suicidality 
Although unlikely, it is possible that by participating in the study it may be discovered that a 
participant is suicidal or experiencing significant mental health issues. Please note that these 
conditions would also likely be detected in the course of usual care. 
 
 
 
2. Protection Against Risk 
 
General/Reaction to Assessments 
Participants will be informed during the consent process and throughout the study they do 
not have to discuss any topics that they do not wish to during treatment or the assessment 
periods.  In addition, participants will be informed in the consent process that they are free to 
stop any session, treatment or assessment, at any time.  Participants are informed that they 
may refuse to answer any questions that make them feel uncomfortable.  
 
All study personnel who conduct the assessments and treatment interventions will be 
qualified, trained, and closely supervised by the Co-PIs.  
 
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Participants will be provided with emergency contact numbers. All participants will be clearly 
informed of their right to withdraw from the study at any point without adversely impacting their 
routine medical, psychiatric, or psychotherapeutic care. 
 
All participants will be offered the opportunity to discuss any situations or experiences 
associated with the study procedures that they deem uncomfortable or adverse with the VA Co-
PI, Dr. Williams, who is a licensed clinical psychologist.  
 
Dr. Williams is a trained psychologist who has experience assessing the level of distress of 
patients and proceeding accordingly whenever an adverse event should arise. 
 
Brain Wave Activity Assessments 
All research staff will be trained to conduct the brain wave activity or EEG assessments and 
treatment procedures in a safe manner. Participants will be told they can stop any EEG 
assessment at any time if they feel uncomfortable.  
 
The research staff member conducting the assessment will ask each participant following 
completion of the assessment whether they experienced any negative effects during the 
assessment they associate with the study procedures.   
 
Treatment 
Researchers will take multiple steps to ensure and monitor the well-being of participants 
during treatment. These include the following: 1) participants will be asked to complete a form 
after each treatment session that asks participants (research and non-research) if they found 
anything unhelpful about the treatment session. Any reporting of a possible adverse event will 
be reported to Dr. Williams. Should such events be identified, they will follow institutional 
protocols for ensuring appropriate management; 2) the Co-PIs will offer ongoing supervision 
and consultation with study clinicians  including routine assessment of any potential problems or 
adverse events; 3) as needed supervision and consultation will be available for clinicians by 
investigator staff. 
 
Group leaders will take steps to ensure groups are as comfortable as possible by facilitating 
relevant discussion, limiting side conversations, and addressing concerns that are raised. Group 
leaders may ask participants to talk more or less to ensure that everyone has an opportunity to 
participate and the conversation is productive and positive.  
 
 
 
 
Sub-Study: Sleep/Wake Diary 
Participants will be informed during the consent process and throughout the sub-study that 
they may refuse to answer any questions that make them feel uncomfortable while completing 
the sleep/wake diary.  In addition, participants will be informed in the consent process that they 
are free to stop any study-related procedures at any time.   
 
Sub-Study: Actigraphy Device 
Participants will be warned about possible irritation to the skin and general discomfort 
wearing the device during the informed consent session. Participants will be informed in the 
consent process that they are free to stop any study-related procedures at any time.   
 
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F1d. Privacy and Confidentiality 
 
We will take multiple steps to protect participants’ privacy and confidentiality. All data 
collected for the study will be de-identified, labeled with a code number that is unique to each 
participant in the study, and maintained separate from any identifying information.   
All of the data collected from participants, both research and non-research, will be kept in strict 
confidence. No information that is linked to a research participant’s identity will be provided to 
anyone outside of the study without permission from the participant.  
 
As mentioned above, all data collected outside of the treatment sessions will be de-
identified, labeled with a code number that is unique to each research participant, and 
maintained separate from any identifying information. All hard copy study data collected outside 
of the treatment sessions will be stored in locked filing cabinets in locked rooms at the 
VAPSHCS. Hard copy forms containing participant identifiers (consent form, HIPAA 
authorization form, personal data sheet) will be stored in locked filing cabinets in the Dr. 
Williams’ office which is locked at all times, i.e. not in the same location as the study data. 
 
All electronic de-identified data collected outside of the treatment sessions will be stored in 
password-protected databases in a limited access folder on the secure VA network drive. One 
exception to this protocol is the raw EEG data collected from participants, which will be stored 
without identifiers on the HIPAA compliant NAS II drive at the UWMC. Another exception is the 
sleep data collected by the actigraph device worn by participants in the sleep sub-study, which 
will be stored without identifiers on a secure drive at the WSU Spokane Sleep and Performance 
Research Center. WSU research staff will not have access to any identifying information of 
research participants collected and stored by VAPSHCS research staff. 
 
An electronic Master List key code will be maintained that links the participants with their 
code number. This key code will be stored in a password-protected database that does not 
contain any study data. This database will also reside in a limited access folder on the secure 
VA network drive. Only approved study personnel will have access to the Master List key code, 
participant identifying information and de-identified study data. We will analyze and report 
participant data in aggregate form and no PHI will be entered into these analyses or reports. 
 
One exception to the protocol of separating all study data from subject identifying 
information pertains to audio recordings generated for each treatment session. Specifically, the 
group treatment sessions will be audio recorded to make sure study clinicians are following 
study procedures.  The study clinicians will notify participants before the start of the session that 
s/he will be recording the session.  The audio recordings will be collected using a VA approved 
encrypted device that will be stored in a locked filing cabinet when not in use.  
The recordings will be uploaded and stored in a limited access folder on the secure VA network 
drive. Each individual recording will be erased from the audio recorder once it has been 
uploaded to the drive. Audio recordings will only be reviewed by study personnel and used for 
assessing consistency between study clinicians. The audio recordings will not be labeled with 
any participant identifying information. The only identifying information that will be contained the 
in recordings will be participants’ voices and if the study clinician or group members state 
participants’ names during the discussion.  
 
Another exception pertains to data collected during the treatment sessions. Gathering these 
data is an integrated part of the clinical care provided to both research and non-research 
participants in the intervention groups. These data will be used by the clinicians in real time as 
part of clinical care, and include information about homework practice, changes in symptoms 
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that occur within and between sessions, and any subjective participant concerns. Following 
each session, per usual care the clinician will enter a progress note in CPRS for each 
participant, indicating attendance or absence for that particular session. The note will also 
include the length of the group session, as well as basic content covered during the session. In 
addition, all case report forms completed by treatment participants will be scanned and stored 
on a secure drive (PUG_Services (\\RO1PUGHSM03.r01.med.va.gov\RCS\Psychology\SKILLS 
CLINICAL GROUPS) within the Rehabilitation Care Service.  
 
Access to this drive will be limited to clinicians who are running the classes, their clinical 
supervisor and unblinded research staff.  
 
 
F1e. Mental Health Issues/ Suicidality 
 
Although the study poses no serious risks to participants, participants may notify research 
personnel about pre-existing mental health issues that have not been previously identified by 
other VA providers. Therefore, participants will be referred to the VA’s Mental Health Division for 
further assessment and/or treatment if a previously undiagnosed psychiatric disorder is 
identified. We will inform participants of this procedure as part of the informed consent process 
and participants must agree to this procedure to be eligible to participate in the study. This 
ensures that we can adequately manage any pre-existing clinical issues that become apparent 
through participant evaluation. For ethical reasons a subject will not be withdrawn from the 
study if they present unstable and/or severe symptoms related to a psychiatric condition 
following enrollment unless study researchers believe it is in the subject’s best interest to be 
withdrawn.  
 
It should be noted that risk of suicide (defined as being on the suicide high risk list, recent 
self-directed violent behavior) is an exclusion criteria for this study, so we anticipate that the 
likelihood of suicide risk is low. For ethical reasons a subject will not be withdrawn from the study 
if deemed a high suicide risk following enrollment, however, unless study researchers believe it 
is in the subject’s best interest to be withdrawn.  
 
Suicide Risk Assessment Protocol: Non-Clinical Research Staff 
A suicide risk assessment protocol will be implemented by non-clinical staff under the 
following condition:  
 
if a participant mentions or alludes to thoughts, intentions, plans or behaviors related to self-
directed violence (SDV) outside of the context of formal assessment.  
 
Study Staff (e.g., Research coordinator, Research Assistant) is not licensed mental health 
providers. This protocol outlines specific steps that study staff will follow to cursorily assess risk. 
Their main responsibility will be to ascertain whether a clinician (study investigator or study 
clinician) needs to be contacted for follow-up assessment and/or triage. In the event that a study 
staff member perceives sufficient risk that further assessment is warranted, the study staff will 
alert an investigator, or a study clinician who can assess risk.  
 
Because our research staff are not clinicians (i.e., they have no official clinical role within the 
VA), our plan primarily reflects the importance of activating the hospital procedures for suicide 
risk assessment and risk management/suicide prevention.  
 
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For participants who are currently at the VA for an outpatient appointment non-clinical 
research staff will ask the participant some clarifying questions, such as  “Let me clarify, are you 
having any thoughts about harming yourself deliberately?” If  “no,”  no further action required. If  
“yes,” then the research staff member will advise the participant that they will request some 
additional mental health assessment. They will use the following script: “Thank you for being 
honest with your answer. To ensure that you are safe and getting any help you might need I am 
going to ask a mental health provider to speak with you more about this.” The research staff 
member will not leave the Veteran unattended until they have either escorted the Veteran to a 
provider who will assess risk or a provider has arrived to assess risk.  
The research staff member will contact a study clinician, study investigator with clinical 
privileges, the Veteran’s established mental health provider, or another VAPSHCS psychologist 
(who may not be affiliated with the study) and ask them to  assess the individual in person if 
possible.  
 
If they cannot assess the participant in person, they may have the option of facilitating this 
assessment over the telephone (i.e., the clinician would call in to the office where the research 
staff member and the participant are present. All information gathered prior to the clinician’s 
assessment will be relayed to the professional provider by the research staff member. VA 
protocol for assessment and management of at-risk patients will be followed by the assessing 
clinician. All information for at risk patients will be documented in an AE/SAE or other required 
documentation for IRB purposes, as well as flagged (if needed) in CPRS.  
 
If the Veteran is currently admitted to the VAPSHCS as an INPATIENT, and the research 
staff member has determined that the participant has had thoughts of harming themselves 
deliberately, they will bypass the process of tracking down a psychologist to do the 
assessment, and immediately inform the patient’s nurse of their concern, and request 
appropriate monitoring until a more in-depth assessment can be made.  
 
The research staff member will ask the RN to alert  participant’s attending physician and any 
mental health staff assigned to the unit where the participant is currently admitted, appraise 
them of the situation, and request that the providers initiate risk assessment and management 
as indicated on their unit (i.e., consult Psychiatry on call for assessment, or the psychology staff 
on the unit, as indicated).  The Psychiatry Consultation and Liaison service is on-site 24/7 and 
can provide thorough suicide assessment, monitoring, and treatment as indicated.  
 
(1) For Veterans who are NOT physically on VA premises (i.e., when risk is noted via telephone) 
the suicide risk assessment protocol would include these steps: 
 
a. The research staff member will ask the participant some clarifying questions, such 
as: “Let me clarify, are you having any thoughts about harming yourself deliberately, 
or more just thinking about dying or that you would be better off dead?”  “Let me 
clarify, are you having any thoughts about harming yourself deliberately?” If the 
subject endorses follow-up questions that suggest risk of suicide, the  research staff 
member will gather additional  information about acute risk (i.e., presence of intent, 
plan, means for self-directed violence, protective factors such as presence of 
dependents). In the course of this discussion, if the Veteran clarifies that while they 
are having thoughts about self-harm, they have no intent or plan, and if they 
volunteer reasons they would not harm themselves (e.g., having dependents, or 
religious beliefs that prevent suicide), then this will be considered a negative screen. 
In the event of a negative screen, the research staff member will complete the 
interaction with the Veteran, and then alert Dr. Williams, Dr. Turner or a study 
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clinician within 24 hours to review the screen and determine if further action needs to 
be taken.  
 
 
(2) In the event of a positive screen over the telephone during an assessment (i.e., if the 
research staff member perceives that there is imminent risk of self-harm because the 
participant has expressed information about intent, means, plans for self-harm) then the 
research staff member will: 
a. verify the contact information and location of the Veteran and will thank them for their 
candor and advise the Veteran that they will be contacting a mental health provider to 
do further assessment. They will use the following script: “Thank you for being honest 
with your answer. To ensure that you are safe and getting any help you might need I 
am going to ask a mental health provider to speak with you more about this.”  
 
The research staff member will keep the Veteran on the phone while using another 
modality of communication (i.e., text, e-mail, pager) to reach Dr. Williams, Dr. Turner 
or a study clinician who is licensed, privileged, and credentialed to do more in-depth 
assessment of risk.  
 
b. Once a psychologist contacts the Veteran they will follow VA policies for the 
assessment and management of suicide risk. (see “Suicide Risk Reduction Protocol- 
Clinical Staff” below). 
 
(3) In the event that a study staff member has reason to believe a participant is in grave danger 
(as would be the case extremely rarely, and only if they made explicit statements to this 
effect):  
a. the research staff could contact local police and request a well-being check. 
 
If a clinician is not available immediately and/or  if the research staff member perceives imminent 
risk:  
b. They will encourage the participant to either to contact the Veteran’s crisis line (800-
273-8255, available 24/7, staffed by VA mental health providers who have access to 
the Veterans’ medical records and can coordinate care at the Veteran’s local facility)  
c. Or to seek immediate evaluation at the nearest ER. Project staff will have a list of 
facilities available for reference. Participants who are enrolled in the study are also 
given a list of referrals at the time of consent. If there is another person present with 
the Veteran the research staff person may ask to talk with that person about their 
concerns and problem solve ways to facilitate getting the Veteran to an ER. The 
research staff member can also contact the crisis responders (from the suicide 
prevention team) for support/guidance.  
d. After directing the participant to the crisis line or ER, the research staff member will 
follow-up with the Crisis Team and Dr. Williams (Dr. Turner if Dr. Williams is not 
available) to determine if additional steps (e.g., calling 911) need to be taken. A study 
clinician will follow up with the Veteran within 24 hours.   
e. Dr. Williams, Dr. Turner or a study clinician will document actions taken in the 
participant’s medical record and alert their medical providers via co-signature within 
24 hours of the event. An AE report will also be filed if indicated. 
 
Because suicide risk assessment for clinician is beyond the role of non-clinical research staff 
members, we propose a low threshold for a positive screen.  
 
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Suicide Risk Assessment Protocol: Clinical Research Staff 
The goal of this protocol is to ensure that reasonable steps are consistently taken by study 
clinicians and investigators to protect Veteran safety and welfare.  
 
It should be noted that risk of suicide (defined as being on the suicide high risk list, recent 
self-directed violent behavior) is an exclusion criteria for this study, so we anticipate that the 
likelihood of suicide risk is low.  
 
The study clinicians will be credentialed and privileged providers at VA Puget Sound Health 
Care System providers. Additionally, both Dr. Williams and Turner are credentialed and 
privileged providers at VA Puget Sound Health Care System providers. Should there be any 
indication of risk for self-directed violence during interactions with study staff, the study 
clinicians/investigators will follow the same specific procedures and policies that  psychologists 
who are clinicians (LIPs) at VAPSHCS follow  for assessing and managing risk.  
 
In instances where the clinician is concerned about safety/suicide risk in a study participant 
(i.e., if they state or allude to thoughts or plans of self-directed violence, mention recent self-
directed violent behavior or behavior preparatory to self-directed violence during a study 
intervention session), or in instances where a study clinician/ investigator is contacted by a 
research staff member and asked to follow-up with a Veteran, the study clinicians/investigators 
will follow the same risk assessment and prevention protocol that is required of VA licensed 
psychologists.  
 
The two relevant documents that explain the requisite assessment and safety planning 
protocols and policies policy  are “MEMORANDUM TX-74, VA PUGET SOUND HEALTH CARE 
SYSTEM, DATE: April 2013”, and “PE-16 Suicide Risk Screening and Assessment, revised 
Feb. 2013.” If these documents are updated during the course of the study, we will follow the 
updated instructions. 
In brief, the VA policy requires that a standardized assessment of risk be performed, and, if 
indicated, the clinician/investigator generate a plan for acute risk reduction (i.e., if the Veteran is 
evaluated to be at moderate or greater acute risk of self-harm).  
 
This assessment follows a standardized template and must be documented in the Veteran’s 
medical record (CPRS) using the specified note titles and templates outlined in the attached 
policy guidelines, and the Veteran’s MH provider (if they have one) must be alerted via co-
signature. If the Veteran does not have an identified mental health provider, Dr. Williams will 
place a consult to Mental Health (MH) to ensure that the Veteran receives appropriate care.   
 
Study clinicians and investigators who are required to assess risk will be instructed on how 
to access the Suicide Prevention Coordinators at each study site (American Lake and Seattle 
Divisions). Suicide Prevention Coordinators can provide consultation and also assist with 
coordinating care and managing acute risk.  
 
Other potential steps that may be taken to manage acute risk include (but are not limited to): 
referral to the nearest emergency room, calling 911 and activating civilian resources to ensure 
safety, contacting the Veteran’s Mental Health provider, referring the Veteran to the Veteran’s 
Help Line or other resource provided on a list at the time of study enrollment, or contacting a 
friend or family member of the Veteran and asking for their assistance in enhancing the 
Veteran’s safety. In the event that any of the above steps are required to ensure safety, study 
confidentiality may be violated; this is outlined in the ICF. 
 
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Furthermore, documentation of any self-directed violent intentions or plan, as well as 
behaviors will be noted within their CPRS medical record, and an AE/SAE/ Unanticipated 
Adverse Problem will be documented and sent to the VA Institutional Review Board according 
to the study protocol and guidelines. 
 
3. Data Safety Monitoring 
3a. Adverse Event  and Serious Problem Information: Definition 
Adverse Event 
An adverse event (AE) is any untoward medical occurrence in a subject during participation 
in the clinical study or with use of the experimental agent being studied. An adverse finding can 
include a sign, symptom, abnormal assessment (laboratory test value, vital signs, 
electrocardiogram finding, etc.), or any combination of these. Staff will document any 
occurrence that meets this definition, is a new symptom/condition for the subject, and 
results in either self-treatment or treatment by a health care provider. 
 
Serious Adverse Event (SAE) 
A serious adverse event (SAE) is any AE that results in one or more of the following outcomes: 
• 
Death 
• 
A life-threatening event 
• 
Inpatient hospitalization or prolongation of existing hospitalization  
• 
A persistent or significant disability/incapacity 
• 
A congenital anomaly or birth defect 
• 
An important medical event based upon appropriate medical judgment 
 
As per the VHA Handbook 1058.01 (4.w), an AE is also considered serious when medical, 
surgical, behavioral, social or other intervention is needed to prevent such an outcome.  
 
Serious Problem 
A serious problem is a problem in human research that may be reasonably regarded as [VHA 
Handbook 1058.01 (4.y)]: 
1) Involving substantive harm, or a genuine risk of substantive harm, to the safety, rights, or 
welfare of human research subjects, research staff, or others; or 
2) Substantively compromising the effectiveness of a facility’s human research protection or 
human research oversight programs. 
 
3b. Classification of AE Severity 
AEs will be labeled according to severity, which is based on their impact on the participant. 
An AE will be termed “mild” if it does not have a major impact on the patient, “moderate” if it 
causes the patient some minor inconvenience, and “severe” if it causes a substantial disruption 
to the patient’s well-being.” Please note that a severe AE and an SAE are distinct terms. A 
subject could experience a severe AE that does not meet the above-listed definition of an SAE; 
alternatively, a subject could experience a moderate AE that meets the SAE definition.  
All AEs and SAEs that affect clinic patients, i.e. non-research participants, within the clinic 
context will be addressed by licensed providers conducting the treatment interventions as per 
VA guidelines. 
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3c. AE Attribution Scale  
A “related AE” in VA research is an AE or problem that may reasonably be regarded as 
caused by, or probably caused by, the research procedures [VHA Handbook 1058.01 (4.r)] AEs 
will be categorized according to the likelihood that they are related to the study intervention 
according to VAPSHCS IRB protocol.  Specifically, they will be labeled probably not related, 
possibly related, and probably related to the study intervention. 
 
3d. AE Reporting and Follow-up 
Each participant will have an adverse events form created and completed during 
participation.  Each AE will be recorded on this particular form that records the subject’s code 
number, date of AE, severity, attribution level to study, action taken and outcome. 
In addition, research staff will record all AEs using a standard VAPSHCS approved Adverse 
Event Reporting Log that records the subject’s code number, date of AE, severity, attribution 
level to study, action taken and outcome.  
These adverse events will be provided annually in this format to the DSMC, both the VAPSHCS 
and UW IRBs and NCCIH in accordance with requirements. If the event is related to the sleep 
sub-study, it will also be reported to the WSU IRB.  
3e. SAE Reporting 
SAEs that are unanticipated, serious, and possibly related to the study intervention will be 
reported to the chair of the DSMC, both the VAPSHCS and UW IRBs and NCCIH in accordance 
with requirements.  If the event is related to the sleep sub-study, it will also be reported to the 
WSU IRB.  
• 
Unanticipated fatal or life-threatening SAEs related to study procedures will be reported 
immediately to the VA HRPP (orally),  NCCIH Program Officer, chair of the DSMC and the 
UW  and VAPSHCS IRBs.  
• 
Other serious and unanticipated SAEs related to study procedures will be reported to the 
NCCIH Program Official, DSMC chair  and to the VAPSHCS IRB within 5 days, and to the 
UW IRB within 10 days. 
Anticipated or unrelated SAEs will be reported to the DSMC and NCCIH Program Officer as  
part of the annual DSM report.  These SAEs will also be reported to the VAPSHCS IRB as part 
of the annual VAPSHCS IRB status report.  The UW IRB does not require reporting SAEs that 
are not related to study procedures. 
 
Research staff will record all SAEs using a standard form that records the subject’s code  
number, date of SAE, severity, attribution level to study, action taken and outcome. These 
adverse events will be provided annually in this format to the DSMC, both the VAPSHCS and 
UW IRBs and NCCIH in accordance with requirements.  
 
The Chair of the DSMC will be contacted when an SAE is discovered to receive consultation 
on the matter.  The Chair of the DSMC will use her discretion to determine whether the other 
DSMC members should also provide additional consultation. 
 
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3f. Data Quality Assurance and Monitoring 
Description of Plan for Data Quality and Management    
The research manager and study staff will review all data collection forms on an ongoing 
basis for data completeness and accuracy as well as protocol compliance. Data verification will 
take place in the form of double-data entry. Specifically, two separate study staff members will 
enter data from the hard copy forms into the database to ensure accuracy of data entry. Visual 
Basic for Applications (VBA) code inserted in the Microsoft Access database will verify the 2nd 
entry against the 1st entry.  Any discrepancies between the two entries will cause a warning 
window to open informing the data operator that a discrepancy has been detected. 
 All data entry discrepancies between these two data entries will be solved by the staff member 
completing the 2nd portion of double entry.  
Exploratory data collected during the treatment sessions will be singly entered into the 
Treatment Database.  For quality control, a second unblinded staff member will review 10% of 
the treatment data at the completion of the study.  If there is more than a 5% error rate, then 
Investigators will be notified to determine a plan of action which may include implementing a 2nd 
entry verification. 
All group treatment sessions will be audio recorded to ensure compliance to treatment 
procedures.   A portion of treatment sessions will be randomly selected to be reviewed by study 
researchers to ascertain fidelity to protocol. Study clinicians will receive feedback as needed if 
they diverge from protocol. 
 
In addition, research study staff will review the study data in detail on a quarterly basis to 
detect any systematic issues with data collection.   
 
Data types that will be reviewed include subject accrual, status of enrolled subjects, 
adherence data regarding study assessments and intervention, any protocol deviation or 
violation that warrants a note-to-file, and AEs, SAEs and unanticipated problems. The results of 
these systematic reviews will be sent to the DSMC members on a quarterly basis.  
 
Review of the rate of subject accrual and compliance with inclusion/exclusion criteria will 
occur monthly during the first six months of recruitment and then every 3 months to ensure that 
a sufficient number of participants are being enrolled to allow for an adequate test of the primary 
study hypothesis and that they meet eligibility criteria. 
Frequency of Data Review 
The frequency of data review for this study differs according to the type of data and can be 
summarized in the following table: 
Data type 
Frequency of review 
Reviewer 
Subject accrual 
Quarterly 
Co-PIs, DSMC 
Status of all enrolled subjects 
Quarterly 
Co-PIs, DSMC 
Adherence data, assessments 
and intervention 
Quarterly 
Co-PIs, DSMC 
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Data type 
Frequency of review 
Reviewer 
AEs 
Quarterly 
Co-PIs, DSMC  
Study-Related SAEs 
Per occurrence 
Co-PIs, DSMC, NCCIH, UW 
and VAPSHCS IRBs 
Unanticipated Serious Problems 
Per occurrence 
Co-PIs, DSMC, NCCIH, UW 
and VAPSHCS IRBs 
 
3g. Subject Accrual and Compliance 
Measurement and Reporting of Subject Accrual, Compliance With Inclusion/Exclusion Criteria 
Review of the rate of subject accrual and compliance with inclusion/exclusion criteria will 
occur monthly during the first six months of recruitment and then every 3 months to ensure that 
a sufficient number of participants are being enrolled to allow for an adequate test of the primary 
study hypothesis and that they meet eligibility criteria. 
 
Measurement and Reporting of Participant Adherence to Treatment Protocol  
Data on adherence to the treatment protocol will be collected monthly by research staff and 
reviewed quarterly by the PI, the DSMC statistician, and the chair of the DSMC. Adherence of 
participants to both assessment completion and treatment will be evaluated by running queries 
to discern adherence rates. If adherence falls below the suggested rate of 75%, which might put 
at risk the ability to test the study’s primary hypothesis, the chair of the DSMC will suggest a 
conference call for study investigators to discuss methods for improving adherence. 
 
3h. Study Discontinuation  
This study will be stopped prior to its completion if: (1) one of the interventions is associated 
with adverse effects that call into question the safety of the intervention; (2) any new information 
becomes available during the trial that necessitates stopping the trial; or (3) other situations 
occur that might warrant stopping the trial. 
3i. Designation of a Monitoring Committee 
 
 
 
Name/Role* 
Credentials Organization 
Expertise 
 
Katherine Davis 
Ph.D. 
Independent 
Consultant 
Biostatistician 
 
Kendall Browne 
Ph.D. 
VAPSHCS 
Staff Psychologist 
 
Tracy Simpson 
Ph.D. 
VAPSHCS 
Clinical Psychologist, 
Behavioral Interventions/Clinical 
Trials 
 
The Data Safety Monitoring Committee (DSMC) for this study is comprised of Drs. Simpson 
(chair), Browne and Davis.  Dr. Davis, an independent consultant, has no professional or 
personal connection with the co- PIs.   
 
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Although Dr. Simpson  is employed at the VAPSHCS, she does not collaborate with any of 
the research team members in a research or clinical capacity on a regular basis.  
Likewise, although Dr. Browne is employed at the VAPSHCS, she does not collaborate with the 
Co-PIs in a research or clinical capacity on a regular basis. 
 
Drs. Simpson and Browne are qualified to review the patient safety data generated by this study 
because of their unique expertise in the area of randomized controlled trials (RCT) examining 
the efficacy of psychological interventions in Veteran populations. Dr. Davis was selected given 
his/her expertise in biostatistics.  
 
 
3j. Methods and Timing for Assessing Recording, and Analyzing Safety Parameters 
Monitoring Subject Safety and Study Compliance 
Study researchers including staff members and study clinicians who conduct the telephone 
assessments, brain wave activity assessments, cognitive assessments, and facilitate the 
treatment groups will collect safety information on an ongoing basis. By systematically 
monitoring for events, we will ensure that problems are detected immediately and addressed as 
indicated. 
 
Brain Wave Activity Assessments 
The research staff member conducting the assessment will ask each participant following 
completion of the assessment whether they experienced any negative effects during the 
assessment they associate with the study procedures.  The response to this question will be 
captured using the EEG Assessment Recording Sheets. 
 
 
 
 
 
Treatment 
The study clinicians moderating the group treatment sessions will disperse forms after each 
treatment session that asks each participant  what they found helpful or unhelpful about the 
treatment session. We believe these questions will allow participants to express any events that 
may be adverse and possibly related to study procedures.    
 
General 
Research staff and study clinicians will collect unsolicited information reported by 
participants during study participation including suicidal thoughts or suicidal ideation (SI), 
increased alcohol/drug use, intentions to harm someone else, or psychological decline.  
 
All information leading to an adverse event (AE), serious adverse event (SAE), or 
unanticipated problem will be reported per VA protocol/requirement, i.e., to VAPSHCS IRB 
using the approved VA IRB forms.  Reports will be submitted within the designated required 
time frame (5 business days).  In addition, staff members will use templates provided by the 
study sponsor to capture specific data pertaining to AEs, SAEs, or unanticipated problems. All 
documentation collected, submitted, and approved will be stored in a regulatory binder located 
within the locked study offices.  We do not plan to monitor charts for AEs. 
 
Study researchers will document any protocol deviations or events that may jeopardize the 
integrity of the study in a ‘Note-to-File’ using the sponsor template for this purpose. 
 
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Safety information collection will begin as soon as study recruitment begins. Safety 
information collection will end once the subject completes the final telephone assessment, i.e. 
approximately six months following completion of the intervention. 
 
Progress Report (Monthly and Quarterly) 
Each month research staff will generate a study report that outlines study progress including 
recruitment, retention/attrition, any protocol deviation or violation that warrants a note-to-file, and 
AEs, SAEs and unanticipated problems for that particular month. This report will be provided to 
the Co-PIs. The Co-PIs may solicit input from the chair of the DSMC if they detect anything of 
concern.  
 
Each quarter research staff will generate the same study report that outlines study progress 
including recruitment, retention/attrition, any protocol deviation or violation that warrants a note-
to-file, and AEs, SAEs and unanticipated problems for that particular quarter. This report will be 
provided to the Co-PIs and the chair of the DSMC.  The chair of the DSMC may solicit input 
from the other DSMC members if she detects anything of concern (e.g. higher rates of AEs than 
anticipated). The Chair of the DSMC will generate a report if there is anything of concern that 
will be supplied to the study PIs, VAPSHCS and UW IRBs and NCCIH. 
 
 
Annual Report 
Study staff will also generate an Annual Report that will include a list and summary of any 
protocol deviation or violation that warrants a note-to-file, and AEs, SAEs and unanticipated 
problems. In addition, the Annual Report will address (1) whether AE rates are consistent with 
pre-study assumptions; (2) reason for dropouts from the study; (3) whether all participants met 
entry criteria; (4) whether continuation of the study is justified on the basis that additional data 
are needed to accomplish the stated aims of the study; and (5) conditions whereby the study 
might be terminated prematurely.  
 
The Annual Report will be sent to all members of the DSMC.  The DSMC along with the Co-
PIs will convene to review and discuss the report.  The annual progress report will be forwarded 
to (1) the VAPSHCS IRB, (2) the UW IRB and (3) NCCIH.  
 
 
3k. Study Report Outline for the Independent Monitors(s) (Interim or Annual Reports)  
The study team will generate progress reports on a quarterly basis for review by the Chair of 
the DSMC, as well as an annual report to be reviewed by all DSMC members. 
Study Report Outline for Progress Reports 
I. 
Table of Contents 
II. 
Introduction 
A. Summary of Study Status and Issues or Problems 
III. 
Study Administration 
A. Recruitment Status 
i. Enrollment by Month/Quarter 
ii. Comparison of Targeted to Actual Enrollment 
B. Retention Status 
i. Overall Subject Status 
ii. Individual Subject Status 
IV. 
Study Data Reports/Tables or Figures 
A. General Information 
i. Enrollment  
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ii. Demographic/Baseline Data 
iii. Subject Status  
B. Safety Assessment 
i. Treatment Duration for All Subjects  
ii. AE Data 
a. Overall Listing  
b. Specific Symptom Listing  
c. SAE Listing  
d. Subject Deaths  
Study Report Outline for Annual Reports 
I. 
Table of Contents 
II. 
Introduction 
A. Summary of Study Status and Issues or Problems 
B. Report Preparation Procedures 
III. 
Study Description 
A. Project Organization Chart, Personnel 
B. Brief Statement of Purpose of Trial 
C. Projected Timetable and Schedule 
IV. 
Study Administration 
A. Recruitment Status 
i. Enrollment by Year/Month 
ii. Comparison of Targeted to Actual Enrollment 
B. Retention Status 
i. Overall Subject Status 
ii. Individual Subject Status 
V. 
Study Data Reports/Tables or Figures 
A. General Information 
i. Enrollment  
ii. Demographic/Baseline Data  
iii. Subject Status  
B. Safety Assessment 
i. Treatment Duration for All Subjects 
ii. AE Data 
a. Overall Listing  
b. Specific Symptom Listing  
c. SAE Listing  
d. Subject Deaths   
Study Report tables will be generated only from aggregate (not by group assignment) 
baseline and aggregate safety data for the study population.  
3l. Reporting Changes in Study Status 
During the funding of this study, any action by an IRB, the DSMC, or one of the study 
investigators that results in a temporary or permanent suspension of the study will be reported 
to the NCCIH Program Official within 1 business day of notification.  
4. Potential Benefits of Research to Participants and Others 
 
Previous studies with the two treatments (HYP and MM) that will be examined support their 
efficacy reducing pain. We anticipate based on this previous research that many of the 
participants will experience significant reductions in their daily pain and other benefits 
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associated with the treatments. Although we do not anticipate that the education control 
condition will result in any improvements in the outcome variables studied, previous participants 
report high levels of satisfaction with this condition, and report that they find the information 
useful.  
 
To increase the chances that those participants assigned to the control condition will get the 
most benefits possible out of their participation, they will all be invited to receive one of the two 
active treatments (their choice) after they complete their final follow-up assessment.   
In addition, we anticipate that some of the participants who are initially randomized to one of the 
active treatments will not benefit from that treatment, and that this may be related to their 
baseline EEG.  Thus, even those who received one of the active treatments will be invited to 
participate in the other treatment they did not receive.   
 
This will not only maximize the chances that they will obtain pain relief from participation in 
the study, but will allow us to determine what percentage of participants who do not respond to 
one of the active treatments respond to the other.  Thus, every study participant will have the 
opportunity to receive at least one of the active treatments being studied. 
 
Sub-Study: 
We do not anticipate participants will experience significant reductions in their daily pain or 
improvement in their sleep quality as a result of participating in the sub-study.  
 
 
 
 
 
 
 
I. Publication of Research Findings 
 
Any manuscript will be made available for review by the study sponsor prior to submission. 
 
 
 
J. Importance of Knowledge to Be Gained 
 
Main Study: 
 
The findings from this study will provide important new information that will have positive 
effects on the lives of Veterans with chronic pain. First, if one or both of the treatments (HYP or 
MM) is found to be effective, as we anticipate will be the case given previous research and the 
findings from our pilot work, Veterans with chronic pain will have another effective treatment 
option for helping them better manage pain.  
 
Second, the findings will provide important new information regarding treatment 
mechanisms (mediators and moderators) of the treatments studied.  
 
As pointed out by Kazdin,110, 111 progress in our understanding of treatments has been 
hampered by the lack of mechanism studies, such as this study, to identify the mechanisms and 
predictors of treatment outcome. The current study will help address this significant gap.  
 
Sub-Study: 
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The findings from the sub-study will provide important new information that will inform future 
treatment and research aimed to improve the lives of Veterans and others living with chronic 
pain. First, if one or both of the treatments are found to be helpful regarding sleep, Veterans and 
other individuals with chronic pain will have another effective treatment option for helping them 
better manage sleep disturbances. Second, the findings will provide new information regarding 
treatment mechanisms (mediators and moderators) and the interplay between pain and sleep. If 
our new evidence supports that a focus on sleep will improve pain, future studies – including 
clinical trials that evaluate non-pharmacological sleep interventions – can build on this work. 
Presently, sleep is not yet regarded as a primary outcome measurement in chronic pain 
research,41 nor is sleep consistently addressed in chronic pain clinical treatment. Our findings 
can advance the field in an innovative way and, potentially, change the way sleep and pain 
symptoms are studied and clinically managed. 
 
Poor sleep is gaining recognition as a significant population health problem in its own right, 
as it has been linked to numerous diseases that create a high societal burden, such as cancer, 
cardiovascular and autoimmune diseases.112 While this study will focus on chronic pain, it is also 
likely that any discoveries related to the tested interventions will be relevant in the management 
of other chronic diseases. Additionally, understanding how non-pharmacological interventions 
can be adopted and how they affect confidence in controlling symptoms may be an important 
approach towards reducing reliance on opioids, sedatives and other medications and reducing 
the significant risks and societal costs associated with these pharmacological interventions.   
 
 
 
 
 
1. Kerns RD, Otis J, Rosenberg R, Reid MC. Veterans' reports of pain and associations with ratings of 
health, health-risk behaviors, affective distress, and use of the healthcare system. J Rehabil Res Dev 
2003; 40(5): 371-9. 
2. Kerns RD, Dobscha SK. Pain among veterans returning from deployment in Iraq and Afghanistan: 
update on the Veterans Health Administration Pain Research Program. Pain Medicine 2009; 10(7): 
1161-4. 
3. Haskell SG, Brandt CA, Krebs EE, Skanderson M, Kerns RD, Goulet JL. Pain among Veterans of 
Operations Enduring Freedom and Iraqi Freedom: do women and men differ? Pain Medicine 2009; 
10(7): 1167-73. 
4. Haskell SG, Heapy A, Reid MC, Papas RK, Kerns RD. The prevalence and age-related 
characteristics of pain in a sample of women veterans receiving primary care. J Womens Health 
(Larchmt) 2006; 15(7): 862-9. 
5. Cardenas DD, Bryce TN, Shem K, Richards JS, Elhefni H. Gender and minority differences in the 
pain experience of people with spinal cord injury. Archives of physical medicine and rehabilitation 2004; 
85(11): 1774-81. 
6. Reiber GE, McFarland LV, Hubbard S, et al. Servicemembers and veterans with major traumatic 
limb loss from Vietnam war and OIF/OEF conflicts: survey methods, participants, and summary findings. 
J Rehabil Res Dev 2010; 47(4): 275-97. 
7. Hirsh AT, Turner AP, Ehde DM, Haselkorn JK. Prevalence and impact of pain in multiple sclerosis: 
physical and psychologic contributors. Archives of physical medicine and rehabilitation 2009; 90(4): 
646-51. 
8. Lew HL, Otis JD, Tun C, Kerns RD, Clark ME, Cifu DX. Prevalence of chronic pain, posttraumatic 
stress disorder, and persistent postconcussive symptoms in OIF/OEF veterans: polytrauma clinical triad. 
J Rehabil Res Dev 2009; 46(6): 697-702. 
VA Puget Sound IRB Approved 
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CPSS Protocol v.23 06-30-2020 
 
Page 100 of 105 
 
9. Haskell SG, Ning Y, Krebs E, et al. Prevalence of painful musculoskeletal conditions in female and 
male veterans in 7 years after return from deployment in Operation Enduring Freedom/Operation Iraqi 
Freedom. Clinical Journal of Pain 2012; 28(2): 163-7. 
10. Morasco BJ, Lovejoy TI, Lu M, Turk DC, Lewis L, Dobscha SK. The relationship between PTSD and 
chronic pain: mediating role of coping strategies and depression. Pain 2013; 154(4): 609-16. 
11. Lang KP, Veazey-Morris K, Andrasik F. Exploring the Role of Insomnia in the Relation Between 
PTSD and Pain in Veterans With Polytrauma Injuries. J Head Trauma Rehabil 2013. 
12. Wallace DM, Shafazand S, Ramos AR, et al. Insomnia characteristics and clinical correlates in 
Operation Enduring Freedom/Operation Iraqi Freedom veterans with post-traumatic stress disorder and 
mild traumatic brain injury: an exploratory study. Sleep Med 2011; 12(9): 850-9. 
13. Beehler GP, Rodrigues AE, Mercurio-Riley D, Dunn AS. Primary Care Utilization among Veterans 
with Chronic Musculoskeletal Pain: A Retrospective Chart Review. Pain Medicine 2013; 14(7): 1021-31. 
14. Morasco BJ, Dobscha SK. Prescription medication misuse and substance use disorder in VA primary 
care patients with chronic pain. General Hospital Psychiatry 2008; 30(2): 93-9. 
15. Patton CM, Hung M, Lawrence BD, et al. Psychological distress in a Department of Veterans Affairs 
spine patient population. Spine J 2012; 12(9): 798-803. 
16. Tan G, Teo I, Srivastava D, et al. Improving access to care for women veterans suffering from 
chronic pain and depression associated with trauma. Pain Medicine 2013; 14(7): 1010-20. 
17. Bras M, Milunovic V, Boban M, et al. Quality of life in Croatian Homeland war (1991-1995) veterans 
who suffer from post-traumatic stress disorder and chronic pain. Health Qual Life Outcomes 2011; 9: 56. 
18. Forman-Hoffman VL, Peloso PM, Black DW, Woolson RF, Letuchy EM, Doebbeling BN. Chronic 
widespread pain in veterans of the first Gulf War: impact of deployment status and associated health 
effects. Journal of Pain 2007; 8(12): 954-61. 
19. Pollmann W, Feneberg W. Current management of pain associated with multiple sclerosis. CNS 
Drugs 2008; 22(4): 291-324. 
20. Wasner G. Central Pain Syndromes. Current Pain and Headache Reports 2010. 
21. Solaro C, Messmer Uccelli M. Pharmacological management of pain in patients with multiple 
sclerosis. Drugs 2010; 70(10): 1245-54. 
22. Baastrup C, Finnerup NB. Pharmacological management of neuropathic pain following spinal cord 
injury. CNS Drugs 2008; 22(6): 455-75. 
23. Trescot AM, Glaser SE, Hansen H, Benyamin R, Patel S, Manchikanti L. Effectiveness of opioids in 
the treatment of chronic non-cancer pain. Pain Physician 2008; 11(2 Suppl): S181-200. 
24. Kemp J BRSDR, 2012. Department of Veterans Affairs Mental Health Services Suicide Prevention 
Program; 2012. http://www.va.gov/opa/docs/ suicide-data-report-2012-final.pdf. Accessed August 20, 
2015. 
25. Ilgen MA BA, Ganoczy D, Bair MJ, McCarthy JF, Blow FC. Opioid dose and risk of suicide. IASP. 
2016;157(5):1079-84. 
26. Im JJ SR, Oliva EM, Henderson PT, Paik MC, Trafton JA, PROGRES Team. Association of care 
practices with suicide attempts in US Veterans prescribed opioid medications for chronic pain 
management. J Gen Intern Med. 2015;30(7):979-91. . 
27. Ratcliffe G EM, Belik S-L, Sareen J. Chronic pain conditions and suicidal ideation and suicide 
attempts: An epidemiologic perspective. Clin J Pain. 2008;24: 204-10. 
28. Bjørngaard J BO, Romundstad P, Gunnell D. Sleeping problems and suicide in 75,000 norwegian 
adults: a 20 year follow-up of the HUNT I study. Sleep. 2011;34(9): 1155-9. 
29. Fishbain DA CB, Lewis JE, Gao J. What is the evidence for chronic pain being etiologically 
associated with the DSM-IV category of sleep disorder due to a general medical condition? A structured 
evidence-based review. Pain Med. 2010;11:158–79. 
30. Harman K KE, Mayes S, Walsh J, MacCallum. Insomnia in clients with chronic, work-related 
musculoskeletal pain in a work recovery rehabilitation program. Work. 2014;48(2):185-192. . 
31. Graves JK JEP, coping, and sleep in children and adolescents with sickle cell disease. J Child Adoles 
Psychiatr Nurs. 2014;27(3):109-120. . 
VA Puget Sound IRB Approved 
07/09/2020

 
CPSS Protocol v.23 06-30-2020 
 
Page 101 of 105 
 
32. Tiede W MW, Baumgärtner U, Durrer B, Ehlert U, Treede RD. Sleep restriction attenuates 
amplitudes and attentional modulation of pain-related evoked potentials, but augments pain ratings in 
healthy volunteers. Pain. 2010;148(1):36-42. . 
33. Tang H VM, Perlis M, Mao JJ, Riegel B. A pilot study of audio visual stimulation as a self-care 
treatment for insomnia in adults with insomnia and chronic pain. Appl Psychophysiol Biofeedback. 
2015;36:219-225. 
34. Karaman S KT, Dogru S, Onder Y, Citil R, Bulut Y, . . . . Suren M. Prevalence of sleep disturbance in 
chronic pain. Eur Rev Med Pharmacol Sci. 2014;18:2475-2481. 
35. O'Donoghue GM FN, Heneghan C, Hurley D. Objective and subjective assessment of sleep in chronic 
low back pain patients compared with healthy age and gender matched controls: a pilot study. BMC 
Musculoskelet Disord. 2009;10:122. 
36. Okifuji A HBDsdctpsCRR-. 
37. Ancoli-Israel S. Actigraphy. Principles and practice of sleep medicine. In: eds. Kryger MH RT, 
Dement WC. Philadelphia: Elsevier Saunders; 2005. 
38. Edwards RR AD, Klick B, Haythornthwaite JA, Smith MT. Duration of sleep contributes to next-day 
pain report in the general population. Pain. 2008;137(1):202-07. 
39. Shearer WT RJ, Mullington JM, Price NJ, Lee B-N, Smith EO, Szuba MP, Van Dongen HPA, Dinges 
DF. Soluble TNF-α receptor 1 and IL-6 plasma levels in humans subjected to the sleep deprivation model 
of spaceflight. J Allergy Clin Immunol. 2001;107(1):165–170. 
40. Haack M SE, Mullington JM. Elevated inflammatory markers in response to prolonged sleep 
restriction are associated with increased pain experience in healthy volunteers. Sleep. 2007;30(9),1145-
52. 
41. Jensen MP, Barber J, Romano JM, et al. A comparison of self-hypnosis versus progressive muscle 
relaxation in patients with multiple sclerosis and chronic pain. International Journal of Clinical and 
Experimental Hypnosis 2009; 57(2): 198-221. 
42. Jensen MP, Barber J, Romano JM, et al. Effects of self-hypnosis training and EMG biofeedback 
relaxation training on chronic pain in persons with spinal-cord injury. International Journal of Clinical 
and Experimental Hypnosis 2009; 57(3): 239-68. 
43. Cohen J. Statistical power analysis for the behavioral sciences. 2nd ed. Hillsdale, NJ: Lawrence 
Erlbaum Associates; 1988. 
44. Crawford HJ. Cognitive and psychophysiological correlates of hypnotic responsiveness and hypnosis. 
In: Brown DP, Fass ML, eds. Creative master in hypnosis and hypnoanalysis:  A festschrift for Erika 
Fromm. Hillsdate, NJ: Erlbaum; 1990: 155-68. 
45. Gevins A, Smith ME, McEvoy L, Yu D. High-resolution EEG mapping of cortical activation related to 
working memory: effects of task difficulty, type of processing, and practice. Cereb Cortex 1997; 7(4): 
374-85. 
46. Buzsáki G. Rhythms of the brain. Oxford ; New York: Oxford University Press; 2006. 
47. Spiegel H, Spiegel D. Trance and treatment : clinical uses of hypnosis. 2nd ed. Washington, DC: 
American Psychiatric Pub.; 2004. 
48. Gruzelier JH. A working model of the neurophysiology of hypnosis:  A review of the evidence. 
Contemporary Hypnosis 1998; 15: 3-21. 
49. Gruzelier JH. The state of hypnosis:  Evidence and applications. Quaraterly Journal of Medicine 
1998; 15: 3-21. 
50. Dienes Z, Hutton S. Understanding hypnosis metacognitively: rTMS applied to left DLPFC increases 
hypnotic suggestibility. Cortex 2013; 49(2): 386-92. 
51. Callahan CM, Unverzagt FW, Hui SL, Perkins AJ, Hendrie HC. Six-item screener to identify 
cognitive impairment among potential subjects for clinical research. Medical care 2002; 40(9): 771-81. 
52. Ehde DM, Jensen MP. Feasibility of a cognitive restructuring intervention for treatment of chronic 
pain in persons with disabilites. Rehabilitation Psychology 2004; 49: 254-8. 
VA Puget Sound IRB Approved 
07/09/2020

 
CPSS Protocol v.23 06-30-2020 
 
Page 102 of 105 
 
53. Jensen MP, Ehde DM, Gertz KJ, et al. Effects of self-hypnosis training and cognitive restructuring on 
daily pain intensity and catastrophizing in individuals with multiple sclerosis and chronic pain. 
International Journal of Clinical and Experimental Hypnosis 2011; 59(1): 45-63. 
54. Jensen MP. Hypnosis for chronic pain management:  Therapist guide. Oxford: Oxford University 
Press; 2011. 
55. Jensen M, Turner JA, Romano JM. What is the maximum number of levels needed in pain intensity 
measurement? Pain 1994; 58: 387-92. 
56. Jensen M, McFarland CA. Increasing the reliability and validity of pain tentensity measurement in 
chronic pain patients. Pain 1993; 55: 195-203. 
57. Jensen MP. Measurement of pain. In: Fishman SM, Ballantyne JC, Rathmell JP, eds. Bonica's 
management of pain. 4th ed. Media, PA: Williams & Wilkins; 2010: 251-70. 
58. Dworkin RH, Turk DC, Farrar JT, et al. Core outcome measures for chronic pain clinical trials: 
IMMPACT recommendations. Pain 2005; 113: 9-19. 
59. Gil KM, Abrams MR, Phillips G, Williams DA. Sickle cell disease pain: 2. Predicting health care use 
and activity level at 9-month follow-up. Journal of Consulting and Clinical Psychology 1992; 60(2): 267-
73. 
60. Von Korff M, Ormel J, Keefe FJ, Dworkin SF. Grading the severity of chronic pain. Pain 1992; 
50(2): 133-49. 
61. Ripamonti C, Groff L, Brunelli C, Polastri D, Stavrakis A, De Conno F. Switching from morphine to 
oral methadone in treating cancer pain: what is the equianalgesic dose ratio? J Clin Oncol 1998; 16(10): 
3216-21. 
 
 
62. Cook KF, Bamer AM, Amtmann D, Molton IR, Jensen MP. Six patient-reported outcome 
measurement information system short form measures have negligible age- or diagnosis-related 
differential item functioning in individuals with disabilities. Arch Phys Med Rehabil 2012; 93(7): 1289-
91. 
63. Weathers F, Litz BT, Huska J, Keane T. PTSD checklist - military version. Boston: National Center 
for PTSD, Behavioral SCiences Division.; 1994. 
64. Dworkin RH, Jensen MP, Gould E, et al. Treatment satisfaction in osteoarthritis and chronic low 
back pain: the role of pain, physical and emotional functioning, sleep, and adverse events. The journal of 
pain : official journal of the American Pain Society 2011; 12(4): 416-24. 
65. Hays RD, Bjorner JB, Revicki DA, Spritzer KL, Cella D. Development of physical and mental health 
summary scores from the patient-reported outcomes measurement information system (PROMIS) global 
items. Quality of life research : an international journal of quality of life aspects of treatment, care and 
rehabilitation 2009; 18(7): 873-80. 
66. Watson D, Clark, L. A., & Tellegen, A. (1988). Development and validation of brief measures of 
positive and negative affect: the PANAS scales. Journal of Personality and Social Psychology, 54(6), 
1063-1070. doi: 10.1037/0022-3514.54.6.1063. 
67. Lai J-S, Garcia SF, Salsman JM, Rosenbloom S, Cella D. The psychosocial impact of cancer: 
evidence in support of independent general positive and negative components. Quality of Life Research 
2012; 21(2): 195-207. 
68. . 
69. McCracken LM, Vowels KE, Eccleston C. The Chronic Pain Acceptance Questionnaire. Pain 2004; 
107(1): 271-7. 
70. Sullivan MJL, Bishop S, Pivik J. The Pain Catastrophizing Scale:  Development and validation. 
Psychological Assessment 1995; 7: 524-32. 
71. Bohlmeijer E, ten Klooster PM, Fledderus M, Veehof M, Baer R. Psychometric properties of the five 
facet mindfulness questionnaire in depressed adults and development of a short form. Assessment 2011; 
18(3): 308-20. 
VA Puget Sound IRB Approved 
07/09/2020

 
CPSS Protocol v.23 06-30-2020 
 
Page 103 of 105 
 
72. Hatcher RL, Gillaspy A. Development and validation of a revised short version of the Working 
Alliance Inventory. Psychotherapy Research 2006; 16: 12-25. 
73. Carver CS, White, T.L. . Behavioral inhibition, behavioral activation, and affective responses to 
impending reward and punishment: The BIS/BAS scales. , 67, 319-333.   . Journal of Personality and 
Social Psychology 1994; 67: 319-33. 
74. Lyubomirsky S, Lepper, H.S. A Measure of Subjective Happiness: Preliminary Reliability and 
Consctruct Validation Social Indicators Research 1999; 46: 137-55. 
75. Weitzenhoffer A, Hilgard ER. Stanford Hypnotic Susceptibility Scale, Form C. Palo Alto, CA: 
Consulting Psychologists Press; 1963. 
76. Perry C, Nadon R, Button J. The measurement of hypnotic ability.  Contemporary hypnosis research. 
New York: Guilford Press; 1992: 235-52. 
77. Hilgard ER. Hypnotic susceptibility. New York: Harcourt Brace & World; 1965. 
78. Holt CS, Heimberg RG. The reaction to treatment questionnaire:  Measuring treatment credibility 
and outcome expectancies. Journal of Behavioral Medicine 1990; 19: 213-4. 
79. Heimberg RG, Dodge CS, Hope DA, Kennedy CR, Zollo LJ, Becker RE. Cognitive behavioral group 
treatment for social phobia: Comparison with a credible placebo control Cognitive Therapy and 
Research 1990; 14: 1-23. 
80. Brent DA, Holder D, Kolko D, et al. A clinical psychotherapy trial for adolescent depression 
comparing cognitive, family, and supportive therapy. Arch Gen Psychiatry 1997; 54(9): 877-85. 
81. Bennett MI, Smith BH, Torrance N, Potter J. The S-LANSS score for identifying pain of 
predominantly neuropathic origin: validation for use in clinical and postal research. J Pain 2005; 6(3): 
149-58. 
82. Freynhagen R, Baron R, Gockel U, Tolle TR. painDETECT: a new screening questionnaire to 
identify neuropathic components in patients with back pain. Curr Med Res Opin 2006; 22(10): 1911-20. 
83. Fortin M, Hudon C, Dubois MF, Almirall J, Lapointe L, Soubhi H. Comparative assessment of three 
different indices of multimorbidity for studies on health-related quality of life. Health Qual Life Outcomes 
2005; 3: 74. 
84. Hill JC, Dunn KM, Lewis M, et al. A primary care back pain screening tool: identifying patient 
subgroups for initial treatment. Arthritis Rheum 2008; 59(5): 632-41. 
85. The Alcohol, Smoking and Substance Involvement Screening Test (ASSIST): development, reliability 
and feasibility. Addiction (Abingdon, England) 2002; 97(9): 1183-94. 
86. Brown RL, Leonard T, Saunders LA, Papasouliotis O. A two-item screening test for alcohol and other 
drug problems. The Journal of family practice 1997; 44(2): 151-60. 
87. MacKenzie KR. The clinical application of a Group Climate measure. In 
R. R. Dies & K. R. MacKenzie (Eds.), Advances in group psychotherapy: 
Integrating research and practice (pp. 159-170). New York: International 
Universities Press. In R R Dies & K R MacKenzie (Eds), Advances in group psychotherapy: 
Integrating research and practice 1983: 159-70. 
88. Campbell CM, Quartana PJ, Buenaver LF, Haythornthwaite JA, Edwards RR. Changes in situation-
specific pain catastrophizing precede changes in pain report during capsaicin pain: a cross-lagged panel 
analysis among healthy, pain-free participants. Journal of Pain 2010; 11(9): 876-84. 
89. Vincent N WK, Lewycky S. Control and coping in chronic insomnia: A daily diary study. Behav Res 
Ther. 2013;51:240-246. . 
90. Lorig K RP, Laurent D, Plant K. The Internet-based arthritis self-management program: A one-year 
randomized trial for patients with arthritis or fibromyalgia. Arthritis Rheumatol. 2008;59(7):1009–1017. 
91. Jackson T WY, Wang Y, Fan H. Self-efficacy and chronic pain outcomes: a meta-analytic review. 
Pain. 2014;15(8):800-14. . 
92. Burns JW, Glenn B, Lofland K, Bruehl S, Harden RN. Stages of change in readiness to adopt a self-
management approach to chronic pain: the moderating role of early-treatment stage progression in 
predicting outcome. Pain 2005; 115(3): 322-31. 
VA Puget Sound IRB Approved 
07/09/2020

 
CPSS Protocol v.23 06-30-2020 
 
Page 104 of 105 
 
93. Glenn B, Burns JW. Pain self-management in the process and outcome of multidisciplinary treatment 
of chronic pain: evaluation of a stage of change model. Journal of Behavioral Medicine 2003; 26(5): 
417-33. 
94. Burns JW, Glenn B, Bruehl S, Harden RN, Lofland K. Cognitive factors influence outcome following 
multidisciplinary chronic pain treatment: a replication and extension of a cross-lagged panel analysis. 
Behaviour Research and Therapy 2003; 41(10): 1163-82. 
95. Burns JW, Kubilus A, Bruehl S, Harden RN, Lofland K. Do changes in cognitive factors influence 
outcome following multidisciplinary treatment for chronic pain? A cross-lagged panel analysis. Journal 
of Consulting and Clinical Psychology 2003; 71(1): 81-91. 
96. Kenny DA. Cross-lagged panel correlation: A test for spuriousness. Psychological Bulletin 1975; 82: 
887-903. 
97. Finkel SE. Causal analysis with panel data. Thousand Oaks, CA: Sage Publications; 1995. 
98. Pascual-Marqui RD, Esslen M, Kochi K, Lehmann D. Functional imaging with low resolution brain 
electromagnetic tomography (LORETA): review, new comparisons, and new validation. Japanese 
Journal of Clinical Neurophysiology 2002; 30: 81-94. 
99. Pizzagalli D, Pascual-Marqui RD, Nitschke JB, et al. Anterior cingulate activity as a predictor of 
degree of treatment response in major depression: evidence from brain electrical tomography analysis. 
Am J Psychiatry 2001; 158(3): 405-15. 
100. 
Cahn BR, Polich J. Meditation states and traits: EEG, ERP, and neuroimaging studies. 
Psychological Bulletin 2006; 132(2): 180-211. 
101. 
Kirenskaya AV, Novototsky-Vlasov VY, Zvonikov VM. Waking EEG spectral power and 
coherence differences between high and low hypnotizable subjects. International Journal of Clinical and 
Experimental Hypnosis 2011; 59(4): 441-53. 
102. 
Van Dongen HPA MG, Dinges DF. Dealing with inter-individual differences in the temporal 
dynamics of fatigue and performance: importance and techniques. ASEM 2004;75:A147-A154. 
103. 
Burns JWB GB, Bruehl S, Harden RN, Lofland K. Cognitive factors influence outcome following 
multidisciplinary chronic pain treatment: A replication and extension of a cross-lagged panel analysis. 
Behav Res Ther. 2003;41(10):1163-182.  . 
104. 
Burns JW KA, Bruehl S, Harden RN, Lofland K. Do changes in cognitive factors influence 
outcome following multidisciplinary treatment for chronic pain? A cross-lagged panel analysis. J Consult 
Clin Psychol. 2003;71(1):81-91. 
105. 
Jensen MP, Hanley MA, Engel JM, et al. Hypnotic analgesia for chronic pain in persons with 
disabilities: A case series. International Journal of Clinical and Experimental Hypnosis 2005; 53: 198-
228. 
106. 
Robinson JP, Czerniecki J, Ehde DM, et al. Trial of amitriptyline for relief of pain in amputees: 
Results of a randomized controlled study. Archives of physical medicine and rehabilitation 2004; 85: 1-6. 
107. 
Honn KA SB, McCauley P, Caldwell JL, Van Dongen HPA. Fatiguing effect of multiple take-offs 
and landings in regional airline operations. Accid Anal Prev. 2016;86:199–208. 
108. 
1971. WBSpiedNYMH. 
109. 
Liira J VJ, Costa G, Driscoll TR, Sallinen M, Isotalo LK, Ruotsalainen JH. Pharmacological 
interventions for sleepiness and sleep disturbances caused by shift work. Cochrane Database of 
Systematic Reviews 2014, Issue 8. Art. No.: CD009776. 
110. 
Kazdin AE. Mediators and mechanisms of change in psychotherapy research. Annu Rev Clin 
Psychol 2007; 3: 1-27. 
111. 
Kazdin AE. Understanding how and why psychotherapy leads to change. Psychother Res 2009; 
19(4-5): 418-28. 
112. 
Mullington JM HM, Toth M, Serrador JM, Meier-Ewert HK. Cardiovascular, inflammatory, and 
metabolic consequences of sleep deprivation. Prog Cardiovasc Dis. 2009;51(4):294-302. 
 
VA Puget Sound IRB Approved 
07/09/2020

 
CPSS Protocol v.23 06-30-2020 
 
Page 105 of 105 
 
 
K. Appendix 1: Evaluation Timeline, Main Study 
 
 
 
* Onset of both enrollment and pre-treatment relative to the onset of treatment may vary given the timing of group sessions 
Assessment
Screening 
Enrollment: Day 0*
Pre-Treatment (Weeks 1-2)*
Treatment Session #1  (Week 3)
Treatment Session #2  (Week 4)
2-Week Assessment (Weeks 4-5)
Treatment Session #3  (Week 5)
Treatment Session #4 (Week 6)
4-Week Assessment (Weeks 6-7)
Treatment Session #5  (Week 7)
Treatment Session #6 (Week 8)
6-Week Assessment (Weeks 8-9)
Treatment Session #7 (Week 9)
Treatment Session #8  (Week 10)
Post-Treatment (Weeks 11-12)
3 Month Assessment (Weeks 22-23)
6 Month Assessment (Weeks 34-35)
Inclusion/Exclusion Criteria
X
Informed Consent Form
X
Cognitive Assessment
X
Hypnotic and Relaxation Exercise
X
Baseline Data and Demographic Form
X
Pain Intensity (Primary Outcome)
X
X
X
X
X
X
X
Secondary Outcomes (e.g. Depression, Anxiety)
X
X
X
X
X
X
X
EEG Data (Mediators: Biological)
X
X
Mediators: Psychological (e.g.  Pain Acceptance, 
Catastrophizing)
X
X
X
X
X
X
X
Pain Intensity, Comfort Levels
X
X
X
X
X
X
X
X
Treatment Homework Completion 
X
X
X
X
X
X
X
X
Participant Engagement
X
X
X
X
X
X
X
X
Adverse Events
X
X
X
X
X
X
X
X
X
X
X
X
VA Puget Sound IRB Approved 
07/09/2020