Pilot Study of Combined Treatment for Veterans With Chronic Pain & Opiate Misuse
Phase: NA
Conditions: Chronic Pain, Problematic Opioid Use
Sponsor: University of New Mexico

 
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NCCAM Protocol 
 
 
FULL PROTOCOL TITLE 
 
A pilot study of integrated treatment for Veterans with chronic pain and opiate misuse 
 
Study Chairman or Principal Investigator:   
 
Kevin E. Vowles, Ph.D., Associate Professor, 
Department of Psychology, University of New Mexico 
 
Supported by:  
The National Center of Complementary and Alternative Medicine  
 
Application #: R34 AT008398-01 
 
Study Intervention Provided by: 
N/A 
 
Sponsor of IND (IDE):  
N/A
 
 
 
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TABLE OF CONTENTS 
Page 
Clinical Intervention Study Protocol Template ....................................................................... 1 
PREFACE................................................................................................................................... 1 
FULL PROTOCOL TITLE ........................................................................................................... 1 
TABLE OF CONTENTS ............................................................................................................. 2 
STUDY TEAM ROSTER ............................................................................................................. 4 
PARTICIPATING STUDY SITES ................................................................................................ 4 
PRÉCIS ...................................................................................................................................... 5 
1. STUDY OBJECTIVES ............................................................................................................ 7 
1.1 
Primary Objective ............................................................................................................. 7 
1.2 
Secondary Objectives ....................................................................................................... 7 
2. BACKGROUND AND RATIONALE ....................................................................................... 7 
2.1 
Background on Condition, Disease, or Other Primary Study Focus .................................. 7 
2.2 
Study Rationale ................................................................................................................ 8 
3. STUDY DESIGN ..................................................................................................................... 8 
4. SELECTION AND ENROLLMENT OF PARTICIPANTS ........................................................ 9 
4.1 
Inclusion Criteria ............................................................................................................. 10 
4.2 
Exclusion Criteria ............................................................................................................ 11 
4.3 
Study Enrollment Procedures ......................................................................................... 11 
5. STUDY INTERVENTIONS .................................................................................................... 12 
5.1 
Interventions, Administration, and Duration ..................................................................... 12 
5.2 
Handling of Study Interventions ...................................................................................... 12 
5.3 
Concomitant Interventions .............................................................................................. 15 
5.3.1 Allowed Interventions ...................................................................................................... 15 
5.3.2 Required Interventions .................................................................................................... 15 
5.3.3 Prohibited Interventions .................................................................................................. 15 
5.4 
Adherence Assessment .................................................................................................. 15 
6. STUDY PROCEDURES ........................................................................................................ 17 
6.1 
Schedule of Evaluations ................................................................................................. 17 
6.2 
Description of Evaluations .............................................................................................. 17 
6.2.1 Screening Evaluation ...................................................................................................... 17 
6.2.2 Enrollment, Baseline, and/or Randomization .................................................................. 18 
6.2.3 Blinding ........................................................................................................................... 19 
6.2.4 Followup Visits ................................................................................................................ 19 
6.2.5 Completion/Final Evaluation ........................................................................................... 19 
7. SAFETY ASSESSMENTS .................................................................................................... 20 
7.1 
Specification of Safety Parameters ................................................................................. 22 
7.2 
Methods and Timing for Assessing, Recording, and Analyzing Safety Parameters ......... 22 
7.3 
Adverse Events and Serious Adverse Events ................................................................. 22 
7.4 
Reporting Procedures ..................................................................................................... 23 
7.5 
Followup for Adverse Events .......................................................................................... 23 
7.6 
Safety Monitoring ............................................................................................................ 23 
8. INTERVENTION DISCONTINUATION ................................................................................. 23 
9. STATISTICAL CONSIDERATIONS ...................................................................................... 23 
9.1 
General Design Issues .................................................................................................... 23 
9.2 
Sample Size and Randomization .................................................................................... 25 
Treatment Assignment Procedures ........................................................................................... 25 
9.3  
Definition of Populations ................................................................................................. 25 
9.4 
Interim Analyses and Stopping Rules ............................................................................. 25 
9.5 
Outcomes ....................................................................................................................... 25 
9.5.1 Primary Outcome ............................................................................................................ 26 
9.6 
Data Analyses................................................................................................................. 26 

 
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10. DATA COLLECTION AND QUALITY ASSURANCE ......................................................... 26 
10.1 Data Collection Forms .................................................................................................... 26 
10.2 Data Management .......................................................................................................... 26 
10.3 Quality Assurance ........................................................................................................... 26 
10.3.1 Training 26 
10.3.2 Quality Control Committee .............................................................................................. 27 
10.3.3 Metrics 27 
10.3.4 Protocol Deviations ......................................................................................................... 27 
10.3.5 Monitoring ....................................................................................................................... 27 
11. PARTICIPANT RIGHTS AND CONFIDENTIALITY ............................................................ 27 
11.1 Institutional Review Board (IRB) Review ......................................................................... 27 
11.2 Informed Consent Forms ................................................................................................ 27 
11.3 Participant Confidentiality ............................................................................................... 28 
11.4 Study Discontinuation ..................................................................................................... 28 
12. COMMITTEES .................................................................................................................... 28 
13. PUBLICATION OF RESEARCH FINDINGS ....................................................................... 28 
14. REFERENCES ................................................................................................................... 28 
15. SUPPLEMENTS/APPENDICES ......................................................................................... 28 
I. 
Telephone Script 
II. 
Consent Form 
III. 
Case Report Form & Site Screening and Enrollment Log 
IV. 
Questionnaires 
V. 
Study Completion Record 
VI. 
Participant Compensation Record 
VII. 
Biosketches - Data Safety Monitoring Board 
VIII. 
Protocol Deviation Tracking Log/Adverse Event Form/Serious Adverse Event Form 
IX. 
Data and Safety Monitoring Log 
 

 
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STUDY TEAM ROSTER  
 
PI - Kevin E. Vowles, PhD 
Department of Psychology, University of New Mexico, MSC03 2220 – Logan Hall, Albuquerque, NM 
87131; 505-277-5676 (tel); 505-277-1394 (fax); k.e.vowles@gmail.com (e-mail). 
 
Co-I – Katie Witkiewitz, PhD 
Department of Psychology, University of New Mexico MSC03 2220 – Logan Hall, Albuquerque, NM 
87131; 505-277-4121 (tel); 505-277-1394 (fax); katiew@unm.edu (e-mail). 
 
 
Co-I – Wesley Gilliam, PhD 
Department of Primary Care, New Mexico Veteran Affairs Healthcare System; 1501 San Pedro Dr SE; 
Albuquerque, NM 87108; 505-265-1711 (ext. 5153) (tel); Wesley.gilliam2@va.gov (e-mail). 
 
  
Co-I – Karen Cardon, MD 
Department of Internal Medicine, New Mexico Veteran Affairs Healthcare System; 1501 San Pedro Dr 
SE; Albuquerque, NM 87108; 505-265-1711 (tel); Karen.Cardon@va.gov (e-mail). 
 
Consultant – Sarah Bowen, PhD 
Department of Psychology, , University of Washington, 1100 NE 45th, Suite 300, Seattle, WA 98105; 
206-685-2995 (tel); swbowen@uw.edu (e-mail) 
 
PARTICIPATING STUDY SITES 
 
University of New Mexico, Department of Psychology, University of New Mexico MSC03 2220 – Logan 
Hall, Albuquerque, NM 87131 
 
Raymond G. Murphy VA Medical Center, New Mexico Veteran Affairs Healthcare System 1501 San 
Pedro SE; Albuquerque, NM 87108 

 
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PRÉCIS  
 
Objectives: Determine the feasibility and acceptability of a combined treatment for veterans with 
comorbid chronic pain and opioid misuse or dependence, as well as assess mechanisms of change 
during the combined intervention.  A secondary objective is to examine weekly progress on specific 
therapy targets (e.g., pain acceptance, self-compassion, opioid craving) in the interventions in order to 
identify potential mechanisms of change and to identify the choice of intermediate endpoints for a larger 
randomized clinical trial. Approach—To test the feasibility of recruitment and retention, as well as study 
weekly progress on treatment targets, within a randomized clinical trial (RCT) of Acceptance and 
Commitment Therapy (ACT) + Mindfulness-Based Relapse Prevention (MBRP) or treatment as usual for 
chronic pain and opiate misuse.   
 
Design and Outcomes: Veterans with chronic pain and opiate misuse, abuse, or dependence who are 
receiving long-term opioid therapy (i.e., 90+ days) will be recruited from the Raymond G Murphy 
Veterans Affairs (VA) Medical Center in Albuquerque, NM.  Treatment will begin in Year 1 and conclude 
in Year 2 with follow-up assessment lasting through the first quarter of Year 3.  At the time of enrolling in 
the trial, individuals will participate in a baseline assessment including self-report and behavioral 
measures.  Participants (n = 120) will then be randomized to one of two treatment conditions: (1) 
treatment services-as-usual (i.e., standard care) or (2) standard care with eight weeks of group ACT plus 
four weeks of group MBRP.  Participants will complete assessments at baseline (entry into the study), 
weekly during the first three months of the study (during treatment), three months after entry in the study 
(end of treatment), and nine months after entry in the study (six months after treatment conclusion).   
 
Self-Report and Behavioral Assessment Batteries—Self-report and behavioral assessments will be used 
to evaluate study hypotheses.  For the follow-up assessments we will use contact information collected 
at baseline to contact participants by phone one week prior to their scheduled follow-up date.  
Participants will be reminded about procedures and scheduled to complete all assessments at the VA.  
 
Demographic Information (Pre-treatment, Post-treatment, and 6 month follow-up assessment): Patient 
demographics (e.g., gender, age, educational achievement) and pain-related information (e.g., 
duration, location, history of treatment) will be collected during the pre-treatment assessment. We will 
re-assess pain-related information and treatment history at post-treatment and the 6-month follow-up 
assessment. 
 
Clinical Outcome Measures (Pre-treatment, Post-treatment, and 6 month follow-up assessment):  
Given the relevance of interference from pain on key aspects of functioning in those with chronic pain, 
we will utilize the NIH PROMIS toolkit measures for pain behavior1 and pain interference2. Both 
PROMIS measures have evidence of excellent psychometric properties in chronic pain. We will also 
collect information on current opioid misuse using the Current Opioid Misuse Measure, a measure of 
aberrant opioid-related behaviors over the past month3. The recommended cut-score of 12 has 
adequate sensitivity (77%) and specificity (77%) for a current diagnosis of prescription drug abuse3. 
Finally, current pain intensity, as well as least, most, and average over the past seven days,  will be 
assessed via 0-10 numerical ratings scales and disability will be assessed via the Sickness Impact 
Profile4. 
 
Weekly Self-Report Progress Measures (20 minutes per week):  In order to examine our secondary 
objective concerning mechanisms of change during treatment, we will collect weekly data during the 12 
weeks of treatment to assess for change in specific therapy targets that are hypothesized to change 
during treatment.  These weekly progress measures will include three self-report questionnaires, each of 
which has evidence for mediating treatment outcomes in either ACT for chronic pain5 or MBRP for 
substance use disorder6,7.  These measures include: 
 
1. 
Chronic Pain Acceptance Questionnaire (CPAQ8).  The CPAQ is a 20-item measure of acceptance 
and willingness to have chronic pain.  It is perhaps the most widely used measure of pain acceptance in 

 
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the literature and its psychometric properties, factor structure, and sensitivity to treatment are well 
established9,10.   
 
2. 
Self-Compassion Scale (SCS11).  The SCS is a 26-item questionnaire which evaluates numerous 
aspects of mindfulness and self-compassion.  Initial psychometric evaluations of the measure have 
provided support for its reliability and validity11.   
 
3. 
Penn Alcohol/Drug Craving Scale (PACS12).  A modified version of the PACS will be used to assess 
both alcohol and drug craving.  The PACS is a 5-item measure including questions about frequency, 
intensity, and duration of craving, and an overall rating of craving for the previous week.  The PACS has 
demonstrated good psychometric properties in our prior studies, including internal consistency reliability 
(α=.87) and criterion validity6,7. 
 
In addition to these three questionnaires, the weekly progress measure will also include items to assess 
mindfulness practice (days/times per day) and homework assignment completion, as well as items 
relating to pain intensity, distress intensity, willingness to experience pain, and engagement in valued 
activity13. 
 
Interventions and Duration: Intervention Conditions—All participants will continue to receive standard 
care for chronic pain within the VA.  In addition, one-half of participants will be randomized to also 
receive ACT plus MBRP.  Standard Care:  Participants in all conditions will receive standard treatment as 
usual at the VA, as indicated by the individual’s treatment plan which will not be manipulated by the 
research team.  Consistent with national and VA standards14,15, care at the recruitment sites typically 
consists of noninvasive interventions, such as analgesic pain medications (e.g., opioids, NSAIDs, anti-
epileptics), topical solutions (e.g., lidocaine), physical therapy, and massage, as well as limited invasive 
interventions (e.g., injections, radiofrequency denervation).  Acceptance and Commitment Therapy 
(Weeks 2–9): The ACT intervention is based on the standardized and manualized protocol of Vowles and 
Sorrell16, which consists of weekly 90-minute group meetings over eight weeks. The protocol has been 
successfully used in previous clinical trials (e.g., 17,18) and is currently available on the VA’s Evidence-
Based Practice SharePoint website.  Over the course of the group meetings, participants will identify 
areas of meaningful functioning that have been adversely impacted by pain, learn methods to enhance 
pain willingness in the service of these meaningful areas, and practice present-focused awareness skills.  
Group sessions will include discussions of the impact of pain and distress avoidance, identifying 
alternatives to this avoidance and establish plans for behavior change, demonstration and role-playing 
exercises, and homework assignments.  Participants will be provided with a treatment manual to help 
guide and inform practice outside of group sessions. Table 1 provides an outline of session content for 
the eight week ACT intervention. We anticipate enrolling approximately eight patients per group. 
Mindfulness Based Relapse Prevention (Weeks 10–13):  The MBRP program is a standardized group 
psycho-educational intervention that consists of weekly 90-minute group meetings spanning four19 to 
eight  weeks20.  For the current study, we will use the four-week program, which will eliminate 
redundancy with the ACT protocol (the eight-week MBRP group has some redundancy with ACT) and 
will also expand upon the 8 weeks of ACT by focusing on reactivity to substance cues, opioid misuse, 
and nonjudgmental awareness.  Briefly, participants will be instructed in mindfulness techniques aimed at 
increasing concentration, improving awareness, and cultivating a nonjudgmental and accepting attitude 
toward craving and automatic thought patterns.  Group sessions include discussions of mindfulness as a 
means of coping with craving and painful cognitions, role-playing exercises, meditation practice, and 
homework assignments.  Each participant will be given audio CDs developed specifically for MBRP for 
independent practice outside of the group sessions.  
 
Sample Size and Population: This study will recruit veterans with chronic pain (n = 120) who are 
currently misusing, abusing, or dependent on prescription opioids.  Participants will be recruited from the 
Co-Occurring Disorders Clinic (a specialty clinic for patients with chronic pain and evidence of 
problematic opioid use), as well as the Ambulatory Care and Primary Care Clinics of Raymond G. 
Murphy VA Medical Center in Albuquerque, New Mexico.  

 
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1. STUDY OBJECTIVES 
 
1.1 
Primary Study Aims:  Determine the feasibility of an integrated psychosocial treatment 
(ACT + MBRP) in veterans with chronic pain with evidence of opioid-related problems. Chronic 
pain patients (n = 120) who are receiving opioid therapy and who are identified as opioid misusing, 
abusing, or dependent will be recruited from the Albuquerque Veterans Administration (VA) Hospital.  
Participants will be randomized to receive standard care or standard care in addition to ACT+MBRP.  
Hypothesis 1: Feasibility of recruitment: Given the high prevalence of both chronic pain and opioid-
related problems in VA populations, we hypothesize it will be possible to recruit our target sample size (n 
= 120) within a 15-18 month timeframe. 
Hypothesis 2: Feasibility of retention: Drop-out rates will be consistent with other trials of similar 
psychosocial interventions for chronic pain (i.e., < 20%5,21–23). 
 
1.2 
Secondary Study Aims: To examine weekly progress on specific therapy targets (e.g., pain 
acceptance, self-compassion, opioid craving) in the interventions in order to identify potential 
mechanisms of change and to identify the choice of intermediate endpoints for a larger 
randomized clinical trial. 
Hypothesis 1: Evidence of treatment mechanisms: The combined ACT+MBRP treatments will be 
associated with changes in treatment mechanisms specified within the therapeutic models and in a 
manner consistent with that of previous work on ACT and MBRP, in comparison with standard care. 
Hypothesis 2: Selection of intermediate endpoints: Weekly progress measures will  
provide data indicating measures of treatment-specific mechanisms that are most sensitive to change.  
We hypothesize that acceptance of pain discomfort will be most sensitive to change in ACT and that 
reductions in reactivity to substance craving will be most sensitive to change in MBRP. 
  
2. BACKGROUND AND RATIONALE 
 
2.1 
Background on Condition, Disease, or Other Primary Study Focus 
 
Prescription drug abuse and opioid use disorders are a significant public health problem in the United 
States.  According to the most recent data from the National Survey on Drug Use and Health24, 
approximately 13% of the U.S. population (more than 34 million people) aged 12 or older reported 
lifetime nonmedical use of prescription pain relievers.  Likewise, in 2011, nearly two million Americans 
reported abuse or dependence on prescription pain relievers within the past year.  Since 1999, there has 
been a 300% increase in overdose deaths caused by prescription opioids, with 14,800 overdose deaths 
in 2008 alone.25 Overdose deaths due to opioids are more common than overdose deaths due to cocaine 
and heroin combined26.  The societal costs of prescription opioid misuse, abuse, and dependence was 
estimated at $55.7 billion in 2007, with workplace and healthcare costs accounting for 91% and criminal 
justice approximately 9% of those costs27.   
 
Substantial increases in morbidity and mortality associated with opioid misuse are particularly relevant in 
the case of chronic pain, a common healthcare concern in primary and specialist care settings28,29 
costing approximately $100 billion annually in the United States30,31.  The available evidence suggests 
opioids are increasingly used in the treatment of chronic pain32 with a recently published study indicating 
that 61% of 26,000 primary care patients surveyed were on long-term (i.e., 90+ consecutive days) 
chronic opioid therapy33.  Unfortunately, aberrant opioid use behaviors, such as opioid dependence and 
overuse or use of other substances, are quite common, occurring in up to 25% of patients on long-term 
opioid therapy34,35.  Furthermore, while comprehensive psychosocial treatments that address pain-related 
distress and disability have a strong evidence base36, patients meeting criteria for opioid dependence are 
at risk for poorer outcomes and noncompletion37.  Therefore, development of interventions that address 
the core issues of distress and disability as well as aberrant opioid use are a high priority.   
 

 
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In military veterans, the issues of chronic pain and opioid-related problems seem even more pronounced.  
Chronic pain is common, distressing, and debilitating, particularly in those that have served since the first 
Gulf War, with prevalence estimates reaching as high as 68%38–42.  As in civilian healthcare settings, 
opioids are commonly - and increasingly - used in the treatment of chronic pain in veterans38,43, with one 
recent large scale study indicating that two-thirds (978 of 1,478) of veterans with a chronic pain diagnosis 
were prescribed opioids as part of their treatment44.  Furthermore, in that same study, half of those 
prescribed opioids (478 of 978) were receiving in excess of 180 mg total daily morphine milligram 
equivalents, a level that represents a substantial increase in overdose risk in comparison with lower 
dosages45.  There is evidence of a vicious cycle of comorbidity amongst chronic pain, opioid abuse, and 
adverse events in veterans46,47.  For example, in one study of over 6,000 veterans, the mere presence of 
a chronic pain diagnosis almost doubled the risk of prescription drug abuse (OR: 1.9; 95% CI: 1.4-2.5)48, 
while another large scale survey of over 15,000 veterans indicated a prescription for opioids for chronic 
pain was related with an increased risk of adverse clinical outcome (e.g., accidents resulting in wounds, 
opioid-related accidents, overdose, violence-related injuries) in a manner that was independent of mental 
health diagnoses or other prescribed medications43.  Clinicians in Veteran Affairs (VA) hospitals are well 
aware of these issues and have noted both frustration and uncertainty in treating chronic pain patients, 
as well as the lack of evidence-based approaches that simultaneously treat problems related to both 
chronic pain and opioid misuse49,50.   
 
2.2 
Study Rationale 
 
In combination, the above data highlight the need for focused treatment development, especially in 
veterans who served in the recent conflicts, including Operation Iraqi Freedom (OIF), Operation Enduring 
Freedom (OEF), and Operation New Dawn (OND).  Two promising approaches are Acceptance and 
Commitment Therapy (ACT) for chronic pain and Mindfulness-Based Relapse Prevention (MBRP).  ACT 
for chronic pain decreases problematic pain avoidance behaviors and enhances engagement in effective 
and meaningful activities which contribute to fewer pain-related restrictions in functioning over the longer 
term51.  Mindfulness-Based Relapse Prevention (MBRP) for substance use disorders may be an ideal 
behavioral intervention for helping individuals cope with the desire, or “craving,” to use opioids, as well as 
the automatic tendency to use opioids when experiencing pain.  MBRP for substance use disorders was 
designed to target these behaviors, with the ultimate goal of reducing problematic substance use52,53.   
 
While there have been no direct examinations of ACT and MBRP in combination, research in ACT and 
MBRP separately presents a number of parallel, compatible findings which support their efficacy.  We 
therefore hypothesize that their combination in veterans experiencing chronic pain and opioid-related 
difficulties will be both appropriate and feasible.  Further, we hypothesize that the combination of these 
treatments will affect specific therapy targets (e.g., pain acceptance and opioid craving) in a manner 
consistent with existing trials.   
 
ACT and MBRP are each promising interventions with good efficacy data7,54 and are likely to 
complement one another in treating this population.  Thus, the proposed research is significant in that we 
are proposing to empirically test a combination of interventions that could greatly decrease pain 
interference, improve functioning, and decrease opioid misuse among the very large number of veterans 
treated for chronic pain.   
 
3. STUDY DESIGN 
 
As noted above, the primary objective of the study is to determine the feasibility and acceptability of a 
combined treatment for veterans with comorbid chronic pain and opioid misuse or dependence, as well 
as assess mechanisms of change during the combined intervention.  Participants will include veterans 
with chronic pain and opiate misuse, abuse, or dependence who are receiving long-term opioid therapy 
(i.e., 90+ days) and who are receiving treatment from the Raymond G. Murphy Veterans Affairs (VA) 
Medical Center in Albuquerque, NM.  Treatment will begin in Year 1 and conclude in Year 2 with follow-

 
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up assessment lasting through the first quarter of Year 3.  At the time of enrolling in the trial, individuals 
will participate in a baseline assessment including self-report and behavioral measures. Participants (n = 
120) will then be randomized to one of two treatment conditions: (1) treatment services-as-usual (i.e., 
standard care) or (2) standard care with eight weeks of group ACT plus four weeks of group MBRP.  
Participants will complete assessments at baseline (entry into the study), weekly during the first three 
months of the study (during treatment), three months after entry in the study (end of treatment), and nine 
months after entry in the study (six months after treatment conclusion).  The trial design is shown in 
Figure 1.   
 
Figure 1.  Proposed Trial Design 
Based on the preliminary data described above and our experience in working with chronic pain patients 
who misuse/abuse their prescription opioids, we hypothesize that the combination of ACT with MBRP 
may be particularly suited for treating this population.  Other interventions (e.g., cognitive-behavioral 
therapy, exercise therapy) were also considered; however, our recent work has suggested that both ACT 
and MBRP may be superior or more suitable in comparison to these other interventions.  Also, ACT and 
MBRP are theoretically aligned, which makes their combination more seamless than other interventions 
that are not theoretically aligned.  Several research designs incorporating ACT and MBRP were also 
considered (e.g., including an MBRP-only condition, a wait-list control group, or a no-treatment control 
group); however, these designs were ruled out because 1) MBRP was designed and has been 
empirically supported as an after-care intervention and has not been empirically studied as a stand-alone 
intervention for chronic pain, and 2) wait-list and no-treatment control groups were considered unethical 
for a treatment seeking population already enrolled in treatment.  We hypothesize that training in ACT 
will help reduce pain interference and improve functioning and that the addition of the MBRP mindfulness 
skills to ACT will help individuals with chronic pain who currently meet criteria or are at high risk for opioid 
misuse to reduce patterns of opioid misuse until they are no longer of clinical concern. 
 
4. SELECTION AND ENROLLMENT OF PARTICIPANTS  
 
Recruitment Sites and Participants— This study will recruit veterans with chronic pain (n = 120) who are 
misusing, abusing, or dependent on prescription opioids.  Participants will be recruited from the Co-
Occurring Disorders Clinic (a specialty clinic for patients with chronic pain and evidence of problematic 
opioid use), as well as the Ambulatory Care and Primary Care Clinics of the Raymond G. Murphy VA 
Medical Center in Albuquerque, New Mexico.   
 
The Albuquerque VA is an ideal recruitment site for the present study for several reasons. First, it has 
approximately 321,140 veterans enrolled in Primary and Ambulatory Care and facility records indicate 
that nearly a quarter of these are currently prescribed chronic opioid therapy as defined by a prescription 
of 90 or more days.  Second, the issue of comorbid chronic pain and problematic opioid use has been 
identified as a priority within this VA, such that a specialty medication management clinic has been 
established.  This clinic receives approximately 25 referrals per month, with only approximately 30% of 
these appropriate for the primary treatment option of Buprenorphine (an opioid agonist)50.  These data 
suggest that there is a large proportion of patients who are seeking help for chronic pain with potential 
opioid misuse who are in need of intervention beyond the currently available treatment options. These 
individuals, as well as veterans in Primary and Ambulatory Care, may be appropriate for recruitment into 
the present study. Finally, the close proximity and history of collaboration between the University of New 

 
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Mexico (UNM) and the Albuquerque VA should aid in decreasing institutional barriers and facilitating 
progress. Historically, Veterans treated at the Albuquerque VA are primarily male, average 62 years of 
age, and are of considerable racial/ethnic diversity, including over 40% Hispanic and about 10% Native 
Americans.   
 
Recruitment methods: The study PI and the research team will work closely with staff in Co-Occuring 
Disorders, Primary and Ambulatory Care clincs at the VA Medical Center. In-service seminars will be 
held to explain the purpose of the study and eligibility criteria to hospital staff at the beginning of the 
study and periodically throughout the recruiting period. An IRB approved recruitment flyer will also be 
distributed to these clinics (see Microsoft Publisher attachments to protocol materials for IRB approved 
flyer and informational brochure). 
 
Before a patient is contacted by the study team, the patient’s primary clinician will be asked to: a) confirm 
patient is between the ages of 21-65; b) confirm a chronic pain diagnosis of six months or longer; c) 
review medications to confirm that patient has been prescribed opioids for ninety days or longer; d) 
confirm that patients pain severity level has been four or greater over the past seven days on a 0 to 10 
scale, where 0 is no pain and 10 is worst pain possible and e) provide the patient with the study flier 
describing the study and invite the patient to meet with the research team to learn about the study and 
be screened for eligibility.  If the patient expresses interest in the study and requests that the study team 
contact him/her for screening, the primary clinician will then alert the study PI via the electronic medical 
record or with PKI encrypted email containing name and last four indicating that the patient is interested 
in being contacted for screening.  No assessments will be administered for research purposes, including 
screening, until the patient has signed the informed consent.  
 
Once potential participants have made voluntary contact with the investigators (e.g. after seeing a 
study flier at the VA facility) or once a member of the research team makes contact with potential 
participants after they express interest to their treatment providers, a full screening will take place 
via telephone to confirm eligibility for the study (using the Telephone Screening Form, which 
contains all exclusion and inclusion criteria listed in section 5). In order to inquire about PHI 
relevant to all inclusion and exclusion (i.e., designated special population membership) criteria, 
the investigators have obtained a HIPPA waiver from the governing IRB. Further, details of the 
study will also be discussed to better inform potential participants about the study requirements. 
Potential participants will be free to ask any questions about the study. At no time during the 
telephone screen is identifiable information collected that can link answers to the potential 
participant. If participants meet the above eligibility criteria and remain interested in taking part in 
the study, an appointment will be set up to meet with the participant at the data collection site, 
which take place in a private office. At this appointment, the participant will complete all baseline 
assessment information. In the event that a potential participant is ineligible or declines to take 
part in the study, any protected health information will be destroyed pursuant to VA information 
security policy. The electronic medical record will be utilized to alert the primary care provider that 
a patient on his/her panel has been enrolled in the study and which study arm the patient was 
assigned to. The payment schedule as according to the section of the Protocol on Participant 
Compensation will be clearly explained to potential participants during the consent process and 
following assignment into study condition. 
 
4.1 
Inclusion Criteria 
 
All participants must meet the following inclusion criteria: 1) be between 21 and 65 years old; 2) have 
had chronic pain for >6 months in duration; 3) averaged 4 or greater on usual pain intensity over the past 
week on a scale of 0–10 with medication; 4) daily use of prescribed opioids for chronic pain for at least 
90 consecutive days preceding assessment; 5) identified as having current opioid misuse [Current Opioid 
Misuse Measure (COMM) score of  > 12]3 or meeting diagnostic criteria for opiate abuse or dependence 
based on the Structured Clinical Interview for the DSM (SCID)56; 6) consent to randomization of 

 
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treatment to usual care with or without ACT+MBRP; 7) be willing to consent to assessment procedures 
and to be contacted for follow-ups; and 8) the ability to read written English. 
 
4.2 
Exclusion Criteria 
 
With regard to exclusionary criteria, participants will not be eligible for study participation if they: (1) meet 
diagnostic criteria for current substance abuse/dependence on a drug other than opioids, (2) meet 
diagnostic criteria for a current or past DSM diagnosis of schizophrenia, delusional disorder, psychotic or 
dissociative disorders, (3) are currently prescribed medications for opioid addiction (e.g., 
Buprenorphine/Naloxone/Suboxone)., or (4) history of suicide attempts or inpatient hospitalization for risk 
of suicide in the past six month. In addition, we will screen for significant suicidal ideation (e.g., marked 
intent or established plan) using a self-report measure at the baseline, post-treatment, and follow-up 
assessments. If significant ideation exists, the study RA will contact the VA’s Acute Psychiatric Clinic, 
which provides on-call and immediate consultation and liason services for the VA. The service is often 
consulted when significant ideation is identified. 
 
During the study period, participants may become ineligible and may be involuntarily removed. The 
conditions for removal are detailed in the Consent Form. These conditions are summarized as follows: 
(1) Individuals may be removed if the study team discerns a significant worsening of stress or mood 
symptoms as a result of study participation, (2) if an participant is incarcerated, they cannot attend 
treatment sessions and will be remvoved, (3) if an individual becomes pregnant, their primary care 
provider will wean them off of opioids (due to documented birth defect risk associated with opioid use) 
which will render the participant ineligible for the study as they will no longer be taking opioids, and (4) if 
the participant displays behaviors that are deemed overly disruptive to other participants in the treatment 
group. 
 
4.3 
Study Enrollment Procedures  
 
A brief screening questionnaire that inquires about eligibility criteria will be administered via telephone to 
patients receiving opioid therapy as part of their treatment for chronic pain at the VA who are interested 
in participating in the research study.  Interested individuals who meet initial screening criteria will be 
seen at the VA for an in-person screening where the procedures and voluntary nature of the study will be 
fully explained.  Participants will meet with a trained Research Assistant (RA) in a private assessment 
office at the VA for the opioid use and psychiatric screening and to obtain Human Research Protections 
Office (HRPO) approved informed consent.  The in-person screening will consist of self-reported opioid 
misuse behaviors on the COMM, as well as a structured clinical interview using the Substance Use 
Disorders model of the SCID, which will enquire about opioid use patterns.  
 
Anticipated wait time from screening to baseline assessment and randomization. After the initial 
screening, eligible participants will be scheduled for an in person assessment to complete informed 
consent and baseline assessments. This assessment will occur within 14 days (and ideally within 7 days) 
of screening. Immediately following completion of informed consent and assessment, participants will be 
randomized to treatment condition. 
 
Anticipated wait time from randomization to intervention beginning. We plan to begin at least one new 
group per month, therefore, wait time for most participants is anticipated to be less than one month from 
the time of study enrollment. As noted, we have planned for recruitment of eight individuals per month, 
which corresponds to our target group size. Should recruitment be faster than expected, we can 
accommodate up to ten individuals in each group to keep waiting times to a minimum. Furthermore, by 
the third month of providing intervention, we will be running three treatment groups at any one point in 
time (as each group will receive treatment for three months total). If the participant backlog surpasses six 
individuals (which is sufficient to compose a group for treatment), we will be able to add a fourth 
treatment group. 

 
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5. STUDY INTERVENTIONS  
 
5.1 
Interventions, Administration, and Duration  
 
Intervention Conditions—All participants will continue to receive standard care for chronic pain within the 
VA.  In addition, one-half of participants will be randomized to also receive ACT plus MBRP. 
 
Standard Care:  All conditions will also receive standard treatment as usual, as indicated by treatment 
plan and not manipulated by the research team.  Consistent with national and VA standards14,15, care at 
the recruitment sites typically consists of noninvasive interventions, such as analgesic pain medications 
(e.g., opioids, NSAIDs, anti-epileptics), topical solutions (e.g., lidocaine), physical therapy, and massage, 
as well as limited invasive interventions (e.g., injections, radiofrequency denervation).   
 
Acceptance and Commitment Therapy (Weeks 2–9):  The ACT intervention is based on the standardized 
and manualized protocol of Vowles and Sorrell16, which consists of weekly 90-minute group meetings 
over eight weeks. The protocol has been successfully used in previous clinical trials (e.g., 17,18) and is 
currently available on the VA’s Evidence-Based Practice Sharepoint website.  Over the course of the 
group meetings, participants will identify areas of meaningful functioning that have been adversely 
impacted by pain, learn methods to enhance pain willingess in the service of these meaningful areas, 
and practice present-focused awareness skills.  Group sessions will include discussions of the impact of 
pain and distress avoidance, identify alternative to this avoidance and establish plans for behavior 
change, demonstration and role-playing exercises, and homework assignments.  Participants will be 
provided with a treatment manual to help guide and inform practice outside of group sessions. Table 1 
provides an outline of session content for the eight week ACT intervention. We anticipate enrolling 
approximatley eight patients per group.  
 
Table 1: Overview of ACT Treatment Sessions 
Session 
Objectives and Content 
1 
a. 
Treatment orientation and overview. 
b. 
Review treatment history and evaluate it in terms of how it has worked relative to patient’s 
 
goals and expectations.  
 
2 
a. 
Review interactions among thoughts, feelings, and action, which often serve to make one 
 
another worse (e.g., become a “vicious cycle”).  
b. 
Exercises to attempt to control thoughts and/or emotions. Review patient experiences about 
 
the difficulty inherent in control attempts. 
c. 
Introduce the idea that changes in action may mean changes that directly contribute towards 
 
meaningful and successful living (i.e., values), rather than changes in stubborn, avoidant, or 
 
“just do it” ways. 
d. 
Introductory awareness training practice consisting of 2 short exercises (sitting and breathing) 
 
and 1 longer exercise (breathing). All exercises followed by discussion to review experience. 
 
3 
a. 
Values clarification exercises. Emphasis on identification and awareness. May include analysis 
 
of ways in which patients’ lives have not been as values-oriented as they would like since pain, 
 
and the effort to control it, has begun. 
b. 
Awareness training (breathing). Emphasis on awareness and “just noticing”, including noticing 
 
distractions.  
 
4 
a. 
Continued values clarification, emphasis on personal values versus those that are dictated by 
 
others.  

 
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b. 
Discussion of barriers and exercises exploring possibilities for values-based action with 
 
continuing aversive experiences. Exercises relating to willingness and unwillingness to have 
 
discomfort. 
c. 
Introduction to effective goal setting, as related to values. 
d. 
Awareness of body sensations exercise, followed by discussion. 
 
5 
a. 
Discussion of activity pacing and activity cycling. 
b. 
Exercises to raise awareness of language-based influences on action, including those that are 
 
arbitrary or fail to work over the longer term. Purpose is to increase awareness of these 
 
processes and highlight opportunities for choosing to behave in ways consistent or inconsistent 
 
with identified values. 
c. 
Awareness exercise (body awareness, including awareness of pain). Fewer cues and 
 
guidance by therapist during exercise. Followed by discussion of experience. 
 
(Table continues) 
 
 

 
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Table 1 (con’t) 
 
6 
a. 
Continued discussion of willingness to have discomfort in the service of meaningful living, 
 
including exercises to explore the longer term impacts of willingness and unwillingness. 
b. 
“Thought watching” exercise. Discussion in middle or at end of exercise to explore experience 
 
of honest, non-avoidant observation. 
c. 
Discussion of effective communication. 
 
7 
a. 
Awareness exercise, pertaining to the ways in which humans add additional, often 
 
unnecessary, distress onto already distressing situations. 
b. 
Continued discussion of willingness, especially related to meaningful living. 
c. 
Walking mindfulness exercise, preferably outside of treatment room. 
 
8 
a. 
Values clarification exercise, emphasizing commitment and future planning. 
b. 
Preparation for relapses and set-backs. 
 
 
Mindfulness Based Relapse Prevention (Weeks 10–13):  The MBRP program is a standardized group 
psycho-educational intervention that consists of weekly 90-minute group meetings lasting from four19 to 
eight weeks20.  For the current study, we will use the four-week program, which will eliminate redundancy 
with the ACT protocol (the eight-week MBRP group has some redundancy with ACT) and will also 
expand upon the eight weeks of ACT by focusing on reactivity to substance cues, opioid misuse, and 
nonjudgmental awareness.  Briefly, participants will be instructed in mindfulness techniques aimed at 
increasing concentration, improving awareness, and cultivating a nonjudgmental and accepting attitude 
toward craving and automatic thought patterns.  Group sessions include discussions of mindfulness as a 
means of coping with craving and painful cognitions, role-playing exercises, meditation practice, and 
homework assignments.  Each participant will be given audio CDs developed specifically for MBRP for 
independent practice outside of the group sessions. 
 
Table 2: Overview of MBRP Treatment Sessions 
Session 
Objectives and Content 
9 
a. 
Treatment orientation and overview. 
b. 
Introduce the concept of “automatic pilot” in relation to opioid use and the tendency to act upon 
 
cravings, pain, or other negative-affective states without awareness. 
c. 
Discussion of triggers for opiate use that include situations, thoughts, emotions, and  
 
sensations (including pain), 
d. 
Mindfulness exercise to increase awareness in daily life. 
10 
a. 
Review home practices of mindfulness to increase awareness. 
b. 
Continue discussion of triggers and high-risk situations for opiate misuse. 
c. 
Introduce “urge surfing” as a method for dealing with urges and other challenging situations. 
11 
a. 
Review home practice of urge surfing and challenges over the past week. 
b. 
Discuss the relapse cycle and the process of discomfort, difficult sensations or emotions, 
 
and negative thoughts leading to opiate misuse and craving. 
c. 
Introduce the “SOBER” breathing space as an exercise that can be used to deal with 
 
craving and other discomfort in the moment. 
12 
a. 
Review home practice of the SOBER breathing space and triggers/challenges over past 
 
week. 
b. 
Discuss lifestyle balance and increasing daily activities that are nurturing, while reducing 
 
depleting activities or those activities that can trigger opiate misuse. 
c. 
Create reminder cards with people to call and alternative activities to prevent opiate misuse. 
d. 
Preparation for incorporating mindfulness into daily life and building a support network. 
e. 
Concluding meditation and closing discussion of skills learned throughout the past 12 
 
weeks. 

 
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5.2 
Handling of Study Interventions  
 
Interventions will be delivered in a group format. The target number of participants for each group will be 
up to eight individuals, although it is possible to conduct the group with as few as four participants or as 
many as ten. Both interventions will be manualized as described in section 5.1 above. Due to the nature 
of the intervention, blinding to condition will not be possible. 
 
Number of therapists: There will be a minimum of two study therapists for each group (one the RA paid 
on the grant and the other a volunteer RA). Study therapists will be appointed through the University of 
New Mexico’s (UNM) graduate program in clinical psychology. The volunteer RA will receive practicum 
credit through UNM in lieu of payment. All therapists will be advanced post-Masters degree doctoral 
students (i.e. with necessary approval of the UNM’s Clinical Committee to engage in clinical work) who 
will have received four and one half days of training (32.5 hours total) in ACT (provided by Dr. Vowles; 
training completed January 2015) and MBRP (provided by Dr. Bowen; training completed December 
2014). Prior to leading any treatment sessions, therapists will be required to demonstrate a minimum 
level of competency, as outline by ACT and MBRP training guidelines. Instructors will also receive 
weekly supervision from an outside supervisor with specific expertise in ACT and MBRP.  
 
5.3  
Concomitant Interventions  
 
Standard care, which will be received by all participants, will proceed as indicated by the patient’s pre-
existing treatment plan (as determined by their primary care of speciality pain treatment provider). As 
noted above, standard care will be consistent with national and VA standards14,15, and will therefore 
typically include noninvasive interventions, such as analgesic pain medications (e.g., opioids, NSAIDs, 
anti-epileptics), topical solutions (e.g., lidocaine), physical therapy, and massage, as well as limited 
invasive interventions (e.g., injections, radiofrequency denervation).   
 
Prohibited interventions, as noted in section 4.2 above will include: (1) active treatment for substance 
abuse/dependence for a drug other than opiates opioids (as this active treatment would indicate current 
criteria for substance abuse/dependence for that other drug); (2) current prescription of medication for 
opioid addiction (e.g., Buprenorphine/Naloxone/ Suboxone, Methadone). 
 
5.3.1 Allowed Interventions 
 
All interventions noted in section 5.3 as “standard care” will be allowed. Aside from the medications 
noted in section 5.3 (e.g., Buprenorphine/Naloxone/Suboxone, Methadone), there will be no drug 
restrictions (e.g., opioids, NSAIDs, anti-epileptics, anti-depressants are all allowed).  
 
5.3.2 Required Interventions 
 
N/A 
 
5.3.3 Prohibited Interventions 
 
No interventions for pain treatment will be prohibited. 
 
5.4 
Adherence Assessment  
 
In relation to the primary aims of this study, concerning recruitment and retention, no pre-determined 
adherence requirement will be established. We will track treatment attendance for all participants and 
examine it as part of our evaluation. We have no plans to exclude patients for non-adherence, nor do we 
have plans to restrict re-entry into treatment following a period of absence.  
 
Commented [KV1]: Comment 5 – How are we going to track 
concomitant interventions? 

 
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5.4.1 Therapist Adherence: Treatment fidelity in ACT will be assessed using the ACT Core 
Competency Rating Form (ACT-CCR)57 and in MBRP will be assessed using the MBRP Adherence and 
Competence Scale (MBRP-AS)58.  Inter-rater reliability of adherence ratings will be ascertained by 
double coding randomly selected practitioner audiotapes throughout the course of the 12-week 
treatment.  Therapists who consistently fail to meet the criteria rating on adherence checklists will be 
decertified and will be required to undergo remedial training before they are allowed to resume seeing 
participants.   
 
 

 
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6. STUDY PROCEDURES  
 
6.1 
Schedule of Evaluations 
 
Assessment 
Telephone 
Screening: 
(Day-30 to 
Day -1) 
Baseline, 
Enrollment, 
Randomization  
Visit 1  
(Day 0) 
Treatment 
Visit 
Visit 2-12  
(W2-12) 
Final 
Treatment 
Visit 13  
(W13) 
6 mo. 
follow-up  
Visit 14 
(W37) 
Screening 
X 
 
 
 
 
Informed Consent Form   
X 
X 
 
 
 
Demographics 
 
X 
 
 
 
Pain-Related Information 
 
X 
 
 
X 
Clinical Outcomes 
 
X 
 
X 
X 
Weekly Assessments  
 
X 
X 
X 
X 
 
6.2 
Description of Evaluations  
 
6.2.1 Screening Evaluation 
 
Screening 
 
Once potential participants make contact with the study team to voice interest in taking part in the study, 
a brief screening questionnaire that inquires about eligibility criteria will be administered via telephone. 
The screening questionnaire will determine if the participant is: 
 
(a) 
Between 21 and 65 years of age. 
(b) 
Has experienced pain daily for at least the past 6 months 
(c) 
Has been taking prescribed opioids for the treatment of chronic pain daily for at least the past 3 
 
months 
(d) 
Experiencing average weekly pain of a four or greater on a 0-10 scale of pain intensity 
 
Each of these criteria will be evaluated by “yes/no” responses from potential participants and responses 
recorded on our IRB-approved telephone script assessing these details (see Appendix I). 
 
Consenting Procedure for Screening 
 
There will be two consenting procedures. The first will be part of the telephone screening evaluation. Our 
IRB has approved the telephone script and determined that verbal consent to complete the screening is 
allowed.  
 
The consent for screening and screening procedure will take place within a single telephone 
conversation. Study RAs will complete the procedure. All study RAs have completed the appropriate 
Human Subject’s Protection Training (completion certificates on file with our local IRB). 
 
For most participants, screening will be completed < 30 days prior to entry into the treatment study (as a 
new course of treatment will begin each month). In some cases, participant preference may delay entry 
into treatment.  
 
 

 
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6.2.2 Enrollment, Baseline, and/or Randomization 
 
Study consenting, enrollment, baseline assessment, and randomization will all take place during a clinic 
visit. All procedures will be completed by study RAs. 
 
Consenting Procedure for Enrollment 
 
This study will follow the Informed Consent Process for Research (UNM HRP-090). Each participant’s 
consenting process will be recorded by the study RA. The consent document will be stored in a locked 
cabinet in Co-I Gilliam’s office in the VA. No minors will be involved in this study, thus parental/guardian 
permission and minor assent is not relevant. None of the identified groups of vulnerable populations are 
included in this study.  
 
The informed consent process will take place in a private office, and participants will have the opportunity 
to choose their seating, read the consent form, and ask any questions they may have at the beginning of 
the data collection session. Signed consent forms will be transported in a locked file separate from other 
paper measures. Participants will be reminded that their involvement in this study is completely 
voluntary, and that they can withdraw it any time without any negative repercussions whatsoever (e.g., 
with regard to clinical care or healthcare access). They will also be explicitly told that they may leave any 
question blank for questionnaires or unanswered for the clinical interview if they do not feel comfortable 
answering.  See Appendix II for the consent form. 
 
Non-English Speaking Participants – Individuals who do not speak or understand English will not be 
recruited to the study. While we recognize the limitations of this approach, practical considerations 
necessitate the inclusion of only those who are able to speak or understand English.  
 
Enrollment date will be recorded on a case report form, which will also include documentation of 
inclusion/exclusion criteria. See Appendix III for case report form and site screening & enrollment log. 
 
Baseline Assessments (Appendix IV) 
 
Demographic Information:  
- 
Patient demographics (e.g., gender, age, educational achievement) 
- 
Pain-related information (e.g., duration, location, history of treatment)  
Opioid Use:  
- 
Current Opioid Misuse Measure (COMM) - We will also collect information on current opioid 
misuse using the COMM, a measure of aberrant opioid-related behaviors over the past month3. 
The recommended cut-score of 12 has adequate sensitivity (77%) and specificity (77%) for a 
current diagnosis of prescription drug abuse3.  
 
- 
Structured Clinical Interview for DSM-IV (SCID) – The Substance Abuse and Dependence 
module of the SCID will be conducted with all participants.  
 
Clinical Outcomes:  
- 
Pain Behavior - PROMIS Bank v1.0 Pain Behavior 
 
- 
Pain Interference - PROMIS Bank v1.0 Pain Interference 
 
- 
Disability – Sickness Impact Profile (SIP) – The SIP is a measure of health-related disability4. It 
has demonstrated utility in chronic pain settings and provides a detailed assessment of 

 
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functioning across multiple domains. The SIP has been widely used in chronic pain settings and 
has demonstrated sensitivity to intervention5,59,60. 
 
- 
Pain intensity, including current and least/most/usual over the past week, will be assessed via a 
0 (no pain) -10 (maximum possible pain) numerical rating scale (NRS). Assessing pain intensity 
via NRS is a widely-used and well-established method in studies of pain61,62. 
 
Randomization 
 
 
Randomization will occur following baseline assessment.  We will use a random order variable-sized 
block randomization procedure with block sizes of 2, 4, and 6. The investigators will be blind to the size 
of each block and randomization allocation. 
 
6.2.3 Blinding 
PI Vowles and Co-I’s Witkiewitz (study statistician), Gilliam, and Cardon will be blinded. Unblinded staff 
will include the Research Coordinator from the Biomedical Institute of New Mexico (BRINM) and 
Graduate Research Assistant as these individuals will handle randomization and delivery of treatment, 
respectively. These individuals will have no access to data and no involvement in data monitoring or 
analyses. 
 
6.2.4 Follow-up Visits 
 
 
Weekly Assessments (Appendix IV) 
 
 
As noted, participants will complete assessments measures at each week’s visit. Measures will include: 
 
- 
Chronic Pain Acceptance Questionnaire (CPAQ8).  The CPAQ is a 20-item measure of 
acceptance and willingness to have chronic pain.  It is perhaps the most widely used measure of 
pain acceptance in the literature and its psychometric properties, factor structure, and sensitivity 
to treatment are well established9,10.   
 
- 
Self-Compassion Scale (SCS11).  The SCS is a 26-item questionnaire, which evaluates numerous 
aspects of mindfulness and self-compassion.  Initial psychometric evaluations of the measure 
have provided support for its reliability and validity11.   
 
- Penn Alcohol/Drug Craving Scale (PACS12).  A modified version of the PACS will be used to 
assess both alcohol and drug craving.  The PACS is a 5-item measure including questions about 
frequency, intensity, and duration of craving, and an overall rating of craving for the previous 
week.  The PACS has demonstrated good psychometric properties in our prior studies, including 
internal consistency reliability (α=.87) and criterion validity7,63. 
 
6.2.5 Completion/Final Evaluation 
 
Six months following the last treatment session, all participants will again complete: 
 
- 
Pain-related information (e.g., duration, location, history of treatment)  
- 
Opioid Use - COMM  
- 
Pain Behavior - PROMIS Bank v1.0 Pain Behavior 
- 
Pain Interference - PROMIS Bank v1.0 Pain Interference 
- 
Disability – SIP 

 
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- 
Pain Intensity – NRS for current and least/most/average over past week. 
- 
Pain Acceptance - CAPQ 
- 
Self-Compassion – SCS 
- 
Alcohol/Drug Craving – PACS 
 
The Study Completion Record is in Appendix V. 
 
6.2.5.1 Participant Compensation 
 
Remuneration for each of the assessments is as follows: Participants will receive $60 for completion of 
the baseline session, $5 per week for completing weekly assessments during active treatment ($60 
total), $50 for completing the end of treatment assessment (week 13), and $50 for completing the six-
month follow-up (week 37), totaling $220. Individuals who complete all assessments will be given a $50 
bonus at the 6-month follow-up, for a maximum compensation of $270. 
 
Participant costs per year are as follows: 
 
Year 1: $9,680 
(64 baseline, 64 X $60=$3840; 64 weekly treatment, 64 X $60=$3840; 40 
post-treatment; 40 X $50=$2000). 
Year 2: $19,520 
(56 baseline, 56 X $60=$3360; 56 weekly treatment, 56 x $60= $3360; 80 
post-treatment, 80 X $50=$4000; 88 six month follow-up, 88 X $50=$4400; 
88 bonus six month maximum completion, 88 X $50=$4400). 
Year 3: $3,200 
(32 six month follow-up, 32 X $50=$1600; 32 bonus six month maximum 
completion, 32 X $50=$1600). 
 
The participant compensation record is displayed in Appendix VI. 
 
7. SAFETY ASSESSMENTS  
 
No vulnerable classes of human participants will be targeted for recruitment, although it is possible that 
participants may, for example, become pregnant during the trial or be incarcerated. We do not foresee 
that the intervention conditions will cause harm to the fetus or distress the pregnant participant. 
In the case that a participant is incarcerated during the course of the study, the research team 
will make every attempt to provide the opportunity for completing assessments only if continued 
assessment presents no more than minimal risk and if adequate assurances can be made that 
parole boards will not take into account prisoners’ participation in the research in making 
decisions regarding parole or probation. Further, each prisoner must be clearly informed in 
advance that participation in the research will have no effect on his or her parole.  
 
Sources of Material: Research material will consist of data collected from participants using structured 
clinical interview and self-report questionnaires. The structured clinical interview will be conducted during 
the baseline assessment to evaluate for mood, anxiety, or psychotic disorders, as well as the presence 
of substance use disorders (prescribed opioid and otherwise). The self-report questionnaires will assess 
a range of relevant constructs, including demographic information (e.g., age, gender, educational 
history), pain-related details (e.g., location, duration, current and past treatments), hypothesized 
treatment mechanisms (i.e., pain acceptance, self-compassion, alcohol and drug craving), and aspects 
of current and past functioning and substance use behaviors (i.e., pain behavior, pain interference, 
aspects involved in current opioid use).  
 
A linkage between personal identification numbers (PINs) and individually identifiable private information 
(participants’ names and contact information) is necessary to facilitate follow-up communication. Great 
care will be taken to maintain the confidentiality of data provided by participants. All data collected on 
participants will be identified with a randomly generated, unique personal identification number (PIN). 
Commented [KV2]: Added Depression? BCMDI with suicide 
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Master lists of PINs and individually identifiable private information will be stored in locked file cabinets 
and computers with restricted access, and will be available only to research staff on this project. The 
linkage and the individually identifiable private information will be destroyed at the earliest opportunity 
consistent with conduct of the research. All data will be collected specifically for the proposed research 
study. 
 
Potential Risks: Risks to participants are primarily psychological in nature and may include discomfort 
associated with answering sensitive questions (e.g., about mental health and substance abuse). The 
information requested may be viewed as private, and therefore the questions may be perceived as 
intrusive. The act of completing assessment materials may cause participants to become cognizant of 
certain behaviors and personal problems which may cause distress. In the event that a participant 
becomes overly anxious, he or she will be evaluated for risk by a licensed mental health clinician. 
Participants are also asked to report on potentially illegal behaviors such as use of illicit and controlled 
substances. Answers to these questions could pose social and legal difficulties if this information were 
linked to their identity and became known to someone outside of the research team.  
 
The therapies employed in the current study, ACT and MBRP, do not involve any known risks. Both 
interventions have been empirically validated. However, participants could become anxious or distressed 
during a session, or they could arrive in crisis to a session. Should this occur, the therapist will abort the 
scheduled materials for that day and implement crisis reduction therapy. In the event of an emergency, 
therapists will be able to reach the PI or study Co-I’s (all of whom are licensed clinical psychologists, with 
the exception of Dr. Cardon, who is a licensed physician) or another designated licensed psychologist 
who is on call for this purpose. Therapists will always have a list of licensed VA psychologists to call in 
the event of an emergency. This practice is standard in the VA and is used, for example, when trainee 
psychologists are in need of consultation or assistance.  
 
Finally, there is the risk that some participants may not benefit from the interventions.  
 
Adverse events will be identified and reported initially to Dr. Gilliam, as part of his role as VA Co-I. Dr. 
Gilliam will be responsible for the assessment, intervention and treatment (if necessary) of these adverse 
events and for the reporting of adverse events to the required oversight entities (i.e., Institutional IRB). 
The known potential risks will be described in the informed consent document and protocol. Study team 
members will no longer have access to paper or electronic records when they are no longer part of the 
research team.  
 
 
We believe this research does not cross the threshold of Minimal Risk for participants for the 
following reasons: 
 
1. There are no known substantial risks associated with questionnaire completion or with 
engagement in psychotherapy. While these activities may result in transient increases in 
distress, the evidence base reliably indicates that any distress associated with questionnaire 
completion is not sustained and engagement in psychotherapy is associated with decreases 
in distress for the majority of participants. 
2. Participant identifying information will not be stored beyond record of consent, which will not 
include a record of whether an individual provided full data/achieved completion of study 
procedure. 
3. Participants will not be informed of the results of any assessment procedure. 
4. Participant treatment providers, family members, friends, etc. will not be informed of the 
results of any assessment procedure. 
 
The approving IRB body has agreed with our risk assessment and granted us permission to conduct the 
study.  

 
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7.1 
Specification of Safety Parameters 
 
Recruitment and Informed Consent: The investigators have taken several steps to protect participants 
against potential risks inherent to the proposed research. First, every effort will be made to protect the 
confidentiality of participant records. We will obtain a Certificate of Confidentiality from the Federal 
government, because we are asking participants about the use of illegal drugs. However, complete 
confidentiality can never be absolutely guaranteed because records may be examined by personnel from 
the UNM Human Research Protections Office and because accidents or other unforeseen circumstances 
sometimes occur despite the best protections put in place. Participants will be informed of this possibility 
prior to signing any consent forms for this study. All records will be kept strictly confidential and will not 
be inspected by any other agency except if required by law. Only research staff and staff of the UNM 
Human Research Protections Office will have access to PHI. Signed consent forms will be kept 
separately from any documents containing Personal Health Information (PHI) or participants’ unique ID 
numbers. The database linking ID numbers to participants’ identity will be kept separately from all PHI 
and ID numbers and only the PI and research staff on this study will have access to this link. Any hard 
copies of data (e.g., consent forms, audiotapes of sessions) will be kept in double locked rooms 
designated for the storage of PHI. Data will be destroyed 7 years after the last publication. The results of 
this research may be presented at meetings or in publications, however participants’ identities will not be 
disclosed. All computers with ID-coded data will be encrypted and password protected.  
 
Distress. Potential psychological risks, including discomfort associated with disclosure of information, 
feelings of compromised privacy and distress that may be caused by increased awareness of one’s 
opiate misuse, will be addressed in the consent form. Participants will be encouraged to contact 
investigators and/or study staff if they have any concerns about their participation or if they experience 
any psychological distress. All study investigators are clinical psychologists with extensive experience in 
the treatment of chronic pain  and substance abuse and/or substance misuse, abuse, or dependence. 
They will train and supervise research staff and the study therapists to utilize data provided at each 
assessment point as well as clinical judgment to monitor and evaluate the condition of participants. 
Therapists will always have a list of licensed psychologists to call in the event of an emergency. If a 
participant discloses suicidal or homicidal intentions or ongoing child or elder abuse, the therapist will 
notify the licensed psychologist on call who will evaluate the participant for risk and follow the NM state 
law regarding mandated reporting. Therapists will disclose these limits of confidentiality to participants at 
their first therapy session. If a participant arrives for treatment or assessment in an intoxicated state, the 
therapist or research assistant will reschedule their session and be advised not to drive and seek 
appropriate transportation back to their homes. All participants will be informed of the right to withdraw 
from the study at any time and still receive full compensation for their time.  
 
 
7.2 
Methods and Timing for Assessing, Recording, and Analyzing Safety Parameters 
 
N/A 
 
7.3 
Adverse Events and Serious Adverse Events  
 
As noted above, we deem the risk of adverse events to be negligible within this study. Adverse events 
can include a breach of study procedures (e.g., use of an expired consent form), distress requiring the 
services of a healthcare provider, or inadvertent breach of confidentiality.  
 
There is no evidence that participation in this treatment trial will increase risk of a serious adverse event. 
 
All adverse events will be recorded and reported within 5 days of occurrence, as required by our IRB of 
record (https://spa.unm.edu/common/documents/irb-guidelines.pdf). 

 
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7.4 
Reporting Procedures 
 
The PI of the study (Dr. Vowles) will be responsible for reporting all adverse events to the IRB of record. 
The IRB uses the “Click” system (http://hsc.unm.edu/som/research/hrrc/click.shtml), which includes a 
reporting mechanism that is sent directly to the IRB. For any adverse events, a course of remediation will 
be proposed (e.g., in the event of a protocol violation, safeguards will be put in place to decrease the 
probability of repeated violation) to the IRB, although the IRB itself will approve/disapprove the 
remediation. 
 
7.5 
Follow-up for Adverse Events 
 
All AE’s will be reported to the IRB of record within five days. Follow-up remediation will occur within five 
days of the IRB’s response or decision. 
 
7.6 
Safety Monitoring  
 
We have established a Data Safety Monitoring Board (DSMB), consisting of three individuals. The first 
member is Professor Barbara McCrady, who is a Distinguished Professor within the Department of 
Psychology at UNM and also director of the Center on Alcoholism, Substance Abuse, and Addictions 
(CASAA). She brings with her 40 years of experience conducting funded clinical trials with substance 
abusing populations. The second member is Professor Ronald Yeo, a Regents’ Professor within the 
Department of Psychology at UNM. Dr Yeo also has extensive experience working with complex clinical 
populations, chiefly schizophrenia and brain injury. He is also a member of the UNM Institutional Review 
Board (IRB) and has expertise in research ethics. The third and final member is Dr J Scott Tonigan, a 
Research Professor within the Department of Psychology and CASAA, as well as Chair of the UNM IRB. 
Dr Tonigan brings with him significant expertise in trial design and research ethics. He also is a highly 
accomplished statistician. Please see biosketches for all three members of the DSMB in Appendix VII. 
 
8. INTERVENTION DISCONTINUATION  
 
- Participant choosing to discontinue. 
-  
- Because this is a feasibility trial, we will not discontinue intervention based on non-attendance. 
 
No other discontinuation criteria are identified.  
 
9. STATISTICAL CONSIDERATIONS  
 
9.1 
General Design Issues  
 
Preliminary Analyses:  Data will be analyzed for missing cases to detect any bias across research groups 
that might result from differential attrition and/or response omission.  For example, participant 
characteristics to include gender, minority status, age, drinking history, pain duration and intensity, 
educational achievement, and previous treatment experiences will be compared for those participants 
retained in the study versus those lost to attrition.  Furthermore, the data will be examined for both 
missing cases and outlier scores on measures.  Variable distributions will be checked for normality and if 
necessary, transformations will be performed to normalize the distributions.  We will compare 
demographics and primary study measures at baseline between randomized treatment groups, using 
Analyses of Variance (ANOVA) for continuous variables (or Kruskal-Wallis if parametric assumptions are 
violated) and using chi-square tests for categorical variables.  Subsequent analyses will adjust for 
significant baseline differences among the randomized groups at α = 0.05.   
 
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Analyses to Test Primary Aim Hypotheses:  The primary analyses for Aim 1 will be descriptive, including 
calculating the percent of individuals enrolled in the study versus those eligible and the percent of 
individuals who remain in the study.  We will pay particular attention to issues of retention, as the 
treatment program will occur over 12 weeks and this length may impact treatment completion (previous 
programs of ACT alone, which have lasted eight weeks, have had drop-outs of < 20%17,21). Therefore, 
we will define multiple levels of treatment retention, including partial treatment completion (% of 
individuals who do not complete all sessions), treatment dropout (% of individuals who dropout of 
treatment but continue to do assessments), research dropouts (% of individ 
uals who remain in treatment, but do not complete research assessments), and treatment + research 
dropouts (% of individuals who do not complete treatment for research assessments).  We will further 
break down the enrollment and retention calculations by examining enrollment/retention differences by 
treatm 
.ent group, gender, age race/ethnicity, and initial severity using cross-classification tables.   
 
Analyses to Test Secondary Aim Hypotheses.  The primary goal of Aim 2 is to identify potential 
mechanisms of change and intermediate endpoints for future randomized clinical trials comparing 
ACT+MBRP to standard care.  We will accomplish this goal by examining initial level and changes in 
targeted mechanisms over time during the course of treatment, as well as the association between 
changes in targeted mechanisms during treatment and 6-month follow-up measures of clinical outcomes.  
Targeted mechanisms will include (1) pain acceptance (2) psychological flexibility, (3) experiential 
avoidance, (4) opioid craving, and (5) reactivity to pain and craving, and will be examined using latent 
growth curve models with fixed effects of treatment and random effects of time.  These analyses will 
provide an estimate of the initial level of each targeted mechanism (i.e., intercept) and the change in the 
targeted mechanisms over time (slope).  Clinical outcome measures will include pain interference, pain 
behavior, and opioid misuse  and will be examined using mediation analyses within the context of latent 
growth curve modeling64, as we have done in prior studies63,65.  Specifically, as shown in simplified form 
in Figure 2, we will examine whether initial level (intercept) or changes (slope) in the targeted 
mechanisms (“M” in figure 2) during treatment mediate the effect of treatment on 6-month clinical 
outcomes, controlling for baseline levels of the outcomes.  These analyses will also provide a test of Aim 
2 Hypothesis 2, which is to identify those measures that are most sensitive to change (measures with the 
largest slope).  Identifying measures that are more sensitive to change will help us in identifying 
intermediate endpoints for a larger RCT.  Validation of intermediate endpoints is challenging and it is 
often recommended that meta-analytic methods be used66, but alternative methods have been 
developed that allow for the evaluation of endpoints in mental-health clinical trials67. 
 
Figure 2. Simplified mediation model (excludes residual terms and covariances) 
 
 
 
 
 
 
 
 
 
 
 
 
Mediati
on 
models will be estimated using the product of coefficients method68, which provides an estimate of the 
mediated effect by multiplying regression coefficients for the regression of the mediators (e.g., slope of 
targeted mechanism) on treatment condition (i.e., a-path or α) and for the regression of the clinical 

 
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outcome on the mediators (i.e., b-path or β).  We will use bootstrapping to obtain 95% confidence 
intervals of the mediated effect69.  We will use maximum likelihood estimation for all analyses, which 
provides the variance-covariance matrix for all available data and is the preferred method for estimation 
when some data are missing70.  Attrition analyses will determine whether there are any differences in 
study variables between those with missing and complete data.  Study variables associated with missing 
data will be covaried in all analyses.   
 
 
9.2 
Sample Size and Randomization 
 
Statistical Power for Secondary Aims:  We estimated statistical power for the mediation analyses using 
parameter estimates from prior studies of mediation following ACT for chronic pain5 and following MBRP 
for substance use disorders7,63 to estimate the effect sizes for the behavioral measures in the current 
study.  Following ACT, numerous behavioral measures significantly mediated changes in disability, 
depression, pain-related anxiety, medical visits, and number of classes of prescribed analgesics, with 
large mediation effect sizes.  The prior studies of MBRP have found that experiential avoidance, 
awareness, and nonjudgment significantly mediated the association between treatment and changes in 
craving (α = 0.56; β = -0.43) and that craving significantly mediated the association between treatment 
and changes in substance use (α = -0.20; β =0.71).  Based on these effect sizes and power estimates for 
testing mediation derived from a simulation study71, we will have power greater than 0.80 to detect 
significant mediating effects with the proposed sample size of 120.   
 
Examining mechanisms of change assumes that treatment influences change in the clinical outcome 
measures at follow-up, thus we also estimated the power to detect a main effect of treatment on the 
clinical outcome measures.  Effect size estimates were drawn from prior studies of ACT for patients with 
chronic pain5,23,60,72 and MBRP for substance use disorders52,63,73.  The effect sizes for ACT in 
comparison to treatment as usual or active treatment for chronic pain have ranged from 0.29 to 1.09.  
The effect sizes for MBRP in comparison to treatment as usual for substance use and craving have 
ranged from 0.21 to 0.52.  Based on these studies, we estimate a minimum average effect size of 
d=0.25.  Using a mixed-effects linear model with α=0.05 (two-tailed test), three repeated assessments 
(baseline, end of treatment, 6-month follow-up), and a correlation among repeated measures of 0.43 
(based on prior studies) we will need 60 subjects per condition (total n = 120) for 80% power to detect a 
main effect of ACT+MBRP in comparison to standard care.   
 
Treatment Assignment Procedures 
 
We will use a random order variable-sized block randomization procedure with block sizes of 2, 4, and 
6. The investigators will be blind to the size of each block and randomization allocation. 
 
9.3  
Definition of Populations 
 
Because of the primary aim of feasibility, and corresponding dependent variables of recruitment and 
retention, we do not plan to differentiate ITT and per protocol populations for the analyses. 
 
9.4 
Interim Analyses and Stopping Rules 
 
We have no plans for interim analyses. 
  
9.5 
Outcomes  
 
Please see response to Section 9.1 above. We have no plans for outcomes to be reviewed and 
adjudicated by a committee.  
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9.5.1 Primary Outcome   
 
The outcome for Aim 1 will be descriptive, including calculating the percent of individuals enrolled in the 
study versus those eligible and the percent of individuals who remain in the study.  We will pay particular 
attention to issues of retention, as the treatment program will occur over 12 weeks and this length may 
impact treatment completion (previous programs of ACT alone, which have lasted eight weeks, have had 
drop-outs of < 20%17,21. The assessment of this latter primary outcome will occur at each treatment 
meeting (as this is the only way to assess retention) and follow-up. 
 
9.6 
Data Entry and Analyses  
 
Data will be entered into the Statistical Package for Social Sciences Software (SPSS; IBM Corp). We will 
update the software license yearly so that the most recent version is used (currently version 22 is used). 
We will use an audit trail for entry, which will include a “sign-in” mechanism, where each session of data 
entry will be recorded. Recorded information within this mechanism will include the RA doing data entry, 
as well as case numbers entered and descriptive information with regard to the data entered (e.g., 
“cases 14-19; post-treatment data entered”. A new database will be saved and individually labeled after 
each session of data entry (e.g., NCCIH R34 – Jan.22.2015). 
 
In addition to responses to section 9.1 and 9.2, where details regarding the data analyses can be found, 
the following information addresses the queries listed in the instructional set for completing this protocol. 
We do not anticipate any confounding variables, although we will assess for the role of gender, age, 
ethnicity, educational achievement, pain duration, and pain location in influencing dependent variables.  
 
10. DATA COLLECTION AND QUALITY ASSURANCE 
 
10.1 Data Collection Forms  
 
All data will be collected by study RAs in a pen-and-paper format. Each participant’s data will be coded 
with their Personal ID number (PID). 
 
10.2 Data Management  
 
All initial data storage will be performed by study RAs. It will be double entered and checked for 
accuracy. All data will be stored initially at the Albuquerque VA on a password-protected computer in a 
locked office within a patrolled area (Co-I Dr. Gilliam’s office). Once all data are collected and ready for 
analysis, data will be transported to the Department of Psychology onto a password-protected computer 
in a locked office suite (PI Dr. Vowles’ laboratory space) for data analysis. At the time of transport, data 
will be de-identified and a back-up copy will be kept on the VA premises. All data collection forms are 
displayed in Appendix IV and detailed in Section 6.2. 
 
10.3 Quality Assurance  
 
10.3.1 Training 
 
 
All staff will complete the human participants protection training required by the University of New Mexico 
(UNM). The University uses the “CITI” training program (Collaborative Institutional Training Initiative; 
https://www.citiprogram.org/). All study members have completed the “Social and Behavioral Research” 
Training program, which includes 13 modules, including: 
 
- History and Ethical Principles 
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- Defining Research with Human Subjects 
- The Federal Regulations  
- Assessing Risk 
- Informed Consent 
- Privacy and Confidentiality 
- Research with Prisoners 
- Research with Children 
- Research in Public Elementary and Secondary Schools 
- International Research 
- Internet-Based Research 
- Conflicts of Interest in Research Involving Human Subjects 
- Unanticipated Problems and Reporting Requirements in Social and Behavioral Research 
 
All staff must provide at least 80% correct responses to pass a required test on each module. A refresher 
course must be passed every 24 months. 
 
10.3.2 Quality Control Committee  
 
There is not a quality control committee. Therapist adherence to the study protocol will be assessed as 
detailed in section 5.4.1. 
 
10.3.3 Metrics 
 
All self-report outcome measures have demonstrated psychometric soundness, including reliability and 
validity. Please see sections 6.6.2 and 6.6.4 for details and supporting citations. 
 
10.3.4 Protocol Deviations 
 
Protocol deviations will be recorded on the Protocol Deviation Tracking Log and, if appropriate, on the 
Adverse Events Form and, if necessary the Serious Adverse Events Form (although as noted, we do not 
foresee any reasonable risk of Serious Adverse Events). See Appendix VIII for all forms. 
 
10.3.5 Monitoring 
 
We will monitor data and safety issues throughout the study. See Data and Safety Monitoring Log in 
Appendix IX. The study RA will be responsible for completion of the log, which will be reviewed by the 
Steering Committee at their monthly meeting. 
 
As noted in section 7.6, we have also established a DSMB. The DSMB will meet at least yearly to review 
Data and Safety Monitoring Logs. In addition, all adverse events will be reported to the DSMB on a 
monthly basis to allow for ad hoc DSMB meetings should the Board determine they are necessary. Any 
Serious Adverse Event will be reported to the DSMB within 5 days and will occasion a meeting of the full 
Board to review the event within 30 days. 
 
11. PARTICIPANT RIGHTS AND CONFIDENTIALITY  
 
11.1 Institutional Review Board (IRB) Review  
 
This protocol and the informed consent document (Appendix II) and any subsequent modifications will be 
reviewed and approved by the IRB responsible for oversight of the study.  
 
11.2 Informed Consent Forms 
 

 
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A signed consent form will be obtained from each participant. Participants who cannot consent for 
themselves in English will not be included in the study. The consent form will describe the purpose of the 
study, the procedures to be followed, and the risks and benefits of participation. Each participant will 
receive a copy, which will be documented in the participant’s record.  
 
11.3 Participant Confidentiality  
 
Any data, specimens, forms, reports, video recordings, and other records that leave the site will be 
identified only by a participant identification number (Participant ID, PID) to maintain confidentiality. All 
records will be kept in a locked file cabinet in a locked office within a patrolled security environment. All 
computer entry and networking programs will be done using PIDs only. Information will not be released 
without written permission of the participant, except as necessary for monitoring by IRB, the FDA, the 
NCCAM, and the OHRP. 
 
11.4 Study Discontinuation  
The study may be discontinued at any time by the IRB, the NCCAM, the OHRP, the FDA, or other 
government agencies as part of their duties to ensure that research participants are protected.  
 
12. COMMITTEES 
 
12.1 Steering Committee – Study PI (Dr. Vowles) and Co-I’s (Drs. Cardon, Gilliam, and Witkiewitz) and 
RAs (TBD) will meet monthly to discuss study progress relative to milestones, coordinate efforts, and 
review any protocol violations or other issues requiring adjustment. 
 
13. PUBLICATION OF RESEARCH FINDINGS  
 
Publication of the results of this trial will be governed by the Steering Committee. Any presentation, 
abstract, or manuscript will be made available for review by the sponsor and the NCCAM prior to 
submission.  
 
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Assessment for Patients with Pain (SOAPP-R). J Pain. 2008;9:360–372. 
56.  First MB, Spitzer RL, Miriam G, Williams JB. Structured Clinical Interview for DSM-IV-TR Axis I Disorders, 
Research Version, Patient Edition. (SCID-I/P). New York: Biometrics Research, New York State Psychiatric 
Institute; 2002. 

 
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57.  Luoma JB, Hayes SC, Walser RD. Learning ACT: An Acceptance and Commitment Therapy skills training 
manual for therapists. Oakland, CA: New Harbinger Publications; 2007. 
58.  Chawla N, Collin S, Bowen S, et al. The mindfulness-based relapse prevention adherence and competence 
scale: development, interrater reliability, and validity. Psychother Res. 2010;20:388–397. 
59.  Vowles KE, Gross RT, McCracken LM. Evaluating outcomes in the interdisciplinary treatment of chronic pain: A 
guide for practicing clinicians. In: Schatman M, Campbell A, eds. Chronic Pain Management: Guidelines for 
Multidisciplinary Program Development. New York: Informa; 2007:203–220. 
60.  Vowles KE, McCracken LM. Acceptance and values-based action in chronic pain: a study of treatment 
effectiveness and process. J Consult Clin Psychol. 2008;76(3):397–407. doi:10.1037/0022-006X.76.3.397. 
61.  Jensen MP, Karoly P. Self-report scales and procedures for assessing pain in adults. In: Turk DC, Melzack R, 
eds. Handbook of Pain Assessment. New York, NY: Guilford Press; 1992:135–151. 
62.  Campbell WI, Vowles KE. Practical methods for pain intensity measurements. In: Rice A, Breivik H, Campbell 
WI, Nicholas MK, eds. Clinical pain management: Practice and procedures. 2nd ed. New York: Hodder Arnold; 
2008:12–27. 
63.  Witkiewitz K, Bowen S. Depression, craving, and substance use following a randomized trial of mindfulness-
based relapse prevention. J Consult Clin Psychol. 2010;78:362–374. 
64.  Mackinnon DP, Fairchild AJ, Fritz MS. Mediation Analysis. Annu Rev Psychol. 2007;58:593–614. 
65.  Witkiewitz K, Bowen S, Donovan DM. Moderating effects of a craving intervention on the relation between 
negative mood and heavy drinking following treatment for alcohol dependence. J Consult Clin Psychol. 
2011;79:54–63. 
66.  Prentice RL. Surrogate endpoints in clinical trials: Definition and operational criteria. Stat Med. 1989;8:431–440. 
67.  Molenberghs G, Burzykowski T, Alonso A, Assam P, Tilahun A, Buyse M. A unified framework for the 
evaluation of surrogate endpoints in mental-health clinical trials. Stat Methods Med Res. 2009;19:205–236. 
doi:10.1177/0962280209105015. 
68.  MacKinnon DP, Lockwood CM, Hoffman JM, West SG, Sheets V. A comparison of methods to test mediation 
and other intervening variable effects. Psychol Methods. 2002;7:83–104. 
69.  MacKinnon DP. Introduction to Statistical Mediation Analysis. New York: Taylor & Francis Group; 2008. 
70.  Schafer JL, Graham JW. Missing data: Our view of the state of the art. Psychol Methods. 2002;7(2):147–177. 
doi:10.1037//1082-989X.7.2.147. 
71.  Fritz MS, Mackinnon DP. Required sample size to detect the mediated effect. Psychol Sci. 2007;18:233–239. 
72.  Veehof MM, Oskam M-J, Schreurs KMG, Bohlmeijer ET. Acceptance-based interventions for the treatment of 
chronic pain: a systematic review and meta-analysis. Pain. 2011;152:533–542. doi:10.1016/j.pain.2010.11.002. 
73.  Witkiewitz K, Warner K, Sully B, et al. A randomized effectiveness trial comparing Mindfulness-Based Relapse 
Prevention with Relapse Prevention for women offenders at a residential addiction treatment center. Subst Use 
Misuse.  
 
 
 

 
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15. SUPPLEMENTS/APPENDICES 
 
 
List of Appendices 
I. 
Telephone Script 
II. 
Consent Form 
III. 
Case Report Form & Site Screening and Enrollment Log 
IV. 
Questionnaires 
V. 
Study Completion Record 
VI. 
Participant Compensation Record 
VII. 
Biosketches - Data Safety Monitoring Board 
VIII. 
Protocol Deviation Tracking Log/Adverse Event Form/Serious Adverse Event Form 
IX. 
Data and Safety Monitoring Log 
 
 
 

 
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Appendix I 
 
A pilot study of integrated treatment for Veterans  
with chronic pain and opiate misuse  
Telephone Screening Form 
07/29/2014 
 
“The purpose of this screening interview is to see if you meet the criteria for taking part in our treatment 
study for people with chronic pain. This interview will take approximately 10 minutes. I am going to go 
through a list of questions. You may choose not to answer these questions. You also may choose to stop 
participating in this interview at any time; if you want to stop, please tell me. Information about you that 
you give me during this interview will be kept as confidential as possible as required by law.  
 
You can choose if you want or do not want to take part in this research screening procedure – it is up to 
you. If you refuse to answer the questions or stop answering them at any time, there will be no penalty, 
and you will not lose any benefits to which you otherwise would be entitled. 
 
The risk to taking part in this interview is small. The screening interview is not designed to ask you for 
sensitive personal information, but it is possible that some people may feel uncomfortable answering 
these questions with a person they do not know. If you qualify to take part in the study and are interested 
in taking part, then I will record your name and information; this will be kept confidential, but there is a 
small risk that people outside of the research team could learn this information. If you are not interested 
in the study, then I will destroy the personal information you give me. 
 
There are no benefits to you to taking part in this screening interview. However, it is possible that the 
information from the study that we will be doing may help researchers to learn more and may benefit 
others in the future. 
 
If you do not want to answer these questions, you have other choices. You can talk to your doctor about 
chronic pain and treatment options. Your choice to participate or not participate in this screening 
interview will not affect your treatment in any way.  
                                                                                
You will not be paid for answering questions in this interview since it is only to see whether you qualify to 
take part in the study.  
 
If you have any questions, concerns or complaints at any time about the research study, Dr. Wes 
Gilliam, or his/her associates will be glad to answer them at (505) 265-1711. If you would like to speak 
with someone other than the research team, you may call the UNMHSC HRPO at (505) 272-1129.” 
 

 
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I will now ask you three questions to determine your eligibility to participate in this study. 
 
1. “Are you between 21 and 65 years of age?” 
 
Answer for eligibility must be: Yes 
 
2. “Have you been diagnosed with a chronic pain condition for past 6 months or longer?” 
 
 
 
 
2a. If clarification needed: “Have you experienced pain each day for the past 6 months or  
 
 
longer?” 
 
Answer for eligibility must be: Yes 
 
3. “On a 0 to 10 scale, where 0 is no pain and 10 is worst pain possible, what has your average pain 
intensity been over the past seven days?” 
 
Answer for eligibility must be: four or greater 
 
4. “Have you been using prescribed opioids for chronic pain daily for the last three months or longer?” 
 
Answer for eligibility must be: Yes 
 
If clarification needed: Types of opioids:  
 Opium 
 Morphine,  
 Darvon, Darvocet 
 Methadone  (Dolophine) 
 Percodan 
 Codeine 
 Dilaudid, Hydromorpone 
 Demerol 
 Oxycodone (Oxycontin, Perco-
 
dan/-cet, , Roxicet) 
 Hydrocodone (Vicodin, Lorcet) 
 
 Fentanyl (Duragesic, “percopop”) 
 
ELIGIBLE - SCRIPT 1 
 
Based on the information you gave me, it looks like you are eligible for this study.  At this point, you have 
three choices: (1) I can take down your contact information and can set up an appointment with you; (2) I 
can give you the number to call when you are ready to set up an appointment; (3) if you are not 
interested in this study, the information just collected will be destroyed. I am also happy to answer any 
questions you have about the study. 
 
___________ OK TO CONTACT (collect contact info) 
___________ SUBJECT TO CONTACT STUDY TEAM (give contact info) 
___________ NOT INTERESTED →  (destroy all information collected) 
___________ CALL BACK → (Phone #:                                           ) 
___________ MAIL ADDRESS →                                                    ) 
 
 
                                                  
                                                    
                                          
INELIGIBLE - SCRIPT 2 
Based on the information you gave me, you are not eligible for this study. Thank you for your time. I am 
happy to answer any questions you have about the study. 
 
 
 

 
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Appendix II 
 
 
VA RESEARCH CONSENT FORM 
 
Subject Name  : 
 
 
 
Date: 
 
 
 
Title of Study   : 
A pilot study of integrated treatment for Veterans with chronic pain and opiate 
misuse 
  
 
Principal 
Investigator: 
Wesley Gilliam, Ph.D. 
 
VAMC: 
 
New Mexico VA Health Care 
System 
 
 
See attached revised consent. 
Department of Veterans Affairs 

 
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Appendix III 
Case Report Form & Site Screening and Enrollment Log 
Baseline Assessment 
Pilot Study of Combined Treatment for Veterans with Chronic Pain and Opioid MIsuse 
Pt_ID:  
 
 
 
Visit Date:             /             /                        
. 
  
 
 
 
 
 
 
 
 
 
 
    dd        mm 
                yyyy 
 
To determine opioid misuse**, please check all assessments completed at this visit: 
 Current Opioid Misuse Measure (COMM) score of  > 12 
  Structured Clinical Interview for the DSM (SCID; opiate abuse or dependence) 
 
Inclusion Criteria 
Participant must: 
1. 
Be between 21 and 65 years old 
 
 
Yes 
 No 
2. 
Have had chronic pain for >6 months in duration 
 
 
Yes 
 No 
3. 
Daily use of prescribed opioids for chronic pain for at least 90 consecutive 
days preceding assessment 
 
 
Yes 
 No 
4. 
Averaged 4 or greater on a pain intensity scale of 0–10 with medication  
 Yes 
 No 
5. 
Identified as having current opioid misuse in initial assessment** 
 
 Yes 
 No 
6. 
Consent to randomization to ACT+MBRP or usual care  
 
 
Yes 
 No 
7. 
Be willing to consent to assessment procedures and to be contacted for the 
follow-up 
 
 
Yes 
 No 
8. 
The ability to read written English 
 
 
Yes 
 No 
 
NOTE: All inclusion criteria must be answered YES to be included in study. 
 
Exclusion Criteria 
Participant cannot: 
1. 
Meet diagnostic criteria for current substance abuse/dependence on a drug 
other than  
 
 
 Yes  
 No 
2. 
Meet diagnostic criteria for a current or past DSM diagnosis of 
schizophrenia, delusional disorder, psychotic or dissociative disorders 
 
 Yes 
 No 
3. 
Be currently taking prescribed medications for opioid addiction (e.g., 
Buprenorphine/Naloxone/ Suboxone, Methadone)
 Yes  
 No 
 
4. 
Have a suicide attempt or inpatient hospitalization for suicidal ideation in 
the past six months 
 Yes  
 No 
 
 
 
NOTE: All exclusion criteria must be answered NO to participate in the study. 
 
 

 
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Did the participant meet the eligibility requirements for this study? 
 Yes 
 No 
 
Is the participant continuing in the study? 
 
 
 
 
 Yes 
 No 
If no, remember to complete a STUDY COMPLETION form. 
If yes: 
 
5. 
Date enrolled (met all eligibility criteria):  
 
          /                /                    . 
 
d d 
m m m 
y y y y 
6. 
Date randomized if different from enrolled: 
 
          /                /                    . 
 
d d 
m m m 
y y y y 
 
7. 
Assignment to Condition: 
 
 Intervention Group 
 Control/Standard Care 
Comments: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Site Screening and Enrollment Log 
Protocol:  Pilot Study of Combined Treatment for Veterans with Chronic Pain and Opioid MIsuse 
 
Subject ID 
Date of Consent 
Date Screened 
Eligible for 
Enrollment? 
Ineligibility Reason (if applicable) 
   
   
   
   
   
   
   
   
   
   
   
   
   
   
   
   
   
   
   
   
   
   
   
   
   
   
   
   
   
   
   
   
   
   
   
 
 
 
 
 
 
 
 
 
 
 
 

 
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Appendix IV 
 
COMM™ 
Please answer each question as honestly as possible. Keep in mind that we are only asking about the 
past 30 days. There are no right or wrong answers. If you are unsure about how to answer the 
question, please give the best answer you can.  
 
Please answer the questions using the following scale: 
 
  
 
Never  
 
Seldom  
 
Sometimes  
 
Often  
 
Very 
Often  
 
0 
 
1  
2  
3  
4  
1. In the past 30 days, how often have you had 
trouble with thinking clearly or had memory 
problems?  
 
O  
O  
O  
O  
O  
2. In the past 30 days, how often do people 
complain that you are not completing necessary 
tasks? (i.e., doing things that need to be done, 
such as going to class, work or appointments)  
 
O  
O  
O  
O  
O  
3. In the past 30 days, how often have you had 
to go to someone other than your prescribing 
physician to get sufficient pain relief from 
medications? (i.e., another doctor, the 
Emergency Room, friends, street sources)  
 
O  
O  
O  
O  
O  
4. In the past 30 days, how often have you 
taken your medications differently from how 
they are prescribed?  
 
O  
O  
O  
O  
O  
5. In the past 30 days, how often have you 
seriously thought about hurting yourself?  
 
O  
O  
O  
O  
O  
6. In the past 30 days, how much of your time 
was spent thinking about opioid medications 
(having enough, taking them, dosing schedule, 
etc.)?  
 
O  
O  
O  
O  
O  
7. In the past 30 days, how often have you 
been in an argument?  
 
O  
O  
O  
O  
O  
8. In the past 30 days, how often have you had 
trouble controlling your anger (e.g., road rage, 
screaming, etc.)?  
 
O  
O  
O  
O  
O  
9. In the past 30 days, how often have you 
needed to take pain medications belonging to 
someone else?  
 
O  
O  
O  
O  
O  
 
 
 

 
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Please answer the questions using the following scale: 
 
  
 
Never  
 
Seldom  
 
Sometimes  
 
Often  
 
Very 
Often  
 
0 
 
1  
2  
3  
4  
 
10. In the past 30 days, how often have you 
been worried about how you’re handling your 
medications?  
 
O  
O  
O  
O  
O  
11. In the past 30 days, how often have others 
been worried about how you’re handling your 
medications?  
 
O  
O  
O  
O  
O  
12. In the past 30 days, how often have you 
had to make an emergency phone call or show 
up at the clinic without an appointment?  
 
O  
O  
O  
O  
O  
13. In the past 30 days, how often have you 
gotten angry with people?  
 
O  
O  
O  
O  
O  
14. In the past 30 days, how often have you 
had to take more of your medication than 
prescribed?  
 
O  
O  
O  
O  
O  
15. In the past 30 days, how often have you 
borrowed pain medication from someone else?  
 
O  
O  
O  
O  
O  
16. In the past 30 days, how often have you 
used your pain medicine for symptoms other 
than for pain (e.g., to help you sleep, improve 
your mood, or relieve stress)?  
 
O  
O  
O  
O  
O  
17. In the past 30 days, how often have you 
had to visit the Emergency Room?  
 
O  
O  
O  
O  
O  
 
 
©2008 Inflexxion, Inc.  
 
 

 
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©2008-2012 PROMIS Health Organization and PROMIS Cooperative Group  
 
 

 
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BC-MDI 
The following is a list of symptoms that you may have experienced. Consider your experience with 
these symptoms over the past two weeks, including today. Please rate each symptom marked in 
the severity scale (0 – 5). 
 
0 
1 
2 
3 
4 
5 
Not a problem 
Very Mild 
Problem 
Mild Problem 
Moderate 
Problem 
Severe 
Problem 
Very Severe 
Problem 
 
 
  
 
 
Severity Rating 
 
 
 
 
1 
I feel sad, down in the dumps, or blue (nearly every day). 
 
 
2 
I lack interest in, or I do not enjoy, most activities (nearly every day) 
 
 
3 
I have trouble falling asleep or staying asleep (nearly every day). 
 
 
4 
I sleep much more than in the past (nearly every day). 
 
 
5 
I feel restless and agitated (nearly every day) 
 
 
6 
I feel slowed down (for example, I move slowly and think slowly)  
(nearly every day). 
 
 
7 
I feel tired and have low energy (nearly every day). 
 
 
8 
I have a poor appetite (nearly every day). 
 
 
9 
I have a greater appetite than in the past. 
 
 
10 
I have lost weight due to poor appetite (in the past 2 weeks). 
 
 
11 
I have gained weight due to greater appetite (in the past 2 weeks). 
 
 
12 
I often feel worthless or useless. 
 
 
13 
I am burdened by guilt (e.g., I feel I have made many mistakes). 
 
 
14 
I have trouble concentrating, thinking, or solving problems (nearly every day). 
 
 
15 
I often think about dying (most days). 
 
 
16 
I think about killing myself. 
 
 
 
Using the scale below, rate the impact that any symptoms and problems have on your life. 
 
0 
1 
2 
3 
4 
No impact on my 
day-to-day life 
Mild impact 
Moderate 
impact 
Severe impact 
Very severe impact on 
my day-to-day life 
 
 
 
                                                   Circle your response 
17 
Impact on my ability to be effective at work or in school 
0 
1 
2 
3 
4 
18 
(Tick here if the last item is not applicable to your current situation ____ ) 
19 
Impact on my family relationships and responsibilities: 
0 
1 
2 
3 
4 
20 
Impact on my social life and recreational activities 
0 
1 
2 
3 
4 

 
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SIP for Chronic Pain 
 
PLEASE RESPOND TO (TICK) ONLY THOSE STATEMENTS THAT YOU ARE SURE 
DESCRIBE YOU TODAY AND ARE RELATED TO YOUR STATE OF HEALTH. 
 
 
SR 
2 
 I sit during much of the day. 
3 
 I am sleeping or dozing most of the time - day and night. 
4 
 I lie down more often during the day in order to rest. 
7 
 I sleep or nap more during the day. 
 
EB 
1 
 I say how bad or useless I am, for example, that I am a burden to others. 
2 
 I laugh or cry suddenly. 
3 
 I often moan and groan in pain or discomfort. 
5 
 I act nervous or restless. 
7 
 I act irritable and impatient with myself; for example, I talk badly about myself, swear at 
myself, and blame myself  for things that happen. 
9 
 I get sudden frights. 
 
BCM 
1 
 I make difficult moves with help, for example, getting into or out of cars, the bath. 
2 
 I do not move in or out of a bed or chair by myself but am moved by another person  
       or mechanical aid. 
6 
 I stand up only with someone's help. 
1
4 
 I do not bathe myself completely, for example, I require assistance with bathing 
1
7 
 I have trouble getting shoes, socks, stocking on. 
1
9 
 I do not fasten my clothing, for example, I require assistance with buttons, zippers,  
       and shoelaces. 
2
3 
 I get dressed only with someone's help. 
 
 
TICK HERE WHEN YOU HAVE READ ALL STATEMENTS ON THIS PAGE 
 
 

 
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This group of statements is to do with anything you usually do in caring for your home or garden.  
Considering just those things that you do, please respond by ticking only those statements that you are 
sure describe you today and are related to your state of health. 
 
M 
1 
 I am getting around only within one building. 
2 
 I stay within one room. 
4 
 I am staying in bed most of the time. 
6 
 I stay at home most of the time. 
8 
 I am not going in to town. 
 
SI 
3 
 I show less interest in other people's problems, for example, I don't listen when they   
       tell me about their problems, I don't offer to help. 
4 
 I often act irritable to those around me, for example, snap at people, give sharp  
       answers, criticize easily. 
5 
 I show less affection. 
9 
 My sexual activity is decreased. 
1
2 
 I make many demands, for example, insist that people do things for me, tell them  
       how to do things. 
1
5 
 I have frequent outbursts of anger at family members, for example, strike at them,  
       scream, or throw things at them. 
2
0 
 I am not joking with my family members as I usually do. 
 
A 
2 
 I do not walk up or down hills. 
3 
 I use stairs only with mechanical support, for example, handrails, stick, crutches. 
7 
 I walk by myself, but with some difficulty, for example, limp, wobble, stumble, have  
      stiff legs. 
1
1 
 I get around only by using a walker, crutches, stick, walls, or furniture. 
 
 
TICK HERE WHEN YOU HAVE READ ALL STATEMENTS ON THIS PAGE 
 
 
 

 
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AB 
1 
 I am confused and start several actions at a time. 
3 
 I react slowly to things that are said or done. 
4 
 I do not finish things that I start. 
5 
 I have difficulty reasoning and solving problems, for example, making plans, making  
       decisions, learning new things. 
8 
 I do not keep my attention on activities for long. 
9 
 I make more mistakes than usual. 
1
0 
 I have difficulty doing activities that involve concentration and thinking. 
 
C 
1 
 I am having trouble writing or typing. 
2 
 I communicate mostly by gestures, for example, moving head, pointing, sign  
       language. 
4 
 I often lose control of my voice when I talk; for example, my voice gets louder, or  
       softer, trembles, changes unexpectedly 
7 
 I have difficulty speaking, for example, get stuck, stutter, stammer, slur my words. 
8 
 I am understood with difficulty. 
9 
 I do not speak clearly when I am under stress. 
 
 
 
 
  
 
 
 
TICK HERE WHEN YOU HAVE READ ALL STATEMENTS ON THIS PAGE 
 
 

 
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This group of statements is to do with activities that you usually do in your free time.   
These activities are things that you might do for relaxation, to pass the time, or for entertainment.  
Please tick only those statements that you are sure describe you today and are related to your state 
of health. 
 
RP 
1 
 I do my hobbies and recreation activities for shorter periods of time. 
2 
 I am going out for entertainment less often. 
5 
 I am doing more inactive pastimes in place of my usual activities. 
6 
 I am doing fewer community activities. 
 
E 
1 
 I am eating much less than usual. 
5 
 I just pick or nibble at my food. 
6 
 I am drinking less fluids. 
7 
 I feed myself with help from someone else. 
Now can you please review the questions to be certain that you have filled out all the information? 
Look at the last tick box on each sheet to make sure that you have not missed a page. 
 
 
 
 
 
 
TICK HERE WHEN YOU HAVE READ ALL STATEMENTS ON THIS PAGE 

 
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CPAQ 
Directions: Below you will find a list of statements.  Please rate the truth of each statement as it applies to you 
by circling a number.  Use the following rating scale to make your choices.  For instance, if you believe a 
statement is “Always True”, you would circle the 6 next to that statement. 
 
0 
 
1 
 
2 
 
3 
 
4 
 
5 
 
6 
Never 
 
Very 
 
Seldom 
 Sometimes  
Often 
 
Almost 
 
Always 
True 
 
Rarely 
 
True 
 
True 
 
True 
 
Always 
 
True 
 
 
True 
 
 
 
 
 
 
 
True 
 
 
 
1. I am getting on with the business of living no matter what my level of 
pain is 
0 
1 
2 
3 
4 
5 
6 
2. My life is going well, even though I have chronic pain 
0 
1 
2 
3 
4 
5 
6 
3. It’s O.K. to experience pain 
0 
1 
2 
3 
4 
5 
6 
4. I would gladly sacrifice important things in my life to control this pain 
better 
0 
1 
2 
3 
4 
5 
6 
5. It’s not necessary for me to control my pain in order to handle my life 
well  
0 
1 
2 
3 
4 
5 
6 
6. Although things have changed, I am living a normal life despite my 
chronic pain 
0 
1 
2 
3 
4 
5 
6 
7. I need to concentrate on getting rid of my pain 
0 
1 
2 
3 
4 
5 
6 
8. There are many activities I do when I feel pain 
0 
1 
2 
3 
4 
5 
6 
9. I lead a full life even though I have chronic pain 
0 
1 
2 
3 
4 
5 
6 
10. Controlling pain is less important than other goals in my life 
0 
1 
2 
3 
4 
5 
6 
11. My thoughts and feelings about pain must change before I can take 
important steps in my life 
0 
1 
2 
3 
4 
5 
6 
12. Despite the pain, I am now sticking to a certain course in my life 
0 
1 
2 
3 
4 
5 
6 
13. Keeping my pain level under control takes first priority whenever I 
am doing something 
0 
1 
2 
3 
4 
5 
6 
14. Before I can make any serious plans, I have to get some control 
over my pain 
0 
1 
2 
3 
4 
5 
6 
15. When my pain increases, I can still take care of my responsibilities 
0 
1 
2 
3 
4 
5 
6 
16. I will have better control over my life if I can control my negative 
thoughts about pain 
0 
1 
2 
3 
4 
5 
6 
17. I avoid putting myself in situations where pain might increase 
0 
1 
2 
3 
4 
5 
6 
18. My worries and fears about what pain will do to me are true 
0 
1 
2 
3 
4 
5 
6 
19. It’s a relief to realize that I don’t have to change my pain to get on 
with my life 
0 
1 
2 
3 
4 
5 
6 
20. I have to struggle to do things when I have pain 
0 
1 
2 
3 
4 
5 
6 

 
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HOW I TYPICALLY ACT TOWARDS MYSELF IN DIFFICULT TIMES 
 
Please read each statement carefully before answering. To the left of each item, indicate how often 
you behave in the stated manner, using the following scale: 
     Almost                                                                                               Almost 
      never                                                                                                 always 
          1                         2                         3                         4                         5 
 
_____ 1.  I’m disapproving and judgmental about my own flaws and inadequacies. 
_____ 2.  When I’m feeling down I tend to obsess and fixate on everything that’s wrong. 
_____ 3.  When things are going badly for me, I see the difficulties as part of life that everyone goes 
through. 
_____ 4.  When I think about my inadequacies, it tends to make me feel more separate and cut off 
from the rest of the world. 
_____ 5.  I try to be loving towards myself when I’m feeling emotional pain. 
_____ 6.  When I fail at something important to me I become consumed by feelings of inadequacy. 
_____ 7. When I'm down and out, I remind myself that there are lots of other people in the world 
feeling like I am. 
_____ 8.  When times are really difficult, I tend to be tough on myself. 
_____ 9.  When something upsets me I try to keep my emotions in balance.   
_____ 10. When I feel inadequate in some way, I try to remind myself that feelings of inadequacy are 
shared by most people. 
_____ 11. I’m intolerant and impatient towards those aspects of my personality I don't like. 
_____ 12. When I’m going through a very hard time, I give myself the caring and tenderness I need. 
_____ 13. When I’m feeling down, I tend to feel like most other people are probably happier than I am. 
_____ 14. When something painful happens I try to take a balanced view of the situation. 
_____ 15. I try to see my failings as part of the human condition. 
_____ 16. When I see aspects of myself that I don’t like, I get down on myself. 
_____ 17. When I fail at something important to me I try to keep things in perspective. 
_____ 18. When I’m really struggling, I tend to feel like other people must be having an easier time of 
it. 
_____ 19. I’m kind to myself when I’m experiencing suffering. 
_____ 20. When something upsets me I get carried away with my feelings. 
_____ 21. I can be a bit cold-hearted towards myself when I'm experiencing suffering. 
_____ 22. When I'm feeling down I try to approach my feelings with curiosity and openness. 
_____ 23. I’m tolerant of my own flaws and inadequacies. 
_____ 24. When something painful happens I tend to blow the incident out of proportion. 
_____ 25. When I fail at something that's important to me, I tend to feel alone in my failure. 
_____ 26. I try to be understanding and patient towards those aspects of my personality I don't like. 

 
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PENN ALCOHOL CRAVING SCALE (Modified) 
Circle the most appropriate number for each item.  
1. How often have you thought about doing drugs or drinking or about how good that would make 
you feel during the past week?  
 
 
Never, that is, 0 times during the past week.  
= 0  
Rarely, that is, 1 to 2 times during the past week.  
= 1  
Occasionally, that is, 3 to 4 during the past week.  
= 2  
Sometimes, that is, 5 to 10 times during the past week or 1 to 2 times a day.  = 3  
Often, that is, 11 to 20 times during the past week or 2 to three times a day.  = 4  
Most of the time, that is, 20 to 40 during the past week or 3 to 6 times a day.  = 5  
Nearly all of the time, that is, more than 40 times during the past week  
or more than 6 times a day.  
= 6 
 
2. At its most severe point, how strong was your craving during the past week?  
 
 
None at all.  
= 0  
Slight, that is a very mild urge.  
= 1  
Mild urge.  
= 2  
Moderate urge.  
= 3  
Strong urge, but easily controlled.  
= 4  
Strong urge and difficult to control.  
= 5  
Strong urge and would have done drugs or drink alcohol if it were available.  = 6  
 
3. How much time have you spent thinking about doing drugs or drinking or about how that would 
make you feel during the past week?  
 
None at all 
= 0  
Less than 20 minutes.  
= 1 
21-45 minutes.  
= 2  
46-90 minutes.  
= 3  
90 minutes-3 hours.  
= 4  
Between 3 to 6 hours.  
= 5  
More than 6 hours.  
= 6 
 
 

 
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4. How difficult would it have been to resist doing drugs or drinking during the past week if you had 
known the drugs or alcohol were in your house?  
 
Not difficult at all.  
= 0  
Very mildly difficult.  
= 1  
Mildly difficult.  
= 2  
Moderately difficult.  
= 3  
Very difficult.  
= 4  
Extremely difficult.  
= 5  
Would not be able to resist.  
= 6  
 
5. Keeping in mind your responses to the previous questions, please rate your overall average drug 
or alcohol craving for the the past week.  
 
Never thought about drugs/drinking and never had the urge to  
do drugs/drink.  
= 0  
Rarely thought about drugs/drinking and rarely had the urge to  
do drugs/drink. 
= 1  
Occasionally thought about drinking and occasionally had the urge to  
do drugs/drink.  
= 2  
 
Sometimes thought about drinking and sometimes had the urge  
 
to do drugs/drink. 
= 3  
Often thought about drinking and often had the urge to do drugs/drink.  
= 4  
Thought about drugs/drinking most of the time and had the urge to do  
drugs/drink most of the time.  
= 5 
Thought about drugs/drinking nearly all of the time and had the urge to do  
drugs/drink nearly all the time. 
=6 
 
 

 
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Weekly Diary (pg 1) 
 
Wk# ______ 
 
 
1. 
 
Rate how bad your pain was overall in the past week. 
 
None 
 
 
 
 
 
 
 
 
 
 
 
Worst 
Possible 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
2.  
 
Rate how upset and/or distressed you were overall in the past week. 
 
None 
 
 
 
 
 
 
 
 
 
 
 
Worst 
Possible 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
3.  
 
Rate how willing were you were to have pain and distress in the past week. 
 
Not 
Willing 
at All 
 
 
 
 
 
 
 
 
 
 
 
Most 
Willing 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
4.  
 
Rate how much effort you put in to making pain or upsetting thoughts, 
feelings, or memories go away this past week. 
 
None 
 
 
 
 
 
 
 
 
 
 
 
Most 
Effort 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
5.  
 
Rate how effective you were in taking actions that contributed to a better, 
more vital, quality of living in the past week. 
 
Not 
at all  
 
 
 
 
 
 
 
 
 
 
 
Most 
Effective 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
 
6.  
 
Rate how effective you were this past week in making progress in the areas 
of your life that that matter to you.  
 
Not 
at all  
 
 
 
 
 
 
 
 
 
 
 
Most 
Effective 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
 
 
 

 
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Weekly Diary (pg 2) 
 
9. Are you currently taking Buprenorphine, Naloxone, or Suboxone  
 
□ Yes □ No 
10. Are you currently in treatment for substance abuse or dependence? 
 
□ Yes □ No 
 
If you checked “Yes”, for which drug(s):_________________________________________ 
11. Since your last session with us, have you had any other treatments for pain?    □ Yes □ No  
 
 
If you checked “Yes”, please complete the rest of this form: 
 
Treatments for pain since last session (check all that apply): 
_____ Operations (Surgery) (how many?_____)  
 
_____ Injections (how many? ___) 
_____ Alterations or changes in pain medications 
 
_____ Physical therapy 
_____ Seen a Chiropractor 
 
 
 
 
_____ Osteopathy 
 
 
 
_____ Stimulator/Pump Implant  
 
 
 
_____ TENS Unit 
 
 
 
____  Psychotherapy or Counselling Sessions 
 
 
_____ Acupuncture 
 
_____ Hypnosis 
 
 
 
 
 
_____ Hydrotherapy (Pool) 
_____ Other ________________________________________________________________________ 
 
 
 
 

 
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Appendix V 
Study Completion/Termination 
Pilot Study of Combined Treatment for Veterans with Chronic Pain and Opioid MIsuse 
Pt_ID:  
 
 
Visit Date:            /                   /                        . 
 
1. 
Date of final study visit: 
            /                   /                        . 
 
d 
d 
m m m 
y 
y 
y 
y 
2. 
Stage at which participant ended participation:  
 
__________________________________________________________________ 
 
 
3. 
Primary reason for terminating participation in the study: 
 Completed study 
 Participant was determined after enrollment to be ineligible (provide comments): 
 
 
 Participant withdrew consent 
 In the principal investigator’s opinion, it was not in the participant’s best interest to continue 
(provide comments):  
 
 Adverse event (If checked, complete the AE form.) 
 Death 
 Lost to follow-up 
 Other (specify):  
 
 Unknown 
Comments: 
 
 
 
 
 
 
 
 
 
PI Signature:  ___________________________________  
Date:  ____________________  
 
 
 

 
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Appendix VI 
Participant Remuneration Log 
Pilot Study of Combined Treatment for Veterans with Chronic Pain and Opioid Misuse 
 
Pt_ID:  
 
 
1. $60 for completion of the baseline session  
 
 Yes 
 No 
 
 
Date of payment: 
            /                   /                        . 
 
d 
d 
m m m 
y 
y 
y 
y 
2. 
$5 per week for completing weekly assessments during active treatment: 
 
WEEK 
DATE PAID 
1 – ACT 
 
2 – ACT 
 
3 – ACT 
 
4 – ACT 
 
5 – ACT 
 
6 – ACT 
 
7 – ACT 
 
8 – ACT 
 
9 – MBSR 
 
10 – MBSR 
 
11 – MBSR 
 
12 – MBSR 
 
 
3. 
$50 for completing the end of treatment assessment (week 13): 
 
 Yes 
 No 
 Date of payment: 
            /                   /                        . 
 
d 
d 
m m m 
y 
y 
y 
y 
4. 
$50 for completing the six-month follow-up (week 37):  
 
 Yes 
 No 
 Date of payment: 
            /                   /                        . 
 
d 
d 
m m m 
y 
y 
y 
y 
5. 
Did participant complete all assessments? 
 
 
 
 
 Yes 
 No 
If yes, provide $50 bonus payment at the 6-month follow-up. 
Date of payment: 
            /                   /                        . 
 
d 
d 
m m m 
y 
y 
y 
y 
Total Remuneration to Participant (upon completion or termination):  $______________ 
 
Comments (e.g. note here if participant terminates prior to receiving full compensation): 
 
 
 
 
 
 
 
 
 
 

 
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Appendix VII 
DSMB Biosketches 
 
 

 
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BIOGRAPHICAL SKETCH 
NAME 
Barbara S. McCrady 
POSITION TITLE 
Distinguished Professor of Psychology and Director, 
Center on Alcoholism, Substance Abuse, and 
Addictions, University of New Mexico 
eRA COMMONS USER NAME 
BMcCrady 
EDUCATION/TRAINING  (Begin with baccalaureate or other initial professional education, such as 
INSTITUTION AND LOCATION 
DEGREE 
(if 
applicable) 
YEAR(s) 
FIELD OF STUDY 
Purdue University 
B.S. 
06/69 
Biological Sciences 
University of Rhode Island 
Ph.D. 
08/75 
Psychology (Clinical) 
A. Personal Statement 
I bring specific skills and accomplishments to my role on the: (1) I have conducted NIH- funded clinical 
trials with substance-abusing populations for 40 years, and have expertise in the design and 
implementation of rigorous clinical studies; (2) I have conducted clinical research in a range of 
nontraditional settings, including (a) research on substance-abusing women on temporary assistance to 
needy families (TANF) seen in inner city welfare offices; (b) screening and brief interventions in inpatient 
and outpatient hospital settings; (c) current research with opioid-dependent prisoners in the county jail; (3) 
I have extensive experience the provision of clinical services; (4) I have a strong background in research 
ethics.   
B. Positions and Honors 
Positions and Employment: 
1974-1975      
Clinical Project Evaluator, Butler Hospital  
1975-1976  
Chief, Psychological Assessment Program, Butler Hospital, Providence, RI 
1976-1983  
Chief, Problem Drinkers Program, Butler Hospital 
1976-1983 
Instructor to Associate Professor of Psychiatry and Human Behavior, Brown University,  
Providence, RI 
1990-1992 
Acting Director, Center of Alcohol Studies, Rutgers University 
1993-2005 
Director of Clinical Training, Ph.D. Clinical Psychology Training Program, Rutgers 
University  
1983-2007   
Clinical Director, Center of Alcohol Studies, Rutgers University, Piscataway, NJ (since 
1983) 
1983-2007      
Associate Professor to Professor II, Rutgers University 
2005-2007  
Chair, Department of Psychology, Rutgers University  
2007-present 
Distinguished Professor of Psychology (since 2008; Professor 2007-2008), University 
of New Mexico 
2007-present 
Director, Center on Alcoholism, Substance Abuse, and Addictions, University of New 
Mexico 
Other Experience (selected): 
1979-1983  
Psychosocial Research Review Committee, NIAAA 
1985-1986 
Consultant, Sixth Report to Congress on Alcohol and Health, National Institute on 
Alcohol Abuse and Alcoholism 
1987-1989 
Member, Institute of Medicine Panel on Research on the Treatment of Alcohol 
Problems  
1989-1992      
Member, Extramural Science Advisory Board, NIAAA 
1990-1997  
Editorial Board, Journal of Substance Abuse 
1991-2003  
Editorial Board, Journal of Consulting and Clinical Psychology 
1991-1996  
Editorial Board, Alcoholism:  Clinical and Experimental Research 

 
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1992-2010  
Editorial Board, Journal of Studies on Alcohol and Drugs 
1993-1995  
Member, Fellows Committee, Division 12, American Psychological Association 
1994-1996 
Member, Panel on Financing and Organization, National Advisory Council on Alcohol 
Abuse and Alcoholism, Subcommittee on Health Services Research  
1995-1998  
Secretary-Treasurer, Association for Advancement of Behavior Therapy 
1997-2001  
Board of Directors, Research Society on Alcoholism 
1998-present   
Addiction (Assistant Editor, 1998-2003; Deputy Regional Editor, 2003-2008; Senior 
Editor, 2009-present) 
2000-2003 
President-Elect, President, Past-President, Division 50 (Addictions), American 
Psychological  Association 
2002-2007 
Board of Directors, Pacific Institute for Research and Evaluation (chair of board, 2004-
2005) 
2002-present 
Editorial Board, Clinical Psychology:  Science and Practice 
2005-2007  
Science and Practice Committee, Division 12, American Psychological  
   
 
Association 
2011-2014  
Vice-President, President, Past-President, Research Society on Alcoholism 
Awards and Honors: 
1993-present    
Fellow, Division 12, American Psychological Association 
1994-present 
Fellow, Division 50, American Psychological Association 
1997    
 
MERIT Award, National Institute on Alcohol Abuse and Alcoholism 
1999 
Association for Medical Education and Research in Substance Abuse, Betty Ford 
Lectureship  
2007 
 
 
Association for Cognitive and Behavioral Therapy, Distinguished Service Award 
2007 
American Psychological Association, Division 50 (Addictions), Distinguished Career 
Contributions to Education and Training Award 
C. Selected peer-reviewed publications (of 240 total publications) 
Most relevant to the current application 
1.  McCrady, B. S., Hayaki, J., Epstein, E. E., & Hirsch, L. S. (2002).  Testing hypothesized predictors of 
change in conjoint behavioral alcoholism treatment for men.  Alcoholism: Clinical and Experimental 
Research, 26, 463-470. 
2. McCrady, B. S., Epstein, E. E., & Kahler, C. W. (2004).  AA and relapse prevention as maintenance 
strategies after conjoint behavioral alcohol treatment for men:  18 month outcomes.  Journal of 
Consulting and Clinical Psychology, 72, 870-878. 
3. Epstein, E.E., McCrady, B.S., Morgan, T.J., Cook, S.M., Kugler, G., & Ziedonis, D. (2007).  The 
successive cohort design:  A model for developing new behavioral therapies for drug use disorders, 
and application to behavioral couple treatment.  Addictive Disorders & Their Treatment, 6, 1-19. 
4. Epstein, E.E., McCrady, B.S., Morgan, T.J., Cook, S.M., Kugler, G., & Ziedonis, D. (2007).Couples 
treatment for drug-dependent males. Addictive Disorders & Their Treatment, 6, 21-37. 
5. McCrady, B. S., Epstein, E. E., Cook, S., Jensen, N. K., & Hildebrandt, T. (2009).  A randomized trial 
of individual and couple behavioral alcohol treatment for women.  Journal of Consulting and Clinical 
Psychology, 77, 243-256.  PMCID19309184  
Additional selected recent publications of importance to the field (in chronological order)  
 
6. McCrady, B. S., Epstein, E. E., & Hirsch, L. S. (1999).   Maintaining change after conjoint behavioral  
alcohol treatment for men:  Outcomes at six months.  Addiction, 94, 1381-1396. 
7. Drapkin, M. L., McCrady, B. S., Swingle, J., Epstein, E. E., & Cook, S. M. (2005).  Exploring 
bidirectional  couple violence in a clinical sample of female alcoholics.  Journal of Studies on 
Alcohol, 66, 213-219.  
8. Morgenstern, J., Blanchard, K. A., Kahler, C., Barbosa, K. M., McCrady, B. S., &  McVeigh, K. H. 
(2008).  Testing mechanisms of action for intensive case management.  Addiction, 103, 469-477. 

 
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9. Hildebrandt, T., McCrady, B. S., Epstein, E. E., Cook, S., & Jensen, N.   (2010). When should 
clinicians switch treatments?: An application of signal detection theory to two treatments for women 
with alcohol use disorders.  Behavior Research and Therapy, 48, 524-530.  PMCID2871965 
10. Ladd, B. O., McCrady, B. S., Manuel, J. K., & Campbell, W. (2010).  Improving the quality of reporting 
alcohol outcome studies: Effects of the CONSORT statement.  Addictive Behaviors, 35, 660-666. 
11. Hunter Reel, D., McCrady, B. S., Hildebrandt, T., & Epstein, E. E. (2010).  The indirect effect of social 
support for drinking on drinking outcomes: The role of motivation.  Journal of Studies on Alcohol and 
Drugs, 71, 930-937. PMCID2965492 
12. Cohn, A. M., McCrady, B. S., Epstein, E. E., & Cook, S.M. (2010).  Men's avoidance coping and 
female partner's drinking behavior: A high-risk context for partner violence?  Journal of Family 
Violence, 25, 679-687.  PMCID3001677 
13. McCrady, B. S., Epstein, E. E., Cook, S., Jensen, N. K., & Ladd, B. O. (2011).  What do women 
want?  Alcohol treatment choices, treatment entry and retention.  Psychology of Addictive Behaviors, 
25, 521-529.  PMCID3178005 
14. Manuel, J. K., Austin, J. L., Miller, W. R., McCrady, B. S., Tonigan, J. S., Meyers, R. J., Smith, J. E., 
& Bogenschutz, M. P.  (2012). Community Reinforcement and Family Training: A pilot comparison of 
group and self-directed delivery.  Journal of Substance Abuse Treatment, 43, 129-136.  
PMCID3331969 
15. Worden, B. L. & McCrady, B. S. (2013).  Effectiveness of a feedback-based brief intervention to 
reduce alcohol use in community substance use disorders treatment.  Alcoholism Treatment 
Quarterly, 31, 186-205. PMC3686515 
 
D. Research Support  
ONGOING 
T32 AA018108-01A1 
 
McCrady (PI)  
 
 
 
 
7/1/10-6/30/15 
Alcohol Research Training: Methods & Mechanisms 
 The central aim of this training program is to provide multidisciplinary pre- and post-doctoral training to 
prepare future scientists to conduct research to elucidate the processes of change in drinking behavior, 
develop and test effective methods to effect change through improved approaches to treatment and 
indicated prevention, and develop and test models of disseminate knowledge of effective interventions 
to diverse populations. 
2U10DA1533-09  
 
Bogenschutz (PI) 
 
 
 
 
9/1/10-8/31/15 
Clinical Trials Network:  Southwest Node 
The major goal of this project is to conduct multiple clinical trials for drug addictions, implemented in 
community treatment programs and coordinated by the Clinical Trials Network.  As a Co-Investigator, 
Dr. McCrady’s role is to contribute to the development and implementation of psychosocial protocols. 
Role:  Co-Investigator 
K01 AA021431 
 
 
Houck (PI) 
 
 
 
 
 
7/15/13-6/30/18 
Imaging Brain Activity in Substance Use Treatment 
The central aim of this grant is to support early career investigator, Dr. Jon Houck, to become an 
independent scientist whose research addresses the neuroscientific basis of therapeutic mechanisms of 
behavior change.  
Role:  Primary Mentor 
1U01DA034743-01A1 
 
Condon (PI)  
 
 
 
 
3/1/14-4/30/17 
Injectible Pharmacotherapy for Opioid Use Disorders (IPO) 
The primary goal of this grant is to test the efficacy of drug education to injectible naltrexone with and 
without a patient navigator for opioid users who are close to release from jail. 
Role:  Co-Investigator 
F31AA023414A     
 
 
Owens (PI) 
 
 
 
 
7/1/14-6/30/16 
Brief Motivational Interventions for Male Drinkers being Released from Jail 
The central aim of this predoctoral research fellowship is to support a doctoral student, Ms. Mandy 
Owens, to further develop her research skills and conduct her dissertation research, a study of a brief 
motivational to enhance motivation to change drinking and improve social support among inmates close 
to release from jail. 

 
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Role:  Primary Mentor 
1R34 AA023027-01 
 
Epstein (PI)  
 
 
 
 
5/1/14-4/30/17 
Adapting Alcohol Behavioral Couple Therapy for Service Members in Post-Deployment 
The primary aim of this study it to modify an existing conjoint treatment model for alcohol use disorders to 
treat soldiers in the reconstitution stage of service, and develop optional psychoeducation modules to 
address relevant co-morbid problems and challenges in this population. 
Role:  Co-Investigator 
1R13AA023455-01  
 
Feldstein-Ewing & Chung (MPIs)  
 
7/1/14-6/30/17 
Neuroimaging Mechanisms of Change in Psychotherapy for Addictive Behaviors 
The conference will facilitate cross-disciplinary collaboration between neuroscientists and clinicians in 
conducting research on mechanisms of behavior change, and will develop guidelines for integrative 
(brain/behavior) research that can improve the effectiveness of addictions treatment.Role:  Co-
Investigator 
COMPLETED 
R01 AA018376-01A1 
 
McCrady (PI)  
 
 
 
 
8/1/10-7/31/14 
Mechanisms of Change: Alcohol Behavioral Couple Therapy 
 The major goal of this project is to study the mechanisms by which social support effects positive 
treatment outcomes, specifically by studying within treatment behavior in Alcohol Behavioral Couple 
Therapy.   
R01 AA017163-01A1  
 
Epstein (PI)   
 
 
 
 
9/30/08-8/31/14 
Testing CBT models and change mechanisms for Alcohol Dependent Women 
 The major goal of this grant is to adapt Individual female specific cognitive behavioral therapy (I-
FSCBT) to treat women with alcohol dependence in a group approach (GFSCBT).  
Role:  Co-Investigator 
F31 AA021031 
 
 
Hallgren (PI)  
 
 
 
 
12/1/11-6/30/13 
NIH/NIAAA 
 
 
 
 
 
 
 
Targeting Social Networks to Maximize Alcohol Use Disorder Treatment & Prevention 
 The major goal of this grant is to advance predoctoral training for Mr. Hallgren, a doctoral candidate in 
clinical psychology.  The primary goal of the research project is to conduct simulation studies of drinking 
in social networks for the purpose of understanding how drinking spreads within a social network.  
Role:  Primary Mentor 
Role:  PI 
CCN2013-0303   
 
McCrady (PI)  
 
 
 
 
4/15/13-12/31/13 
Bernalillo County, NM 
 
 
 
 
 
 
 
 
An evaluation of the methadone maintenance program at the Bernalillo County Detention Center 
The primary goal of this is evaluation project is to examine outcomes in terms of continuity of methadone 
maintenance treatment, recidivism, and cost-effectiveness of a methadone maintenance program 
administered in the county jail. 
90CU0047   
 
 
 
Spear (PI)  
 
 
 
 
10/1/07-12/15/10 
Recovering Together Program 
The major goal of this program is to test an integrated model of treatment for substance abusing women 
involved with child protective services.  As an Investigator, Dr. McCrady has responsibility for human 
subjects issues, research design and selection of measures, planning data analyses, interpreting 
results, and writing research reports. 
Role:  Co-Investigator 
 
 
 
 
 

 
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BIOGRAPHICAL SKETCH 
 
NAME 
Yeo, Ronald A. 
POSITION TITLE 
Regents Professor of Psychology 
eRA COMMONS USER NAME  
ronyeo 
EDUCATION/TRAINING   
INSTITUTION AND LOCATION 
DEGREE 
(if 
applicable) 
MM/YY 
FIELD OF STUDY 
Colby College, Waterville, ME 
BA 
1975 
Psychology & Biology 
University of Texas at Austin 
Ph.D. 
1984 
Clinical 
 
Boston VA Medical Center 
 
Internship 
 
1983 
 Neuropsychology 
Neuropsychology 
Boston University Aphasia Research Center 
Post-doc 
 
Neuropsychology 
 
 
 
 
 
A. Personal Statement 
 
 
I am happy to serve on the Data Safety and Monitoring Board for the project of Dr Vowles. In addition to 
my familiarity with human subjects research, particularly with complex participants diagnosed with 
schizophrenia or traumatic brain injury, I serve on the University’s Institutional Review Board. I bring with 
me extensive experience in interdisciplinary work as well. These experiences will allow me to adequately 
fulfill my role in this project.  
 
B. Positions and Honors 
2012 – present: Regents Professor, Department of Psychology, University of New Mexico 
2011 – 2012: Principal Investigator coordinator, MIND Research Network, Albuquerque, NM 
2010:  Earl Walker Award, Outstanding Neuroscience Research, University of New Mexico 
2004 - 2008: Chair, Department of Psychology, University of New Mexico. 
1998 - 2012: Professor, Department of Psychology, University of New Mexico. 
2006: 
Outstanding Teacher of the Year, University of New Mexico 
2000 - 2004: Director of Clinical Training, Department of Psychology, University of New Mexico. 
1994 - 1998: Associate Chair for Graduate Studies, Department of Psychology, University of New Mexico. 
1983 - 1984: Post-Doctoral fellow in clinical neuropsychology at the Aphasia Research Center, Boston VA 
 
Medical Center, funded by National Institute of Health training grant. 
 
C. Selected Peer-reviewed publications (from over 140 publications) 
1. Raz, N., Raz, S., Yeo, R. A., Turkheimer, E., Bigler, E. D., & Cullum, C. M. (1986).  Relationship 
between cognitive and morphological asymmetry in dementia of the Alzheimer type:  A CT study.  
International Journal of Neuroscience, 26, 301-309. 
2. Yeo, R. A., Turkheimer, E., Raz, N., & Bigler, E. D. (1987).  Volumetric asymmetries of the human 
brain:  Intellectual correlates.  Brain and Cognition, 6, 15-23. 
3. Willis, L., & Yeo, R. A. (1988).  Differential declines in cognitive function with aging: The possible role of 
health status.   Developmental Neuropsychology, 4, 23-28. 
4. Hunt, A., Orrison, W. W., Yeo, R. A., Haaland, K. Y., Rhyne, R., Garry, P., & Rosenberg, G. A. 
(1989).  Clinical significance of MRI white matter hyperintensities in the elderly.   Neurology, 39, 
1470-1474. 
5. Gennis, V., Garry, P. J., Haaland, K. Y., Yeo, R. A., & Goodwin, J. S. (1991).  Hearing and cognition in 
the elderly.  Archives of Internal Medicine, 151, 2259-2265. 

 
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6. Burke, H. L., & Yeo, R. (1994). Systematic variations in callosal morphology: The effects of age, gender, 
hand preference, and anatomic asymmetry.  Neuropsychology, 8, 563-571. 
7. Yeo, R. A., Gangestad, S. W., Thoma, R. A., Shaw, P., & Repa, K.  (1997).  Developmental instability 
and cerebral lateralization. Neuropsychology, 11, 552-561. 
8. Yeo, R. A., Hodde-Vargas, J., Hendren, R. L., Vargas, L. A., Brooks, W. M., Ford, C. C., Gangestad, S. 
W., Hart, B. F.  (1997). Brain abnormalities in schizophrenia-spectrum children: Implications for a 
neurodevelopmental perspective.  Psychiatry Research, 76, 1-13.  
9. Brooks, W.M., Hodde-Vargas, J., Vargas, L., Yeo, R.A., Ford, C.C., & Hendren, R.   Frontal lobe of 
adolescents with schizotypal signs: A 1H- MRS study. (1998). Biological Psychiatry, 43, 263-269. 
10. Friedman, S. D., Brooks, W. M., Jung, R. E., Hart, B. L., & Yeo, R. A.  (1998). Proton MR 
spectroscopic findings correspond to diffuse neuropsychological function in traumatic brain injury.  The 
American Journal of Neuroradiology, 19, 1879-1885. 
11. Friedman, S. F., Brooks, W. M., Jung, R. E., Chuilli, S. J., Sloan, J. H., Montoya, B. T., Hart, B. L., & 
Yeo, R. A. (1999).  Quantitative 1H-MRS predicts outcome following traumatic brain injury.  Neurology, 
52, 1384-1396. 
12. Jung, R. E., Brooks, W. M., Yeo, R. A., Weers, D., Hart, B., & Sibbitt, W.L.  (1999). Biochemical 
markers of intelligence: A proton MR spectroscopy study of the normal human brain.  Proceedings of 
the Royal Society B, 266, 1375-1379. 
13. Brooks, W. M., Stidely, C. A., Petropoulos, H., Jung, R. E., Weers, D, C., Friedman, S. D., Barlow, M. 
A., Sibbitt, W. L., & Yeo, R. A. (2000). Metabolic and cognitive response to trumatic brain injury: A 
proton magnetic resonance study in humans. Journal of Neurotrauma, 17, 629-640. 
14. Yeo, R. A., Hill, D. E., Campbell, R. A., Brooks, W. M., Vigil, J., Hart, B., & Zamora, L. (2003). A proton 
magnetic resonance spectroscopy investigation of the right frontal lobe in children with attention deficit 
hyperactivity disorder.  Journal of the American Academy of Child and Adolescent Psychiatry, 42, 303-
310. 
15. Driscoll, I. Hamilton, D. A., Petropoulos, H., Yeo, R. A., Brooks, W. M., Baumgartner, R. N., & 
Sutherland, R. J.  (2003). The aging hippocampus: Cognitive, biochemical and structural variations. 
Cerebral Cortex, 13, 1344-1351. 
10. Driscoll, I., Hamilton, D. A., Yeo, R. A., Brooks, W. M., and Sutherland, R. J. (2005). Virtual 
 Navigation in Humans: The Impact of Age, Sex, and Hormones on Place Learning. Hormones and 
Behavior, 47, 326-335. 
16. Rowland, L. M., Bustillo, J. R., Mullins, P. G., Jung, R. E., Lenroot, R., Landgraf, E., Barrow, R., Yeo, 
R. A., Lauriello, J., Brooks, W. M. (2005). Effects of ketamine on anterior cingulated glutamate 
metabolism in healthy humans: A 4-T proton MRS study.  American Journal of Psychiatry, 162, 394-
396.   
17. Rowland, L. M., Astur, R. S., Jung, R. E. Bustillo, J. B., Lauriello, J., & Yeo, R. A.  (2005). Selective 
Cognitive Impairments Associated with NMDA Receptor Blockade in Humans. 
Neuropsychopharmacology, 30, 633-639. 
18. Yeo, R. A., Brooks, W. M., Jung, R. E. (2006).  NAA  and higher cognitive function in humans. 
Advanced Experimental Medicine and Biology, 576: 215-26, 2006. 
19. Yeo, R. A., Hill, D. E., Campbell, R. A., Brooks, W. M., Vigil, J., Hart, B., & Zamora, L. (2003). A proton 
magnetic resonance spectroscopy investigation of the right frontal lobe in children with attention deficit 
hyperactivity disorder.  Journal of the American Academy of Child and Adolescent Psychiatry, 42, 303-
310. 
20. Hill, D. E., Yeo, R. A., Campbell, R. A., Hart, B., Vigil, J, & Brooks, W. M. MRI Correlates of Attention 
Deficit/Hyperactivity Disorder (ADHD) in Children. (2003). Neuropsychology, 17, 491-506. 
21. Haier, R. J., Jung, R. E., Yeo, R. A., Head, K., Alkire, M. T. (2004) Structural brain variation and 
general intelligence.  NeuroImage, 23, 425-433. 
22. Rowland, L. M., Bustillo, J. R., Mullins, P. G., Jung, R. E., Lenroot, R., Landgraf, E., Barrow, R., Yeo, 
R. A., Lauriello, J., Brooks, W. M. (2005). Effects of ketamine on anterior cingulate glutamate 
metabolism in healthy humans: A 4-T proton MRS study.  American Journal of Psychiatry, 162, 394-
396.   

 
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23. Edgar, C., Yeo, R. A., Canive, J., Miller, G. Reduced auditory M100.  (2006).  
Asymmetry in 
schizophrenia and dyslexia: Applying a developmental instability approach to assess atypical brain 
asymmetry. Neuropsychologia, 44, 289-299. 
24.  Thoma, R. J., Yeo, R. A., Gangestad, S. W., Halgren, E., Davis, J., Paulson, K. M.,  
& Lewine, J. 
D. (2006). Developmental instability and the neural dynamics of the speed-intelligence relationship. 
NeuroImage, 32(3), 1456-1464. 
25. Yeo, R. A., Phillips., J. P., Jung, R. E., Brown,. A. J., Campbell, R. C., & Brooks, W.  
M. (2006). 
Magnetic resonance spectroscopy detects brain injury and predicts  cognitive functioning in children 
with brain injuries. Journal of Neurotrauma, 23 (10), 1427-1435. 
26. Yeo, R. A., Gangestad, S. G., & Thoma, R. J. (2007). Developmental instability and individual variation 
in brain development: Implications for the etiology of neurodevelopmental disorders.  Current Directions 
in Psychological Science, 16, 245-249. 
27. Gasparovic, C., Yeo, R. A., Mannell, M., Elgie, R., Phillips, J. P., Dozema, D., & Mayer, A. R. (2009). 
Neurometabolite Concentrations in Gray and White Matter in Mild Traumatic Brain Injury: A 1H–
Magnetic Resonance Spectroscopy Study. Journal of Neurotrauma, 26, 1635-1643. 
28. Mayer, A. M., Mannell, M. V., Ling, J., Elgie, R., Gasparovic, C., Phillips, J. P., Dozema, D., & Yeo, R. 
A. (2009). Auditory orienting and inhibition of return in mild traumatic brain injury: A fMRI study. Human 
Brain Mapping, 30, 1652-1666. 
29. Mayer, A. R., Ling, J., Mannell, M. V., Gasparovic, C., Phillips, J. P., Doezema, D., Reichard, R., & 
Yeo, R. A. (2010). A Prospective Diffusion Tensor Imaging Study in Mild Traumatic Brain Injury. 
Neurology, 74, 643-650. 
30. Thoma, R. J., Monnig, M. A., Ruhl, D. A., Lysne, P., Pommy, J., Bogenschutz, M., Tonigan, S., Yeo, R. 
A. (2011). Substance abuse in adolescence: The effects of alcohol, marijuana, tobacco, and risk status 
on neuropsychological performance. Alcoholism: Clinical and Experimental Research, 35, 1-8. 
31. Yeo, R. A., Gasparovic, C., Merideth, F., Ruhl, D., Doezema, D., & Mayer, A. R. (2011).  A 
Longitudinal proton magnetic resonance spectroscopy study of mild traumatic brain injury. Journal of 
Neurotrauma, 28, 1-11. 
32. Yeo, R. A., Gangestad, S. W., Liu, J., Calhoun, V. D., Hutchison, K. (2011). Rare copy number 
deletions predicts individual variation in intelligence. Public Library of Science One. 
33. Yeo, R. A., Arden, R., & Jung, R. E. (2011). Alzheimer’s disease and intelligence. Current Alzheimer 
Research, 8(4), 345-353.  
34. Yeo, R. A., Gangestad. S. W., Gasparovic, C., Liu, J., Calhoun, V. D. Thoma, R. J., Mayer, A. R., 
Kalnayam, R., & Hutchison, K. E. (2011). Rare copy number deletions predict individual variation in 
human brain metabolite concentrations in individuals with alcohol use disorders. Biological Psychiatry, 
70(6), 537-544. 
35. Mayer, A. M., Ling, J., Mannell, M., Gasparovic, C., Yeo, R. A. (2011). Default mode network activity 
on mild traumatic brain injury: A fMRI study. Human Brain Mapping, 32: 1825- 1835. 
36. Ling, J., Pena, A., Yeo, R. A., Merideth, F., Klimaj, S., Gasparovic, C., & Mayer, A. R. (2012). An 
examination of diffusion anisotropy in replication and longitudinal samples of Mild Traumatic Brain 
Injury. Brain, 135, 1281-1292.  
37. Monnig, M. A., Tonigan, J. S., Yeo, R. A., Thoma, R. J., & McCrady, B. S. (2012). Review and meta-
analysis of white matter volume in alcohol use disorders. Addictions Biology, 17, 1369-1375. 
38. Mayer, A. R., Yang, Z., Yeo, R. A., Pena, A., Ling, J., Mannell, M. V. & Gasparovic, C. (2012).  A fMRI 
study of multimodal selective attention following mild Traumatic Brain Injury. Brain Imaging and 
Behavior, 6, 343-354. 
39. Yang, Z., Yeo, R. A., Pena, A., Ling, J. M., Klimaj, S., Campbell, R. A., Doezema, D., & Mayer, A. R. 
(2012). A fMRI study of auditory orienting and inhibition of return in pediatric mild traumatic brain injury. 
Journal of Neurotrauma, 29, 2109-2123. 
40. Mayer, A. R., Ling, J., Yang, Z., Pena, A., Yeo, R. A., & Klimaj, S. (2012). Diffusion Abnormalities in 
Pediatric Mild Traumatic Brain Injury. Journal of Neuroscience, 32, 17961-17969. 
41. Yeo, R. A., Thoma, R. J., Gasparovic, C., Monnig, M., Harlaar, N., Calhoun, V. D., Kalyanam, R., 
Durazzo, T. C., & Hutchison, K. E. (2013). Neurometabolite concentration and clinical features of 
alcohol use disorders: A proton magnetic resonance spectroscopy study. Psychiatry Research 
Neuroimaging, 211, 141-147. 

 
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42. Monnig, M., Caprihan, A., Yeo, R. A., Gasparovic, C., Ruhl, D., Lysne, P., Tonigan, S., Bogenschutz, 
M., Hutchison, K., Thoma, R. J. (2013). Diffusion tensor imaging of white matter networks in individuals 
with current and remitted alcohol use disorders and comorbid conditions.  Psychology of Addictive 
Behaviors. 
43.  Liu, J., Ulloa, A., Perrone-Bizzozero, N., Yeo, R. A., Calhoun, V. C. (2012). Collective effects of 
22q13.31 deletions on gray matter concentration in schizophrenia. Public Library of Science 
One,10.1371/journal.pone.0052865. 
44. Yeo, R. A., Thoma, R. J., Gasparovic, C., Monnig, M., Harlaar, N., Calhoun, V. D., Kalyanam, R., 
Durazzo, T. C., & Hutchison, K. E. (2013). Neurometabolite concentration and clinical features of 
alcohol use disorders: A proton magnetic resonance spectroscopy study. Psychiatry Research 
Neuroimaging, 211, 141 -147. 
45.  Yeo, R. A., Gangestad, S. W., Liu, J., Thoma, R. J., Pommy, J., Mayer, A. R., Schulz, S. C., Ehrlich, 
S., Wassink, T., Morrow, E., Bustillo, J., Ho, B-C., Calhoun, V. D. (2013). The impact of copy number 
deletions on general cognitive ability and ventricle size in patients with schizophrenia and healthy 
controls. Biological Psychiatry, 73: 540-545. 
46. Yeo, R. A., Martinez, D., Pommy, J. M., Ehrlich, S., Schulz, S. C., Ho, B.-C., Bustillo, J. R., & Calhoun, 
V. D. (2013, online). The impact of parent socioeconomic status on executive functioning and cortical 
morphology in individuals with schizophrenia and healthy controls. Psychological Medicine. DOI: 
10.1017/S0033291713001608. 
47. Monnig, M. A., Caprihan, A., Yeo, R. A., Bryan, A. Claus, E. D., Calhoun, V. D., Thoma, R. J., & 
Hutchison, K. E.  (2013). Alcohol abuse is associated with white matter variation in reward and self-
regulation networks: A DTI-BOLD study. Brain and Behavior, 4, 158-170. 
48. Yeo, R. A., Martinez, D., Pommy, J. M., Ehrlich, S., Schulz, S. C., Ho, B.-C., Bustillo, J. R., & Calhoun, 
V. D. (2014). The impact of parent socioeconomic status on executive functioning and cortical 
morphology in individuals with schizophrenia and healthy controls. Psychological Medicine, 44, 1257-
1265. 
49. Yeo, R. A., Gangestad, S. W., Walton, E., Ehrlich, S., Pommy, J., Turner, J. A., Liu, J., Mayer, A. R., 
Schulz, S. C., Ho, B. C., Bustillo, J. R., Wassink, T. H., Sponheim, S. R., & Calhoun, V. D. (2014). 
Genetic influences on cognitive endophenotypes in schizophrenia. Schizophrenia Research, 156, 71-
75. 
50.  Ryman, S. G., van den Heuvel, M., Yeo, R. A., Vakhtin, A. A., Carrassco, J., Flores, A. A., Wertz, C., 
& Jung, R. E. (2014). Sex differences in the relationship between complex connectivity and creativity. 
NeuroImage, 101, 380-389. 
 
Ongoing Research Support 
 
Principal Investigator: Robin Ohls, MD, Co-Investigator: Ronald A. Yeo, Ph.D. 
Title: Brain Imaging and developmental follow-up of infants treated with Erythropoietin 
Agency: National Institutes of Health, Developmental brain disorders study section 
Type: R01, Period 6/1/10 – 5/31/15. 
 
This study will utilize multimodal neuroimaging (MRI, DTI, MRS) and neurocognitive assessment to 
evaluate the impact of treatment of very low birth weight infants with recombinant erythropoietin, 
which stimulates red blood cell production and may serve as a neuroprotective agent. 
 
Principal Investigator: Andrew Mayer, Ph.D., Co-Investigator: Ronald A. Yeo, Ph.D. 
Title: A Multidimensional Approach for Understanding Cognitive Control Deficits in Psychopathology 
Agency: NIH 
Type: RO1 
This study is investigating multimodal cognitive control using fMRI and genetics in a population of 
individuals with psychotic disorders. 
 
 
 

 
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BIOGRAPHICAL SKETCH 
NAME 
J. Scott Tonigan, Ph.D. 
POSITION TITLE 
Research Professor 
 
eRA COMMONS USER NAME 
jtonigan 
EDUCATION/TRAINING  
INSTITUTION AND LOCATION 
DEGREE 
(if 
applicable) 
YEAR(s) 
FIELD OF STUDY 
The University of New Mexico, Albuquerque, NM 
B.A. 
1977 
History/Economics 
The University of New Mexico, Albuquerque, NM 
M.A. 
1982 
Educational Psychology 
The University of New Mexico, Albuquerque, NM 
Ph.D. 
1989 
Educational Psychology 
 
A. Personal Statement 
I am an applied statistician trained in the tradition of NIH funded RCT’s investigating addiction-
focused interventions. I also have a long-standing commitment to the formal psychometric 
development of self-report questionnaires and semi-structured interviews in addictions research. 
Since 1993 I have served as an NIH measurement consultant, work that has contributed to the 
dissemination of two clinician-based assessment reference/training manuals. I also serve as the 
chair of the main campus Institutional Review Board for the University of New Mexico. I am facile in 
the application of the proposed analytic methods described in this application, and I have published 
extensively in the areas of moderated and mediated effects within the context of psychosocial 
interventions for substance abuse. I have substantial experience working with data safety and 
monitoring and am well-qualified to serve in this capacity on this project.  
 
Positions and Honors.  
1993-95 
Research Assistant Professor of Psychology, UNM 
1994-present    
National Institute on Alcoholism and Alcohol Abuse (NIAAA) Assessment 
Consultant  
1995-01   
Research Associate Professor of Psychology, UNM 
2001-present   
Research Professor of Psychology, UNM 
2002-2002      
Consulting Editor, Journal of Consulting and Clinical Psychology 
2003 
Co-Director, Center of Alcoholism, Substance Abuse, and Addictions 
(CASAA), UNM 
2003-2007      
Member, Clinical and treatment subcommittee (NIAAA) initial review group 
(AA-3) 
2008-2010 
Chair, Clinical, Treatment and Health Services Research Review 
Subcommittee, NIAAA 
2004-present 
Editorial Review Board: Journal of Substance Abuse Treatment; Alcoholism 
Treatment Quarterly; Psychology of Addictive Behavior; Journal of 
Behavioral Medicine 
2007-present   
Chair, Main Campus University of New Mexico Institutional Review Board 
2009-present   
Associate Editor, Psychology of Addictive Behaviors 
2010-2011 
Associate Editor, Journal of Behavioral Health 
 
 

 
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B. 
Selected peer-reviewed publications most relevant to current application 
Miller, W. R., & Tonigan, J. S. (1996). Assessing drinkers motivation for change: The Stages of  
 
Change Readiness and Treatment Eagerness Scale (SOCRATES), Psychology of Addictive  
 
Behaviors. 10, 81-89. 
Tonigan, J. S., Miller, W. R., & Brown, J. M. (1997). The reliability of Form 90: An instrument for 
assessing alcohol treatment outcome, Journal of Studies on Alcohol 58, 358-364. 
 
Westerberg, V. S., Miller, W. R., & Tonigan, J. S. (1999).  Reliability of Form 90D: An instrument for 
quantifying drug use, Substance Abuse, 19, 4, p. 179-189.  
Tonigan, J. S., & Miller, W. R. (2002). The Inventory of Drug Use Consequences (InDuC): Test-retest 
Stability and sensitivity to Detect Change. Psychology of Addictive Behaviors, 16(2):165-168. 
Slesnick, N. & Tonigan, J. S. (2004). Assessment of alcohol and other drug use by runaway youths: A 
test-retest study of the Form 90, Alcoholism Treatment Quarterly, 22, 2 
Freyer, J., Tonigan, J. S., Keller, S., Rumpf, H.-J., John U., Hapke, U. (2005). Readiness for change and 
readiness for help-seeking: A composite assessment of client motivation, Alcohol and Alcoholism, 
40 (6), 540-544. 
Tonigan, J. S. (2007). Statistical Considerations in Identifying Mechanisms of Change, Alcoholism: 
Clinical and Experimental Research, 31, S3. 
Forcehimes, A.A., Tonigan, J.S., Miller, W.R., Kenna, G.A. & Baer, J.S. (2007). Psychometrics of the 
Drinker Inventory of Consequences (DrInC). Addictive Behaviors, 32, 1699-1704. 
Huebner, R., & Tonigan, J.S. (2007). The search for mechanisms of behavior change in evidence-based 
behavioral treatments for alcohol use disorders: Overview. Alcoholism: Clinical and Experimental 
Research, 31(Suppl 3), 1S-3S. 
Hettema, J. E., Miller, W. R., Tonigan, J. S., & Delaney, H. (2008). The reliability of the Form 90-DWI: 
An  instrument for assessing intoxicated drivers.  Psychology of Addictive Behaviors, 22, 1, p 117-
121 
Bogenschutz, M. P. , Tonigan, J. S., & Pettinati, H. M., (2009). Effects of alcoholism typology on 
response to naltrexone in the COMBINE trial, Alcoholism: Clinical and Experimental Research.33, 
1,p 10-18. 
Freyer-Adam J, Coder B, Ottersbach C, Tonigan J S, Rumpf H-J, John U Hapke U (2009). The 
Performance of Two Motivation Measures and Outcome after Alcohol Detoxification, Alcohol and 
Alcoholism, 44(1): 77-83. 
Bogenschutz, M. P., Abbott, P.J. Kushner, R., Tonigan, J. S., & Woody, G. E. (2010).  Effects of 
buprenorphine and hepitis C on liver enzymes in adolescents and young adults.  Journal of 
Addiction Medicine, 4, 4, 211-216. 
Tonigan, J. S. & Rynes, K. N. (in press). Do changes in selfishness explain 12-step benefit? : A 
prospective lagged meditational analysis.  Substance Abuse. 
Rynes, K. N, & Tonigan, J. S.  (in press) Do Social Networks Explain 12-Step Sponsorship Effects? A 
Prospective Lagged Mediation Analysis. Psychology of Addictive Behaviors. 
 
C. 
Ongoing Research Support 
 
R21 AA020242-01 Tonigan (PI) 
NIH/NIAAA 
Review of the AA Literature: Clinical and Research Implications. 
This review is applying meta-analytic techniques to summarize the AA literature 1993-2010. Initial 
efforts to identify relevant articles are now in progress. Analyses will first focus on the associations 
between AA attendance, drinking, and secondary outcomes.  The review will also report the 
magnitude of associations for mediation pathways in MOC research on AA, e.g. spirituality and social 
support. The moderating effects of study and sample characteristics will be reported, e.g., dual 
diagnosis, and the relative effectiveness of different therapeutic approaches to facilitate 12-step 
attendance will be documented. 
 
 

 
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R01 AA018376-01 McCrady (PI) 
 
 
 
 
 
08/10/10-07/31/13 
NIH/NIAAA 
 Mechanisms of Change: Alcohol Behavioral Couple Therapy 
This study will identify if spousal behavior in couples therapy in the first therapy session predicts later 
drinking.  Other aims will test if couple interactions change through the course of therapy, how such 
changes may predict drinking, and how pretreatment couple characteristics moderate relationships of 
interest.  Existing audiotapes of 186 first session and 136 mid- treatment sessions from four 
randomized clinical trials of ABCT will be coded. Dr. Tonigan is a Co-I on this project and is 
responsible for the primary data analyses. 
 
U10DA1533 Southwest Clinical Trials Network Node Bogenschutz (PI) 09/01/10-08/31/15 
NIH/NIDA 
This multisite cooperative agreement is intended to partner with community-based treatment providers 
to assess the efficacy and effectiveness of various pharmacotherapy and psychosocial treatments for 
substance abuse.  Dr. Tonigan is Co-I for the Albuquerque node. 
 
Templeton Foundation, Pagano, (PI) 
 
 
 
 
04/01/09-03/31/12 
Helping Others and Long-term Outcomes among Youth with Substance Use Disorders.  
This is a naturalistic follow-up study of adolescents with substance abuse problems. The project has 
three primary aims: (1) to validate the “Helping Others” questionnaire, (2) to investigate faith-based 
mechanisms for sustaining service over time, and (3) to examine health and social outcomes in 
relation to youth involvement in service. Administered by Case Western University, Dr. Tonigan is a 
consultant on the project. 
 
Completed Research Support 
 
R01-AA014197-01A1-08 Tonigan (PI) 
 
 
 
 
04/15/05-09/29/11 
NIH/NIAAA 
A Transtheoretical Model of AA-related Behavior Change 
This single-group longitudinal study recruited 253 AA-exposed adults from community-based AA and 
outpatient treatment.  Prospective hypotheses about the relative importance of change readiness, 
self-efficacy, perceived social group dynamics, and AA-specific change mechanisms, e.g., spirituality, 
have been tested with preliminary reports provided at RSA in 2009 and 2010.  Several papers are 
now under review reporting findings out to the 24 month follow-up.  An extended 5 year follow-up is 
currently in progess.  
 
K02-AA00326-10, Tonigan (PI) 
 
 
 
 
 
09/01/06- 08/27/11 
NIH/ NIAAA 
The Social Context for AA-related Behavior Change 
This award is focused on the acquisition of analytic skills and knowledge gains in social psychology 
necessary to model AA-related behavior change in a dynamic social context.  To achieve these 
objectives Dr. Tonigan’s career plan included didactic coursework, statistical workshops, coordination 
of MOC-based workshops at RSA, and structured consultations.   The K02 award fully supports Dr. 
Tonigan’s research efforts. 
 
R21AA 017313-02, Thoma (PI) 
 
 
 
 
 
09/30/07-08/31/11 
NIH/NIAAA 
Adolescent Neurodevelopment and Alcohol. 
This study is investigating the effect of adolescent alcohol abuse on brain development.  We have 
collected intake, 1 and 6-month measures including neuropsychological variables, self-reported 
drinking measures, magnetic resonance spectroscopy, diffusion tensor imaging, morphometric 
assessment, EEG, and MEG data.  Three groups were recruited: (1) a control group of non-drinking, 

 
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but high-risk participants (N = 10), a healthy, normal control (HC; N = 10), and adolescents entering 
treatment for chronic alcohol abuse (CAA N = 20). Preliminary analyses are underway. We are 
currently in the data analysis phase, and Dr. Tonigan is a Co-I on the project. 
 
R21DA025241-02, Geppert (PI) 
 
 
 
 
 
08/01/09-07/31/11 
NIH/NIDA 
A Survey Study of Informed Consent Processes in Addiction Treatment 
The study surveyed 1,500 clinicians from treatment programs of the NIDA Clinical Trials Network 
(CTN) via an Internet web-based platform. The survey instrument focused on knowledge of clinical 
ethics concerning the informed consent process, consent practices, and attitudes toward informed 
consent situations. Participating sites include 16 CTN nodes each linked with five to ten or more 
Community-based Programs. Preliminary findings are reported in this application, Training in the 
Responsible Conduct of Research. 
 
R01 AA015419-05 Bogenschutz (PI) 
 
 
 
 
09/01/05-05/31/11 
NIH/NIAAA 
12-step Facilitation Adapted for the Dually Diagnosed 
This study adapted the 12-step manual developed for Project MATCH for use with dually diagnosed 
clients (N = 121).  The primary objective of this adapted manual was to facilitate attendance in Double 
Trouble (DT), a mutual-help program for dually diagnosed substance abusers.  Follow-up was done at 
3, 6, 9, and 12 months, and attendance and commitment to DT and AA was closely monitored and 
documented.  The project is now in the data analysis phase. Dr. Tonigan is a Co-I on this project. 
 
R21AA016974-03 Tonigan (PI)  
 
 
 
 
 
08/31/07-07/30/10 
NIH/NIAAA 
Therapeutic Mechanisms in AA 
This study investigated the plausibility that causal mechanisms identified in the core AA literature 
accounted for AA-related benefit, i.e., reduced anger and selfishness and increased spirituality. We 
recruited 130 alcohol dependent adults from community-based AA and outpatient treatment with 
limited treatment and AA histories and interviewed them at intake, 3, 6, and 9-months.  Preliminary 
results have been reported at RSA in 2010 and several papers are now under peer-review. 
R21 AA 016762-03 Kelly (PI) 
 
 
 
 
 
05/01/08-03/29/10 
NIH/NIAAA 
Mechanisms and Moderators of Behavior Change in Alcoholics Anonymous 
This study conducted secondary analyses on the Project MATCH data set with special attention paid 
to identifying change mechanism in AA and how such benefit is moderated by static and dynamic 
client characteristics.  Dr. Tonigan served as a co-investigator on this project and has co-authored 
four papers with the investigative team. 
 
R21AA13073-01 Tonigan (PI) 
 
 
 
 
 
10/01/00-09/30/03 
NIH/NIAAA 
Spirituality and AA practices: 10 year MATCH follow-up. 
This study examined the temporal relationships between prescribed AA-related behaviors, spiritual 
development, and drinking by conducting a 10-year follow-up of the Project MATCH sample (N = 122) 
recruited at the Albuquerque clinical research unit. 
 
 
 
 

 
A pilot study of integrated treatment for Veterans with chronic pain and opiate misuse 
 
69 of 76 
 
Version 1.1 (Date: 22 January 2015) 
Appendix VIII 
Protocol Deviation Tracking Log 
Protocol ID/Number: 
   
Site 
Name/Number: 
  VA Medical Center, Albuquerque, NM 
Protocol Title 
(Abbreviated): 
Combined Treatment for Chronic Pain and 
Opioid MIsuse 
Principal Investigator: 
   
Page number [1]: 
   
Ref 
No. 
Subject 
ID 
Date of 
Deviation 
Date 
Identified 
Deviation Description 
Dev. 
Type 
[2] 
Resulted 
in AE? 
Did Subject 
Continue in 
Study? 
Meets IRB 
Reporting 
Req. 
(Yes/No) 
IRB 
Reporting 
Date 
1 
   
   
   
   
   
   
   
   
   
2 
   
   
   
   
   
   
   
   
   
3 
   
   
   
   
   
   
   
   
   
4 
   
   
   
   
   
   
   
   
   
5 
   
   
   
   
   
   
   
   
   
6 
   
   
   
   
   
   
   
   
   
7 
   
   
   
   
   
   
   
   
   
Investigator Signature:  
 
Date:  
 

 
 
Form Instructions:  
[1] Each page should be separately numbered to allow cross-referencing (e.g., deviation #2 on p. 7) 
[2] Deviation Type: (A-J) See codes below—enter the appropriate deviation code from the list.  
Protocol Deviation Codes: 
A – Consent Procedures 
B – Inclusion/Exclusion Criteria 
C – Concomitant Medication/Therapy 
D – Laboratory Assessments/Procedures 
E – Study Procedures 
F – Serious Adverse Event Reporting/Unanticipated Adverse Device Effect 
G – Randomization Procedures/Study Drug Dosing 
H – Visit Schedule/Interval 
I – Efficacy Ratings 
J – Other 
 
 
 

 
 
Adverse Event Form 
Pilot Study of Combined Treatment for Veterans with Chronic Pain and Opioid Misuse 
Pt_ID:_________________________ 
This form is cumulative and captures adverse events of a single participant 
throughout the study.  
 
Severity 
Study Event 
Relationship 
Action Taken 
Regarding Study 
Intervention 
Outcome of 
AE 
Expected 
Serious Adverse 
Event (SAE) 
1 = Mild 
2 = Moderate 
3 = Severe 
4 = Life-
Threatening 
0 = Not related 
1 = Unlikely related 
2 = Possibly related 
3 = Probably 
related 
4 = Definitely 
related 
0 = None 
1 = Dose 
modification 
2 = Medical 
Intervention 
3 = Hospitalization 
4 = Intervention 
discontinued 
5 = Other 
1 = Resolved 
2 = Recovered with 
minor sequelae 
3 = Recovered with 
major sequelae 
4 = 
Ongoing/Continu
ing treatment 
5 = Condition 
worsening 
6 = Death 
7 = Unknown 
1 = Yes 
2 = No 
1 = Yes 
2 = No 
 
(if yes, complete 
SAE form) 
At end of study only: Check this box if participant had no adverse events 
 
None 
 
 

 
 
Adverse Event 
Start Date 
Stop Date 
Severity 
Relation-
ship 
Action 
Taken 
Outcome of 
AE 
Expected? 
SAE? 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
Serious Adverse Event (SAE)  
Report Form 
Pilot Study of Combined Treatment for Veterans with Chronic Pain and Opioid MIsuse 
 
Pt ID: 
 
Date Participant Reported: 
            /                   /                        . 
 d d 
m m m 
y y y y 
 
1. 
SAE onset date: 
___ ___ / ___ ___ ___ / ___ ___ ___ ___ 
 
d d 
m m m 
y 
y 
y 
y 
2. 
SAE stop date:  
___ ___ / ___ ___ ___ / ___ ___ ___ ___ 
 
d d 
m m m 
y 
y 
y 
y 
3. 
Location of SAE: 
 
4. 
Was this an unexpected adverse event? 
 Yes 
 No 
5. 
Brief description of participants with no personal identifiers: 
Sex:  
 F 
 M 
Age:  
 
Diagnosis for study participation: 
 
 
 
6. 
Brief description of the nature of the SAE (attach description if more space is needed):  
 
 
 
 
7. 
Category of the SAE: 
 Date of death ___/_____/_______ 
 
 
(dd/mmm/yyyy) 
 Life threatening 
 Hospitalization – initial or prolonged 
 Disability/incapacity 
 Congenital anomaly/birth defect 
 Required intervention to prevent permanent 
impairment 
 Other: 
 

 
8. 
Intervention type: 
 Behavioral/lifestyle (specify): Psychosocial intervention: Combined ACT and MBSR 
9. 
Relationship of event to intervention: 
 Unrelated (clearly not related to the intervention) 
 Possible (may be related to intervention) 
 Definite (clearly related to intervention) 
10. Was study intervention discontinued due to event? 
 Yes 
 No 
11. What medications or other steps were taken to treat the SAE? 
 
 
12. List any relevant tests, laboratory data, and history, including preexisting medical conditions: 
 
 
13. Type of report: 
 Initial 
 Follow-up 
 Final 
Signature of principal investigator:  __________________________  Date:  _______________  
 
 

 
Appendix IX 
Data and Safety Monitoring Log 
Table 1. Enrollment by Month of Study 
Month 
# 
Expected 
# 
Screene
d 
# Enrolled or 
Randomized 
# 
Withdrawn 
# Actual 
(# Enrolled - # 
Withdrawn) 
# Cumulative 
(Sum of # Actual by 
Month) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
*Enrollment can also be displayed graphically in a Figure, with cumulative subject accrual plotted over time. 
Table 2. Demographics 
 
Characteristics 
N 
N% 
Gender 
 
 
Female 
 
 
Male 
 
 
Ethnicity 
 
 
Hispanic or Latino 
 
 
Not Hispanic or Latino 
 
 
Unknown 
 
 
Age  
 
Mean (SE) 
 
 
Race 
 
 
AIAN 
 
 
Asian 
 
 
Nat Hawaiian/Other Pac 
Islander 
 
 
Black or African American 
 
 
White 
 
 
Other 
 
 
More than one race 
 
 
Unknown 
 
 
Table 3. Subject Status 
Pt 
Identifie
r 
Date 
Enrolled 
Date 
Completed 
Study 
Study Status 
Reason for 
Withdrawal 
% Adherence to 
Intervention 
Intervention 
Duration 
(Weeks) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Status: 
% Compliance to Intervention: 
A = Active 
(# tablets taken/total # per protocol)*100 
C = Completed 
or 
W = Withdrew 
(# classes taken/total # of sessions should have attended  
L = Lost to followup  
per protocol)*100 
 
 

 
Table 4. Adverse Events 
Pt 
Identifi
er 
AE 
Onset 
AE 
End 
AE 
Code 
(MedR
A, 
CTCA
E) 
Severit
y 
SAE
? 
(Y/N
) 
Relate
d-ness 
Action 
Taken 
Outco
me 
Comments 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
  
 
 
 
Severity of AE: 
Relatedness to Intervention:  
1 = Mild 
0 = Definitely unrelated 
2 = Moderate 
1 = Unlikely 
 
3 = Severe 
2 = Possibly related 
4 = Life threatening or disabling 
3 = Probably related 
4 = Definitely related 
Action Taken: 
0 = None 
Outcome: 
1 = Dose modification 
1 = Resolved 
2 = Medical intervention  
2 = Recovered with minor sequelae 
(specify in comments) 
3 = Recovered with major sequelae 
3 = Hospitalization 
4 = Continuing treatment 
4 = Intervention discontinued 
5 = Condition worsening 
5 = Other 
6 = Patient death** 
**Provide further details regarding all reported serious AEs and deaths in the SAE and Subject Deaths tables 
listed at the end of this section. 
Table 5. Serious Adverse Events 
Pt 
Identifier Age 
Treatment 
Date 
SAE 
SAE Date 
Related to 
Intervention 
Description of Actions and 
Outcomes (e.g., 
hospitalization, withdrawn from 
study) 
 
 
 
 
Table 6. Subject Deaths 
Pt 
Identifier 
DOB 
Date 
Enrolled 
Treatment 
Date 
Cause of Death 
Date of 
Death 
Comments