Evaluation of a Mindfulness-Based Intervention for Gulf War Illness
Phase: NA
Conditions: Gulf War, Fatigue, Pain, Depression
Sponsor: VA Office of Research and Development

[MIRB 00873] A Randomized Clinical Trial of Group Interventions for Veterans with 
Chronic Multi-Symptom Illness
Funding Agency: VA HSR&D
Principal Investigator: Tracy Simpson, PhD
Version 10; 7/7/2021
Human Subjects Protocol
VA Puget Sound IRB
 
VA Puget Sound IRB 2
Effective Date:
June 17, 2021

Abstract
The study will recruit and randomize up to 308 participants.  Half (n=154) 
of these will be Gulf War Veterans who meet criteria for Chronic Multi-Symptom 
Illness (CMI), and the other half (n=154) will be Veterans from other periods of 
service who also meet criteria for CMI.  Half of the Gulf War Veterans (n=77) and 
half of the non-Gulf War Veterans (n=77) will be randomly assigned to the 
Mindfulness-Based  Stress  Reduction  (MBSR) group,  and  the  other  154 
participants (77 Gulf War Veterans, 77 non-Gulf War Veterans) will be randomly 
assigned  to  the  augmented  Chronic  Disease  Self-Management  Program 
(aCDSMP) group.  As of July 2020, these groups will be conducted remotely 
using the VA’s Video Connect software, due to the restrictions resulting from the 
COVID-19 virus. Each of the group sessions are 2.5 hours long, and they meet 
once a week for 8-weeks, as well as once on a Saturday for 4 hours (between 
Week 6  and  7).  As of July 2020,  we  will  no  longer be  including  Saturday 
sessions, given the difficulties of doing so in a remote learning format. Each 
cohort  will  randomize  30  subjects or  until  one  intervention  reaches  18 
randomized participants, whichever occurs first. As of July 2020, groups are 
capped at 10 participants each, or 19 subjects randomized per cohort; this cap 
reflects ideal group sizes for the remote learning format.
Data will be collected from subjects during  five assessments while they 
are enrolled in the study: 1) at Baseline,  which will take place  within  6 weeks 
prior to beginning MBSR or aCDSMP; 2) at “Midpoint,” between Week 4 and 
Week 5; 3) at “Post,” within a month following the completion of the group series; 
4) at 3-months after the group ended; and 5) at 6-months after the group ended.
At  each  of  these  assessments except  the  Midpoint,  researchers  will 
provide  and administer self-report  measures to  the  participants using  a  VA 
computer to assess changes in the following symptoms and attitudes over time 
and between the two study arms: pain, fatigue, cognitive failures, depression, 
PTSD, health- and mental-health-related quality of life, drug use, alcohol use and 
negative consequences, gastrointestinal distress, mindfulness, self-compassion, 
and decentering. These assessments can be completed both in person or by 
phone, as of March of 2020 all assessments will be completed by phone because 
of COVID-19 restructions. At the Midpoint, participants complete a pen-and-
paper set of questionnaires assessing potential mediations (e.g. mindfulness and 
self-efficacy) and primary endpoints, which will allow mediation analyses to be 
performed in the future. 
At the Post Assessment, a qualitative interview will be conducted with Gulf War veterans to  
explore  impressions  of,  and  satisfaction  with,  the  two  different  treatments  (MBSR  and 
aCDSMP). List of Abbreviations
CMI – Chronic Multi-Symptom Illness
GW – Gulf War
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GWS – Gulf War Syndrome
MBSR – Mindfulness-based Stress Reduction
aCDSMP – adapted Chronic Disease Self-Management Program
CPRS – Computerized Patient Record System (electronic medical record)
PROMIS – Patient-reported Outcome Measures Information System
VVC- VA Video Connect
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Contents
Protocol Title:...............................................................................................................................5
1.0
Study Personnel................................................................................................................5
2.0
Introduction.......................................................................................................................5
3.0
Objectives.........................................................................................................................8
4.0
Resources and Personnel.................................................................................................8
5.0
Study Procedures............................................................................................................10
5.1 Study Design....................................................................................................................10
5.2 Recruitment Methods.......................................................................................................14
5.3 Informed Consent Procedures..........................................................................................16
5.4 Inclusion/Exclusion Criteria..............................................................................................17
5.5 Study Evaluations............................................................................................................17
5.6 Data Analysis...................................................................................................................20
5.7 Withdrawal of Subjects.....................................................................................................21
6.0
Reporting........................................................................................................................21
7.0
Privacy and Confidentiality..............................................................................................21
8.0
Communication Plan.......................................................................................................22
9.0
References......................................................................................................................23
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Protocol Title:  A randomized clinical trial of group interventions for 
Veterans with Chronic Multi-Symptom Illness
1.0
Study Personnel

Provide  name,  contact  information,  and  affiliations/employee  status  for  the 
following:
Principal Investigator: 
Tracy Simpson, 206-277-3337, Tracy.Simpson@va.gov, VA employee 8/8ths
Co-Investigators:
Tiffanie Fennell, 206-277-4434, Tiffanie.Fennell@va.gov, VA employee 8/8ths
George Sayre, 206-277-4187, George.sayre@va.gov, VA employee 8/8ths
Collaborators (at other institutions, not covered under the VA IRB approval): N/A
2.0
Introduction
There have been numerous attempts to determine the cause of CMI among 
Gulf War (GW) Veterans1,2, but studies of treatment approaches to CMI remain 
limited,  and  thousands  of  Veterans  continue  to  suffer.3 Treatment  models 
developed for CMI recommend interventions that are integrative and include 
educational and self-management components.4,5 To date, there has been one 
published clinical trial for GW Veterans with CMI that evaluated an integrative 
approach and it suggested a modest benefit of cognitive behavioral therapy 
(CBT) and/or exercise on symptoms of CMI, which declined over follow-up.6 In 
addition, there was no significant effect of CBT on fatigue relative to usual care, 
limited effects on pain, and adherence to the treatment regimen was poor – only 
38% of the CBT plus exercise group, 36% of the CBT group, and 47% of the
exercise  group  attended  two-thirds  or  more  of  the  treatment  sessions.  The 
relative paucity of integrative treatment trials is noted in a recent Institute of 
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Medicine  (IOM)  report,7 which  emphasizes  the  need  for  additional  rigorous 
studies  of  integrative  approaches,  including  Complementary  and  Alternative 
Medicine (CAM) interventions.
Mindfulness-Based Interventions (MBIs) such as Mindfulness-Based Stress 
Reduction  (MBSR)  emphasize  patient  education  and  self-management,  and 
foster the ability to attend to thoughts, emotions, and bodily sensations with an 
attitude of curiosity, openness, acceptance, and love.8 Such an attitudinal shift 
has been theorized to promote cognitive and behavioral changes, and to foster 
more adaptive responses to stress and pain.9 There is evidence that MBIs also 
influence the key components of the biopsychosocial model: biological (e.g. the 
stress response), psychological (e.g. anxiety about symptoms, interpretations of 
symptoms), and social (e.g. engagement in health care/self-care activities and 
social support).8,10,11 MBIs can be considered an integrative approach, because of 
their potential to foster improvement across multiple domains of health,11-14 and 
thus  may be particularly well suited to the health concerns of GW Veterans. 
Participation in an MBI can be framed as teaching a person a life skill, the 
benefits  of  which  can  grow  over  time.12 MBSR  teaches  self-care  practices 
(mindfulness meditation) that participants are encouraged to utilize on a regular 
basis after finishing the course (and uptake of these practices has been shown to 
occur at a high rate; at least 75% report using mindfulness techniques in daily life 
at follow-up ranging from 6-48 months).9,15  
MBIs have been applied  to  the  hallmark of symptoms of CMI,  including 
musculoskeletal pain, fatigue, and concentration/memory or mood disturbances. 
A brief summary of the effect of MBIs on these cardinal symptoms of CMI is 
provided below.
A  meta-analysis of acceptance-based  approaches for chronic pain  found 
medium effects for pain intensity (d=0.48).14 Another review of 16 trials of MBIs 
showed reductions in pain intensity in 6 of 8 randomized controlled trials (RCTs), 
with medium effect sizes.12 Furthermore, when analyses were limited to samples 
involving clinical pain, 9 of 11 studies showed reductions in pain intensity.12 
There have been few comparisons of MBSR to an active control. One non-
randomized pilot study (n=50) compared MBSR to CBT and found a larger effect 
size  in  favor  of  MBSR  (d=0.87).16 Another  non-randomized  study  (n=58) 
compared MBSR to a social support group and found medium effects in favor of 
MBSR for sensory/affective pain, and large effects (d=1.10) using a pain visual 
analogue scale.17 The findings of prior pilots – subject to the limitations of small 
sample sizes – are generally consistent with the data from our small pilot study 
among GW Veterans (n=55), which showed greater reductions in  pain severity 
after MBSR as compared to usual care (d=0.66).
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One mechanism hypothesized to account for reduced pain is that enhanced 
mindfulness leads to ‘uncoupling’ of the cognitive and emotional elements from 
the sensory experience of chronic pain, which results in decreased distress and 
suffering18; it has been proposed that the affective component of pain can be 
distinguished  from  pain  intensity,  and  that  the  affective  component  can  be 
differentially targeted19. Data from both correlational and experimental studies 
performed in chronic pain populations suggest that enhanced mindfulness is 
associated with reduced pain intensity ratings.12,20,21 Studies of healthy volunteers 
also support reduced pain intensity associated with MBIs. One study found that 
three days of mindfulness meditation training led to reduced pain intensity ratings 
following  electrical  stimuli22 and  another  study  showed  that  three  days  of 
mindfulness training was superior to guided imagery in increasing pain tolerance 
to the cold pressor test.22 Other research has found that anxiety decreases pain 
threshold and lowers pain tolerance.23 Thus, interventions that reduce anxiety 
would be expected to lead to reductions in pain severity.
For fatigue, a meta-analysis of MBIs  found that participation in an MBI led to 
improvement in symptoms for somatoform disorders (a categorization similar to 
CMI), including both fatigue and pain.13 For chronic fatigue syndrome, there is 
initial  evidence  that  MBIs  result  in  clinical  improvement.21 In  three  small 
exploratory studies of an MBI for chronic fatigue syndrome, large effect sizes 
were reported in a small RCT in comparison to a waitlist (d=0.93) as well as in 
pre-post designs (d=0.84, d=1.6),21  which are consistent with our pilot work. 
Reappraisal of thoughts and feelings that contribute to fatigue, as taught in MBIs, 
is theorized to lead to cognitive and behavioral changes that lessen fatigue. 21
CMI can also include decrements in concentration, memory, and mood. There 
is evidence of a negative correlation between measures of mindfulness and 
cognitive failures24-26 which is consistent with our pilot work. Lapses in attention 
and memory are associated with cognitive failures in daily life, and enhanced 
mindfulness, which involves consciously paying more thorough attention to what 
is at hand, may lead to a reduction in these common errors and mishaps.26 
Additionally, mood disturbances often occur in CMI,27 and multiple prior studies of 
MBIs28 indicate improvement in depressive symptoms.
(A more thorough review of the evidence supporting this research is provided 
in the study grant, which is included in the application packet.)
We will not be including any vulnerable populations in our research, except 
for pregnant women. There is no scientifically supported or theoretical reason to 
believe  that  participation  in  the  MBSR  or  CDSMP  group,  or  other  study 
procedures, would pose special risk to a pregnant woman or her fetus.  Given the 
reasons that are supported for believing participation in either of these groups 
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could provide benefit to a pregnant woman, we will not exclude this population 
(although we are not targeting them specifically with any recruitment materials).
3.0
Objectives
The  purpose  of  this  study  is  to  determine  whether  there  is  clinical 
evidence  to  support  the  use  of  Mindfulness-Based  Stress  Reduction  as  a 
treatment for Veterans with Chronic Multi-Symptom Illness: pain, fatigue, and 
cognitive or mood disturbances. 
Hypothesis One (re: outcomes): Participants randomized to CDSMP will 
derive  benefit  for  the  primary  outcomes,  but  with  smaller  effects  than  the 
participants randomized to MBSR. We hypothesize that Veterans randomized to 
MBSR will report significantly greater reduction in each of the three primary 
outcome measures (pain, fatigue and cognitive failures) at 6-month follow-up as 
compared to aCDSMP.
Hypothesis  Two  (re:  acceptability):  MBSR  will  be  an  acceptable  and 
satisfactory program for Veterans with CMI, as indicated by attendance rates, a 
self-report measure of satisfaction, and qualitative interviews. We hypothesize 
that Veterans with CMI randomized to MBSR will report greater satisfaction with 
care than their peers randomized to CDSMP.
4.0
Resources and Personnel
The study procedures will take place at VA Puget Sound, Seattle Division, 
executed by the GROW study team:
Tracy Simpson, PhD (Principal Investigator): Dr. Simpson will have overall 
responsibility for the conduct and performance of the study. She will take the lead 
on recruitment, as well as the organization, quality control and oversight of the 
MBSR courses. She will have primary responsibility for supervision of the project 
manager and research assistant, and will also be responsible for human subjects 
regulatory requirements. She will oversee all aspects of data collection, data 
quality control, and she will take the lead on manuscript preparation. Dr. Simpson 
will have access to PHI, and she can obtain informed consent if the Project 
Manager and Research Coordinator are not available to do so.
Tiffanie Fennell, PhD (Co-investigator): Dr. Fennell will be responsible for 
troubleshooting any issues with the CDSMP classes or group leaders. She will 
also train the CDSMP group leaders to administer the three additional sessions 
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(designed  to  make  CDSMP  the  same  duration  as  MBSR).  Dr.  Fennell  will 
participate in all manuscript preparation. Dr. Fennell will have access to PHI.
George  Sayre,  PsyD:  Dr.  Sayre  will  provide  expertise  on  qualitative 
methods,  developing  the  interview  protocol,  conducting  qualitative  survey 
questions,  and  analysis  of  qualitative  data.  He  has  successfully  provided 
qualitative research expertise for multiple VA funded qualitative research projects 
including MBSR. Dr. Sayre will oversee the qualitative methodology in the study 
procedures. Dr. Sayre will have access to the qualitative data.
Carol  Malte,  MSW:  Ms.  Malte  will  assist  the  study  coordinator  in 
organizing  and  managing  the  study  dataset,  and  will  serve  as  the  Senior 
Biostatistician for this project, providing consultation and advice to the primary 
investigators.
Meghan Storms, MSW (Project Manager): Ms. Storms will be the Project 
Manager, and will work closely with the principal investigator (Dr. Simpson) to 
provide day to day oversight of the study activities as well as supervision of the 
research  assistant.  The  project  manager  will  help  to  create  the  study 
management database as well as the randomization protocol. She will monitor 
the day to day activities of the clinical trial, including tracking the progress at all 
sites and troubleshooting any issues that arise. The project manager will conduct 
randomization.  The  project  manager  will  also  conduct  the  semi-structured 
qualitative  interviews,  as  well  as  have  shared  responsibility  for  performing 
activities at the Seattle VA related to the activities of a research coordinator (e.g. 
recruitment of potential participants; conducting initial phone screens and major 
assessments; assisting with monitoring compliance and follow-up on missed 
appointments. The Project Manager will perform basic statistical analyses as the 
study proceeds to assist the principal investigators and the statisticians, and may 
assist in manuscript preparation. The Project Manager will have access to PHI 
and obtain informed consent.
A Data Safety Monitoring Board has been appointed by VA HSR&D. The 
PI and study team will submit period reports to the centralized Data Safety 
Monitoring Board. The Data Safety Monitoring Board will review the reasons for 
study  termination  for  any  participant  who  discontinues  the  study  before 
completion, and any adverse events that take place. 
Ashley  Morris  (2017-2019),  Kimberly  Moore  (2019-current)  (Research 
Coordinator): The Research Coordinator will work closely with the investigators 
and administer the study assessments, under supervision of the Project Manager 
and PI. The study coordinator will also perform initial telephone screens and 
assist in recruitment and scheduling. She will organize study materials and files, 
carry out data management and cleaning in consultation with Dr. Simpson and 
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the co-investigators. The Research Coordinator will have access to PHI and 
obtain informed consent.
Contracted Services & Team Members
The following individuals may be contracted to serve as MBSR Teachers for 
participants randomly assigned to MBSR; only two are needed for each MBSR 
group cohort:
-
Carolyn McManus, PT, MA, MS
-
Jonas Batt, MA, LMHC
-
Kurt Hoelting, M.Div
-
Lisa Hardmeyer Gray
-
Diane Hetrick, PT
The following individuals have committed to lead CDSMP groups for this project. 
-
Melissa Packard
-
Pamela K. Johnson, RNa
5.0
Study Procedures
5.1 Study Design
This study is a randomized controlled trial comparing Mindfulness-Based Stress 
Reduction  (MBSR)  with  an  active  control,  augmented  Chronic  Disease  Self-
Management  Program  (aCDSMP),  to  assess  the  efficacy  of  MBSR  for  Gulf  War 
Veterans with Chronic Multi-symptom Illness (CMI). GW Veterans (n=154) with CMI will 
be randomized to either 8 weeks of MBSR (n=77) or aCDSMP (n=77). All participants 
will complete assessments at baseline, immediately post-treatment, as well as at 3-
months  and  6-months  post-treatment.  They  will  also  complete  a  short  Midpoint 
assessment halfway through the class series. 
Brief  semi-structured  interviews  will  also  be  included  in  the  MBSR/CDSMP 
assessments of the Gulf War veterans at the post-test time to collect data for qualitative 
analysis.  The  qualitative  analysis  will  be  conducted  to  develop  a  more  complete 
understanding of the acceptability and satisfaction with MBSR and aCDSMP by GW 
Veterans. These interviews will be conducted on a subset of GW Veterans who either 
complete or fail to complete (attend fewer than 4 class sessions) for both MBSR and 
CDSMP. For Veterans who discontinue treatment, interviews will be conducted within 
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two weeks of discontinuation. Interviewers will be provided interview training specific to 
this study methods by Dr. Sayre. Data will be catalogued using Atlas.ti software system 
where upon the data cleaning and quality assurance process will be conducted to 
assure creditability and trustworthiness. Dr. Sayre will conduct a comparison of the 
notes,  taped  interviews  and  transcripts  to  assess  the  following:  interview  protocol 
adherence, creditability of memos and notes, and detection of leading questions and 
produce  a  quality  assurance  report  that  will  be  presented  to  the  research  team 
members.
A comprehensive outline of the various data collection tools/measured to be 
administered  at  each  of  the  four  assessments  is  provided  in  Section  5.5  Study 
Evaluations. 
The active control, aCDSMP, will account for the non-specific elements of MBSR 
(e.g. group support, positive expectancy). The standard CDSMP program is a group-
based  6  session,  2.5  hour  per  session  program.  For  this  study,  we  added  three 
sessions after the completion of standard CDSMP so that each intervention will be of 
identical duration and structure. Fidelity coding from audiotapes will evaluate protocol 
adherence for both MBSR and CDSMP. Similar to MBSR, CDSMP is taught by trained, 
experienced  facilitators  who  believe  in  the  benefit  of  the  program;  allegiance  of 
researchers or therapists has been shown to be a predictor of treatment outcomes.
Risk and Benefit: The risks for this study involve the potential for psychological 
distress associated with collection of self-report data and the qualitative interview, and 
the possibility that undergoing either the MBSR class or CDSMP could be stressful and 
worsen  symptoms.  Further,  there  is  a  risk  that  MBSR  and  CDSMP  will  not  be 
efficacious for some individuals. We plan to educate patients about the possible risks 
and  benefits  prior  to  study  enrollment  by  providing  a  thorough  orientation  to  the 
research  and  an  overview  of  each  intervention  prior  to  giving  informed  consent. 
Potential benefits for those randomized to either condition may take the form of reduced 
CMI symptoms, and increased health-related quality of life. Veterans’ families may also 
benefit as a result of the shift in emotional state. However, a participant may not benefit 
directly from participation in the study. Information gained in the study may be of benefit 
in the future to persons with CMI.  Specific measures for minimizing risk are outlined 
below.
Procedures to Minimize Risk to Subjects and Protect Confidentiality:
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1) Group sessions will include reminders to patients that they can choose what they 
will and will not do, and that it can be flexible in meeting an individual’s needs 
(e.g. in MBSR a patient may meditate with eyes open, choose not to lie down, 
shorten the meditation time, choose not to practice some of the yoga postures, 
etc., while in aCDSMP a patient may choose to share more or less of their 
personal material with the group, etc.)
2) If a research subject experiences distress or worsening of his/her condition, we 
will  consult  the  individual’s  primary  provider  for  assistance.  If  the  condition 
involves  a  psychiatric  emergency,  we  will  utilize  the  psychiatric  emergency 
services available in order to help stabilize the Veteran’s condition. If needed, the 
Veteran can be admitted to a psychiatric inpatient unit for further care. The 
Veteran will not bear any additional costs for care.
3) Any decision to withdraw from the protocol due to suicidality, depression, anxiety 
or increased PTSD symptoms will be made on a case by case basis, with input 
from the Veteran and his/her mental health provider. If there is clear evidence of 
decompensation  or functional  regression  that is considered likely to  lead  to 
unsafe behavior, the Veteran will be advised that another course of treatment 
could be better for them, and the study staff will assist them in making that 
change.
4) Confidentiality:  We  plan  to maintain  the  confidentiality of patient records as 
described  above  in  the  Source  of  Materials  section.  If  at  any  point  in  the 
recruitment process or during the course of the study, a participate appears to be 
at risk to themselves or others we will initiate a series of harm-prevention steps, 
which will include a licensed psychologist in the State of Washington assessing 
the patient, short term contracts with the participant, calling the Mental Health 
Professional  (Crisis  Line)  to  discuss  the  situation,  as  well  as  informing  our 
Human Subjects committee administrator. If necessary, a referral will be made to 
the appropriate agency. Any serious adverse events will be immediately reported 
to the IRB and the Data Safety Monitor.
5) Since  studies  with  trauma  exposed  populations  have  found  that  some 
participants experience unexpected levels of distress following participation in the 
research, we will take the following steps to minimize this possibility: We will 
state clearly in the consent forms that participation in the research study may 
involve  discussing  details  about  traumatic  events  and  about  symptoms.  In 
addition, at the beginning and end of each of the assessment sessions, we will 
provide participants with time to ask questions. We will inform participants, both 
prior to the initial screening questions on the phone and prior to beginning 
treatment, that some individuals do experience increases in symptoms after 
discussing aspects of the traumatic experience and that if these symptoms do 
not return to their prior levels within a few days, participants are encouraged to 
call the Primary Investigators. We will provide all participants with a study phone 
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number they can use to alert us if they are experiencing distress. The phones will 
be checked daily for messages and distressed participants will be called the 
same day (for calls made during business hours or the next business day for 
after hour calls). Lastly, all participants will be provided with the county crisis 
clinic phone numbers and the VA suicide hotline so that they can reach someone 
immediately should they feel they need immediate assistance. 
6) If  any  point  in  the  study  during  the  assessments  or  treatment  sessions  a 
participant endorses suicidality or homicidality, the group instructor(s) will notify 
the PI (Dr. Simpson), or Dr. Fennell, who will contact the patient. Drs. Simpson 
and Fennell are licensed Clinical Psychologists with extensive experience in 
assessment and treatment of Veterans. Should there be concern about risk of 
harm, a clinical interview will be conducted to assess level of risk and need for 
intervention. Participants who indicate acute suicidality or homicidality including a 
plan will be immediately referred for VA mental health services. It is important to 
note that in more than 7 years of conducting clinical research, we have never had 
a participant unwilling to accept referral for suicidality, and have never had to 
make an involuntary admission or report.
7) All data and other information in this study will be maintained confidentiality, but 
will not be anonymous due to the longitudinal nature of participation. Detailed 
contact information as well as responses to study questionnaires will be collected 
at all assessments. Due to the sensitive nature of the study, i.e., the assessment 
of PTSD, depression, alcohol, and substance use, several steps will be in place 
for data collection and storage to protect participant confidentiality. First, a unique 
ID  code  (PIN)  is  given  to  each  participant,  serving  to  link their information 
together in the on-line database. No names or identifying information will ever be 
stored in the on-line database or data files that will later be used for statistical 
analyses. All information transferred between client and server machines will be 
secured  in  a  restricted  VA  network  folder.  We  have  previously  used  these 
procedures to conduct web-based assessment of sensitive and illegal behaviors.
8) Participants' names, addresses, and phone numbers will be accessible to project 
staff in order to engage in telephone contacts and to schedule study visits with 
participants. However, these data will be kept separate from actual study data 
and from study ID codes. These data will not be shared with individuals who are 
not directly involved in the study. All participant data will be coded in a way that 
does not contain any participant identifiers. The data safety and monitoring plan 
is described below.
9) Participants may refuse to be recorded for the assessments without jeopardizing 
their participation in the study. However, due to the group nature of MBSR and of 
aCDSMP, those who are unwilling to be in an MBSR class or CDSMP group that 
is being audiotaped will need to seek other services.
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10)In addition, as per VA regulations, each participant will have their participation in 
the study documented in the Computerized Patient Record System (CPRS; i.e., 
enrollment as well as completion or early termination). No session notes or 
assessment information will be included. Access to VA medical records is strictly 
controlled  and  only  VA  affiliated  individuals  who  have  undergone  extensive 
background checks and have either clinical privileges or clinical research access 
may enter the system 
5.2 Recruitment Methods
The recruitment goal is 308 total, at least half (n=154) of whom will be Gulf War 
Veterans with CMI. The remaining subjects will be non-GW Veterans with CMI. 
In order to provide groups that are the same size as typically offered for both 
MBSR and CDSMP, we plan to form MBSR/aCDSMP groups of up to 18 participants 
per MBSR or aCDSMP group until 30 Veterans per cohort have been recruited (i.e., 30 
Veterans will be recruited per research cohort, and we will randomize participants until 
30 total Veterans per cohort are enrolled or one intervention reaches 18 participants, 
whichever occurs first; these 30 Veterans will be randomized in equal proportion to 
MBSR or aCDSMP). (As of July 2020 groups will be capped at 10 per group, in order to 
meet the recommended class size for remote instruction.)  However, in order to allow us 
to answer additional scientific questions about CMI outcomes among non-GW Veterans, 
and because we think it could be challenging to form cohorts comprised entirely of GW 
Veterans (which would require recruitment of 30 GW Veterans per cohort), we designed 
the study so that only approximately half of each cohort (15 Veterans) will be GW 
Veterans. (10 GW Veterans post July 2020)  The remaining 15 Veterans in each cohort 
will be Veterans who meet all other inclusion / exclusion criteria (including presence of 
CMI) but who were not deployed during the GW.  The non-GW Veterans will complete 
the same study measures at the same points as described for GW Veterans throughout 
this application, but non-GW Veterans are not considered in the power calculations for 
the primary study hypotheses.  We think that this approach provides the ability to 
answer  additional  questions  (described  below)  while  simultaneously  enhancing  the 
feasibility of the study.
The  recruitment  strategy  described  above  affords  several  practical  and 
theoretical advantages, including:  1) it will allow groups of sufficient size (30 Veterans 
per cohort) to be formed more easily, which will assure that there will be enough 
participants in each study cohort to allow the groups to proceed; 2) as part of an 
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exploratory aim, it will allow assessment of outcomes for Veterans with CMI who are not 
GW Veterans, which will provide the opportunity to compare outcomes for GW vs. non-
GW Veterans; 3) if outcomes for non-GW Veterans are shown to be similar to GW 
Veterans, it would support a role for MBSR for Veterans with CMI more generally, and 
4) as part of ancillary analyses, it will provide enhanced statistical power to detect small 
changes in CMI outcomes for the entire population recruited (both GW and non-GW 
Veterans).
The primary mechanism of recruitment of GW Veterans will be letters and a 
pamphlet sent to Veterans with an indicator in the hospital database that their period of 
service was the Persian GW, and who were at least 18 years old in August 1990. We 
also will access the Gulf War Registry to recruit Veterans known to be deployed during 
the Gulf War. The letter will inform veterans that they may receive up to 3 calls from 
study staff members inviting them to participate in the study. If they do not wish to 
receive study contact, they may contact the study coordinator and they will not receive 
any further study contact. The list of potentially eligible Persian GW Veterans will be 
generated using a VistA/fileman query or a VINCI query; this meets the approval of our 
local IRB.  If they respond to the letter, they will be screened by telephone for inclusion 
criteria, which will be confirmed at an in-person baseline visit.  Using this method, in our 
pilot trial of MBSR for GW Illness (see preliminary studies) we successfully recruited 6-8 
GW Veterans per month – a rate higher than the proposed trial.  Over a 1.5 year time 
period we recruited and randomized 55 GW Veterans with CMI; we developed the 
methodology to send letters  midway through this pilot project; upon initiation of this 
method of recruitment, it markedly increased our enrollment rates.  Currently, we are 
applying the same recruitment methodology to a CSR&D trial for Veterans with PTSD, 
which has resulted in recruitment of approximately 2-5 Veterans per week (we have 
about a 4% response rate for letters, and half of those (2% of letters sent) pass a phone 
screen for eligibility).  Extrapolating to this proposal, we would need to send out 7,700 
letters to recruit 154 GW Veterans.  We performed a data pull as preparation for this 
proposal, and found that there are 30,452 unique Veterans with a period of service of 
‘Persian GW’ who received care at VAPSHCS in FY14 and were at least 18 years old at 
the time of GW I (August, 1990). Thus, the recruitment goals are feasible.
We will apply a similar strategy to recruit non-GW Veterans with CMI.  Non-GW 
subjects will be recruited by sending letters to Veterans with an indicator in VistA that 
they have a diagnosis related to 1) a chronic pain condition or 2)  a diagnosis related to 
chronic fatigue.  In a data pull performed as preparation for this proposal, there were 
29,160 unique Veterans who received care at VAPSHCS in FY14 with a diagnosis 
related to pain who could be contacted as potential non-GW Veteran participants.  CMI 
is very common in primary care; we expect that this strategy will easily lead to an 
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adequate number of non-GW Veterans enrollees.  Non-GW participants must meet the 
same criteria for CMI as GW Veterans.
Participants will  paid $40 for baseline, $20 for the midpoint, $40 for the post-
assessment, $45 for 3-month, and $55 for the 6-month follow-ups. In addition, Gulf War 
subjects who complete the qualitative interview at the post-assessment time point will 
be paid $30.  The maximum remuneration is $230 if randomized to MBSR or aCDSMP. 
Subject payment checks will be processed within a week of the assessment to which 
they apply.
5.3 Informed Consent Procedures
We  are  requesting  a  waiver  of  informed  consent  for  recruitment/screening 
purposes only. This will allow us to create recruitment mailing lists that can target the 
most-likely-to-be-eligible populations, and not waste resources and other patients’ time 
advertising the study to patients who won’t be eligible to participate.  
We will obtain informed consent prior to beginning any data collection study 
procedures that will be maintained for analysis. Informed consent will take place at the 
beginning of the appointment that includes the subject’s in-person screening and (if still 
eligible) baseline  assessments.   The  study coordinator,  project  manager,  or other 
approved researcher administering the screening and baseline measures will obtain 
informed consent at this time.  We will not be enrolling anyone with impaired decision 
making ability who requires the use of a legally authorized representative.  
All study personnel will be trained in human subjects protections requirements as 
required by R&D (e.g. Privacy Policy & HIPAA training), and the PI or Project Manager 
will train any other study team members how to appropriately obtain informed consent 
as needed. 
5.4 Inclusion/Exclusion Criteria
Inclusion criteria:  All participants (both GW and non-GW Veterans)  must meet 
criteria for CMI, defined as self-report of at least two of the following 1) fatigue that limits 
usual activity; 2) musculoskeletal pain involving two or more regions of the body; 3) 
cognitive symptoms (memory, concentration, or mood disturbances).13 GW Veterans 
must have been deployed to the GW theater of operations between 8/1990 – 8/1991, 
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have symptoms of CMI that began after 8/1990, lasted at least 6 months, and are 
present at the time of the interview.
Exclusion  criteria: At  baseline,  the  MINI  psychiatric  interview75 will  determine 
psychiatric exclusion criteria: 1) current psychotic disorder; 2) current bipolar affective 
disorder with mania; 3) current suicidal or homicidal ideation.  Additional exclusion 
criteria include a chart diagnosis of borderline or antisocial personality disorder or prior 
formal participation in MBSR or CDSMP.  We will include subjects with the entire range 
of alcohol SUD (defined by the MINI), but exclude those for whom alcohol use poses a 
safety threat (defined as current drinking and a past-year history of alcohol-related 
seizures or delirium tremens).  We will also exclude current DSM-V substance use 
disorder other than cannabis or nicotine, as well as inpatient psychiatric admission 
within the past month. Medication, supportive individual or group counseling, case 
management,  and  self-help  programs  will  be  allowed  and  assessed  as  potential 
covariates. As of July 2020, participants must have the required technology in order to 
participate in VVC intervention groups. 
5.5 Study Evaluations
(B=baseline; M=midway through treatment; P=post-treatment; 3=3-months post-treatment; 6=6-
months post-treatment)
Measure/Data Collection Tool
Assessment
Purpose/Variable that the tool measures
Study Sample Description Data (describes subject population and generalizability of results)
Demographic Information 
B
Sample description, blocking (gender), moderators
Life Events Checklist (LEC)
B
Sample description; trauma history
Deployment Risk and Resilience 
Inventory (DRRI)
B
Wartime exposures 
Rome III – IBS 
B
Sample  description,  to  indicate  prevalence  of 
Irritable Bowel Syndrome in sample
Eligibility Evaluation (inclusion/exclusion criteria)
Chronic Multi-Symptom Illness 
(CMI) Questionnaire
B
Sample description, eligibility evaluation
MINI International 
Neuropsychiatric Interview V-5 
(DSM-V) 
B
Sample  description,  eligibility  evaluation,  SUD 
classification (possible moderator)
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Medical history interview 
(seizures, delirium tremens)
B
Sample description; eligibility evaluation
Tracking
Contact form
B, P, 3, 6
Updating subject contact information; retention
Primary Outcomes
Short Form McGill Pain 
Questionnaire (SF-MPQ-2) total 
score
B, M, P, 3, 6
Pain
General Fatigue subscale of the 
Multidimensional Fatigue 
Inventory (MFI)
B, M, P, 3, 6
General fatigue symptoms
Cognitive Failures Questionnaire 
(CFQ)
B, M, P, 3, 6
Concentration and memory disturbances
Client Satisfaction Questionnaire 
(CSQ-8)
P, 6
Satisfaction with the group (MBSR or aCDSMP) 
Qualitative Interviews
P
Data merging and mixed methods techniques, used 
to  analyze  patient  impressions  of,  and  levels  of 
satisfaction with, MBSR and aCDSMP
Secondary Outcomes
Patient Health Questionnaire 
(PHQ-9) 
B, P, 3, 6
Depressive symptoms
PTSD Checklist – Civilian 
Version (PCL-C)
B, P, 3, 6
Post-traumatic Stress Disorder symptoms
SF-12 (Mental and Physical 
Component Summary Scores)
B, P, 3, 6
Health-related quality of life 
Drug Abuse Screening Test 
(DAST) for drug use other than 
alcohol or tobacco
B, P, 3, 6
Drug use: frequency and severity
NIH Patient Reported Outcome 
Measures Information System 
(PROMIS) for Alcohol Use and 
Negative Consequences, short 
form
B, P, 3, 6
Substance Use Disorder (SUD) symptom severity 
for alcohol
NIH Patient Reported Outcome 
Measures Information System 
(PROMIS) for Gastrointestinal 
B, P, 3, 6
Gastrointestinal Symptoms, including IBS
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Distress
Potential Mediators
Pain Self-Efficacy Questionnaire 
(PSEQ)
B, M, P, 3, 6
Coping Strategies Questionnaire 
(CSQ)
B, M, P, 3, 6
Five-Facet Mindfulness 
Questionnaire (FFMQ-15)
B, M, P, 3, 6
Dispositional  mindfulness,  and  mindfulness 
subscales:  Observing,  Describing,  Acting  with 
Awareness, Nonjudging and Nonreactivity to inner 
experiences 
Self-Compassion Scale (short 
form)
B, M, P, 3, 6
Self-compassion
Experiences questionnaire
B, M, P, 3, 6
Decentering
Potential Moderator (in addition to demographic info)
Credibility/Expectancy 
Questionnaire
M
Participants’ belief in treatment rationale/Treatment 
credibility and positive expectancy
VA Health Care
CPRS review for engagement in 
other treatments since baseline
6
Other  care  received  during  study  as  possible 
moderator
5.6 Data Analysis
We powered the study to detect a between group effect size Cohen’s d ≥ 0.50 for 
each of the primary outcome measures.  An effect size d = 0.5 represents a medium 
effect,  and  a  change  smaller  than  d=0.50  has  been  advocated  as  a  reasonable 
threshold of clinical significance when assessing patient reported outcomes, including 
pain and physical and emotional functioning.8   The literature (see section on MBIs for 
CMI), and our  pilot data (preliminary studies section) suggest medium to large effect 
sizes for CMI, supporting the feasibility of detecting this level of difference.  Although 
effect sizes derived from small samples are inherently unreliable,7 we included effect 
sizes from our pilot work as part of a broader review of the literature on outcomes of 
CMI symptoms after MBIs.  As described above, the ability to detect a medium effect 
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size is supported by evidence of only modest effects in the proposed comparison 
condition.  Overall, we think that powering the study to detect a difference of d=0.50 or 
greater between arms is conservative and clinically relevant.
Assuming a between group effect size of at least d=.50, equal allocation to either 
intervention, a two-sided α = 0.05, and β = 0.20, at least 64 GW Veterans are required 
in each randomization arm.97 To protect against the effects of attrition, we added 20% to 
this final sample size for a recruitment goal of 154 GW Veterans with CMI. This attrition 
estimate is conservative; it is slightly greater than in on our pilot RCTs comparing MBSR 
to TAU.3 The sample size required per arm of the study (at 80% and 90% power) is 
presented across a range of effect sizes (Table 3).97  
Intraclass  correlation  (ICC):   our  pilot  study  of  MBSR  for  GW  Veterans 
(preliminary studies) showed an ICC for primary outcomes of ρ= 0.00 at follow-up. 
Because our data do not indicate significant ICCs for any of the primary outcome 
measures, the proposed analyses do not incorporate ICC results and are not powered 
to account for them.
Qualitative data will be coded (a sort of pre-analysis) continuously as participants 
complete their qualitative interviews; when saturation is reached, and no new codes are 
being generated, the research team will stop conducting the interviews and begin to 
analyze the qualitative data more extensively. The Project Manager and Dr. George 
Sayre will be primarily involved in the qualitative data analysis. 
Quantitative  data  will  be  analyzed  following  the  completion  of  the  final 
assessments of the last subject cohort, which is projected to take place in the last six 
months of Year Four of the study.  The dataset will be analyzed by Carol Malte, in 
consultation with Dr. Zhou.
5.7 Withdrawal of Subjects
If the study subject becomes a threat to the safety of others in his or her 
treatment group, or to the research team, that subject’s participation in the study will be 
withdrawn from the research without their consent. 
If  a  subject  wishes  to  withdraw  from  the  study  before  all  procedures  are 
complete,  he  or  she  simply  needs  to  notify  the  study’s  project  manager,  study 
coordinator, or other study team member by phone or in person that he or she no longer 
wishes to participate, and the subject with be withdrawn fro the study and no longer 
contacted regarding study procedures. A primary study contact number will be provided 
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to  each  participant  so  they  know  how  to  reach  the  study  team  to  request  early 
withdrawal (or for any other questions).
6.0
Reporting
When an unexpected serious adverse event occurs, we will log it in an “Adverse 
Events & Problems” log, to be used for providing reports to the Data Safety Monitoring 
Board (DSMB), in addition to submitting a report to the IRB within 5 days as required. 
All other adverse events, problems, and protocol deviations will be logged and reported 
to the Safety Monitor and the IRB with annual reviews.
Adverse  Events  related  to  worsening  depression  symptoms  will  be  actively 
monitored by tracking PHQ-9 scores. We will define as an AE an increase in PHQ-9 
depression  score  by  2  or  more  severity  categories.  For  example,  if  a  patient 
experiences an increase in depression from moderate to severe, this would be an 
increase in two categories of severity.  The PHQ-9 categorizes depression as none, 
mild, moderate, moderately severe, and severe according to the total score; this has 
been previously validated. At the midpoint of the study, the data monitor would then 
analyze whether significantly greater adverse events occur in one arm of the study, 
which might warrant stopping the study.
7.0
Privacy and Confidentiality
The  study  will  obtain  Protected  Health  Information  by  collecting  data  (e.g. 
medications and other treatment relevant to the symptoms evaluated for the study) from 
the subjects’ CPRS records, as well as contact information (PII) for following up with 
subjects regarding ongoing study procedures.  Health information will also be collected 
through the questionnaires and interviews. This health information will be maintained as 
de-identified study data, and will not be disclosed to unauthorized entities.  We will be 
obtaining a Certificate of Confidentiality for this study, as we ask about substance use.
A password-protected crosswalk will be maintained to link identifying information (full 
names and last 4 SSN) to study subjects’ unique study IDs (e.g. 695-001, 695-002, 695-
003….695-308).  All files containing study data, hard copy or electronic, will include only 
the subject’s study ID so that no data can be linked directly to an individual.  All study 
team members, as VA employees (WOC or otherwise) are required to undergo Privacy 
& HIPAA training as well as VA Privacy and Information Security Awareness and Rules 
of Behavior.  Any non-VA-affiliated study team members will be required to undergo 
equivalent training.  Only study team members will have access to the electronic study 
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folder, located on the R: drive on the VA server. Hard copy data and consent forms will 
be stored in locked filing cabinets in the offices of the PI and/or the Project Manager.
8.0
Communication Plan
N/A, this is not a multi-site research project.
9.0
     Information Security and Privacy
Data pertaining to medication usage and other treatment received during the 
subject’s study enrollment period will be gathered from accessing CPRS and 
recording the information on a hard copy paper, linked to the participant by Study 
ID only, which will be filed in a locked researcher file cabinet (in the office of the 
Project Manager or the PI).  Consent forms and other hard copy documents with 
identifying information (e.g. emergency contact page) will be filed in separate 
hanging folders from any documents with study IDs and study data on them, so 
that the identifying information cannot be linked to the corresponding data. 
Data  from self-report measures will  be  collected  through  an  MS Access 
database. The administering researcher will open the database from the study 
folder on a VA computer, and then the participants will fill out the questionnaires. 
Each set of questionnaires will be linked to subjects through their study IDs or 
other unique identifiers (no PII recorded in the MS Access database), and these 
identifiers will be recorded and tracked by the study team.  When needed, a 
report or query of these outcome/response data from these questionnaires will be 
generated from MS Access and saved to the study folder.
Audio files from the qualitative interviews will be available to certified medical 
transcriptionists  through  secure  VA  folders;  all  transcriptionists  are  VA 
employees.   Additionally, the interviewer does not use the name of the subject 
during the interviews to help maintain confidentiality. 
Participants  in  VVC  interventions  will  be  notified  about  the  limits  to 
confidentiality inherent in an internet delivered group format at the time of their 
consenting. 
10.0 References
1. Gulf War and Health, Volume 4: Health Effects of Serving in the Gulf War. 
Washington, DC: National Academies press, 2006.
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2. IOM (Institute of medicine). Gulf War and Health, Volume 8: Update of Health 
Effects of Serving in the Gulf War. Washington, DC: The National Academies 
Press, 2010.
3. Li B, Mahan CM, Kang HK, et al. Longitudinal health study of US 1991 Gulf War 
veterans: changes in health status at 10-year follow-up. American Journal of 
Epidemiology 2011: kwr154.
4. Hunt SC, Richardson RD, Engel CC. Clinical management of Gulf War veterans 
with  medically  unexplained  physically  symptoms.  Military  Medicine  2002; 
167:414-420.
5. Engel  CC, Roy M, Kayanan D, et al.  Multisciplinary treatment of persistent 
symptoms after Gulf War service. Military Medicine 1998; 163:202-208.
6. Donta ST, Clauw DJ, Engel CC, Jr, et al. Cognitive Behavioral Therapy and 
Aerobic Exercise for Gulf War Veterans’ Illnesses: A Randomized Controlled 
Trial. JAMA 2003;289:1396-1404.
7. Institute of Medicine. Gulf War and Health, Volume 9. Treatment for Chronic 
Multisymptom Illness. Washington, DC, 2013.
8. Siegel DJ. The Mindful Brain: Reflection and attunement in the cultivation of well-
being. New York, NY: W.W. Norton & Company, Inc., 2007.
9. Baer  RA.  Mindfulness  training  as  a  clinical  intervention:  A  conceptual  and 
empirical review. Clinical Psychology: Science and Practice 2003; 10:125-143.
10.Chiesa A, Serretti A. Mindfulness-based stress reduction for stress management 
in healthy people: a review and meta-analysis. The journal of alternative and 
complementary medicine 2009; 15:593-600.
11.Grossman P, Niemann L, Schmidt S, et al. Mindfulness-based stress reduction 
and health benefits—A meta-analysis. Journal of Psychosomatic Research 2004; 
57:35-43.
12.Reiner K, Tibi L, Lipsitz JD. Do mindfulness-based interventions reduce pain 
intensity? A critical review of the literature. Pain Medicine 2013; 14:230-242.
13.Lakhan  SE,  Schoefield  KL. Mindfulness-based  therapies in the  treatment of 
somatization disorders: a systematic review and meta-analysis. PloS one 2013; 
8e71834.
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14.Veehof MM, Oskam M-J, Schreurs KM, et al. Acceptance-based interventions for 
the treatment of chronic pain: a systematic review and meta-analysis. Pain 2011; 
152:533-542.
15.Kabat-Zinn J, Lipworth L, Burney R, et al. Four-year follow-up of a meditation-
based program for the self-regulation of chronic pain: Treatment outcomes and 
compliance. The Clinical Journal of Pain 1987; 2:159-173.
16.Smith BW, Shelley BM, Dalen J, et al. A pilot study comparing the effects of 
mindfulness-based  and  cognitive-behavioral  stress  reduction. The  Journal  of 
Alternative and Complementary Medicine 2008; 14:251-258.
17.Grossman P, Tiefanthaler-Gilmer U, Raysz A, et al. Mindfulness training as an 
intervention for fibromyalgia: Evidence of postintervention and 3-year follow-up 
benefits in well-being. Psychotherapy and Psychosomatics 2007; 76:226-233.
18.Kabat-Zinn J. An outpatient program in behavioral medicine for chronic pain 
patients  based  on  the  practice  of  mindfulness  meditation:  Theoretical 
considerations and preliminary results. General Hospital psychiatry 1982; 4:33-
47.
19.Dworkin RH, Turk DC, Farrar JT, et al. Core outcome measures for chronic pain 
clinical trials: IMMPACT recommendations. Pain 2005;113:9-19.
20.Carmody J, Baer RA. Relationships between mindfulness practice and levels of 
mindfulness,  medical  and  psychological  al  symptoms  and  well-being  in  a 
mindfulness based stress reduction program. Journal of Behavioral Medicine 
2008; 31:23-33.
21.Surawy C, Roberts J, Silver A. The effect of mindfulness training on mood and 
measures of fatigue, activity, and quality of life in patients with chronic fatigue 
syndrome on a hospital waiting list: A series of exploratory studies. Behavioural 
and Cognitive Psychotherapy 2005; 33:103-109.
22.Zeidan  F,  Gordon  NS,  Merchant  J,  et  al.  The  effects  of  brief  mindfulness 
meditation training on experimentally induced pain. Journal of Pain 2010; 11:199-
209.
23.Dersh J, Polatin PB, Gatchel RJ. Chronic pain and psychopathology: Research 
findings and theoretical considerations. Psychosom Med 2002; 64:773-86.
24.Lau  MA,  Bishop  SR,  Segal  ZV,  et  al.  The  Toronto  mindfulness  scale: 
Development and validation. Journal of Clinical Psychology 2006; 62:1445-1467.
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25.Cheyne JA, Carriere JS, Smilek D. Absent-mindedness: Lapses of conscious 
awareness and everyday cognitive failures. Consciousness and cognition 2006; 
15:578-592.
26.Herndon F. Testing mindfulness with perceptual and cognitive factors: External 
vs. internal encoding, and the cognitive failures questionnaire. Personality and 
Individual Diffrences 2008; 44:32-41.
27.The Iowa Persian Gulf Study Group. Self-reported Illness and Health Status 
Among Gulf War Veterans: A population-based study. JAMA 1997;277:238-245.
28.Hoffman SG, Sawyer AT, Witt AA, et al. The effect of mindfulness-based therapy 
on anxiety and depression: A meta-analytic review. Journal of Consulting and 
Clinical Psychology 2010; 78:169-183.
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