Groups for Regaining Our Wellbeing

Study Overview
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Brief Summary
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This study is a randomized clinical trial measuring outcomes up to 6-months post-intervention. The objective of this study is to evaluate outcomes of two different group interventions for Veterans with Chronic Multisymptom Illness (CMI). The interventions to be compared are Mindfulness-Based Stress Reduction and an adapted version of the Chronic Disease Self-Management Program (aCDSMP) for Veterans experiencing symptoms of Chronic Multi-Symptom Illness (CMI) - musculoskeletal pain, fatigue, and cognitive failures - especially those who were deployed to Gulf War I. Hypothesis One (re: Outcomes): Participants randomized to the adapted Chronic Disease Self-Management Program (aCDSMP) will derive benefit for the primary outcomes, but with smaller effects than the participants randomized to Mindfulness-Based Stress Reduction (MBSR). The investigators hypothesize that Veterans randomized to MBSR will report greater reductions 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 measured by attendance rates, a self-report measure of satisfaction, and qualitative interviews. The investigators hypothesize that Veterans with CMI randomized to MBSR will report greater satisfaction with care than their peers randomized to aCDSMP.

Detailed Description
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The investigators will enroll 308 participants. Half of these will be Gulf War Veterans who meet criteria for CMI, and the other half will be Veterans from other periods of service who also meet criteria for CMI. Each participant will be randomized to either participate in MBSR or aCDSMP (stratified by Gulf War deployment status so there are  7-8 Gulf War Veterans in each group for every cohort). Measures to collect primary outcome data (pain, fatigue, cognitive failures, patient satisfaction), secondary outcomes, and potential mediators will be administered at four assessments: (1) Baseline; (2) Post-Intervention; (3) at 3-months after the group ended; and (4) at 6-months after the group ended. Sample demographic data (age, gender, race, income, education, etc.) will be collected at baseline only. All study procedures will take place at VA Puget Sound Health Care System in Seattle, WA.

Official Title
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Evaluation of a Mindfulness-Based Intervention for Gulf War Illness

Conditions
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Gulf War, Fatigue, Pain, Depression

Intervention / Treatment
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* Behavioral: Mindfulness-Based Stress Reduction
* Behavioral: Chronic Disease Self-Management Program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Self-report all the criteria for Chronic Multi-Symptom Illness Fluent in English and able to provide informed consent Exclusion Criteria: Currently drinking with past-year history of alcohol-related seizures or delirium tremens Current DMS-V substance use disorder other than cannabis or nicotine Moderate or high risk of suicide as assessed with MINI Current psychotic disorder Current manic episode Diagnosis of borderline personality disorder or antisocial personality disorder Inpatient admittance for psychiatric reasons in the past month Prior participation in MBSR or CDSMP (attended at least one session)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness-Based Stress Reduction<br>An 8-week standardized group program to teach mindfulness skills. In MBSR, participants meet for 2.5 hours per week for 8 weeks in a group format. Participants receive instruction in mindfulness meditation according to a standardized curriculum and have the opportunity to ask questions. | Behavioral: Mindfulness-Based Stress Reduction<br>* An 8-week standardized group program to teach mindfulness skills. In MBSR, participants meet for 2.5 hours per week for 8 weeks in a group format. Participants receive instruction in mindfulness meditation according to a standardized curriculum and have the opportunity to ask questions.<br>* Other names: MBSR;|
| Active Comparator: Chronic Disease Self-Management Program<br>The CDSMP is a structured program to teach self-management skills based on self-efficacy theory. CDSMP teaches self-management strategies and attempts to modify illness beliefs, enhance self-management capabilities and reinforce successful management strategies. CDSMP is based on self-efficacy theory, which posits that key determinants of behavior are: 1). self-efficacy (confidence in the ability to carry out an action) and 2). outcome expectancy (expectation that a particular goal will be achieved). | Behavioral: Chronic Disease Self-Management Program<br>* The CDSMP is a structured program to teach self-management skills based on self-efficacy theory. CDSMP teaches self-management strategies and attempts to modify illness beliefs, enhance self-management capabilities and reinforce successful management strategies. CDSMP is based on self-efficacy theory, which posits that key determinants of behavior are: 1). self-efficacy (confidence in the ability to carry out an action) and 2). outcome expectancy (expectation that a particular goal will be achieved).<br>* Other names: CDSMP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short Form McGill Pain Questionnaire (SF-MPQ-2) total score | A validated measure of pain | Change from baseline to 6 months after completing the intervention | 
| General Fatigue subscale of the Multidimensional Fatigue Inventory (MFI) | A measure of general fatigue symptoms | Change from baseline to 6 months after completing the intervention | 
| Cognitive Failures Questionnaire (CFQ) | A measure of concentration and memory disturbances | Change from baseline to 6 months after completing the intervention | 
| Client Satisfaction Questionnaire (CSQ-8) | A measure of satisfaction with the interventions | Change from baseline to 6 months after completing the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Health Questionnaire (PHQ-9) | A measure of depression | Change from baseline to 6 months after completing the intervention | 
| PTSD Checklist - Civilian Version (PCL-C) | A measure of PTSD | Change from baseline to 6 months after completing the intervention | 
| SF-36 (Mental and Physical Component Summary Scores) | A measure of functional status and wellbeing | Change from baseline to 6 months after completing the intervention | 
| NIH Patient Reported Outcome Measures Information System (PROMIS) for Alcohol Use and Negative Consequences, short form | Substance Use Disorder (SUD) symptom severity for alcohol | Change from baseline to 6 months after completing the intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain management, fatigue, mindfulness, Gulf War