Groups for Regaining Our Wellbeing

Not Applicable

Completed

Interventions: Behavioral: Mindfulness-Based Stress Reduction
Behavioral: Chronic Disease Self-Management Program

Brief Summary: 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: 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.

Recruitment & Eligibility

Inclusion Criteria

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)

Arm && Interventions

Group	Intervention	Description
Mindfulness-Based Stress Reduction	Mindfulness-Based Stress Reduction	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.
Chronic Disease Self-Management Program	Chronic Disease Self-Management Program	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).

Primary Outcome Measures

Name	Time	Method
Short Form McGill Pain Questionnaire (SF-MPQ-2) Total Score	Change from baseline to 6 months after completing the intervention	A validated measure of pain, minimum value: 0, maximum value: 222, higher scores indicate worse outcomes.
General Fatigue Subscale of the Multidimensional Fatigue Inventory (MFI)	Change from baseline to 6 months after completing the intervention	A measure of general fatigue symptoms. Minimum value: 0, maximum value: 80, higher scores indicate worse outcomes.
Cognitive Failures Questionnaire (CFQ)	Change from baseline to 6 months after completing the intervention	A measure of concentration and memory disturbances. Minimum value: 0, maximum value: 100, higher scores indicate worse outcomes.
Client Satisfaction Questionnaire (CSQ-8)	report at post-intervention assessment, 3-4 months after baseline	A measure of satisfaction with the interventions. Minimum value: 8, maximum value: 32, higher scores indicate higher satisfaction.

Secondary Outcome Measures

Name	Time	Method
PTSD Checklist - Civilian Version (PCL-C)	Change from baseline to 6 months after completing the intervention	A measure of PTSD. Minimum value: 0, maximum value: 80. Higher score indicates worse outcome.
Patient Health Questionnaire (PHQ-9)	Change from baseline to 6 months after completing the intervention	A measure of depression. Minimum value: 0, maximum value: 27, higher scores indicate worse outcomes.
NIH Patient Reported Outcome Measures Information System (PROMIS) for Alcohol Negative Consequences, Short Form	Change from baseline to 6 months after completing the intervention	Substance Use Disorder (SUD) symptom severity for alcohol. Minimum score: 0, maximum score: 35. Higher scores indicate worse outcomes.
SF-12, Standard (Mental and Physical Component Summary Scores)	Change from baseline to 6 months after completing the intervention	A measure of functional status and wellbeing. Two scores generated: a mental component score (MCS) and a physical component score (PCS). For each measure: minimum value: 0, maximum value: 100. Lower score indicates worse outcome.

Locations (1): VA Puget Sound Health Care System Seattle Division, Seattle, WA
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Seattle, Washington, United States