Groups for Regaining Our Wellbeing (GROW)

VA Office of Research and Development

Status: Completed

Conditions: Depression; Fatigue; Pain; Gulf War

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

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT03058952

SDR 15-197

Details and patient eligibility

About

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.

Full 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.

Enrollment: 245 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

245 participants in 2 patient groups

Mindfulness-Based Stress Reduction

Experimental group

Description:

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.

Treatment:

Behavioral: Mindfulness-Based Stress Reduction

Chronic Disease Self-Management Program

Active Comparator group

Description:

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).

Treatment:

Behavioral: Chronic Disease Self-Management Program