GROW: Groups for Regaining Our Wellbeing

Sponsor
VA Office of Research and Development (U.S. Fed)
Overall Status
Completed
CT.gov ID
NCT03058952
Collaborator
(none)
245
1
2
58.9
4.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Mindfulness-Based Stress Reduction
  • Behavioral: Chronic Disease Self-Management Program
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
245 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Evaluation of a Mindfulness-Based Intervention for Gulf War Illness
Actual Study Start Date :
Jul 3, 2017
Actual Primary Completion Date :
Mar 31, 2022
Actual Study Completion Date :
May 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Behavioral: 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.
Other Names:
  • MBSR
  • Active Comparator: 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).

    Behavioral: 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).
    Other Names:
  • CDSMP
  • Outcome Measures

    Primary Outcome Measures

    1. 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

    2. 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

    3. Cognitive Failures Questionnaire (CFQ) [Change from baseline to 6 months after completing the intervention]

      A measure of concentration and memory disturbances

    4. Client Satisfaction Questionnaire (CSQ-8) [Change from baseline to 6 months after completing the intervention]

      A measure of satisfaction with the interventions

    Secondary Outcome Measures

    1. Patient Health Questionnaire (PHQ-9) [Change from baseline to 6 months after completing the intervention]

      A measure of depression

    2. PTSD Checklist - Civilian Version (PCL-C) [Change from baseline to 6 months after completing the intervention]

      A measure of PTSD

    3. SF-36 (Mental and Physical Component Summary Scores) [Change from baseline to 6 months after completing the intervention]

      A measure of functional status and wellbeing

    4. NIH Patient Reported Outcome Measures Information System (PROMIS) for Alcohol Use and Negative Consequences, short form [Change from baseline to 6 months after completing the intervention]

      Substance Use Disorder (SUD) symptom severity for alcohol

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 VA Puget Sound Health Care System Seattle Division, Seattle, WA Seattle Washington United States 98108

    Sponsors and Collaborators

    • VA Office of Research and Development

    Investigators

    • Principal Investigator: Tracy L Simpson, PhD, VA Puget Sound Health Care System Seattle Division, Seattle, WA

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    VA Office of Research and Development
    ClinicalTrials.gov Identifier:
    NCT03058952
    Other Study ID Numbers:
    • SDR 15-197
    First Posted:
    Feb 23, 2017
    Last Update Posted:
    Jul 20, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by VA Office of Research and Development
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 20, 2022