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Completed

NCT Number: NCT03058952

Groups for Regaining Our Wellbeing

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.

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Key information

Conditions

Gulf War Agnosia Behavior Behavioral Symptoms Depression Fatigue Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Seattle, Washington, 98108, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Mindfulness-Based Stress Reduction

Behavioral

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

Chronic Disease Self-Management Program

Behavioral

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

Primary outcomes

  1. Short Form McGill Pain Questionnaire (SF-MPQ-2) Total Score

    Time frame: 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.

  2. General Fatigue Subscale of the Multidimensional Fatigue Inventory (MFI)

    Time frame: 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.

  3. Cognitive Failures Questionnaire (CFQ)

    Time frame: 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.

  4. Client Satisfaction Questionnaire (CSQ-8)

    Time frame: 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 outcomes

  1. Patient Health Questionnaire (PHQ-9)

    Time frame: 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.

  2. PTSD Checklist - Civilian Version (PCL-C)

    Time frame: 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.

  3. SF-12, Standard (Mental and Physical Component Summary Scores)

    Time frame: 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.

  4. NIH Patient Reported Outcome Measures Information System (PROMIS) for Alcohol Negative Consequences, Short Form

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

Evaluation of a Mindfulness-Based Intervention for Gulf War Illness

Acronym: GROW

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Feb 23, 2017
Registry last updated
Jun 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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