Clinical trial NCT03058952: Groups for Regaining Our Wellbeing
Official title: Evaluation of a Mindfulness-Based Intervention for Gulf War Illness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gulf War
Fatigue
Pain
Depression
Keywords: pain management
fatigue
mindfulness
Gulf War
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2017-02-23
Enrollment: 245
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Short Form McGill Pain Questionnaire (SF-MPQ-2) Total Score
timeFrame: Change from baseline to 6 months after completing the intervention
measure: General Fatigue Subscale of the Multidimensional Fatigue Inventory (MFI)
timeFrame: Change from baseline to 6 months after completing the intervention
measure: Cognitive Failures Questionnaire (CFQ)
timeFrame: Change from baseline to 6 months after completing the intervention
measure: Client Satisfaction Questionnaire (CSQ-8)
timeFrame: report at post-intervention assessment, 3-4 months after baseline
Secondary outcomes:
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Change from baseline to 6 months after completing the intervention
measure: PTSD Checklist - Civilian Version (PCL-C)
timeFrame: Change from baseline to 6 months after completing the intervention
measure: SF-12, Standard (Mental and Physical Component Summary Scores)
timeFrame: Change from baseline to 6 months after completing the intervention
measure: NIH Patient Reported Outcome Measures Information System (PROMIS) for Alcohol Negative Consequences, Short Form
timeFrame: Change from baseline to 6 months after completing the intervention
Other outcomes:
Locations:
city: Seattle
country: United States
facility: VA Puget Sound Health Care System Seattle Division, Seattle, WA
state: Washington
Study officials:
affiliation: VA Puget Sound Health Care System Seattle Division, Seattle, WA
name: Tracy L Simpson, PhD
role: PRINCIPAL_INVESTIGATOR
References: