N/A
N=245
Groups for Regaining Our Wellbeing
Gulf War · Fatigue · Pain · Depression
Bottom Line
View on ClinicalTrials.gov: NCT03058952 ↗Enrolled (actual)
245
Serious AEs
0.0%
Results posted
Jun 2024
Primary outcome: Primary: Short Form McGill Pain Questionnaire (SF-MPQ-2) Total Score — 69.2; 64.9; 62.3; 55.5 score on scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Mindfulness-Based Stress Reduction (Behavioral); Chronic Disease Self-Management Program (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Mar 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Short Form McGill Pain Questionnaire (SF-MPQ-2) Total Score |
69.2; 64.9; 62.3; 55.5 | — |
| PRIMARY General Fatigue Subscale of the Multidimensional Fatigue Inventory (MFI) |
15.1; 14.8; 14.2; 13.6 | — |
| PRIMARY Cognitive Failures Questionnaire (CFQ) |
47.0; 49.5; 43.5; 43.5 | — |
| PRIMARY Client Satisfaction Questionnaire (CSQ-8) |
25.7; 26.1 | — |
| SECONDARY Patient Health Questionnaire (PHQ-9) |
9.8; 9.7; 7.8; 7.1 | — |
| SECONDARY PTSD Checklist - Civilian Version (PCL-C) |
31.7; 31.3; 28.8; 30.3 | — |
| SECONDARY SF-12, Standard (Mental and Physical Component Summary Scores) |
40.3; 42.3; 43.5; 44.2; 24.7; 23.4 | — |
| SECONDARY NIH Patient Reported Outcome Measures Information System (PROMIS) for Alcohol Negative Consequences, Short Form |
4.1; 4.5; 4.7; 5.2 | — |
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.
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)
Data sourced from ClinicalTrials.gov (NCT03058952). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.