Groups for Regaining Our Wellbeing
| Status: | Recruiting |
|---|---|
| Conditions: | Chronic Pain, Depression, Other Indications |
| Therapuetic Areas: | Musculoskeletal, Psychiatry / Psychology, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/30/2019 |
| Start Date: | July 3, 2017 |
| End Date: | April 30, 2021 |
| Contact: | David J Kearney, MD |
| Email: | david.kearney@va.gov |
| Phone: | (206) 277-1445 |
Evaluation of a Mindfulness-Based Intervention for Gulf War Illness
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.
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.
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.
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.
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)
We found this trial at
1
site
Seattle, Washington 98108
Principal Investigator: David J. Kearney, MD
Phone: 206-277-1445
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