Evaluation of a Mindfulness-Based Intervention for Gulf War Illness
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 245
- 试验地点
- 2
- 主要终点
- Short Form McGill Pain Questionnaire (SF-MPQ-2) Total Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Self-report all the criteria for Chronic Multi-Symptom Illness
- •Fluent in English and able to provide informed consent
排除标准
- •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)
结局指标
主要结局
Short Form McGill Pain Questionnaire (SF-MPQ-2) Total Score
时间窗: 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.
General Fatigue Subscale of the Multidimensional Fatigue Inventory (MFI)
时间窗: 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.
Cognitive Failures Questionnaire (CFQ)
时间窗: 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.
Client Satisfaction Questionnaire (CSQ-8)
时间窗: 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.
次要结局
- PTSD Checklist - Civilian Version (PCL-C)(Change from baseline to 6 months after completing the intervention)
- Patient Health Questionnaire (PHQ-9)(Change from baseline to 6 months after completing the intervention)
- NIH Patient Reported Outcome Measures Information System (PROMIS) for Alcohol Negative Consequences, Short Form(Change from baseline to 6 months after completing the intervention)
- SF-12, Standard (Mental and Physical Component Summary Scores)(Change from baseline to 6 months after completing the intervention)