Groups for Regaining Our Wellbeing

Depression Clinical Trial

— GROW  

Official title:

Evaluation of a Mindfulness-Based Intervention for Gulf War Illness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03058952
• Other study ID #: SDR 15-197
• Status: Completed
• Phase: N/A
• Start date: August 8, 2017
• Est. completion date: May 31, 2022

Study information

• Verified date: February 2024
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 245
• Est. completion date: May 31, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Depression
• Fatigue
• Gulf War
• Pain

Intervention

Behavioral:
• Mindfulness-Based Stress Reduction
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.
• Chronic Disease Self-Management Program
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).

Locations

Country	Name	City	State
United States	VA Puget Sound Health Care System Seattle Division, Seattle, WA	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Short Form McGill Pain Questionnaire (SF-MPQ-2) Total Score	A validated measure of pain, minimum value: 0, maximum value: 222, higher scores indicate worse outcomes.	Change from baseline to 6 months after completing the intervention
Primary	General Fatigue Subscale of the Multidimensional Fatigue Inventory (MFI)	A measure of general fatigue symptoms. Minimum value: 0, maximum value: 80, higher scores indicate worse outcomes.	Change from baseline to 6 months after completing the intervention
Primary	Cognitive Failures Questionnaire (CFQ)	A measure of concentration and memory disturbances. Minimum value: 0, maximum value: 100, higher scores indicate worse outcomes.	Change from baseline to 6 months after completing the intervention
Primary	Client Satisfaction Questionnaire (CSQ-8)	A measure of satisfaction with the interventions. Minimum value: 8, maximum value: 32, higher scores indicate higher satisfaction.	report at post-intervention assessment, 3-4 months after baseline
Secondary	Patient Health Questionnaire (PHQ-9)	A measure of depression. Minimum value: 0, maximum value: 27, higher scores indicate worse outcomes.	Change from baseline to 6 months after completing the intervention
Secondary	PTSD Checklist - Civilian Version (PCL-C)	A measure of PTSD. Minimum value: 0, maximum value: 80. Higher score indicates worse outcome.	Change from baseline to 6 months after completing the intervention
Secondary	SF-12, Standard (Mental and Physical Component Summary Scores)	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.	Change from baseline to 6 months after completing the intervention
Secondary	NIH Patient Reported Outcome Measures Information System (PROMIS) for Alcohol Negative Consequences, Short Form	Substance Use Disorder (SUD) symptom severity for alcohol. Minimum score: 0, maximum score: 35. Higher scores indicate worse outcomes.	Change from baseline to 6 months after completing the intervention