Groups for Regaining Our Wellbeing

NCT03058952 | Completed Results DMC

• 1 other identifier: SDR 15-197
• Study Type: interventional
• Target: 245
• Locations: 1 country
• Sites: 1

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.

Conditions

Gulf War; Fatigue; Pain; Depression

Keywords

pain management; fatigue; mindfulness; Gulf War

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (4)

• Patient Health Questionnaire (PHQ-9)

  Change from baseline to 6 months after completing the intervention

• PTSD Checklist - Civilian Version (PCL-C)

  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

• NIH Patient Reported Outcome Measures Information System (PROMIS) for Alcohol Negative Consequences, Short Form

  Change from baseline to 6 months after completing the intervention

Study Arms (2)

Mindfulness-Based Stress Reduction

EXPERIMENTAL

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.

Behavioral: Mindfulness-Based Stress Reduction

Chronic Disease Self-Management Program

ACTIVE COMPARATOR

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).

Behavioral: Chronic Disease Self-Management Program

Interventions

Mindfulness-Based Stress Reduction BEHAVIORAL

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.

Also known as: MBSR

Mindfulness-Based Stress Reduction

Chronic Disease Self-Management Program BEHAVIORAL

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).

Also known as: CDSMP

Chronic Disease Self-Management Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Self-report all the criteria for Chronic Multi-Symptom Illness
• Fluent in English and able to provide informed consent

You may not qualify if:

• 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)

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Seattle, Washington, 98108, United States

Location

MeSH Terms

Conditions

Fatigue; Pain; Depression; Agnosia

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Behavioral Symptoms; Behavior; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Dr. Tracy Simpson
• Organization: VA Puget Sound

Tracy.Simpson@va.gov

(206) 277-3337

Study Officials

• Tracy L Simpson, PhD

  VA Puget Sound Health Care System Seattle Division, Seattle, WA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2017
• First Posted: February 23, 2017
• Study Start: August 8, 2017
• Primary Completion: March 31, 2022
• Study Completion: May 31, 2022
• Last Updated: June 21, 2024
• Results First Posted: June 21, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share

Locations

US (1)