search
Back to results

Groups for Regaining Our Wellbeing (GROW)

Primary Purpose

Gulf War, Fatigue, Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness-Based Stress Reduction
Chronic Disease Self-Management Program
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gulf War focused on measuring pain management, fatigue, mindfulness, Gulf War

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mindfulness-Based Stress Reduction

Chronic Disease Self-Management Program

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

Short Form McGill Pain Questionnaire (SF-MPQ-2) total score
A validated measure of pain
General Fatigue subscale of the Multidimensional Fatigue Inventory (MFI)
A measure of general fatigue symptoms
Cognitive Failures Questionnaire (CFQ)
A measure of concentration and memory disturbances
Client Satisfaction Questionnaire (CSQ-8)
A measure of satisfaction with the interventions

Secondary Outcome Measures

Patient Health Questionnaire (PHQ-9)
A measure of depression
PTSD Checklist - Civilian Version (PCL-C)
A measure of PTSD
SF-36 (Mental and Physical Component Summary Scores)
A measure of functional status and wellbeing
NIH Patient Reported Outcome Measures Information System (PROMIS) for Alcohol Use and Negative Consequences, short form
Substance Use Disorder (SUD) symptom severity for alcohol

Full Information

First Posted
February 7, 2017
Last Updated
July 19, 2022
Sponsor
VA Office of Research and Development
search

1. Study Identification

Unique Protocol Identification Number
NCT03058952
Brief Title
Groups for Regaining Our Wellbeing
Acronym
GROW
Official Title
Evaluation of a Mindfulness-Based Intervention for Gulf War Illness
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
July 3, 2017 (Actual)
Primary Completion Date
March 31, 2022 (Actual)
Study Completion Date
May 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gulf War, Fatigue, Pain, Depression
Keywords
pain management, fatigue, mindfulness, Gulf War

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
245 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness-Based Stress Reduction
Arm Type
Experimental
Arm Description
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.
Arm Title
Chronic Disease Self-Management Program
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-Based Stress Reduction
Other Intervention Name(s)
MBSR
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Chronic Disease Self-Management Program
Other Intervention Name(s)
CDSMP
Intervention Description
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).
Primary Outcome Measure Information:
Title
Short Form McGill Pain Questionnaire (SF-MPQ-2) total score
Description
A validated measure of pain
Time Frame
Change from baseline to 6 months after completing the intervention
Title
General Fatigue subscale of the Multidimensional Fatigue Inventory (MFI)
Description
A measure of general fatigue symptoms
Time Frame
Change from baseline to 6 months after completing the intervention
Title
Cognitive Failures Questionnaire (CFQ)
Description
A measure of concentration and memory disturbances
Time Frame
Change from baseline to 6 months after completing the intervention
Title
Client Satisfaction Questionnaire (CSQ-8)
Description
A measure of satisfaction with the interventions
Time Frame
Change from baseline to 6 months after completing the intervention
Secondary Outcome Measure Information:
Title
Patient Health Questionnaire (PHQ-9)
Description
A measure of depression
Time Frame
Change from baseline to 6 months after completing the intervention
Title
PTSD Checklist - Civilian Version (PCL-C)
Description
A measure of PTSD
Time Frame
Change from baseline to 6 months after completing the intervention
Title
SF-36 (Mental and Physical Component Summary Scores)
Description
A measure of functional status and wellbeing
Time Frame
Change from baseline to 6 months after completing the intervention
Title
NIH Patient Reported Outcome Measures Information System (PROMIS) for Alcohol Use and Negative Consequences, short form
Description
Substance Use Disorder (SUD) symptom severity for alcohol
Time Frame
Change from baseline to 6 months after completing the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tracy L Simpson, PhD
Organizational Affiliation
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Puget Sound Health Care System Seattle Division, Seattle, WA
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
A de-identified, anonymized dataset will be created and shared. Only de-identified data, with no individually identifiable patient information, will be shared.

Learn more about this trial

Groups for Regaining Our Wellbeing

We'll reach out to this number within 24 hrs