Groups for Regaining Our Wellbeing

Evaluation of a Mindfulness-Based Intervention for Gulf War Illness

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03058952

Acronym

GROW

Enrollment

245

Registered

2017-02-23

Start date

2017-08-08

Completion date

2022-05-31

Last updated

2024-06-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression, Fatigue, Gulf War, Pain

Keywords

pain management, fatigue, mindfulness, Gulf War

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.

Interventions

BEHAVIORALMindfulness-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.

BEHAVIORALChronic 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).

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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)

Design outcomes

Primary

Measure	Time frame	Description
Client Satisfaction Questionnaire (CSQ-8)	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.
Short Form McGill Pain Questionnaire (SF-MPQ-2) Total Score	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)	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)	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.

Secondary

Measure	Time frame	Description
Patient Health Questionnaire (PHQ-9)	Change from baseline to 6 months after completing the intervention	A measure of depression. Minimum value: 0, maximum value: 27, higher scores indicate worse outcomes.
PTSD Checklist - Civilian Version (PCL-C)	Change from baseline to 6 months after completing the intervention	A measure of PTSD. Minimum value: 0, maximum value: 80. Higher score indicates worse outcome.
SF-12, Standard (Mental and Physical Component Summary Scores)	Change from baseline to 6 months after completing the intervention	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.
NIH Patient Reported Outcome Measures Information System (PROMIS) for Alcohol Negative Consequences, Short Form	Change from baseline to 6 months after completing the intervention	Substance Use Disorder (SUD) symptom severity for alcohol. Minimum score: 0, maximum score: 35. Higher scores indicate worse outcomes.

Countries

United States

Participant flow

Recruitment details

Participants were recruited based off of direct mailings generated by a VINCI data pull and the Gulf War Registry, between July 2017 and December 2020. The first participant was enrolled on August 8, 2017, and the last participant was enrolled on December 30, 2020.

Pre-assignment details

Of 258 enrolled participants, 245 met inclusion criteria and were randomized to treatment.

Participants by arm

Arm	Count
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. 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.	115
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). 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).	114
Total	229

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Adverse Event	1	0
Overall Study	Lost to Follow-up	15	15
Overall Study	Withdrawal by Subject	7	11

Baseline characteristics

Characteristic	Chronic Disease Self-Management Program	Mindfulness-Based Stress Reduction	Total
Age, Continuous	55.6 years STANDARD_DEVIATION 8.7	57.4 years STANDARD_DEVIATION 9.4	56.5 years STANDARD_DEVIATION 9.1
Ethnicity (NIH/OMB) Hispanic or Latino	11 Participants	9 Participants	20 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	103 Participants	106 Participants	209 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Gulf-War Veteran Status	43 Participants	44 Participants	87 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants	1 Participants	2 Participants
Race (NIH/OMB) Asian	4 Participants	1 Participants	5 Participants
Race (NIH/OMB) Black or African American	23 Participants	30 Participants	53 Participants
Race (NIH/OMB) More than one race	17 Participants	3 Participants	20 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants	2 Participants	4 Participants
Race (NIH/OMB) Unknown or Not Reported	12 Participants	9 Participants	21 Participants
Race (NIH/OMB) White	55 Participants	69 Participants	124 Participants
Sex/Gender, Customized Gender Female	18 Participants	14 Participants	32 Participants
Sex/Gender, Customized Gender Male	95 Participants	101 Participants	196 Participants
Sex/Gender, Customized Gender Transgender	1 Participants	0 Participants	1 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 123	0 / 122
other Total, other adverse events	2 / 123	0 / 122
serious Total, serious adverse events	0 / 123	0 / 122

Outcome results

Primary

Client Satisfaction Questionnaire (CSQ-8)

A measure of satisfaction with the interventions. Minimum value: 8, maximum value: 32, higher scores indicate higher satisfaction.

Time frame: report at post-intervention assessment, 3-4 months after baseline

Population: participants who completed at least 1 intervention session

Arm	Measure	Value (MEAN)	Dispersion
Mindfulness-Based Stress Reduction	Client Satisfaction Questionnaire (CSQ-8)	25.7 score on a scale	Standard Deviation 5.5
Chronic Disease Self-Management Program	Client Satisfaction Questionnaire (CSQ-8)	26.1 score on a scale	Standard Deviation 4.6

Primary

Cognitive Failures Questionnaire (CFQ)

A measure of concentration and memory disturbances. Minimum value: 0, maximum value: 100, higher scores indicate worse outcomes.