Gulf WarGROWNCT03058952

Groups for Regaining Our Wellbeing

A study testing Mindfulness-Based Stress Reduction and Chronic Disease Self-Management Program in people with Gulf War and Fatigue, run by VA Office of Research and Development at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Gulf War, Fatigue, Pain
What is being tested?: Mindfulness-Based Stress Reduction and Chronic Disease Self-Management Program
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 245 participants
Where: 1 siteUnited States
Study dates: 8 Aug 2017to 31 May 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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)

Trial locations and contacts

1 site in 1 country.

United States1 site

VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, 98108

Other trials in United States

About this study

Official title: Evaluation of a Mindfulness-Based Intervention for Gulf War Illness

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.

Read the 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.

Conditions: Gulf War, Fatigue, Pain, Depression
Being tested: Mindfulness-Based Stress Reduction, Chronic Disease Self-Management Program
Keywords: pain management, fatigue, mindfulness, Gulf War
Medical subject headings: Fatigue, Pain, Depression, Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Mindfulness-Based Stress ReductionBehavioural
Also called MBSR
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 ProgramBehavioural
Also called CDSMP
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 groups in NCT03058952
Study group	Role	What they receive
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. Receives: 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). Receives: Behavioral: Chronic Disease Self-Management Program

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: report at post-intervention assessment, 3-4 months after baseline

Secondary outcomes (4)

Patient Health Questionnaire (PHQ-9)
A measure of depression. Minimum value: 0, maximum value: 27, higher scores indicate worse outcomes.
Measured: Change from baseline to 6 months after completing the intervention
PTSD Checklist - Civilian Version (PCL-C)
A measure of PTSD. Minimum value: 0, maximum value: 80. Higher score indicates worse outcome.
Measured: Change from baseline to 6 months after completing the intervention
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.
Measured: Change from baseline to 6 months after completing the intervention
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.
Measured: Change from baseline to 6 months after completing the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Aug 201731 May 2022

First posted23 Feb 2017
Study start8 Aug 2017
Primary completion31 Mar 2022
Study completion31 May 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Gulf WarStudies of the same condition, open and under way.
More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 245 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03058952
Sponsor's protocol ID: SDR 15-197
Acronym: GROW
Status last verified: Feb 2024
First submitted: 7 Feb 2017
Last updated: 21 Jun 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: A de-identified, anonymized dataset will be created and shared. Only de-identified data, with no individually identifiable patient information, will be shared.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
NIH Investigative Deep Phenotyping Study of Gulf War Veteran Health (Project NIH IN-DEPTH)
Gulf War Illness
RecruitingPhase 2
Ca-Mg Butyrate in Gulf War Illness
Gulf War Illness, Chronic Fatigue
Not yet recruiting
Pycnogenol (French Maritime Pine Bark) for the Treatment of Gulf War Illness
Gulf War Syndrome
Active, not recruitingObservational study
Gulf War Era Cohort and Biorepository
Gulf War Era Cohort
RecruitingPhase 1
Clinical Evaluation of Montelukast in Veterans With Gulf War Illness
Gulf War Syndrome

All Gulf War trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of a Mindfulness-Based Intervention for Gulf War Illness
ClinicalTrials.gov ID: NCT03058952
Acronym / sponsor ID: GROW / SDR 15-197
Conditions: Gulf War, Fatigue, Pain, Depression
Keywords: pain management, fatigue, mindfulness, Gulf War
Study type: Interventional
Recruitment status: Completed
Enrolment: 245 participants (actual)
Lead sponsor: VA Office of Research and DevelopmentUS federal agency
Study start: 8 Aug 2017 (actual)
Primary completion: 31 Mar 2022 (actual)
Study completion: 31 May 2022 (actual)
First posted: 23 Feb 2017 (actual)
Results: Posted 21 Jun 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Mindfulness-Based Stress Reduction	Experimental	Behavioral: Mindfulness-Based Stress ReductionAn 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	Active comparator	Behavioral: Chronic Disease Self-Management ProgramThe 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).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Mindfulness-Based Stress ReductionAlso: MBSRAn 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.	Behavioural	Mindfulness-Based Stress Reduction
Chronic Disease Self-Management ProgramAlso: CDSMPThe 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).	Behavioural	Chronic Disease Self-Management Program

Primary outcome

Short Form McGill Pain Questionnaire (SF-MPQ-2) Total Score
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.

4 secondary outcomes

Patient Health Questionnaire (PHQ-9)
Time frame: Change from baseline to 6 months after completing the intervention
PTSD Checklist - Civilian Version (PCL-C)
Time frame: Change from baseline to 6 months after completing the intervention
SF-12, Standard (Mental and Physical Component Summary Scores)
Time frame: Change from baseline to 6 months after completing the intervention
NIH Patient Reported Outcome Measures Information System (PROMIS) for Alcohol Negative Consequences, Short Form
Time frame: Change from baseline to 6 months after completing the intervention

Results and safety

Results posted to the registry on 21 Jun 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Mindfulness-Based Stress Reduction	123	100
Chronic Disease Self-Management Program	122	96

Primary outcome: Short Form McGill Pain Questionnaire (SF-MPQ-2) Total Score

Time frame: Change from baseline to 6 months after completing the intervention. Mean (Standard Deviation). Unit: score on scale

Measure	Mindfulness-Based Stress Reduction n = 108	Chronic Disease Self-Management Program n = 105
Baseline	69.2 (42.1)	64.9 (34.9)
final 6-month post-intervention	62.3 (43.4)	55.5 (38.7)

Population analysed: Intent-to-treat population with complete data on the measure

Primary outcome: General Fatigue Subscale of the Multidimensional Fatigue Inventory (MFI)

Time frame: Change from baseline to 6 months after completing the intervention. Mean (Standard Deviation). Unit: score on a scale

Measure	Mindfulness-Based Stress Reduction n = 114	Chronic Disease Self-Management Program n = 109
Baseline	15.1 (3.7)	14.8 (3.6)
final 6-month post-intervention	14.2 (4.1)	13.6 (4.0)

Population analysed: Intent-to-treat population with complete data on the measure

Primary outcome: Cognitive Failures Questionnaire (CFQ)

Time frame: Change from baseline to 6 months after completing the intervention. Mean (Standard Deviation). Unit: score on a scale

Measure	Mindfulness-Based Stress Reduction n = 111	Chronic Disease Self-Management Program n = 111
Baseline	47.0 (18.6)	49.5 (15.3)
final 6-month post-intervention	43.5 (17.3)	43.5 (14.7)

Population analysed: Intent-to-treat population with complete data on measure

Primary outcome: Client Satisfaction Questionnaire (CSQ-8)

Time frame: report at post-intervention assessment, 3-4 months after baseline. Mean (Standard Deviation). Unit: score on a scale

Measure	Mindfulness-Based Stress Reduction n = 86	Chronic Disease Self-Management Program n = 83
Value	25.7 (5.5)	26.1 (4.6)

Population analysed: participants who completed at least 1 intervention session

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: AEs, SAEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 8-9 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Mindfulness-Based Stress Reduction	0 of 123 (0%)	2 of 123 (1.6%)	0 of 123
Chronic Disease Self-Management Program	0 of 122 (0%)	0 of 122 (0%)	0 of 122

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. A de-identified, anonymized dataset will be created and shared. Only de-identified data, with no individually identifiable patient information, will be shared.

Related trials for Gulf War

RecruitingObservational study
NIH Investigative Deep Phenotyping Study of Gulf War Veteran Health (Project NIH IN-DEPTH)
Gulf War Illness
RecruitingPhase 2
Ca-Mg Butyrate in Gulf War Illness
Gulf War Illness, Chronic Fatigue
Not yet recruiting
Pycnogenol (French Maritime Pine Bark) for the Treatment of Gulf War Illness
Gulf War Syndrome
Active, not recruitingObservational study
Gulf War Era Cohort and Biorepository
Gulf War Era Cohort
RecruitingPhase 1
Clinical Evaluation of Montelukast in Veterans With Gulf War Illness
Gulf War Syndrome

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Tracy L Simpson, PhD principal investigator

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Short Form McGill Pain Questionnaire (SF-MPQ-2) Total Score (time frame: Change from baseline to 6 months after completing the intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03058952.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2024.