CAM in Veterans With Gulf War Illnesses

NCT ID: NCT02180243

Last Updated: 2023-09-01

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-12

Study Completion Date

2021-10-01

Brief Summary

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The purpose of this study is to explore the effectiveness Gulf War Health Education (GWHE) and iRest Yoga Nidra (mindfulness meditation)/auricular (ear) acupuncture for Veterans with Gulf War Veterans' Illnesses (GWVI).

Detailed Description

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Gulf War Veterans have reported irritable bowel syndrome, chronic fatigue, musculoskeletal pain, sleep difficulties, and neurocognitive dysfunction (for example, concentration, memory, and attention problems). The most effective treatment approach for what appears to a broad spectrum problem found in GWVI may require complementary alternative medicine (CAM) approaches to enhance positive outcomes. Mindfulness meditation and acupuncture are each broad spectrum CAM treatments designed to target multiple biological systems simultaneously, and thus may be well suited for GWVI. Gulf War Health Education group will promote wellness and prevention by utilizing a proactive patient care model.

Conditions

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Gulf War Veterans' Illness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
RBANS assessment was blinded

Study Groups

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Mindfulness meditation/Acupuncture

Eligible participants may be randomized to participate in iRest Yoga Nidra/ auricular acupuncture group classes.

Group Type EXPERIMENTAL

Mindfulness meditation/Acupuncture

Intervention Type BEHAVIORAL

Individuals randomized to this group will participate in iRest Yoga Nidra and auricular acupuncture.

Gulf War Health Education

Eligible participants may be randomized to participate in Gulf War Health Education group classes.

Group Type ACTIVE_COMPARATOR

Gulf War Health Education

Intervention Type OTHER

Participants randomized to this group will take part in a health education group.

Interventions

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Mindfulness meditation/Acupuncture

Individuals randomized to this group will participate in iRest Yoga Nidra and auricular acupuncture.

Intervention Type BEHAVIORAL

Gulf War Health Education

Participants randomized to this group will take part in a health education group.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* U.S. Veteran
* Deployed to the Gulf War between 1990-1991
* Currently suffers from Gulf War Veterans' Illness (i.e. fatigue, pain, cognitive impairment)

Exclusion Criteria

* Addiction to drugs or alcohol
* Experiences hallucinations or delusions
* Currently manic
* Currently suicidal
* Hearing difficulties that would interfere with group participation
* Current involvement in a meditation or acupuncture group
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Georgetown University

OTHER

Sponsor Role collaborator

MedStar Health

OTHER

Sponsor Role collaborator

VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Matthew J. Reinhard, PsyD

Role: PRINCIPAL_INVESTIGATOR

Washington DC VA Medical Center, Washington, DC

Locations

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Washington DC VA Medical Center, Washington, DC

Washington D.C., District of Columbia, United States

Site Status

Countries

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United States

References

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Breneman CB, Reinhard MJ, Allen N, Belouali A, Chun T, Crock L, Duncan AD, Dutton MA. Gulf War Illness: A Randomized Controlled Trial Combining Mindfulness Meditation and Auricular Acupuncture. Glob Adv Integr Med Health. 2023 May 3;12:27536130231171854. doi: 10.1177/27536130231171854. eCollection 2023 Jan-Dec.

Reference Type DERIVED
PMID: 37151571 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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CX000801-01A2

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

SPLD-013-13S

Identifier Type: -

Identifier Source: org_study_id

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