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Mindfulness-Based Stress Reduction for Gulf War Syndrome

US Department of Veterans Affairs (VA) logo

US Department of Veterans Affairs (VA)

Status

Completed

Conditions

Persian Gulf Syndrome

Treatments

Behavioral: Mindfulness-based stress reduction

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT01267045
SPLD-008-10S

Details and patient eligibility

About

This pilot study is a two arm randomized, controlled clinical trial that evaluated whether a standardized Mindfulness-Based Stress Reduction (MBSR) intervention reduces symptoms associated with Gulf War Syndrome (GWS) more effectively than treatment as usual. Fifty-five veterans meeting diagnostic criteria for Gulf War Syndrome were randomized to treatment as usual (TAU) or TAU plus an 8-week course of course of MBSR. Study measures were collected at baseline, immediate post-MBSR, and 6 months post intervention. Measures were obtained at equivalent time points for veterans randomized to TAU only. Following completion of all study activities, veterans randomized to TAU only had the opportunity to enroll in MBSR.

Full description

A randomized controlled trial with two arms. 55 veterans meeting diagnostic criteria for Gulf War Syndrome were randomized to standard care or standard care plus an 8-week course of course of Mindfulness-Based Stress Reduction (MBSR). Study measures were collected at baseline, immediate post-MBSR (within one week of completion of the MBSR class) and 6 months following completion of the MBSR course. Measures were obtained at equivalent time points for veterans randomized to usual care only. Following completion, veterans randomized to standard care only had the opportunity to enroll in MBSR.

This pilot study will whether there is sufficient evidence of benefit to warrant further study, and gathered data that will allow estimation of the sample size needed in future studies. We also obtained measures working memory and attention, in addition to patient self-report measures of symptoms, in order to provide additional assessment of whether MBSR is effective. This project is prerequisite to a larger study.

Enrollment

55 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Chart Diagnosis of PTSD

Exclusion criteria

  • any past or present psychiatric disorder involving a history of psychosis (schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorder not otherwise specified, etc.)
  • Mania or poorly controlled bipolar
  • Current suicidal or homicidal ideation
  • Prior training in mindfulness meditation
  • Active substance abuse or dependence
  • Must not have had an inpatient admission for psychiatric reasons within the past month

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

55 participants in 2 patient groups

Arm 1
Experimental group
Description:
Participants in this arm undergo the mindfulness training intervention through taking part in a Mindfulness-Based Stress Reduction course
Treatment:
Behavioral: Mindfulness-based stress reduction
Arm 2
No Intervention group
Description:
Treatment as usual for Gulf War Syndrome symptoms (medications, psychotherapy, etc.)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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