Text Size

MBSR for Gulf War Syndrome

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01267045
First received: December 23, 2010
Last updated: June 12, 2013
Last verified: June 2013
History of Changes
  Purpose

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


Condition Intervention
Persian Gulf Syndrome
 Behavioral: Mindfulness-based stress reduction

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of a Mindfulness Based Intervention for Gulf War Syndrome

Resource links provided by NLM:

MedlinePlus related topics: Fatigue
U.S. FDA Resources

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • The Short-form McGill Pain Questionnaire; the Multidimensional Fatigue Inventory; The Cognitive Failures Questionnaire [ Time Frame: 8 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: September 2010
Estimated Study Completion Date: December 2013
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Participants in this arm undergo the mindfulness training intervention through taking part in a Mindfulness-Based Stress Reduction course
 Behavioral: Mindfulness-based stress reduction
The most common clinical method of teaching mindfulness is a standardized class called "mindfulness-based stress reduction" (MBSR), which is available at over 250 hospitals nationwide. MBSR teaches mindfulness as a non-religious practice of self-observation and self-awareness. Kabat-Zinn developed MBSR in 1979 in response to a growing awareness that medical interventions were often inadequate at addressing chronic pain issues and restoring function and life satisfaction. He drew on his meditation and yoga training to develop this program as a complement to traditional medicine that could help patients live fully despite their chronic medical and psychiatric conditions. Through MBSR an individual's emphasis shifts from a preoccupation with what is wrong to a growing appreciation for what is right and what can be built upon.
No Intervention: Arm 2
Treatment as usual for Gulf War Syndrome symptoms (medications, psychotherapy, etc.)

Detailed Description:

A randomized controlled trial with two arms. 60 veterans meeting diagnostic criteria for Gulf War Syndrome will be randomized to standard care or standard care plus an 8-week course of course of Mindfulness-Based Stress Reduction (MBSR). Study measures will be 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 will be obtained at equivalent time points for veterans randomized to usual care only. Following completion, veterans randomized to standard care only will have the opportunity to enroll in MBSR.

This pilot study will assess whether there is sufficient evidence of benefit to warrant further study, and will gather data that will allow estimation of the sample size needed in future studies. We will also obtain 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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Were deployed to the Gulf War theater of operations between Aug. 1990 and Aug 1991

Report at least two of the following:

  • Fatigue
  • Musculoskeletal pain
  • neuro-cognitive dysfunction

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01267045

Locations
United States, Washington
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, United States, 98108
Sponsors and Collaborators
Department of Veterans Affairs
Investigators
Principal Investigator: David J. Kearney, MD VA Puget Sound Health Care System Seattle Division, Seattle, WA
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01267045     History of Changes
Other Study ID Numbers: SPLD-008-10S
Study First Received: December 23, 2010
Last Updated: June 12, 2013
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Persian Gulf Syndrome
Pain
Fatigue
Attention
Meditation

Additional relevant MeSH terms:
Persian Gulf Syndrome
Occupational Diseases

ClinicalTrials.gov processed this record on June 17, 2013