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: November 13, 2013
Last verified: November 2013

December 23, 2010
November 13, 2013
September 2010
September 2012   (final data collection date for primary outcome measure)
The Short-form McGill Pain Questionnaire; the Multidimensional Fatigue Inventory; The Cognitive Failures Questionnaire [ Time Frame: 8 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01267045 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
MBSR for Gulf War Syndrome
A Randomized Controlled Trial of a Mindfulness Based Intervention for Gulf War Syndrome

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Persian Gulf Syndrome
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.
  • Experimental: Arm 1
    Participants in this arm undergo the mindfulness training intervention through taking part in a Mindfulness-Based Stress Reduction course
    Intervention: Behavioral: Mindfulness-based stress reduction
  • No Intervention: Arm 2
    Treatment as usual for Gulf War Syndrome symptoms (medications, psychotherapy, etc.)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
60
December 2013
September 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01267045
SPLD-008-10S
No
Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Principal Investigator: David J. Kearney, MD VA Puget Sound Health Care System Seattle Division, Seattle, WA
Department of Veterans Affairs
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP