Clinical trial NCT01267045: Mindfulness-Based Stress Reduction for Gulf War Syndrome
Official title: A Randomized Controlled Trial of a Mindfulness Based Intervention for Gulf War Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Persian Gulf Syndrome
Keywords: Persian Gulf Syndrome
Pain
Fatigue
Attention
Meditation
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2010-12-24
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: The Short-form McGill Pain Questionnaire
timeFrame: 2 months
measure: The Short-Form McGill Pain Questionnaire
timeFrame: 8 months
measure: Multidimensional Fatigue Inventory - General Fatigue
timeFrame: 2 months
measure: Multidimensional Fatigue Inventory - General Fatigue
timeFrame: 8 months
measure: Cognitive Failures Questionnaire
timeFrame: 2 months
measure: Cognitive Failures Questionnaire
timeFrame: 8 months
Secondary outcomes:
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: 2 months
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: 8 months
measure: PTSD Symptom Severity Interview (PSSI)
timeFrame: 2 months
measure: PTSD Symptom Severity Interview (PSSI)
timeFrame: 8 months
measure: PROMIS Fatigue
timeFrame: 2 months
measure: PROMIS Fatigue
timeFrame: 8 months
measure: Five Facet Mindfulness Questionnaire
timeFrame: 2 months
measure: Five Facet Mindfulness Questionnaire
timeFrame: 8 months
Other outcomes:
Locations:
city: Seattle
country: United States
facility: VA Puget Sound Health Care System Seattle Division, Seattle, WA
state: Washington
Study officials:
affiliation: VA Puget Sound Health Care System Seattle Division, Seattle, WA
name: David J Kearney, MD
role: PRINCIPAL_INVESTIGATOR
References: