A Randomized Controlled Trial of a Mindfulness Based Intervention for Gulf War Syndrome
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Persian Gulf Syndrome
- Sponsor
- US Department of Veterans Affairs
- Enrollment
- 55
- Locations
- 1
- Primary Endpoint
- The Short-Form McGill Pain Questionnaire
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
The Short-Form McGill Pain Questionnaire
Time Frame: 8 months
The Short-Form McGill Pain Questionnaire is a self-report 22-item measure that assesses various types of pain on a scale of 0 (none) to 10 (worst possible) experienced during the past week. Score ranges from a minimum of 0 to a maximum of 220; the higher the score, the worse the outcome.
The Short-form McGill Pain Questionnaire
Time Frame: 2 months
The Short-Form McGill Pain Questionnaire is a self-report 22-item measure that assesses various types of pain on a scale of 0 (none) to 10 (worst possible) experienced during the past week. Score ranges from a minimum of 0 to a maximum of 220; the higher the score, the worse the outcome.
Multidimensional Fatigue Inventory - General Fatigue
Time Frame: 8 months
The Multidimensional Fatigue Inventory is a 20-item self-report measure of various types of fatigue. Each item is a statement, and the subject indicates how much, on a scale of 1 (yes, that is true) to 5 (no, that is not true), he or she agrees with the statement (e.g. "I feel very active.") Scores range from a minimum of 20 to a maximum of 100; the higher the score, the worse the outcome.
Cognitive Failures Questionnaire
Time Frame: 8 months
The Cognitive Failure Questionnaire is a 25-item self-report measure of cognitive difficulty during daily living in the past six months. Each item is a question indicating a situation involving a type of cognitive failure (e.g. "Do you find you forget why you went from one part of the house to another?"), and the subject indicates how often that happens to them, on a scale of 0 (never) to 4 (very often). Scores range from a minimum of 0 to a maximum of 100; the higher the score, the worse the outcome.
Secondary Outcomes
- PTSD Symptom Severity Interview (PSSI)(8 months)
- PROMIS Fatigue(8 months)
- Patient Health Questionnaire (PHQ-9)(8 months)
- Five Facet Mindfulness Questionnaire(8 months)