N/A
N=55
Mindfulness-Based Stress Reduction for Gulf War Syndrome
Persian Gulf Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT01267045 ↗Enrolled (actual)
55
Serious AEs
3.6%
Results posted
Dec 2014
Primary outcome: Primary: The Short-form McGill Pain Questionnaire — 54.0; 65.5 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Mindfulness-based stress reduction (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- US Department of Veterans Affairs
- Primary completion
- Dec 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Short-form McGill Pain Questionnaire |
57.1; 76.6 | — |
| PRIMARY The Short-Form McGill Pain Questionnaire |
57.1; 76.6 | — |
| PRIMARY Multidimensional Fatigue Inventory - General Fatigue |
13.6; 15.3 | — |
| PRIMARY Multidimensional Fatigue Inventory - General Fatigue |
13.6; 15.3 | — |
| PRIMARY Cognitive Failures Questionnaire |
46.6; 61.9 | — |
| PRIMARY Cognitive Failures Questionnaire |
46.6; 61.9 | — |
| SECONDARY Patient Health Questionnaire (PHQ-9) |
9.5; 12.3 | — |
| SECONDARY Patient Health Questionnaire (PHQ-9) |
9.5; 12.3 | — |
| SECONDARY PTSD Symptom Severity Interview (PSSI) |
21.7; 23.6 | — |
| SECONDARY PTSD Symptom Severity Interview (PSSI) |
21.7; 23.6 | — |
| SECONDARY PROMIS Fatigue |
57.5; 62.0 | — |
| SECONDARY PROMIS Fatigue |
57.5; 62.0 | — |
| SECONDARY Five Facet Mindfulness Questionnaire |
129.4; 114.6 | — |
| SECONDARY Five Facet Mindfulness Questionnaire |
129.4; 114.6 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01267045). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.