A Randomized Controlled Study of Mind-Body Skills Groups for Treatment of War Zone Stress in Military and Veteran Populations
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 108
- Locations
- 2
- Primary Endpoint
- PTSD checklist - military version
Study Overview
Brief Summary
The purpose of this study is to determine whether participation in mind-body skills groups by veterans who have experienced a stressful war-related situation and have symptoms of posttraumatic stress disorder (PTSD), will improve symptoms of PTSD, depression and anxiety, reduce anger, improve quality of life, quality of sleep and result in posttraumatic growth (a positive change that people can experience when they have been in a traumatic situation).
Detailed Description
The study will be a randomized controlled study where participants will be randomly selected to either participate in the mind-body skills program and to answer questionnaires before and after the program and again 6 months later or, if they are not randomized to the mind-body skills group program, they will answer the questionnaires during the same time periods without participating in the program. Both groups will also continue their medical treatment as usual. The mind-body skills group intervention consists of groups of 8-10 participants. Two formats will be offered. (1) A 2 hour group session once a week for 10 weeks or (2) Weekend groups which will be run on alternating Saturdays, with a 2 hour session in the morning and another 2 hour session in the afternoon. The groups will be run for a total of 5 Saturday sessions. Additional "reunion" groups will be held at 1 month, 3 months, and 6 months in order to reinforce skills and to provide continuing social support.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •having experienced a deployment-related criterion A stressor and reporting post deployment stress symptoms which include: clinically diagnosed posttraumatic stress disorder (PTSD), or subthreshold PTSD symptoms
- •comorbid conditions may also include mild traumatic brain injury, or clinically significant levels of depression or anxiety.
Exclusion Criteria
- •current uncontrolled psychotic or bipolar disorder
- •significant cognitive impairment
- •moderate or severe TBI
- •substance dependence
- •suicidal or homicidal ideation
Outcomes
Primary Outcomes
PTSD checklist - military version
Time Frame: Baseline; 12 weeks; 20 weeks
The PTSD checklist contains 17 items corresponding to the DSM-IV criteria for PTSD. Past month symptom severity is indicated using a 5 point scale.
Secondary Outcomes
- State-Trait Anxiety Inventory(Baseline; 12 weeks; 20 weeks)
- State-Trait Anger Expression Inventory-2(Baseline;12 weeks; 20 weeks)
- The Pittsburgh Sleep Quality Index(Baseline;12 weeks; 20 weeks)
- The Patient Health Questionnaire-9(Baseline;12 weeks; 20 weeks)
- The Posttraumatic Growth Inventory(Baseline;12 weeks; 20 weeks)
- The Medical Outcomes Study Short Form SF-36(Baseline; 12 weeks; 20 weeks)
- The Inventory of Functional Impairment(Baseline;12 weeks; 20 weeks)
Investigators
James S. Gordon, M.D.
Founder and Director
The Center for Mind-Body Medicine