Clinical trial NCT01093053: Mind-Body Skills Groups for the Treatment of War Zone Stress in Military and Veteran Populations
Official title: A Randomized Controlled Study of Mind-Body Skills Groups for Treatment of War Zone Stress in Military and Veteran Populations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Disorders, Post Traumatic
Brain Injuries
Depressive Disorder
Anxiety Disorders
Anger
Keywords: Mind-Body Therapies
Lead sponsor: The Center for Mind-Body Medicine
Sponsor class: OTHER
Collaborators: name: U.S. Army Medical Research and Development Command
name: Southeast Louisiana Veterans Health Care System
First posted: 2010-03-25
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: PTSD checklist - military version
timeFrame: Baseline; 12 weeks; 20 weeks
Secondary outcomes:
measure: State-Trait Anger Expression Inventory-2
timeFrame: Baseline;12 weeks; 20 weeks
measure: The Pittsburgh Sleep Quality Index
timeFrame: Baseline;12 weeks; 20 weeks
measure: The Patient Health Questionnaire-9
timeFrame: Baseline;12 weeks; 20 weeks
measure: State-Trait Anxiety Inventory
timeFrame: Baseline; 12 weeks; 20 weeks
measure: The Posttraumatic Growth Inventory
timeFrame: Baseline;12 weeks; 20 weeks
measure: The Medical Outcomes Study Short Form SF-36
timeFrame: Baseline; 12 weeks; 20 weeks
measure: The Inventory of Functional Impairment
timeFrame: Baseline;12 weeks; 20 weeks
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: Southeast Louisiana Veterans Healthcare System
state: Louisiana
Study officials:
affiliation: The Center for Mind-Body Medicine
name: James S Gordon, MD
role: PRINCIPAL_INVESTIGATOR
References: