Mind-Body Skills Groups for the Treatment of War Zone Stress in Military and Veteran Populations

Not Applicable

Completed

• Conditions: Stress Disorders, Post Traumatic; Depressive Disorder; Anxiety Disorders; Anger; Brain Injuries
• Interventions: Behavioral: Mind-Body Skills Groups; Other: Standard Treatment

• Registration Number: NCT01093053
• Lead Sponsor: The Center for Mind-Body Medicine

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 Timeline

• Study First Submitted: 2010-03-24
• Study First Submitted QC: 2010-03-24
• Study First Posted: 2010-03-25
• Study Start: 2010-09
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-27
• Last Update Posted: 2014-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mind-Body Skills Groups	Mind-Body Skills Groups	-
Standard Treatment	Standard Treatment	-

Primary Outcome Measures

Name	Time	Method
PTSD checklist - military version	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 Outcome Measures

Name	Time	Method
State-Trait Anxiety Inventory	Baseline; 12 weeks; 20 weeks	The State anxiety subscale will be used. It has 20 questions and uses a 4 point scale.
State-Trait Anger Expression Inventory-2	Baseline;12 weeks; 20 weeks	This is a 57 item consisting of a 4 point scale that measures the intensity of anger as an emotional state at a particular time (State Anger) and how often angry feelings are experienced over time as a personality trait (Trait Anger). There are 4 additional subscales which measure the outward expression of anger (Anger Expression-Out), holding or suppressing angry feelings (Anger Expression-In); controlling angry feelings by preventing the outward expression of anger (Anger Control-Out); and controlling anger feeling by calming down (Anger Control-In)
The Pittsburgh Sleep Quality Index	Baseline;12 weeks; 20 weeks	This 9 item questionnaire using a 4 point scale measures seven areas of sleep: subjective sleep quality, sleep latency, sleep duration, habitual seep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction.
The Patient Health Questionnaire-9	Baseline;12 weeks; 20 weeks	The Patient Health Questionnaire-9 is a 9 item self-report measure and is a widely used screening tool for depression.
The Posttraumatic Growth Inventory	Baseline;12 weeks; 20 weeks	The Posttraumatic Growth Inventory measures positive change that people can experience when they have been in a traumatic situation. It is a 21 item self report scale that includes five subscales: relating to others, new possibilities, personal strength, spiritual challenge, and appreciation of life.
The Medical Outcomes Study Short Form SF-36	Baseline; 12 weeks; 20 weeks	The SF-36 has 36 questions and measures functional status in eight dimensions: physical functioning, social functioning, role functioning-physical, role functioning-emotional, vitality, mental health, bodily pain, and general health perception.
The Inventory of Functional Impairment	Baseline;12 weeks; 20 weeks	The Inventory of Functional Impairment is an 87-item self-report measure designed to assess multiple dimensions of functional impairment experienced by active duty service members and veterans.

Trial Locations

Locations (1)

Southeast Louisiana Veterans Healthcare System; 🇺🇸 New Orleans, Louisiana, United States