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

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.

Official Title
-----------------
A Randomized Controlled Study of Mind-Body Skills Groups for Treatment of War Zone Stress in Military and Veteran Populations

Conditions
-----------------
Stress Disorders, Post Traumatic, Brain Injuries, Depressive Disorder, Anxiety Disorders, Anger

Intervention / Treatment
-----------------
* Behavioral: Mind-Body Skills Groups
* Other: Standard Treatment


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mind-Body Skills Groups<br> | Behavioral: Mind-Body Skills Groups<br>* The mind-body skills group program teaches participants how to do meditation, guided imagery, breathing techniques, and biofeedback. These mind-body techniques are taught and practiced in small groups of 8 to 10 people and also contain an element of social support.<br>|
| Active Comparator: Standard Treatment<br> | Other: Standard Treatment<br>* May include individual or group psychotherapy consisting of cognitive behavioral therapy or present-centered (i.e. unrelated to mindfulness) psychotherapy as well as medication management. Medications for depression, anxiety, and sleep disorders are the most commonly used in standard treatment.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PTSD checklist - military version | 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. | Baseline; 12 weeks; 20 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| State-Trait Anger Expression Inventory-2 | 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) | Baseline;12 weeks; 20 weeks | 
| The Pittsburgh Sleep Quality Index | 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. | Baseline;12 weeks; 20 weeks | 
| The Patient Health Questionnaire-9 | The Patient Health Questionnaire-9 is a 9 item self-report measure and is a widely used screening tool for depression. | Baseline;12 weeks; 20 weeks | 
| State-Trait Anxiety Inventory | The State anxiety subscale will be used. It has 20 questions and uses a 4 point scale. | Baseline; 12 weeks; 20 weeks | 
| The Posttraumatic Growth Inventory | 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. | Baseline;12 weeks; 20 weeks | 
| The Medical Outcomes Study Short Form SF-36 | 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. | Baseline; 12 weeks; 20 weeks | 
| The Inventory of Functional Impairment | 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. | Baseline;12 weeks; 20 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mind-Body Therapies