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

Sponsor

The Center for Mind-Body Medicine (Other)

Overall Status

Completed

CT.gov ID

NCT01093053

Collaborator

U.S. Army Medical Research and Development Command (U.S. Fed), Southeast Louisiana Veterans Health Care System (U.S. Fed)

108

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Stress Disorders, Post Traumatic Brain Injuries Depressive Disorder Anxiety Disorders Anger	Behavioral: Mind-Body Skills Groups Other: Standard Treatment	N/A

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

Actual Enrollment :

108 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2010

Actual Primary Completion Date :

Sep 1, 2013

Actual Study Completion Date :

Sep 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Mind-Body Skills Groups	Behavioral: Mind-Body Skills Groups 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.
Active Comparator: Standard Treatment	Other: Standard Treatment 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.

Arm

Intervention/Treatment

Experimental: Mind-Body Skills Groups

Behavioral: Mind-Body Skills Groups

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.

Active Comparator: Standard Treatment

Other: Standard Treatment

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.

Outcome Measures

Primary Outcome Measures

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

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.
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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

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.