Mind-Body Skills Groups for the Treatment of War Zone Stress in Military and Veteran Populations
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|ClinicalTrials.gov Identifier: NCT01093053|
Recruitment Status : Completed
First Posted : March 25, 2010
Last Update Posted : January 29, 2014
|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||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||108 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 :||September 2010|
|Actual Primary Completion Date :||September 2013|
|Actual Study Completion Date :||September 2013|
|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.
- 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.
- State-Trait Anger Expression Inventory-2 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01093053
|United States, Louisiana|
|Southeast Louisiana Veterans Healthcare System|
|New Orleans, Louisiana, United States, 70112|
|Principal Investigator:||James S Gordon, MD||The Center for Mind-Body Medicine|