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