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

This study has been completed.
Sponsor:
Collaborators:
U.S. Army Medical Research and Materiel Command
Southeast Louisiana Veterans Health Care System
Information provided by (Responsible Party):
James S. Gordon, M.D., The Center for Mind-Body Medicine
ClinicalTrials.gov Identifier:
NCT01093053
First received: March 24, 2010
Last updated: January 27, 2014
Last verified: January 2014
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by The Center for Mind-Body Medicine:

Primary Outcome Measures:
  • PTSD checklist - military version [ Time Frame: Baseline; 12 weeks; 20 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline;12 weeks; 20 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 108
Study Start Date: September 2010
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01093053

Locations
United States, Louisiana
Southeast Louisiana Veterans Healthcare System
New Orleans, Louisiana, United States, 70112
Sponsors and Collaborators
The Center for Mind-Body Medicine
U.S. Army Medical Research and Materiel Command
Southeast Louisiana Veterans Health Care System
Investigators
Principal Investigator: James S Gordon, MD The Center for Mind-Body Medicine
  More Information

No publications provided

Responsible Party: James S. Gordon, M.D., Founder and Director, The Center for Mind-Body Medicine
ClinicalTrials.gov Identifier: NCT01093053     History of Changes
Other Study ID Numbers: 08144040
Study First Received: March 24, 2010
Last Updated: January 27, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by The Center for Mind-Body Medicine:
Mind-Body Therapies

Additional relevant MeSH terms:
Anxiety Disorders
Brain Injuries
Depression
Depressive Disorder
Disease
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Behavioral Symptoms
Brain Diseases
Central Nervous System Diseases
Craniocerebral Trauma
Mental Disorders
Mood Disorders
Nervous System Diseases
Pathologic Processes
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on October 23, 2014