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

March 24, 2010
January 27, 2014
September 2010
September 2013   (final data collection date for primary outcome measure)
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.
PTSD checklist - military version [ Time Frame: 12 weeks and 6 months ] [ 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.
Complete list of historical versions of study NCT01093053 on ClinicalTrials.gov Archive Site
  • 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.
  • State-Trait Anger Expression Inventory-2 [ Time Frame: 12 weeks and 6 months ] [ 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: 12 weeks and 6 months ] [ 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: 12 weeks and 6 months ] [ 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: 12 weeks and 6 months ] [ 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: 12 weeks and 6 months ] [ 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: 12 weeks and 6 months ] [ 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: 12 weeks and 6 months ] [ 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.
Not Provided
Not Provided
 
Mind-Body Skills Groups for the Treatment of War Zone Stress in Military and Veteran Populations
A Randomized Controlled Study of Mind-Body Skills Groups for Treatment of War Zone Stress in Military and Veteran Populations

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).

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Stress Disorders, Post Traumatic
  • Brain Injuries
  • Depressive Disorder
  • Anxiety Disorders
  • Anger
  • 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.
  • 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.
  • Experimental: Mind-Body Skills Groups
    Intervention: Behavioral: Mind-Body Skills Groups
  • Active Comparator: Standard Treatment
    Intervention: Other: Standard Treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
108
September 2013
September 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01093053
08144040
No
James S. Gordon, M.D., The Center for Mind-Body Medicine
The Center for Mind-Body Medicine
  • U.S. Army Medical Research and Materiel Command
  • Southeast Louisiana Veterans Health Care System
Principal Investigator: James S Gordon, MD The Center for Mind-Body Medicine
The Center for Mind-Body Medicine
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP