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

Primary Purpose

Stress Disorders, Post Traumatic, Brain Injuries, Depressive Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mind-Body Skills Groups
Standard Treatment
Sponsored by
The Center for Mind-Body Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Disorders, Post Traumatic focused on measuring Mind-Body Therapies

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Southeast Louisiana Veterans Healthcare System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mind-Body Skills Groups

Standard Treatment

Arm Description

Outcomes

Primary Outcome Measures

PTSD checklist - military version
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
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
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
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
The State anxiety subscale will be used. It has 20 questions and uses a 4 point scale.
The Posttraumatic Growth Inventory
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
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
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.

Full Information

First Posted
March 24, 2010
Last Updated
January 27, 2014
Sponsor
The Center for Mind-Body Medicine
Collaborators
U.S. Army Medical Research and Development Command, Southeast Louisiana Veterans Health Care System
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1. Study Identification

Unique Protocol Identification Number
NCT01093053
Brief Title
Mind-Body Skills Groups for the Treatment of War Zone Stress in Military and Veteran Populations
Official Title
A Randomized Controlled Study of Mind-Body Skills Groups for Treatment of War Zone Stress in Military and Veteran Populations
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Center for Mind-Body Medicine
Collaborators
U.S. Army Medical Research and Development Command, Southeast Louisiana Veterans Health Care System

4. Oversight

Data Monitoring Committee
No

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Disorders, Post Traumatic, Brain Injuries, Depressive Disorder, Anxiety Disorders, Anger
Keywords
Mind-Body Therapies

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
108 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mind-Body Skills Groups
Arm Type
Experimental
Arm Title
Standard Treatment
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Mind-Body Skills Groups
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard Treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
PTSD checklist - military version
Description
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.
Time Frame
Baseline; 12 weeks; 20 weeks
Secondary Outcome Measure Information:
Title
State-Trait Anger Expression Inventory-2
Description
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)
Time Frame
Baseline;12 weeks; 20 weeks
Title
The Pittsburgh Sleep Quality Index
Description
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.
Time Frame
Baseline;12 weeks; 20 weeks
Title
The Patient Health Questionnaire-9
Description
The Patient Health Questionnaire-9 is a 9 item self-report measure and is a widely used screening tool for depression.
Time Frame
Baseline;12 weeks; 20 weeks
Title
State-Trait Anxiety Inventory
Description
The State anxiety subscale will be used. It has 20 questions and uses a 4 point scale.
Time Frame
Baseline; 12 weeks; 20 weeks
Title
The Posttraumatic Growth Inventory
Description
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.
Time Frame
Baseline;12 weeks; 20 weeks
Title
The Medical Outcomes Study Short Form SF-36
Description
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.
Time Frame
Baseline; 12 weeks; 20 weeks
Title
The Inventory of Functional Impairment
Description
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.
Time Frame
Baseline;12 weeks; 20 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James S Gordon, MD
Organizational Affiliation
The Center for Mind-Body Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southeast Louisiana Veterans Healthcare System
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States

12. IPD Sharing Statement

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

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