View Clinical Trial (Medical Research Study)
A Randomized Controlled Study of Mind-Body Skills Groups for Treatment of War Zone Stress in Military and Veteran Populations
| City: |
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New Orleans |
| State: |
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Louisiana |
| Zip Code: |
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70112 |
| Conditions: |
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Stress Disorders, Post Traumatic - Brain Injuries - Depressive Disorder - Anxiety Disorders - Anger |
| Purpose: |
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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).
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| Study Summary: |
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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.
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| Criteria: |
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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
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| NCT ID: |
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NCT01093053 |
| Primary Contact: |
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Principal Investigator
James S Gordon, MD
The Center for Mind-Body Medicine
Madeline Uddo, Ph.D
Phone: 504-571-8107
Email: Madeline.Uddo@va.gov
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| Backup Contact: |
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Email: Michelle.Hamilton@va.gov
Michelle Hamilton, PhD
Phone: 504-571-8104
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| Location Contact: |
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New Orleans, Louisiana 70112
United States
Madeline Uddo, Ph.D.
Phone: 504-571-8107
Email: Madeline.Uddo@va.gov
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 18, 2013 |
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