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

T

The Center for Mind-Body Medicine

Status

Completed

Conditions

Brain Injuries
Stress Disorders, Post Traumatic
Anger
Anxiety Disorders
Depressive Disorder

Treatments

Behavioral: Mind-Body Skills Groups
Other: Standard Treatment

Study type

Interventional

Funder types

Other
Other U.S. Federal agency

Identifiers

NCT01093053
08144040

Details and patient eligibility

About

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).

Full 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.

Enrollment

108 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

108 participants in 2 patient groups

Mind-Body Skills Groups
Experimental group
Treatment:
Behavioral: Mind-Body Skills Groups
Standard Treatment
Active Comparator group
Treatment:
Other: Standard Treatment

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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