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Completed

NCT Number: NCT01093053

Mind-Body Skills Groups for the 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).

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Key information

Conditions

Stress Disorders, Post Traumatic Anger Anxiety Disorders Brain Diseases Brain Injuries Central Nervous System Diseases Combat Disorders Craniocerebral Trauma Depressive Disorder Mental Disorders Mood Disorders Nervous System Diseases Stress Disorders, Traumatic Trauma and Stressor Related Disorders Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Southeast Louisiana Veterans Healthcare System

New Orleans, Louisiana, 70112, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mind-Body Skills Groups

Behavioral

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.

standard treatment

Other

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 outcomes

  1. PTSD checklist - military version

    Time frame: Baseline; 12 weeks; 20 weeks

    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 outcomes

  1. State-Trait Anger Expression Inventory-2

    Time frame: Baseline;12 weeks; 20 weeks

    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)

  2. The Pittsburgh Sleep Quality Index

    Time frame: Baseline;12 weeks; 20 weeks

    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.

  3. The Patient Health Questionnaire-9

    Time frame: Baseline;12 weeks; 20 weeks

    The Patient Health Questionnaire-9 is a 9 item self-report measure and is a widely used screening tool for depression.

  4. State-Trait Anxiety Inventory

    Time frame: Baseline; 12 weeks; 20 weeks

    The State anxiety subscale will be used. It has 20 questions and uses a 4 point scale.

  5. The Posttraumatic Growth Inventory

    Time frame: Baseline;12 weeks; 20 weeks

    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.

  6. The Medical Outcomes Study Short Form SF-36

    Time frame: Baseline; 12 weeks; 20 weeks

    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.

  7. The Inventory of Functional Impairment

    Time frame: Baseline;12 weeks; 20 weeks

    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.

Sponsors and collaborators

Lead sponsor

The Center for Mind-Body Medicine

Other

Collaborators

  • Southeast Louisiana Veterans Health Care System
  • U.S. Army Medical Research and Development Command

Registry information

Official study title

A Randomized Controlled Study of Mind-Body Skills Groups for Treatment of War Zone Stress in Military and Veteran Populations

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Mar 25, 2010
Registry last updated
Jan 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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