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Completed

NCT Number: NCT00984698

A Trial of Group Psychotherapy for Veterans and Military Personnel With Post Traumatic Stress Disorder (PTSD)

The purpose of this study is to test the effectiveness of group psychotherapy designed specifically for male veterans and active-duty personnel with Post-traumatic Stress Disorder (PTSD), Major Depressive Disorder (MDD) and with disturbances in their sleep or daily routine.

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Key information

Conditions

Posttraumatic Stress Disorder Behavior Behavioral Symptoms Depression Dyssomnias Insomnia Disorder Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Southern Arizona VA Healthcare System (SAVAHCS), Tucson, Arizona, United States

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About this study

The purpose of this study is to test the effectiveness of a group psychotherapy designed specifically for male veterans and active-duty personnel with Post-traumatic Stress Disorder (PTSD), Major Depressive Disorder (MDD) and with disturbances in their sleep or daily routine. We will compare two group therapies, one of which has been examined in previous studies for veterans with PTSD. Both group therapies have been shown to reduce symptoms of anxiety and depression in some veterans. However, neither group therapy has been proven to be more effective than treatment as usual for PTSD.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Veteran or active duty military personnel
  • Current posttraumatic stress disorder (PTSD), at least moderate severity
  • Criterion A exposure to trauma occurring after the age of 18
  • Major depressive disorder (MDD), at least moderate severity
  • Disturbances in sleep (primary insomnia, insomnia related to PTSD, or nightmare disorder) or daily routine

Exclusion criteria

  • Current or past bipolar disorder
  • Current psychotic disorder
  • Substance abuse/dependence in last 30 days
  • Uncontrolled serious medical condition or neurological disorder
  • Currently working an overnight shift
  • Primary untreated sleep apnea, restless legs syndrome

Treatment and study plan

Cognitive Behavioral Social Rhythm Group Therapy

Behavioral

12 weeks, 2h structured group therapy

Present Centered Group Therapy

Behavioral

12 weeks, 2h relatively unstructured group therapy

Primary outcomes

  1. Depression

    Time frame: post-treatment, at 12 weeks

    Hamilton Rating Scale for Depression, 17 item The Hamilton Rating Scale for Depression is an interview assessment of depression symptom severity. Total score range is from 0 (no symptoms of depression) to 52 (maximum symptoms of depression).

Secondary outcomes

  1. PTSD

    Time frame: post-treatment, at 12 weeks

    Clinician-Administered PTSD Scale (CAPS), DSM-IV The CAPS is a 17-item interview assessment post-traumatic stress disorder (PTSD) symptom severity. Total score ranges from 0 (no PTSD symptoms) to 136 (maximum PTSD symptoms).

Sponsors and collaborators

Lead sponsor

University of Arizona

Other

Collaborators

  • Southern Arizona VA Health Care System
  • United States Department of Defense

Registry information

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Sep 25, 2009
Registry last updated
Mar 31, 2014

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

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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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