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

February 14, 2014 updated by: Tricia Haynes, University of Arizona
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

115

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85724
        • University of Arizona
      • Tucson, Arizona, United States, 85723
        • Southern Arizona VA Healthcare System (SAVAHCS)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Structured Therapy
Cognitive Behavioral Social Rhythm Group Therapy is designed to improve mood and sleep by stabilizing social rhythms, increasing exposure to ambient light, changing dysfunctional bed/bedtime associations, activating the imagery system by changing nightmare content, and challenging dysfunctional automatic thoughts that might contribute to behavioral inactivation and nonadherence to the therapy protocol. There is no discussion of past traumatic events.
Behavioral: Cognitive Behavioral Social Rhythm Group Therapy
12 weeks, 2h structured group therapy
ACTIVE_COMPARATOR: Unstructured Therapy
Present Centered Group Therapy includes education about the typical symptoms and features associated with PTSD and MDD, with a focus on how these symptoms affect interpersonal relationships. It uses the group format to decrease isolation, normalize symptoms, and provide the experience of giving and receiving support. Some relaxation training is provided early in therapy. There is no discussion of past traumatic events.
Behavioral: Present Centered Group Therapy
12 weeks, 2h relatively unstructured group therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
post-treatment, at 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
post-treatment, at 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Arizona

Collaborators

United States Department of Defense
Southern Arizona VA Health Care System

Investigators

  • Principal Investigator: Patricia Haynes, PhD, University of Arizona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (ACTUAL)

May 1, 2012

Study Completion (ACTUAL)

August 1, 2012

Study Registration Dates

First Submitted

September 24, 2009

First Submitted That Met QC Criteria

September 24, 2009

First Posted (ESTIMATE)

September 25, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

March 31, 2014

Last Update Submitted That Met QC Criteria

February 14, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • W81XWH-08-2-0121

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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