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

This study has been completed.
Sponsor:
Collaborators:
Southern Arizona VA Health Care System
Information provided by (Responsible Party):
Tricia Haynes, University of Arizona
ClinicalTrials.gov Identifier:
NCT00984698
First received: September 24, 2009
Last updated: February 14, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Posttraumatic Stress Disorder
Depression
Insomnia Disorder
Behavioral: Cognitive Behavioral Social Rhythm Group Therapy
Behavioral: Present Centered Group Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Trial of Group Psychotherapy for Veterans and Military Personnel With Post Traumatic Stress Disorder (PTSD)

Resource links provided by NLM:


Further study details as provided by University of Arizona:

Primary Outcome Measures:
  • Depression [ Time Frame: post-treatment, at 12 weeks ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • PTSD [ Time Frame: post-treatment, at 12 weeks ] [ Designated as safety issue: No ]
    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).


Enrollment: 115
Study Start Date: May 2009
Study Completion Date: August 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00984698

Locations
United States, Arizona
Southern Arizona VA Healthcare System (SAVAHCS)
Tucson, Arizona, United States, 85723
University of Arizona
Tucson, Arizona, United States, 85724
Sponsors and Collaborators
University of Arizona
Southern Arizona VA Health Care System
Investigators
Principal Investigator: Patricia Haynes, PhD University of Arizona
  More Information

Additional Information:
No publications provided

Responsible Party: Tricia Haynes, Assistant Professor, Dept of Psychiatry, University of Arizona
ClinicalTrials.gov Identifier: NCT00984698     History of Changes
Other Study ID Numbers: W81XWH-08-2-0121
Study First Received: September 24, 2009
Results First Received: January 6, 2014
Last Updated: February 14, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Arizona:
Posttraumatic Stress Disorder
Depression
Sleep Initiation and Maintenance Disorders
Insomnia
Psychotherapy, Group
Cognitive Behavioral Therapy
Randomized Controlled Trial
Veterans
Social Rhythms

Additional relevant MeSH terms:
Depression
Depressive Disorder
Disease
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Behavioral Symptoms
Mood Disorders
Mental Disorders
Pathologic Processes
Anxiety Disorders

ClinicalTrials.gov processed this record on September 18, 2014