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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

September 24, 2009
February 14, 2014
May 2009
May 2012   (final data collection date for primary outcome measure)
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).
  • Evidence of therapy versus control in improving sleep in patients with posttraumatic stress disorder (PTSD), major depressive disorder, and sleep or social rhythm disturbances [ Time Frame: At end of therapy, 3- and 6- month follow-ups ] [ Designated as safety issue: No ]
  • Evidence of CBSRT versus control in improving depression symptoms in patients with posttraumatic stress disorder (PTSD), major depressive disorder, and sleep or social rhythm disturbances [ Time Frame: At end of therapy, 3- and 6- month follow-ups ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00984698 on ClinicalTrials.gov Archive Site
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).
  • Evidence of CBSRT versus control in improving posttraumatic stress disorder (PTSD) symptoms [ Time Frame: At end of therapy, 3- and 6- month follow-up ] [ Designated as safety issue: No ]
  • Preliminary data testing CBSRT in veterans and active duty military personnel returning from Operation Iraqi Freedom (OIF) and Operation Enduring Freedom (OEF). [ Time Frame: At end of therapy, 3- and 6- month follow-ups ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Trial of Group Psychotherapy for Veterans and Military Personnel With Post Traumatic Stress Disorder (PTSD)
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
  • Posttraumatic Stress Disorder
  • Depression
  • Insomnia Disorder
  • Behavioral: Cognitive Behavioral Social Rhythm Group Therapy
    12 weeks, 2h structured group therapy
  • Behavioral: Present Centered Group Therapy
    12 weeks, 2h relatively unstructured group therapy
  • 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.
    Intervention: Behavioral: Cognitive Behavioral Social Rhythm 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.
    Intervention: Behavioral: Present Centered Group Therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
115
August 2012
May 2012   (final data collection date for primary outcome measure)

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
Male
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00984698
W81XWH-08-2-0121
Yes
Tricia Haynes, University of Arizona
University of Arizona
  • Department of Defense
  • Southern Arizona VA Health Care System
Principal Investigator: Patricia Haynes, PhD University of Arizona
University of Arizona
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP