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

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborators:

Department of Defense

Southern Arizona VA Health Care System

Information provided by:

University of Arizona

ClinicalTrials.gov Identifier:

NCT00984698

First received: September 24, 2009

Last updated: August 9, 2011

Last verified: August 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

September 24, 2009

Last Updated Date

August 9, 2011

Start Date ^ICMJE

May 2009

Estimated Primary Completion Date

May 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Insomnia, Nightmares, and Other Mental Health Symptoms [ Time Frame: 12 week group therapy, 3 and 6 month follow-ups ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

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 ]

Change History

Complete list of historical versions of study NCT00984698 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

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 ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

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 ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Posttraumatic Stress Disorder
Depression
Sleep Initiation and Maintenance Disorders (i.e. Insomnia)

Intervention ^ICMJE

Behavioral: Structured group therapy
One therapy is a highly structured, integrative cognitive behavioral therapy administered in a group format. The group meets once per week for 12 weeks. Each session is 2 hours. Discussion of traumatic events is minimized, but not avoided.
Behavioral: Unstructured Group Therapy
In the unstructured condition, patients discuss current problems, with group process as a primary focus. The group meets once per week for 12 weeks and last for 2 hours. Discussion of past traumatic experiences is minimized, but not avoided.

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

May 2012

Estimated Primary Completion Date

May 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Male

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00984698

Other Study ID Numbers ^ICMJE

W81XWH-08-2-0121

Has Data Monitoring Committee

Yes

Responsible Party

Patricia Haynes, PhD (Principal Investigator), Southern Arizona VA Healthcare System

Study Sponsor ^ICMJE

University of Arizona

Collaborators ^ICMJE

Department of Defense
Southern Arizona VA Health Care System

Investigators ^ICMJE

Principal Investigator:

Patricia Haynes, PhD

University of Arizona

Information Provided By

University of Arizona

Verification Date

August 2011

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

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