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

Not Applicable

Completed

• Conditions: Posttraumatic Stress Disorder; Depression; Insomnia Disorder

• Registration Number: NCT00984698
• Lead Sponsor: University of Arizona

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 Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-09-24
• Study First Submitted QC: 2009-09-24
• Study First Posted: 2009-09-25
• Primary Completion: 2012-05
• Study Completion: 2012-08
• Results First Submitted: 2014-01-06
• Status Verified: 2014-02
• Results First Submitted QC: 2014-02-14
• Last Update Submitted: 2014-02-14
• Results First Posted: 2014-03-31
• Last Update Posted: 2014-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 115

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Depression	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 Outcome Measures

Name	Time	Method
PTSD	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).

Trial Locations

Locations (2)

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

University of Arizona; 🇺🇸 Tucson, Arizona, United States