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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00984698
• Other study ID #: W81XWH-08-2-0121
• Status: Completed
• Phase: N/A
• First received: September 24, 2009
• Last updated: February 14, 2014
• Start date: May 2009
• Est. completion date: August 2012

Study information

• Verified date: February 2014
• Source: University of Arizona
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: August 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Depression
• Disease
• Insomnia Disorder
• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Cognitive Behavioral Social Rhythm Group Therapy
12 weeks, 2h structured group therapy
• Present Centered Group Therapy
12 weeks, 2h relatively unstructured group therapy

Locations

Country	Name	City	State
United States	Southern Arizona VA Healthcare System (SAVAHCS)	Tucson	Arizona
United States	University of Arizona	Tucson	Arizona

Sponsors (3)

Lead Sponsor	Collaborator
University of Arizona	Southern Arizona VA Health Care System, United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depression	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	No
Secondary	PTSD	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	No

External Links

•   Click here for more information about this study: A Randomized Controlled Trial of Group Psychotherapy for Veterans and Military Personnel With PTSD