Group Based Exposure Therapy for Combat-Related PTSD

NCT00535223 | Completed Results

• 1 other identifier: MHBA-010-06F
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this randomized controlled trial is to determine if Group Based Exposure Therapy (GBET) is more effective than treatment as usual in reducing the symptoms of war-related Posttraumatic Stress Disorder (PTSD).

Conditions

Posttraumatic Stress Disorder

Keywords

Cognitive Behavior Therapy; Group therapy; Posttraumatic Stress Disorder; Randomized Controlled Trial; Treatment outcome; Veterans; War

Outcome Measures

Primary Outcomes (1)

• Clinician Administered PTSD Scale (CAPS)

  This is an interview regarding the frequency and intensity of each of the 17 PTSD symptoms found in DSM IV and includes information about the degree to which these symptoms are interfering with functioning. This interview includes that clinician rating the participants responses for both the frequency of each symptom and the intensity of each symptom on a scale of zero to four. A score of 0, best possible score, would indicate that the participant is no longer reporting any of the 17 DSM IV symptoms of PTSD. The worse possible score is 136, this would indicate that a participant was reporting every symptoms of PTSD occurring daily or almost daily and that each symptom is causing the most extreme level of distress.

  Pre treatment, Post treatment (16 weeks) and One year post treatment

Secondary Outcomes (1)

• Posttraumatic Cognitions Inventory (PTCI)

  Pre-treatment, Post-Treatment (16 weeks) and One year Post Treatment

Study Arms (2)

Group Based Exposure Therapy

EXPERIMENTAL

Behavioral: GBET is a 16-week program during which patients attend group therapy twice a week for three hours of group per day and are required to make two war trauma presentations to their group. These are recorded and the patients are required to listen to these recordings a minimum of 10 times. There are generally 10 patients per group and through the combination of making their own presentations, listening to recordings of these presentations, and hearing the presentations of the other nine group members, there are over 60 hours of exposure. Patients also learn about PTSD symptoms, sleep hygiene, specific stress/anger management techniques, and ways to cognitively restructure trauma-related thinking.

Behavioral: Group Based Exposure Therapy

Present Centered Group Therapy

EXPERIMENTAL

Present Centered Group Therapy includes psych-education about PTSD and a problem solving "here and now" focus. This lasted for 16 weeks.

Behavioral: Present Centered Group Therapy

Interventions

Group Based Exposure Therapy BEHAVIORAL

GBET is a 16-week program during which patients attend group therapy twice a week for three hours of group per day and are required to make two war trauma presentations to their group. These are recorded and the patients are required to listen to these recordings a minimum of 10 times. There are generally 10 patients per group and through the combination of making their own presentations, listening to recordings of these presentations, and hearing the presentations of the other nine group members, there are over 60 hours of exposure. Patients also learn about PTSD symptoms, sleep hygiene, specific stress/anger management techniques, and ways to cognitively restructure trauma-related thinking.

Group Based Exposure Therapy

Present Centered Group Therapy BEHAVIORAL

Present Centered Group Therapy includes psych-education about PTSD and a problem solving "here and now" focus.

Present Centered Group Therapy

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male veterans diagnosed with war-related PTSD as assessed by the CAPS. Patients must provide a DD214 or other documentation of war exposure.
• Patients must have the ability to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments (as evident by the ability to pass informed consent test, to fill out self-report assessment measures and to respond appropriately during the clinical interview).
• Patients must be either stable on psychotropic medication (defined as no additional psychotropic medications or significant increases in previously prescribed psychotropic medications for a period of at least three months) or not on psychotropic medication.
• Patients must be currently in treatment within the Mental Health Clinic (MHC) of the Atlanta VA Medical Center for a minimum of four months prior to participation. This would insure adequate psychiatric coverage and case management. If a change in medication were needed during the study, it would be made. Such changes would be tracked for analysis if they occur in a significant number of patients.
• Patients must have the support of their current Mental Health Clinic Treatment Team to participate in the study.

You may not qualify if:

• Patients with current or history of mania or schizophrenia would be excluded because the stress of exposure therapy may precipitate an increase in symptoms of these co-morbid conditions that could interfere with the patient's ability to benefit from treatment.
• Patients suffering from current active psychosis, active mania, or sufficient mental impairment, as assessed by a Mini Mental State Exam score below 24, which would prevent the patient from providing valid consent or participating safely or understanding the treatment.
• Patients with current, prominent suicidal ideation. All patients would be screened for suicidal ideation and intention by the RC in the initial screening and again by the IA in the initial assessment through a brief clinical interview. A BDI #9 score above 3 would prompt a more in-depth inquiry concerning suicidal thoughts and intentions during the initial assessment.
• Patients who currently meet diagnostic criteria for substance abuse or dependence or have met such criteria during the previous three months (as measured by the clinical interview and the Kreek-McHugh-Schluger-Kellogg scale (50)).

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (1)

VA Medical Center, Decatur

Decatur, Georgia, 30033, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Results Point of Contact

• Title: David J. Ready,Ph.D.
• Organization: Atlanta VA Medical Center

David.Ready@va.gov

(404) 321-6111

Study Officials

• David Ready, PhD MS

  VA Medical Center, Decatur

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2007
• First Posted: September 26, 2007
• Study Start: July 1, 2007
• Primary Completion: July 1, 2010
• Study Completion: August 1, 2012
• Last Updated: March 26, 2015
• Results First Posted: March 26, 2015

Record last verified: 2015-03

Locations

US (1)