Group Based Exposure Therapy for Combat-Related PTSD

Completed · Not applicable

Conditions studied: Posttraumatic Stress Disorder

In brief

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).

Key facts

Study ID

NCT00535223

Run by

US Department of Veterans Affairs

People needed

81

Starts

2007-07-01

Expected to finish

2012-08-01

Last updated by the study team

2015-03-26

Who can join

Age: any. Sex: male. Healthy volunteers: not accepted.

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…

• Exclusion criteria are intended to exclude patients who might be harmed by study participation and to yield as ecologically valid a sample as possible.
• 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)).

Where it is running

• VA Medical Center, Decatur — Decatur, Georgia, United States

Full record on ClinicalTrials.gov

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