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NCT00656344 Clinical Trial

Cognitive Behavioral Treatment of Posttraumatic Stress Disorder Enhanced by Virtual Reality for Individuals With PTSD and Substance Abuse

Posttraumatic Stress Disorder Clinical Trial

Official title:
Cognitive Behavioral Treatment of Posttraumatic Stress Disorder Enhanced by Virtual Reality for Individuals With PTSD and Substance Abuse

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00656344
Other study ID # 9603000551
Secondary ID
Status Completed
Phase N/A
First received April 7, 2008
Last updated December 6, 2013
Start date October 2006
Est. completion date December 2013

Study information
Verified date December 2013
Source Weill Medical College of Cornell University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

This study is exploring the use of an intervention designed to treat PTSD in individuals with comorbid PTSD and substance abuse resulting from the attacks of September 11 or from military service in Iraq. A cognitive behavioral treatment protocol will be used to treat PTSD. The exposure component of the protocol will be enhanced with the use of virtual reality in which the client will view a virtual environment while describing their trauma.

Recruitment information / eligibility
Status Completed
Enrollment 3
Est. completion date December 2013
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- English-speaking

- Between the ages of 18 and 70

- Exposed to the WTC Attacks (were in towers or in the immediate area) or veterans of the Iraq War

- Diagnosed with PTSD symptoms

- Current substance abuse disorder or history of substance abuse disorder

Exclusion Criteria:

- Presence of current organic mental disorder

- Presence or history of schizophrenia, bipolar disorder or depression with psychotic features, delusional disorder

- Active suicidal ideation, intent, or plan

- Active homicidal ideation, intent, or plan

- Use of pacemaker

- Medically unstable

- History of seizures

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Other:
• Cognitive behavioral treatment enhanced by virtual reality
A cognitive behavioral protocol with cognitive and behavioral techniques will be used to treat symptoms. The exposure part of the treatment will be enhanced with the use of a virtual environment.

Locations
Country Name City State
United States Weill Cornell Medical College New York New York

Sponsors (1)
Lead Sponsor Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary posttraumatic stress symptomatology prior to treatment, during the treatment, immediately following treatment and 6 months after the completion of treatment No
Secondary substance use symptomatology prior to treatment, during treatment, immediately following treatment, and 6 months after the completion of treatment No
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