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

This study is currently recruiting participants.
Verified April 2013 by Weill Medical College of Cornell University
Sponsor:
Information provided by (Responsible Party):
Joann Difede, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00656344
First received: April 7, 2008
Last updated: April 12, 2013
Last verified: April 2013
History of Changes
  Purpose

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.


Condition Intervention
Posttraumatic Stress Disorder
Substance Abuse
 Other: Cognitive behavioral treatment enhanced by virtual reality

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Cognitive Behavioral Treatment of Posttraumatic Stress Disorder Enhanced by Virtual Reality for Individuals With PTSD and Substance Abuse

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • posttraumatic stress symptomatology [ Time Frame: prior to treatment, during the treatment, immediately following treatment and 6 months after the completion of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • substance use symptomatology [ Time Frame: prior to treatment, during treatment, immediately following treatment, and 6 months after the completion of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: October 2006
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00656344

Contacts
Contact: Judith Cukor, PhD 212-746-4492 juc2010@med.cornell.edu
Contact: JoAnn Difede, PhD 212-746-3079 jdifede@med.cornell.edu

Locations
United States, New York
Weill Cornell Medical College Recruiting
New York, New York, United States, 10065
Contact: Judith Cukor, PhD     212-746-4492     juc2010@med.cornell.edu    
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Principal Investigator: JoAnn Difede Weill Medical College of Cornell University
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Joann Difede, Professor of Psychology in Psychiatry, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT00656344     History of Changes
Other Study ID Numbers: 9603000551
Study First Received: April 7, 2008
Last Updated: April 12, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Weill Medical College of Cornell University:
PTSD
Substance Abuse
WTC attacks
Iraq War

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Substance-Related Disorders
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 23, 2013