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

This study has been completed.
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: December 6, 2013
Last verified: December 2013
  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:


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 ]

Enrollment: 3
Study Start Date: October 2006
Study Completion Date: December 2013
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, New York
Weill Cornell Medical College
New York, New York, United States, 10065
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Principal Investigator: JoAnn Difede Weill Medical College of Cornell University
  More Information

Additional Information:
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: December 6, 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
Chemically-Induced Disorders

ClinicalTrials.gov processed this record on August 20, 2014