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

Primary Purpose

Posttraumatic Stress Disorder, Substance Abuse

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive behavioral treatment enhanced by virtual reality
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorder focused on measuring PTSD, Substance Abuse, WTC attacks, Iraq War

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Weill Cornell Medical College

Outcomes

Primary Outcome Measures

posttraumatic stress symptomatology

Secondary Outcome Measures

substance use symptomatology

Full Information

First Posted
April 7, 2008
Last Updated
December 6, 2013
Sponsor
Weill Medical College of Cornell University
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1. Study Identification

Unique Protocol Identification Number
NCT00656344
Brief Title
Cognitive Behavioral Treatment of Posttraumatic Stress Disorder Enhanced by Virtual Reality for Individuals With PTSD and Substance Abuse
Official Title
Cognitive Behavioral Treatment of Posttraumatic Stress Disorder Enhanced by Virtual Reality for Individuals With PTSD and Substance Abuse
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Weill Medical College of Cornell University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder, Substance Abuse
Keywords
PTSD, Substance Abuse, WTC attacks, Iraq War

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
Cognitive behavioral treatment enhanced by virtual reality
Intervention Description
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.
Primary Outcome Measure Information:
Title
posttraumatic stress symptomatology
Time Frame
prior to treatment, during the treatment, immediately following treatment and 6 months after the completion of treatment
Secondary Outcome Measure Information:
Title
substance use symptomatology
Time Frame
prior to treatment, during treatment, immediately following treatment, and 6 months after the completion of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JoAnn Difede
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.patss.com
Description
Related Info

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

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