Brief Internet Based Treatment for PTSD

This study is not yet open for participant recruitment.
Verified December 2012 by Hadassah Medical Organization
Sponsor:
Collaborator:
Bar-Ilan University, Israel
Information provided by (Responsible Party):
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01760213
First received: December 12, 2012
Last updated: May 22, 2013
Last verified: December 2012
  Purpose

The goal of the project is to overcome some of the common barriers to treatment amongst recent survivors of traumatic events, by combining the world of evidence-based intervention with that of modern Internet technology. Specifically, it aims to test the feasibility and effectiveness of an Internet delivery of early-intervention trauma-focused cognitive behavioral therapy (CBT) for preventing post-traumatic stress disorder (PTSD). Over the course of the study the following objectives will be achieved:

  1. The development of an Internet-based Virtual Reality intervention for preventing PTSD among patients who have recently experienced a traumatic event.
  2. The evaluation of the feasibility of administering this intervention, and
  3. The evaluation of the efficacy of this Internet based intervention in the prevention of PTSD in recent trauma survivors.

Condition Intervention
PTSD
Other: CBT delivered via Internet

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Internet Based Treatment Using Virtual Reality in the Prevention of PTSD

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • Levels of PTSD symptoms [ Time Frame: 12 months after end of treatment ] [ Designated as safety issue: No ]
    the main outcome measure will be PTSD symptoms as measured by the CAPS.


Estimated Enrollment: 900
Study Start Date: January 2013
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment
intervention delivered via internet
Other: CBT delivered via Internet
No Intervention: Control

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Exposed to a traumatic event that meets DSM Criteria (objectively could cause physical injury;
  • Subjectively involves helplessness or fear);
  • Aged over 18; Aged under 65;
  • Hebrew speaking; Suffering from PTSD (without the time criteria i.e. less than one month of symptoms);
  • Able to give informed consent.

Exclusion Criteria:

  • Suffering from, or have suffered from in the past, bipolar disorder;
  • Suffering from, or have suffered from in the past, psychotic disorder;
  • Suffering from, or have suffered from in the past, substance abuse;
  • Suffering from PTSD;
  • Suffering from another Axis I anxiety disorder that requires immediate treatment;
  • Currently presents as a suicide risk, requiring hospitalization.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01760213

Contacts
Contact: Rena Cooper, MD crena@hadassah.org.il
Contact: Sara Freedman, PhD sarafreedman@gmail.com

Locations
Israel
Hadassah medical organization Not yet recruiting
Jerusalem, Israel, 91200
Sponsors and Collaborators
Hadassah Medical Organization
Bar-Ilan University, Israel
Investigators
Principal Investigator: Rena Cooper, MD HMO
Study Director: Sara Freedman, PhD Bar Ilan University
  More Information

No publications provided

Responsible Party: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01760213     History of Changes
Other Study ID Numbers: VRInternet
Study First Received: December 12, 2012
Last Updated: May 22, 2013
Health Authority: Israel: Ministry of Health

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

ClinicalTrials.gov processed this record on April 15, 2014