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Brief Internet Based Treatment for PTSD

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ClinicalTrials.gov Identifier: NCT01760213
Recruitment Status : Unknown
Verified December 2012 by Hadassah Medical Organization.
Recruitment status was:  Not yet recruiting
First Posted : January 4, 2013
Last Update Posted : May 23, 2013
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 or disease Intervention/treatment
PTSD Other: CBT delivered via Internet

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 900 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Internet Based Treatment Using Virtual Reality in the Prevention of PTSD
Study Start Date : January 2013
Estimated Primary Completion Date : January 2015
Estimated Study Completion Date : August 2015
Arms and Interventions

Arm Intervention/treatment
Experimental: Treatment
intervention delivered via internet
Other: CBT delivered via Internet
No Intervention: Control


Outcome Measures

Primary Outcome Measures :
  1. Levels of PTSD symptoms [ Time Frame: 12 months after end of treatment ]
    the main outcome measure will be PTSD symptoms as measured by the CAPS.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01760213     History of Changes
Other Study ID Numbers: VRInternet
First Posted: January 4, 2013    Key Record Dates
Last Update Posted: May 23, 2013
Last Verified: December 2012