Brief Internet Based Treatment for PTSD

May 22, 2013 updated by: Hadassah Medical Organization

Internet Based Treatment Using Virtual Reality in the Prevention of PTSD

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

900

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Israel
      • Jerusalem, Israel, 91200
        • Hadassah Medical Organization

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Control
EXPERIMENTAL: Treatment
intervention delivered via internet
Other: CBT delivered via Internet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months after end of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hadassah Medical Organization

Collaborators

Bar-Ilan University, Israel

Investigators

  • Principal Investigator: Rena Cooper, MD, HMO
  • Study Director: Sara Freedman, PhD, Bar Ilan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (ANTICIPATED)

January 1, 2015

Study Completion (ANTICIPATED)

August 1, 2015

Study Registration Dates

First Submitted

December 12, 2012

First Submitted That Met QC Criteria

January 3, 2013

First Posted (ESTIMATE)

January 4, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

May 23, 2013

Last Update Submitted That Met QC Criteria

May 22, 2013

Last Verified

December 1, 2012

More Information

Terms related to this study

Other Study ID Numbers

  • VRInternet

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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