Brief Internet Based Treatment for PTSD

PTSD Clinical Trial

Official title:

Internet Based Treatment Using Virtual Reality in the Prevention of PTSD

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01760213
• Other study ID #: VRInternet
• Status: Not yet recruiting
• Phase: N/A
• First received: December 12, 2012
• Last updated: May 22, 2013
• Start date: January 2013
• Est. completion date: August 2015

Study information

• Verified date: December 2012
• Source: Hadassah Medical Organization
• Contact: Rena Cooper, MD
• Email: crena[@]hadassah.org.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 900
• Est. completion date: August 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• PTSD

Intervention

Other:
• CBT delivered via Internet

Locations

Country	Name	City	State
Israel	Hadassah medical organization	Jerusalem

Sponsors (2)

Lead Sponsor	Collaborator
Hadassah Medical Organization	Bar-Ilan University, Israel

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Levels of PTSD symptoms	the main outcome measure will be PTSD symptoms as measured by the CAPS.	12 months after end of treatment	No