Brief Internet Based Treatment for PTSD

NCT01760213 | Unknown DMC

• 1 other identifier: VRInternet
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 1

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

Conditions

PTSD

Outcome Measures

Primary Outcomes (1)

• Levels of PTSD symptoms

  the main outcome measure will be PTSD symptoms as measured by the CAPS.

  12 months after end of treatment

Study Arms (2)

Treatment

EXPERIMENTAL

intervention delivered via internet

Other: CBT delivered via Internet

Control

NO INTERVENTION

Interventions

CBT delivered via Internet OTHER

Treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hadassah Medical Organization: lead
• Bar-Ilan University, Israel: collaborator

Study Sites (1)

Hadassah medical organization

Jerusalem, Israel, 91200, Israel

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Rena Cooper, MD

  HMO

  PRINCIPAL INVESTIGATOR

• Sara Freedman, PhD

  Bar Ilan University

  STUDY DIRECTOR

Central Study Contacts

Rena Cooper, MD

CONTACT

crena@hadassah.org.il

Sara Freedman, PhD

CONTACT

sarafreedman@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2012
• First Posted: January 4, 2013
• Study Start: January 1, 2013
• Primary Completion: January 1, 2015
• Study Completion: August 1, 2015
• Last Updated: May 23, 2013

Record last verified: 2012-12

Locations

IL (1)