Brief Internet Based Treatment for PTSD

NCT ID: NCT01760213

Last Updated: 2013-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

900 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2015-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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PTSD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Treatment

intervention delivered via internet

Group Type EXPERIMENTAL

CBT delivered via Internet

Intervention Type OTHER

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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CBT delivered via Internet

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bar-Ilan University, Israel

OTHER

Sponsor Role collaborator

Hadassah Medical Organization

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rena Cooper, MD

Role: PRINCIPAL_INVESTIGATOR

HMO

Sara Freedman, PhD

Role: STUDY_DIRECTOR

Bar Ilan University

Locations

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Hadassah medical organization

Jerusalem, Israel, Israel

Site Status

Countries

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Israel

Central Contacts

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Rena Cooper, MD

Role: CONTACT

Sara Freedman, PhD

Role: CONTACT

Other Identifiers

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VRInternet

Identifier Type: -

Identifier Source: org_study_id

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