NCT00474305

Brief Summary

This study will examine whether the use of a Virtual World will be effective in helping treat Posttraumatic Stress Disorder (PTSD). This is a pilot study, with five victims of bus bombings who have developed PTSD. The study will examine pre- and post-treatment levels of PTSD, anxiety, depression and day-to-day functioning.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 15, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 16, 2007

Completed
7 months until next milestone

Study Start

First participant enrolled

December 1, 2007

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

December 16, 2010

Status Verified

May 1, 2010

Enrollment Period

3.7 years

First QC Date

May 15, 2007

Last Update Submit

December 15, 2010

Conditions

PTSD

Keywords

PTSDProlonged ExposureVirtual Reality

Outcome Measures

Primary Outcomes (1)

  • Clinician Administered PTSD Scale (CAPS)

    Pre and Post Treatment

Secondary Outcomes (2)

  • Beck Depression Inventory

    Pre and Post Treatment

  • Activity Card Sort

    Pre and Post Treatment

Interventions

Virtual Reality Treatment for PTSDBEHAVIORAL

12 session protocol for Prolonged Exposure with Virtual Reality. All sessions 90 minutes.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • PTSD following a bus bombing
  • Hebrew speaking

You may not qualify if:

  • Other psychiatric illness
  • Other concurrent intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Organization

Jerusalem, 91120, Israel

RECRUITING

Related Publications (2)

  • Difede J, Cukor J, Patt I, Giosan C, Hoffman H. The application of virtual reality to the treatment of PTSD following the WTC attack. Ann N Y Acad Sci. 2006 Jul;1071:500-1. doi: 10.1196/annals.1364.052.

    PMID: 16891607BACKGROUND

  • Freedman SA, Hoffman HG, Garcia-Palacios A, Tamar Weiss PL, Avitzour S, Josman N. Prolonged exposure and virtual reality-enhanced imaginal exposure for PTSD following a terrorist bulldozer attack: a case study. Cyberpsychol Behav Soc Netw. 2010 Feb;13(1):95-101. doi: 10.1089/cyber.2009.0271.

    PMID: 20528299DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Sara A Freedman, PhD

    Hadassah Medical Organization

    STUDY DIRECTOR

Central Study Contacts

Rena Cooper Kazaz, MD

CONTACT

97226777348

Hadas Lemberg, PhD

CONTACT

97226777572lhadas@hadassah.org.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 15, 2007

First Posted

May 16, 2007

Study Start

December 1, 2007

Primary Completion

August 1, 2011

Study Completion

December 1, 2011

Last Updated

December 16, 2010

Record last verified: 2010-05

Locations

IL(1)