NCT01162044

Brief Summary

PTSD is a common and distressing possible outcome following exposure to a traumatic event. Recent studies show that memory processes may be central to the development of the disorder, and interrupting the consolidation of traumatic memories may prevent the disorder from developing. Specifically the use of a visual spatial task has been shown to reduce a key characteristic of PTSD, intrusions, in non-clinical populations. This study aims to administer a visual spatial task to recent trauma survivors in the Emergency Room, and compare PTSD and symptoms development in these patients as compared to a control group who did not carry out the task. The study hypothesizes that the task will result in less PTSD, lower levels of intrusions, dissociation and pain.

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
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2010

Shorter than P25 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

July 13, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 14, 2010

Completed
4 months until next milestone

Study Start

First participant enrolled

November 1, 2010

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

July 14, 2010

Status Verified

July 1, 2010

Enrollment Period

7 months

First QC Date

July 13, 2010

Last Update Submit

July 13, 2010

Conditions

Posttraumatic Stress Disorder

Keywords

PTSDprevention

Outcome Measures

Primary Outcomes (1)

  • PTSD symptoms

    PTSD status and symptoms as measured by the PSS

    6 months

Study Arms (2)

No intervention

NO INTERVENTION

Subjects will be assessed, but no active intervention given

Computer game

EXPERIMENTAL

Subjects will play with computer game while in the Emergency Room

Other: Computer game

Interventions

Computer gameOTHER

Playing with specially designed computer game while in emergency room

Computer game

Eligibility Criteria

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

You may qualify if:

  • age 18-65,
  • no loss of consciousness,
  • ability to understand study procedures and give informed consent,
  • Hebrew as first language,
  • experienced a potentially traumatic event as defined in DSM (objective danger and subjective feeling of fear).

You may not qualify if:

  • current or past psychiatric treatment,
  • current or past PTSD.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Center

Jerusalem, Israel

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Rena Cooper, MD

    Hadassah Medical Organization

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara A Freedman, PhD

CONTACT

972544704636sarafreedman@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 13, 2010

First Posted

July 14, 2010

Study Start

November 1, 2010

Primary Completion

June 1, 2011

Study Completion

September 1, 2011

Last Updated

July 14, 2010

Record last verified: 2010-07

Locations

IL(1)