- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01162044
Examining an Emergency Room Intervention for the Prevention of Post Traumatic Stress Disorder (PTSD)
July 13, 2010 updated by: Hadassah Medical Organization
Interrupting Traumatic Memories: An Emergency Room Intervention for the Prevention of PTSD
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Jerusalem, Israel
- Hadassah Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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).
Exclusion Criteria:
- current or past psychiatric treatment,
- current or past PTSD.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: No intervention
Subjects will be assessed, but no active intervention given
|
|
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Experimental: Computer game
Subjects will play with computer game while in the Emergency Room
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Playing with specially designed computer game while in emergency room
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PTSD symptoms
Time Frame: 6 months
|
PTSD status and symptoms as measured by the PSS
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: rena Cooper, MD, Hadassah Medical Organization
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2010
Primary Completion (Anticipated)
June 1, 2011
Study Completion (Anticipated)
September 1, 2011
Study Registration Dates
First Submitted
July 13, 2010
First Submitted That Met QC Criteria
July 13, 2010
First Posted (Estimate)
July 14, 2010
Study Record Updates
Last Update Posted (Estimate)
July 14, 2010
Last Update Submitted That Met QC Criteria
July 13, 2010
Last Verified
July 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ER-PTSD-HMO-CTIL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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