Examining an Emergency Room Intervention for the Prevention of Post Traumatic Stress Disorder (PTSD)
Primary Purpose
Posttraumatic Stress Disorder
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Computer game
Sponsored by
About this trial
This is an interventional prevention trial for Posttraumatic Stress Disorder focused on measuring PTSD, prevention
Eligibility Criteria
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.
Sites / Locations
- Hadassah Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
No intervention
Computer game
Arm Description
Subjects will be assessed, but no active intervention given
Subjects will play with computer game while in the Emergency Room
Outcomes
Primary Outcome Measures
PTSD symptoms
PTSD status and symptoms as measured by the PSS
Secondary Outcome Measures
Full Information
NCT ID
NCT01162044
First Posted
July 13, 2010
Last Updated
July 13, 2010
Sponsor
Hadassah Medical Organization
1. Study Identification
Unique Protocol Identification Number
NCT01162044
Brief Title
Examining an Emergency Room Intervention for the Prevention of Post Traumatic Stress Disorder (PTSD)
Official Title
Interrupting Traumatic Memories: An Emergency Room Intervention for the Prevention of PTSD
Study Type
Interventional
2. Study Status
Record Verification Date
July 2010
Overall Recruitment Status
Unknown status
Study Start Date
November 2010 (undefined)
Primary Completion Date
June 2011 (Anticipated)
Study Completion Date
September 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Hadassah Medical Organization
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder
Keywords
PTSD, prevention
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
Subjects will be assessed, but no active intervention given
Arm Title
Computer game
Arm Type
Experimental
Arm Description
Subjects will play with computer game while in the Emergency Room
Intervention Type
Other
Intervention Name(s)
Computer game
Intervention Description
Playing with specially designed computer game while in emergency room
Primary Outcome Measure Information:
Title
PTSD symptoms
Description
PTSD status and symptoms as measured by the PSS
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sara A Freedman, PhD
Phone
972544704636
Email
sarafreedman@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rena Cooper, MD
Organizational Affiliation
Hadassah Medical Organization
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hadassah Medical Center
City
Jerusalem
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Examining an Emergency Room Intervention for the Prevention of Post Traumatic Stress Disorder (PTSD)
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