Examining an Emergency Room Intervention for the Preventi... | NCT01162044

Studies
Examining an Emergency Room Intervention for the Prevention of Post Traumatic Stress Disorder (PTSD)

NCT01162044

Sponsor

Hadassah Medical Organization

Status

Unknown status

Last Update Posted

Jul 14, 2010Estimated

Enrollment

80Estimated

Phase

Not Applicable

Conditions

Posttraumatic Stress Disorder

Interventions

Computer game

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2010

Primary Completion Date

Jun 2011Estimated

Completion Date

Sep 2011Estimated

First Submitted Date

Jul 13, 2010

First Submission Date that Met QC Criteria

Jul 13, 2010

First Posted Date

Jul 14, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 13, 2010

Last Update Posted Date

Jul 14, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Computer game	Other	Playing with specially designed computer game while in emergency room	Computer game

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
PTSD symptoms	PTSD status and symptoms as measured by the PSS	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sara A Freedman, PhD	Contact	972544704636		sarafreedman@gmail.com

Overall Officials

Name	Affiliation	Role
Rena Cooper, MD	Hadassah Medical Organization	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hadassah Medical Center		Jerusalem			Israel

Condition Browse Module

MeSH Terms

ID	Term
D013313	Stress Disorders, Post-Traumatic

Ancestor Terms

ID	Term
D040921	Stress Disorders, Traumatic
D000068099	Trauma and Stressor Related Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided