Early Prevention of Post Traumatic Stress Disorder

August 9, 2016 updated by: Sunnybrook Health Sciences Centre

Program Development in Guideline Development, Early Recognition and Specialized Treatment of Post Traumatic Stress Disorder (PTSD) at Sunnybrook Health Sciences Center, Canada's Largest Trauma Center

Sunnybrook Health Sciences Centre is Canada's largest trauma centre, treating 1,100 patients annually. A traumatic experience can lead to post-traumatic stress disorder, which increases hospital stays, emergency visits and disability. Despite developing leadership to manage a "Code Orange" mass trauma, Sunnybrook lacks guidelines in the psychological management of patients who have experienced trauma. The department of psychiatry currently holds a Traumatic Brain Injury clinic and PTSD services for youth but lacks both immediate intervention, prevention and adult services. This research will enable us to gain best evidence expertise to develop guidelines as well as a sustainable PTSD treatment program, with clear outcomes to assess effectiveness, psychiatric morbidity, use of healthcare, disability and substance abuse.

The five world-expert-consensus intervention resilience based principles will be operationalized in guidelines for the management of trauma patients, their caregivers and in routine nursing and trauma team care from the Emergency to the ward, and discharge, through to outpatient care. It is hypothesized that this will improve the psychological recovery of patients at risk of developing PTSD after a traumatic injury. In addition, early screening and intervention for increased risk of PTSD will be implemented one month after the trauma. It is hypothesized that such trauma informed psychological management, early screening and expert treatment using prolonged exposure will reduce hospital stays, functional disability, as well as longer-term psychiatric morbidity, including substance abuse.

Study Overview

Detailed Description

The study is a longitudinal interventional study, with a control group who have treatment for their trauma with no guidelines for psychological management, staff training, patient and family intervention/education. In the intervention group, who will have all of the above, participants will be stratified according to risk factors for PTSD and randomized 1:1 in "low risk" and "at risk" groups-those who will have a prolonged exposure intervention and those who will not.

Study Type

Interventional

Enrollment (Actual)

99

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

    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Health Sciences Center

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

14 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • undergone severe physical trauma within the last 3 days
  • An abbreviated Injury Severity score of 1-3

Exclusion Criteria:

  • 14 years of age or younger
  • an inability to communicate sufficiently in English
  • A diagnosis of psychosis, mental retardation and/or autism

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Control
Treatment as Usual

Participants will experience treatment as usual.

Patients will receive questionnaires at recruitment, 1 month, 3 months and 6 months based on the timeline of Diagnostic and Statistical Manual (DSM) -IV criteria for PTSD

Other: Intervention
Psychological management guidelines + patient education

Psychological guidelines and PET

Patients will receive questionnaires at recruitment, 1 month, 3 months and 6 months based on the timeline of Diagnostic and Statistical Manual (DSM) -IV criteria for PTSD.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence & severity of PTSD symptoms
Time Frame: 1 month, 3 months & 6 months

The aim of the study is to observe whether there's a presence and severity (if applicable) of Posttraumatic symptoms in patients who've received the intervention, compared to those who have not.

Presence and severity of PTSD symptoms will be measured by:

  • follow-up at 1 month, 3 months & 6 months which involve specific PTSD self-report symptom measures: PTSD Symptom Scale
  • Structured Clinical Interview for the Diagnostic and Statistical Manual for Mental Disorder (SCID) Semi-structured interview performed at 6 months either over the phone or in person
1 month, 3 months & 6 months
Depressive symptoms
Time Frame: recruitment, 1 month, 3 months & 6 months
The Beck Depression Inventory - Second Edition (BDI-II) will be used at recruitment, 1 month, 3 months, and 6 months follow-up to measure the presence and/or change in depressive symptoms of the patient.
recruitment, 1 month, 3 months & 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety & dissociation symptoms
Time Frame: recruitment & 1 month
Patients will be assessed for anxiety and dissociation symptoms at recruitment and follow-up at 1 month with the Stanford Acute Stress Reaction Questionnaire (SASRQ).
recruitment & 1 month
Change in patient health & well-being
Time Frame: 6 months
The Short Form (36) Health Survey (SF-36v2) will be used at 6 months follow-up to assess a patient's health and/or disability.
6 months
Change in substance use
Time Frame: recruitment, 1 month, 3 months & 6 months
PTSD is highly correlated with substance use. By implementing a preventative intervention, one aim is to reduce overall substance use. This will be assessed using the Alcohol Use Disorders Identification Test (AUDIT) and the Drug Abuse Screening Test (DAST) at recruitment, 1 month, 3 months and 6 months.
recruitment, 1 month, 3 months & 6 months
Presence & severity of trauma related thoughts and beliefs
Time Frame: 1 month, 3 months & 6 months
follow-up at 1 month, 3 months & 6 months which involve specific PTSD self-report symptom measures: The Posttraumatic Cogntions Inventory (PTCI)
1 month, 3 months & 6 months
Self-esteem
Time Frame: recruitment, 1 month, 3 months & 6 months
The Rosenberg Self-Esteem Scale (RSES) will be used at recruitment, 1 month, 3 months, and 6 months follow-up to measure any change in the patient's self-esteem over time.
recruitment, 1 month, 3 months & 6 months
Locus of Control
Time Frame: recruitment, 1 month, 3 months & 6 months
The Internal Control Index (ICI) will be used at recruitment, 1 month, 3 months, and 6 months follow-up to measure any changes with a patient's Locus of Control, the extent to which they feel they can control the events that occur to them.
recruitment, 1 month, 3 months & 6 months
Self-efficacy
Time Frame: recruitment, 1 month, 3 months & 6 months
The Self-Efficacy Scale will be used at recruitment, 1 month, 3 months & 6 months follow-up to asses any changes in a patient's self-efficacy/personal competence.
recruitment, 1 month, 3 months & 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Janet Ellis, Dr., Sunnybrook Health Sciences Centre

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

January 1, 2013

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

February 22, 2013

First Submitted That Met QC Criteria

December 3, 2013

First Posted (Estimate)

December 9, 2013

Study Record Updates

Last Update Posted (Estimate)

August 10, 2016

Last Update Submitted That Met QC Criteria

August 9, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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