Early Prevention of Post Traumatic Stress Disorder
Primary Purpose
Post Traumatic Stress Disorder
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Intervention
Treatment as usual
Sponsored by
About this trial
This is an interventional prevention trial for Post Traumatic Stress Disorder focused on measuring Early Intervention, Prevention, Risk Factors, Exposure Therapy, Psychoeducation
Eligibility Criteria
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
Sites / Locations
- Sunnybrook Health Sciences Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Control
Intervention
Arm Description
Treatment as Usual
Psychological management guidelines + patient education
Outcomes
Primary Outcome Measures
Presence & severity of PTSD symptoms
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
Depressive symptoms
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.
Secondary Outcome Measures
Anxiety & dissociation symptoms
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).
Change in patient health & well-being
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.
Change in substance use
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.
Presence & severity of trauma related thoughts and beliefs
follow-up at 1 month, 3 months & 6 months which involve specific PTSD self-report symptom measures: The Posttraumatic Cogntions Inventory (PTCI)
Self-esteem
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.
Locus of Control
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.
Self-efficacy
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.
Full Information
NCT ID
NCT02004743
First Posted
February 22, 2013
Last Updated
August 9, 2016
Sponsor
Sunnybrook Health Sciences Centre
1. Study Identification
Unique Protocol Identification Number
NCT02004743
Brief Title
Early Prevention of Post Traumatic Stress Disorder
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sunnybrook Health Sciences Centre
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Traumatic Stress Disorder
Keywords
Early Intervention, Prevention, Risk Factors, Exposure Therapy, Psychoeducation
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
99 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Other
Arm Description
Treatment as Usual
Arm Title
Intervention
Arm Type
Other
Arm Description
Psychological management guidelines + patient education
Intervention Type
Behavioral
Intervention Name(s)
Intervention
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Treatment as usual
Intervention Description
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
Primary Outcome Measure Information:
Title
Presence & severity of PTSD symptoms
Description
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
Time Frame
1 month, 3 months & 6 months
Title
Depressive symptoms
Description
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.
Time Frame
recruitment, 1 month, 3 months & 6 months
Secondary Outcome Measure Information:
Title
Anxiety & dissociation symptoms
Description
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).
Time Frame
recruitment & 1 month
Title
Change in patient health & well-being
Description
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.
Time Frame
6 months
Title
Change in substance use
Description
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.
Time Frame
recruitment, 1 month, 3 months & 6 months
Title
Presence & severity of trauma related thoughts and beliefs
Description
follow-up at 1 month, 3 months & 6 months which involve specific PTSD self-report symptom measures: The Posttraumatic Cogntions Inventory (PTCI)
Time Frame
1 month, 3 months & 6 months
Title
Self-esteem
Description
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.
Time Frame
recruitment, 1 month, 3 months & 6 months
Title
Locus of Control
Description
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.
Time Frame
recruitment, 1 month, 3 months & 6 months
Title
Self-efficacy
Description
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.
Time Frame
recruitment, 1 month, 3 months & 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janet Ellis, Dr.
Organizational Affiliation
Sunnybrook Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sunnybrook Health Sciences Center
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Early Prevention of Post Traumatic Stress Disorder
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