Early Prevention of Post Traumatic Stress Disorder
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|ClinicalTrials.gov Identifier: NCT02004743|
Recruitment Status : Completed
First Posted : December 9, 2013
Last Update Posted : August 10, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Post Traumatic Stress Disorder||Behavioral: Intervention Other: Treatment as usual||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||99 participants|
|Intervention Model:||Parallel Assignment|
|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 Start Date :||January 2013|
|Actual Primary Completion Date :||September 2014|
|Actual Study Completion Date :||September 2015|
Treatment as Usual
Other: 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
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.
- 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
- 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.
- 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).
- 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.
- 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.
- 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)
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02004743
|Sunnybrook Health Sciences Center|
|Toronto, Ontario, Canada, M4N 3M5|
|Principal Investigator:||Janet Ellis, Dr.||Sunnybrook Health Sciences Centre|