An interventional study of Intervention and Treatment as usual in Post Traumatic Stress Disorder, sponsored by Sunnybrook Health Sciences Centre. Completed at 1 site in Canada. Open to participants aged 14 Years and older. Per ClinicalTrials.gov, last updated 2016-08-10.
Sponsored by Sunnybrook Health Sciences Centre · Not applicable, Interventional, and Prevention
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.
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.
1,148 studies on the registry are indexed under Stress Disorders, Traumatic; 108 are open to participants now.
This study's enrollment of 99 is above the median of 60 across 909 interventional studies indexed under Stress Disorders, Traumatic.
Browse Stress Disorders, Traumatic studies →Sunnybrook Health Sciences Centre is the lead sponsor of 566 studies on the registry; 134 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
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Exclusion Criteria:
Treatment as Usual
Other: Treatment as usual
Psychological management guidelines + patient education
Behavioral: Intervention
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.
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
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
Time frame: 1 month, 3 months & 6 months
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.
Time frame: recruitment, 1 month, 3 months & 6 months
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).
Time frame: recruitment & 1 month
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.
Time frame: 6 months
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.
Time frame: recruitment, 1 month, 3 months & 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)
Time frame: 1 month, 3 months & 6 months
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.
Time frame: recruitment, 1 month, 3 months & 6 months
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.
Time frame: recruitment, 1 month, 3 months & 6 months
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.
Time frame: recruitment, 1 month, 3 months & 6 months
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.
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Sunnybrook Health Sciences Centre