Clinical trial NCT02004743: 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
Overall status: COMPLETED
Phase: NA
Conditions: Post Traumatic Stress Disorder
Keywords: Early Intervention
Prevention
Risk Factors
Exposure Therapy
Psychoeducation
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2013-12-09
Enrollment: 99
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Presence & severity of PTSD symptoms
timeFrame: 1 month, 3 months & 6 months
measure: Depressive symptoms
timeFrame: recruitment, 1 month, 3 months & 6 months
Secondary outcomes:
measure: Anxiety & dissociation symptoms
timeFrame: recruitment & 1 month
measure: Change in patient health & well-being
timeFrame: 6 months
measure: Change in substance use
timeFrame: recruitment, 1 month, 3 months & 6 months
measure: Presence & severity of trauma related thoughts and beliefs
timeFrame: 1 month, 3 months & 6 months
measure: Self-esteem
timeFrame: recruitment, 1 month, 3 months & 6 months
measure: Locus of Control
timeFrame: recruitment, 1 month, 3 months & 6 months
measure: Self-efficacy
timeFrame: recruitment, 1 month, 3 months & 6 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Center
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Janet Ellis, Dr.
role: PRINCIPAL_INVESTIGATOR
References: