Early Prevention of Post Traumatic Stress Disorder

Post Traumatic Stress Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02004743
• Other study ID #: 258-2012
• Status: Completed
• Phase: N/A
• First received: February 22, 2013
• Last updated: August 9, 2016
• Start date: January 2013
• Est. completion date: September 2015

Study information

• Verified date: August 2016
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: September 2015
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Disease
• Post Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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.

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

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Center	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1 month, 3 months & 6 months	No
Primary	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.	recruitment, 1 month, 3 months & 6 months	No
Secondary	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).	recruitment & 1 month	No
Secondary	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.	6 months	No
Secondary	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.	recruitment, 1 month, 3 months & 6 months	No
Secondary	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)	1 month, 3 months & 6 months	No
Secondary	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.	recruitment, 1 month, 3 months & 6 months	No
Secondary	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.	recruitment, 1 month, 3 months & 6 months	No
Secondary	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.	recruitment, 1 month, 3 months & 6 months	No