Early Prevention of Post Traumatic Stress Disorder

NCT02004743 | Completed DMC

• 1 other identifier: 258-2012
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Traumatic Stress Disorder

Keywords

Early Intervention; Prevention; Risk Factors; Exposure Therapy; Psychoeducation

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (7)

• Anxiety & dissociation symptoms

  recruitment & 1 month

• Change in patient health & well-being

  6 months

• Change in substance use

  recruitment, 1 month, 3 months & 6 months

• Presence & severity of trauma related thoughts and beliefs

  1 month, 3 months & 6 months

• Self-esteem

  recruitment, 1 month, 3 months & 6 months

Study Arms (2)

Control

OTHER

Treatment as Usual

Other: Treatment as usual

Intervention

OTHER

Psychological management guidelines + patient education

Behavioral: Intervention

Interventions

Intervention BEHAVIORAL

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

Treatment as usual OTHER

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

Control

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• undergone severe physical trauma within the last 3 days
• An abbreviated Injury Severity score of 1-3

You may not qualify if:

• years of age or younger
• an inability to communicate sufficiently in English
• A diagnosis of psychosis, mental retardation and/or autism

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Sciences Center

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Methods; Therapeutics

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Janet Ellis, Dr.

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2013
• First Posted: December 9, 2013
• Study Start: January 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2015
• Last Updated: August 10, 2016

Record last verified: 2016-08

Locations

CA (1)