Early Prevention of PTSD in Patients Within One Week of Acute Physical Trauma

NCT02915497 | Suspended DMC

• 1 other identifier: 411-2014
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to assess the feasibility and effectiveness of AEPET plus Resilience Based Therapy (RBT) versus RBT alone for the prevention of PTSD and depression in trauma patients. The intervention group who have AEPET plus RBT will have reduced level of post traumatic stress symptoms and depression post sessions as well as reduced symptoms of PTSD and depression at 4- 6 weeks as compared to the control group who have -"Resilience Based" less specific supportive therapy.

Conditions

Post Traumatic Stress Disorder

Keywords

Prolonged Exposure Therapy

Outcome Measures

Primary Outcomes (1)

• PTSD Presence and Severity at 1 month follow-up

  Scale used to assess presence and measure severity: The Post-Traumatic Stress Disorder (PTSD) Symptom Scale -Interview (PSS-I)

  1 - 2 Months

Secondary Outcomes (4)

• Change from Baseline Trauma-related Thoughts and Beliefs at Therapy Time-Point 2 and 1 month follow-up

  1 - 2 Months

• Change from Baseline Depresssive Symptoms at Therapy Time-Point 2 and 1 month follow-up

  1 - 2 Months

• PTSD Presence and Severity and Diagnosis at 1 month follow-up

  1 - 2 Months

• Psychological Well-being at 1 month follow-up

  1 - 2 Months

Study Arms (2)

Treatment As Usual + Resilience-Based Supportive Therapy

NO INTERVENTION

Routine psychosocial management of trauma patients, including Manualized Resilience-Based Therapy.

Abbreviated Early Prolonged Exposure Therapy

EXPERIMENTAL

AEPET, including Manualized Resilience-Based supportive Therapy.

Behavioral: Abbreviated Early Prolonged Exposure Therapy

Interventions

Abbreviated Early Prolonged Exposure Therapy BEHAVIORAL

Since many trauma patients are discharged within 4 weeks, AEPET with the same length (45 minutes - 1 hour) and number of sessions as PET, is given in a shorter time period (daily for 3 days as opposed to weekly over 3 weeks).

Abbreviated Early Prolonged Exposure Therapy

Eligibility Criteria

• Age: 17 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 17-75
• Experienced an acute physical trauma in the past 4 days where the patient believed it was potentially life-threatening in their mind at the time of the trauma
• Have some clear memories of the trauma
• Contain any risk factors for PTSD
• An abbreviated Injury Severity (AIS) score of 1-3 (Minor, Moderate and Severe; not life threatening)

You may not qualify if:

• Inability to communicate sufficiently in English to be able to complete questionnaires and provide informed consent
• A diagnosis of psychosis, mental retardation or autism
• Blood alcohol level of \>0.08mmol/L (25 mg/dl) at time of admission
• Cognitive impairment apparent on interview/collateral from trauma team
• Severe head injury
• Withdrawal Criteria
• If the patient is thought to be at risk to self or others, or be in need of immediate psychiatric assessment, in which case the patient will be referred urgently for assessment with psychosocial oncology or department of psychiatry
• If the patient wishes to discontinue the study
• If the patient is noted to be cognitively impaired during the course of the study such that he/she cannot complete a questionnaire reliably or physically impaired such that it is too burdensome for the patient to complete the questionnaire package.

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

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

Study Officials

• Janet Ellis, MD

  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: July 14, 2016
• First Posted: September 27, 2016
• Study Start: February 1, 2016
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2025
• Last Updated: December 5, 2024

Record last verified: 2024-12

Locations

CA (1)