Cognitive-Behavioural Therapy as a Preventive Treatment for Post Traumatic Stress Disorder

NCT03116165 | Terminated DMC

• 1 other identifier: EPN 2015/1820-31
• Study Type: interventional
• Target: 352
• Locations: 1 country
• Sites: 1

Brief Summary

This study will examine the use of modified prolonged exposure therapy in trauma patients recently exposed to trauma in an emergency room to prevent the onset of post-traumatic stress disorder.

Conditions

Post Traumatic Stress Disorder

Outcome Measures

Primary Outcomes (1)

• CLINICIAN-ADMINISTERED PTSD SCALE for Diagnostic and Statistical Manual of Mental Disorders-5 (CAPS)

  Clinical interview that gives a continuous measure of PTSD severity and dichotomous diagnosis of PTSD

  Change 2-, 6- (primary endpoint) and 12 months after intervention

Secondary Outcomes (10)

• PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders-5 (PCL-5)

  Change 2-, 6- (primary endpoint) and 12 months after intervention

• Montgomery Åsberg Depression Rating Scale - Self-report (MADRS-S)

  Change from baseline to 2, 6 (primary endpoint) and 12 months after intervention

• Euroqol (EQ-5D)

  Measured 6 months after intervention

• WHO Disability Assessment Schedule (WHODAS)

  Change 2-, 6- (primary endpoint) and 12 months after intervention

• Adverse events

  Change 2-, 6- (primary endpoint) and 12 months after intervention

Study Arms (2)

Modified prolonged exposure therapy

EXPERIMENTAL

Participants will receive three sessions of modified prolonged exposure therapy.

Behavioral: Modified prolonged exposure therapy

Attention control

PLACEBO COMPARATOR

Participants will receive three sessions of supportive counselling and psychoeducation

Behavioral: Attention control

Interventions

Modified prolonged exposure therapy BEHAVIORAL

Participants will receive three sessions of modified prolonged exposure therapy.

Modified prolonged exposure therapy

Attention control BEHAVIORAL

Participants will receive three sessions of supportive counselling and psychoeducation

Attention control

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Presenting to the emergency department at the Karolinska University hospital Solna in the past 72 hours before the intervention
• Meets diagnostic criterion A for post-traumatic stress disorder in the fifth version of Diagnostic and Statistical Manual of Mental Disorders, DSM-5

You may not qualify if:

• Do not want to participate in the study
• Ongoing intoxication (e.g. severe alcohol intoxication)
• Other serious psychiatric comorbidity that demands attention (e.g. manic episode, acute suicidal ideation)
• Not oriented
• Not having a memory ot the tramatic event

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Karolinska Institutet

Stockholm, 17177, Sweden

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 3, 2017
• First Posted: April 14, 2017
• Study Start: April 18, 2017
• Primary Completion: December 11, 2017
• Study Completion: December 11, 2017
• Last Updated: May 17, 2018

Record last verified: 2018-05

Locations

SE (1)