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

Cognitive-Behavioural Therapy as a Preventive Treatment for Post Traumatic Stress Disorder: An Randomized Controlled Trial in the Acute Trauma Care

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.

Study Overview

• Status: Terminated
• Conditions: Post Traumatic Stress Disorder
• Intervention / Treatment: Behavioral: Modified prolonged exposure therapy; Behavioral: Attention control

Detailed Description

This study investigates if prolonged exposure is an effective treatment in reducing PTSD symptoms people who have recently experienced trauma. The study will also investigate predictive markers of PTSD, moderators of successful treatment and health economic aspects of the intervention.

Participants will first undergo an evaluation session that will include an interview (Immediate Stress Reaction Checklist) and questionnaires. Participants will subsequently be randomly assigned to receive either modified prolonged exposure therapy or attention control, starting the assigned intervention immediately. Participants in each arm will receive three weekly treatment sessions. Treatment will involve psychoeducation about common reactions to trauma, imaginal exposure (revisiting memories of a recent trauma out loud with a therapist and audio-recording these for review at home), exposure in vivo and breathing retraining. All participants will undergo assessments 2, 6 (primary endpoint) and 12 months after the intervention by blinded assessors. Patients unable to come to the clinic for follow-up assessments will be interviewed via telephone or skype. Source data will be quality monitored by an independent party (Karolinska trial alliance) according to the Helsinki Declaration.

• Study Type: Interventional
• Enrollment (Actual): 352
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, 17177
    • Karolinska Institutet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Modified prolonged exposure therapy; Participants will receive three sessions of modified prolonged exposure therapy.	Behavioral: Modified prolonged exposure therapy; Participants will receive three sessions of modified prolonged exposure therapy.
Placebo Comparator: Attention control; Participants will receive three sessions of supportive counselling and psychoeducation	Behavioral: Attention control; Participants will receive three sessions of supportive counselling and psychoeducation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders-5 (PCL-5)	Self-report questionnaire for the assessment of PTSD severity	Change 2-, 6- (primary endpoint) and 12 months after intervention
Montgomery Åsberg Depression Rating Scale - Self-report (MADRS-S)	Self-report questionnaire for the assessment of severity of depression	Change from baseline to 2, 6 (primary endpoint) and 12 months after intervention
Euroqol (EQ-5D)	Measure of general health and quality of life	Measured 6 months after intervention
WHO Disability Assessment Schedule (WHODAS)	Measure of general health and function	Change 2-, 6- (primary endpoint) and 12 months after intervention
Adverse events	Measure of number adverse events	Change 2-, 6- (primary endpoint) and 12 months after intervention
Subjective unit of distress scale (SUD)	Ratings of distress	Change at week 1, week 2 and week 3
Intrusion diary	A self-report diary on number of intrusions	Change at week 1, week 2 and week 3
Insomnia Severity Index (ISI)	Self-report questionnaire regarding insomnia	Change 2-, 6- (primary endpoint) and 12 months after intervention
Multidimensional Scale of Perceived Social Support (MSPSS)	A measure to assess for social support	Change 2-, 6- (primary endpoint) and 12 months after intervention
Trimbos Institute of costs in psychiatry (TIC-P)	Self-report measure on societal costs	Measured at 6 (primary endpoint) months after the intervention

Collaborators and Investigators

• Sponsor: Karolinska Institutet

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2017
• Primary Completion (Actual): December 11, 2017
• Study Completion (Actual): December 11, 2017

Study Registration Dates

• First Submitted: April 3, 2017
• First Submitted That Met QC Criteria: April 11, 2017
• First Posted (Actual): April 14, 2017

Study Record Updates

• Last Update Posted (Actual): May 17, 2018
• Last Update Submitted That Met QC Criteria: May 13, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: EPN 2015/1820-31

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No