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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Post Traumatic Stress Disorder

Intervention / Treatment
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* Behavioral: Modified prolonged exposure therapy
* Behavioral: Attention control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 |