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

Not Applicable

Terminated

Interventions: Behavioral: Modified prolonged exposure therapy
Behavioral: Attention control

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.

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Modified prolonged exposure therapy	Modified prolonged exposure therapy	Participants will receive three sessions of modified prolonged exposure therapy.
Attention control	Attention control	Participants will receive three sessions of supportive counselling and psychoeducation

Primary Outcome Measures

Name	Time	Method
CLINICIAN-ADMINISTERED PTSD SCALE for Diagnostic and Statistical Manual of Mental Disorders-5 (CAPS)	Change 2-, 6- (primary endpoint) and 12 months after intervention	Clinical interview that gives a continuous measure of PTSD severity and dichotomous diagnosis of PTSD

Secondary Outcome Measures

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