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

Karolinska Institute

Status: Terminated

Conditions: Post Traumatic Stress Disorder

Treatments: Behavioral: Attention control; Behavioral: Modified prolonged exposure therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03116165

EPN 2015/1820-31

Details and patient eligibility

About

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.

Full 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.

Enrollment: 352 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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352 participants in 2 patient groups, including a placebo group

Modified prolonged exposure therapy

Experimental group

Description:

Participants will receive three sessions of modified prolonged exposure therapy.

Treatment:

Behavioral: Modified prolonged exposure therapy

Attention control

Placebo Comparator group

Description:

Participants will receive three sessions of supportive counselling and psychoeducation

Treatment:

Behavioral: Attention control