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

NCT ID: NCT03116165

Last Updated: 2018-05-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 352 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-18
• Study Completion Date: 2017-12-11

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.

Conditions

Post Traumatic Stress Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Attention control

Participants will receive three sessions of supportive counselling and psychoeducation

Group Type: PLACEBO_COMPARATOR

Attention control

Intervention Type: BEHAVIORAL

Participants will receive three sessions of supportive counselling and psychoeducation

Modified prolonged exposure therapy

Participants will receive three sessions of modified prolonged exposure therapy.

Group Type: EXPERIMENTAL

Modified prolonged exposure therapy

Intervention Type: BEHAVIORAL

Participants will receive three sessions of modified prolonged exposure therapy.

Interventions

Modified prolonged exposure therapy

Participants will receive three sessions of modified prolonged exposure therapy.

Intervention Type: BEHAVIORAL

Attention control

Participants will receive three sessions of supportive counselling and psychoeducation

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Erik Andersson

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Karolinska Institutet

Stockholm, , Sweden

Countries

Sweden

Other Identifiers

EPN 2015/1820-31

Identifier Type: -

Identifier Source: org_study_id