Post Traumatic Stress Disorder Clinical Trial
Official title:
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.
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.
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