Clinical trial NCT03116165: Cognitive-Behavioural Therapy as a Preventive Treatment for Post Traumatic Stress Disorder
Official title: Cognitive-Behavioural Therapy as a Preventive Treatment for Post Traumatic Stress Disorder: An Randomized Controlled Trial in the Acute Trauma Care
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Post Traumatic Stress Disorder
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2017-04-14
Enrollment: 352
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: CLINICIAN-ADMINISTERED PTSD SCALE for Diagnostic and Statistical Manual of Mental Disorders-5 (CAPS)
timeFrame: Change 2-, 6- (primary endpoint) and 12 months after intervention
Secondary outcomes:
measure: PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders-5 (PCL-5)
timeFrame: Change 2-, 6- (primary endpoint) and 12 months after intervention
measure: Montgomery Åsberg Depression Rating Scale - Self-report (MADRS-S)
timeFrame: Change from baseline to 2, 6 (primary endpoint) and 12 months after intervention
measure: Euroqol (EQ-5D)
timeFrame: Measured 6 months after intervention
measure: WHO Disability Assessment Schedule (WHODAS)
timeFrame: Change 2-, 6- (primary endpoint) and 12 months after intervention
measure: Adverse events
timeFrame: Change 2-, 6- (primary endpoint) and 12 months after intervention
measure: Subjective unit of distress scale (SUD)
timeFrame: Change at week 1, week 2 and week 3
measure: Intrusion diary
timeFrame: Change at week 1, week 2 and week 3
measure: Insomnia Severity Index (ISI)
timeFrame: Change 2-, 6- (primary endpoint) and 12 months after intervention
measure: Multidimensional Scale of Perceived Social Support (MSPSS)
timeFrame: Change 2-, 6- (primary endpoint) and 12 months after intervention
measure: Trimbos Institute of costs in psychiatry (TIC-P)
timeFrame: Measured at 6 (primary endpoint) months after the intervention
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet
Study officials:
References: