Cognitive-Behavioural Therapy as a Preventive Treatment for Post Traumatic Stress Disorder
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Modified prolonged exposure therapy Participants will receive three sessions of modified prolonged exposure therapy. |
Behavioral: Modified prolonged exposure therapy
Participants will receive three sessions of modified prolonged exposure therapy.
|
| Placebo Comparator: Attention control Participants will receive three sessions of supportive counselling and psychoeducation |
Behavioral: Attention control
Participants will receive three sessions of supportive counselling and psychoeducation
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
- 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
- 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
- Intrusion diary [Change at week 1, week 2 and week 3]
A self-report diary on number of intrusions
- Insomnia Severity Index (ISI) [Change 2-, 6- (primary endpoint) and 12 months after intervention]
Self-report questionnaire regarding insomnia
- Multidimensional Scale of Perceived Social Support (MSPSS) [Change 2-, 6- (primary endpoint) and 12 months after intervention]
A measure to assess for social support
- Trimbos Institute of costs in psychiatry (TIC-P) [Measured at 6 (primary endpoint) months after the intervention]
Self-report measure on societal costs
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Presenting to the emergency department at the Karolinska University hospital Solna in the past 72 hours before the intervention
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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:
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Do not want to participate in the study
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Ongoing intoxication (e.g. severe alcohol intoxication)
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Other serious psychiatric comorbidity that demands attention (e.g. manic episode, acute suicidal ideation)
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Not oriented
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Not having a memory ot the tramatic event
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Karolinska Institutet | Stockholm | Sweden | 17177 |
Sponsors and Collaborators
- Karolinska Institutet
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- EPN 2015/1820-31