An interventional study of Modified prolonged exposure therapy and Attention control in Post Traumatic Stress Disorder, sponsored by Karolinska Institutet. Terminated at 1 site in Sweden. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2018-05-17.
Sponsored by Karolinska Institutet · Not applicable, Interventional, and Prevention
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.
1,147 studies on the registry are indexed under Stress Disorders, Traumatic; 108 are open to participants now.
This study's enrollment of 352 is above the median of 60 across 908 interventional studies indexed under Stress Disorders, Traumatic.
Browse Stress Disorders, Traumatic studies →Karolinska Institutet is the lead sponsor of 1,113 studies on the registry; 267 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive three sessions of modified prolonged exposure therapy.
Behavioral: Modified prolonged exposure therapy
Participants will receive three sessions of supportive counselling and psychoeducation
Behavioral: Attention control
Participants will receive three sessions of modified prolonged exposure therapy.
Participants will receive three sessions of supportive counselling and psychoeducation
CLINICIAN-ADMINISTERED PTSD SCALE for Diagnostic and Statistical Manual of Mental Disorders-5 (CAPS)
Clinical interview that gives a continuous measure of PTSD severity and dichotomous diagnosis of PTSD
Time frame: Change 2-, 6- (primary endpoint) and 12 months after intervention
PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders-5 (PCL-5)
Self-report questionnaire for the assessment of PTSD severity
Time frame: Change 2-, 6- (primary endpoint) and 12 months after intervention
Montgomery Åsberg Depression Rating Scale - Self-report (MADRS-S)
Self-report questionnaire for the assessment of severity of depression
Time frame: Change from baseline to 2, 6 (primary endpoint) and 12 months after intervention
Euroqol (EQ-5D)
Measure of general health and quality of life
Time frame: Measured 6 months after intervention
WHO Disability Assessment Schedule (WHODAS)
Measure of general health and function
Time frame: Change 2-, 6- (primary endpoint) and 12 months after intervention
Adverse events
Measure of number adverse events
Time frame: Change 2-, 6- (primary endpoint) and 12 months after intervention
Subjective unit of distress scale (SUD)
Ratings of distress
Time frame: Change at week 1, week 2 and week 3
Intrusion diary
A self-report diary on number of intrusions
Time frame: Change at week 1, week 2 and week 3
Insomnia Severity Index (ISI)
Self-report questionnaire regarding insomnia
Time frame: Change 2-, 6- (primary endpoint) and 12 months after intervention
Multidimensional Scale of Perceived Social Support (MSPSS)
A measure to assess for social support
Time frame: Change 2-, 6- (primary endpoint) and 12 months after intervention
Trimbos Institute of costs in psychiatry (TIC-P)
Self-report measure on societal costs
Time frame: Measured at 6 (primary endpoint) months after the intervention
This study is terminated, as verified in May 2018. You cannot join it, but the record below documents what was studied.
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Karolinska Institutet