Concentrated Exposure Therapy for Post-traumatic Stress Disorder - a Cohort Study

Study Overview
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Brief Summary
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Post-traumatic stress disorder (PTSD) is a prevalent and disabling condition. Trauma-focused psychotherapy, including cognitive behavioural therapy (CBT), are among the recommended first-line treatment alternatives. However, a substantial proportion of patients decline, drop-out or do not respond to current psychotherapies. Previous research suggests that intensive or concentrated formats of trauma-focused psychotherapy can lead to faster recover and lower attrition, but there are currently few studies of these approaches. The current study will investigate the acceptability. treatment satisfaction and preliminary changes in symptoms after four consecutive days of concentrated CBT for PTSD.

Detailed Description
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The study will investigate the research questions in three stages. In the first stage four patients will be treated individually. In the second stage two groups of four patients will be treated, with at least a 1:1 ratio between therapists and patients per group. In the third stage 30 patients will be treated in groups of about four patients per group, with at least a 1:1 ratio between therapists and patients per group. The primary outcome measure is changes in PTSD-related symptoms as measured using the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). Acceptability will be measured as the proportion of patients accepting treatment when offered, while attrition is measured as the proportion of patients that withdraw from treatment after it has started. Several other measures will be collected to measure treatment satisfaction, related symptoms, and functional impairment.

Official Title
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Concentrated Exposure Therapy for Post-traumatic Stress Disorder - a Cohort Study

Conditions
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PTSD

Intervention / Treatment
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* Behavioral: Concentrated cognitive behavioral therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: fulfills DSM-5 criteria for PTSD One or more single traumas in adolescence or adulthood Speaks and writes Norwegian Exclusion Criteria: New or unstable psychopharmacological treatment within last four weeks fulfills ICD-11 criteria for complex PTSD Ongoing substance abuse Ongoing danger of suicide Ongoing borderline personality disorder Ongoing psychosis Intellectual disability

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Individual therapy over four consecutive days<br>Treatment will be delivered individually over four consecutive days | Behavioral: Concentrated cognitive behavioral therapy<br>* A psychological intervention consisting of psychoeducation and exposure therapy with the goal of changing the tolerability and negative interpretations of post-traumatic symptoms. The treatment is tailored to the individual patient through all stages, including relapse prevention and planning how to use treatment principles in daily life<br>* Other names: Bergen 4-Day Treatment;|
| Combined Individual and group therapy over four consecutive days<br>Treatment will be delivered in a mix of individual and group sessions over four consecutive days | Behavioral: Concentrated cognitive behavioral therapy<br>* A psychological intervention consisting of psychoeducation and exposure therapy with the goal of changing the tolerability and negative interpretations of post-traumatic symptoms. The treatment is tailored to the individual patient through all stages, including relapse prevention and planning how to use treatment principles in daily life<br>* Other names: Bergen 4-Day Treatment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) | Clinician-administered interview to diagnose and the severity of PTSD | Change in scores from before treatment to one week after treatment | 
| Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) | Clinician-administered interview to diagnose and the severity of PTSD | Change in scores from one week after treatment to three months after treatment | 
| Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) | Clinician-administered interview to diagnose and the severity of PTSD | Change in scores from three months after treatment to twelve months after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Client Satisfaction Questionnaire 8 (CSQ-8) | Patient-rated questionnaire of treatment satisfaction | One week after treatment | 
| Client Satisfaction Questionnaire 8 (CSQ-8) | Patient-rated questionnaire of treatment satisfaction | Three months after treatment | 
| Client Satisfaction Questionnaire 8 (CSQ-8) | Patient-rated questionnaire of treatment satisfaction | Twelve months after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CBT, CAPS, Group therapy, Psychotherapy, Treatment satisfaction