The Modum Bad Complex Posttraumatic Stress Disorder Study

Study Overview
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Brief Summary
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This study compares three established, manual based psychotherapies for Complex Post-traumatic Stress disorder (CPTSD) in patients with childhood trauma (e.g. sexual abuse, violence). The primary aim of the study is to compare phase-oriented treatment (Stabilization + Exposure) with two non-phased treatments, Exposure and Stabilization.

Detailed Description
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Available treatment procedures for PTSD are largely developed within the context of adult trauma (e.g. accidents, natural disasters, rape or combat). The need for additional treatment options targeting dysfunctional affect regulation and interpersonal problems in patients suffering after childhood trauma is debated in research and clinical settings. 96 patients will be recruited from referrals to an in-patient clinic in Norway called Modum Bad. After assessment, patients will be randomly assigned to one of three treatment arms. One-third will receive 10 weeks of Prolonged Exposure, one-third 10 weeks of Skills Training in Affect and Interpersonal Regulation (STAIR), and the last third a phase-based treatment lasting 16 weeks (STAIR + Narrative Therapy).

Official Title
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Comparison of Treatments for Complex Posttraumatic Stress Disorder -a Randomized Controlled Trial

Conditions
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Post-Traumatic Stress Disorder

Intervention / Treatment
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* Behavioral: Psychotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: childhood trauma (e.g. sexual abuse, violence prior to age 18), a diagnosis of Posttraumatic Stress Disorder PTSD according to DSM-5 a diagnosis of Complex PTSD according to the suggested additional criteria for complex PTSD in International Classification of Diseases (ICD-11) Exclusion Criteria: severe psychotic disorder dissociative identity disorder (DID) active phase substance dependence acute suicidality major current life crisis severely disturbed group functioning mental disability

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prolonged Exposure<br>Psychotherapy: 10 weeks, Prolonged Exposure (individual sessions) according to the manual developed by Foa et al., adapted for a residential care setting | Behavioral: Psychotherapy<br>* Three established psychotherapeutic models for treatment of complex posttraumatic stress disorders are compared in a residential care setting. Combination of group and individual sessions.<br>|
| Experimental: STAIR<br>Psychotherapy: 10 weeks, Skills Training in Affect and Interpersonal Regulation (STAIR) (group sessions), according to the manual developed by Cloitre et al., adapted for a residential care setting | Behavioral: Psychotherapy<br>* Three established psychotherapeutic models for treatment of complex posttraumatic stress disorders are compared in a residential care setting. Combination of group and individual sessions.<br>|
| Experimental: STAIR/NT<br>Psychotherapy: 16 weeks, 10 weeks Skills Training in Affect and Interpersonal Regulation (STAIR) (group sessions), followed by 6 weeks of Narrative Therapy (NT) (individual sessions), according to the manual developed by Cloitre et al., adapted for a residential care setting. | Behavioral: Psychotherapy<br>* Three established psychotherapeutic models for treatment of complex posttraumatic stress disorders are compared in a residential care setting. Combination of group and individual sessions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinician-Administered PTSD Scale (CAPS-5) for the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) | 30 items structured interview corresponding to the definition of PTSD in DSM-5. 20 items correspond to the symptoms for PTSD and are scored on a 0-4 severity scale to establish symptom severity (range 0-40) | approximately 15 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The PTSD Checklist for DSM-5 (PCL-5) | 20 items self-report measure for PTSD symptoms corresponding to DSM-5 criteria for PTSD. Severity is scored on a 0-4 scale (range 0-40) | approximately 15 months | 
| Inventory of Interpersonal Problems (IIP-64) | 64 items self-report measure for interpersonal problems. Severity is scored on a 0-4 scale (range 0-256) | approximately 15 months | 
| Beck Depression Inventory-Second Edition (BDI-II) | 21 item self-report measure for depressive symptoms. Severity is scored on a 0-3 scale (range 0-63 | approximately 15 months |