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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prolonged Exposure | Experimental | Psychotherapy: 10 weeks, Prolonged Exposure (individual sessions) according to the manual developed by Foa et al., adapted for a residential care setting |
|
| STAIR | Experimental | 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 |
|
| STAIR/NT | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Psychotherapy | Behavioral | Three established psychotherapeutic models for treatment of complex posttraumatic stress disorders are compared in a residential care setting. Combination of group and individual sessions. |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Modum Bad | Vikersund | Buskerud | N-3370 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37871452 | Derived | Sele P, Hoffart A, Cloitre M, Hembree E, Oktedalen T. Comparing phase-based treatment, prolonged exposure, and skills-training for Complex Posttraumatic Stress Disorder: A randomized controlled trial. J Anxiety Disord. 2023 Dec;100:102786. doi: 10.1016/j.janxdis.2023.102786. Epub 2023 Oct 12. |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| ID | Term |
|---|---|
| D004191 | Behavioral Disciplines and Activities |
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Outcome is assessed with CAPS-V by research assistants blind to the patients allocation to treatment arms
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 |