The Modum Bad Complex Posttraumatic Stress Disorder Study
- Conditions
- Post-Traumatic Stress Disorder
- Interventions
- Behavioral: Psychotherapy
- Registration Number
- NCT03509844
- Lead Sponsor
- Modum Bad
- Brief Summary
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
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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 96
- 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)
- severe psychotic disorder
- dissociative identity disorder (DID)
- active phase substance dependence
- acute suicidality
- major current life crisis
- severely disturbed group functioning
- mental disability
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description STAIR Psychotherapy 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 Psychotherapy 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. Prolonged Exposure Psychotherapy Psychotherapy: 10 weeks, Prolonged Exposure (individual sessions) according to the manual developed by Foa et al., adapted for a residential care setting
- Primary Outcome Measures
Name Time Method Clinician-Administered PTSD Scale (CAPS-5) for the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) approximately 15 months 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)
- Secondary Outcome Measures
Name Time Method The PTSD Checklist for DSM-5 (PCL-5) approximately 15 months 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)
Inventory of Interpersonal Problems (IIP-64) approximately 15 months 64 items self-report measure for interpersonal problems. Severity is scored on a 0-4 scale (range 0-256)
Beck Depression Inventory-Second Edition (BDI-II) approximately 15 months 21 item self-report measure for depressive symptoms. Severity is scored on a 0-3 scale (range 0-63
Trial Locations
- Locations (1)
Modum Bad
🇳🇴Vikersund, Buskerud, Norway