The Modum Bad Complex Posttraumatic Stress Disorder Study

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

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.

Study Overview

• Status: Completed
• Conditions: Post-Traumatic Stress Disorder
• Intervention / Treatment: Behavioral: Psychotherapy

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).

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Buskerud
    • Vikersund, Buskerud, Norway, N-3370
      • Modum Bad

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prolonged Exposure; Psychotherapy: 10 weeks, Prolonged Exposure (individual sessions) according to the manual developed by Foa et al., adapted for a residential care setting	Behavioral: Psychotherapy; Three established psychotherapeutic models for treatment of complex posttraumatic stress disorders are compared in a residential care setting. Combination of group and individual sessions.
Experimental: STAIR; 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; Three established psychotherapeutic models for treatment of complex posttraumatic stress disorders are compared in a residential care setting. Combination of group and individual sessions.
Experimental: STAIR/NT; 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; Three established psychotherapeutic models for treatment of complex posttraumatic stress disorders are compared in a residential care setting. Combination of group and individual sessions.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Modum Bad

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2017
• Primary Completion (Actual): October 30, 2021
• Study Completion (Actual): October 30, 2021

Study Registration Dates

• First Submitted: March 22, 2018
• First Submitted That Met QC Criteria: April 17, 2018
• First Posted (Actual): April 26, 2018

Study Record Updates

• Last Update Posted (Actual): March 30, 2023
• Last Update Submitted That Met QC Criteria: March 29, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: CPTSD-Peter_Sele

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No