The Modum Bad Complex Posttraumatic Stress Disorder Study

NCT03509844 | Completed

• 1 other identifier: CPTSD-Peter_Sele
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-Traumatic Stress Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• The PTSD Checklist for DSM-5 (PCL-5)

  approximately 15 months

• Inventory of Interpersonal Problems (IIP-64)

  approximately 15 months

• Beck Depression Inventory-Second Edition (BDI-II)

  approximately 15 months

Study Arms (3)

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

Behavioral: Psychotherapy

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

Behavioral: Psychotherapy

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.

Behavioral: Psychotherapy

Interventions

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.

Prolonged Exposure; STAIR; STAIR/NT

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• severe psychotic disorder
• dissociative identity disorder (DID)
• active phase substance dependence
• acute suicidality
• major current life crisis
• severely disturbed group functioning
• mental disability

Sponsors & Collaborators

• Modum Bad: lead

Study Sites (1)

Modum Bad

Vikersund, Buskerud, N-3370, Norway

Location

Related Publications (1)

• 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.

  PMID: 37871452 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Psychotherapy

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome is assessed with CAPS-V by research assistants blind to the patients allocation to treatment arms
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2018
• First Posted: April 26, 2018
• Study Start: September 20, 2017
• Primary Completion: October 30, 2021
• Study Completion: October 30, 2021
• Last Updated: March 30, 2023

Record last verified: 2023-03

Locations

NO (1)