The Modum Bad Complex Posttraumatic Stress Disorder Study

NCT ID: NCT03509844

Last Updated: 2023-03-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-20
• Study Completion Date: 2021-10-30

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).

Conditions

Post-Traumatic Stress Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Prolonged Exposure

Psychotherapy: 10 weeks, Prolonged Exposure (individual sessions) according to the manual developed by Foa et al., adapted for a residential care setting

Group Type: EXPERIMENTAL

Psychotherapy

Intervention Type: 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.

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

Group Type: EXPERIMENTAL

Psychotherapy

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Psychotherapy

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Modum Bad

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Modum Bad

Vikersund, Buskerud, Norway

Countries

Norway

References

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.

Reference Type: DERIVED

PMID: 37871452 (View on PubMed)

Other Identifiers

CPTSD-Peter_Sele

Identifier Type: -

Identifier Source: org_study_id