The Modum Bad Complex Posttraumatic Stress Disorder Study

Post-Traumatic Stress Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03509844
• Other study ID #: CPTSD-Peter_Sele
• Status: Completed
• Phase: N/A
• Start date: September 20, 2017
• Est. completion date: October 30, 2021

Study information

• Verified date: March 2023
• Source: Modum Bad
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: October 30, 2021
• Est. primary completion date: October 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Post-Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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.

Locations

Country	Name	City	State
Norway	Modum Bad	Vikersund	Buskerud

Sponsors (1)

Lead Sponsor	Collaborator
Modum Bad

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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