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The Modum Bad Complex Posttraumatic Stress Disorder Study

Primary Purpose

Post-Traumatic Stress Disorder

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Psychotherapy
Sponsored by
Modum Bad
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-Traumatic Stress Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Modum Bad

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Prolonged Exposure

STAIR

STAIR/NT

Arm Description

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

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

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)
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)
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

Full Information

First Posted
March 22, 2018
Last Updated
March 29, 2023
Sponsor
Modum Bad
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1. Study Identification

Unique Protocol Identification Number
NCT03509844
Brief Title
The Modum Bad Complex Posttraumatic Stress Disorder Study
Official Title
Comparison of Treatments for Complex Posttraumatic Stress Disorder -a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
September 20, 2017 (Actual)
Primary Completion Date
October 30, 2021 (Actual)
Study Completion Date
October 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Modum Bad

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Traumatic Stress Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Outcome is assessed with CAPS-V by research assistants blind to the patients allocation to treatment arms
Allocation
Randomized
Enrollment
96 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prolonged Exposure
Arm Type
Experimental
Arm Description
Psychotherapy: 10 weeks, Prolonged Exposure (individual sessions) according to the manual developed by Foa et al., adapted for a residential care setting
Arm Title
STAIR
Arm Type
Experimental
Arm Description
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
Arm Title
STAIR/NT
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Psychotherapy
Intervention Description
Three established psychotherapeutic models for treatment of complex posttraumatic stress disorders are compared in a residential care setting. Combination of group and individual sessions.
Primary Outcome Measure Information:
Title
Clinician-Administered PTSD Scale (CAPS-5) for the Diagnostic and Statistical Manual of Mental Disorders (DSM-5)
Description
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)
Time Frame
approximately 15 months
Secondary Outcome Measure Information:
Title
The PTSD Checklist for DSM-5 (PCL-5)
Description
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)
Time Frame
approximately 15 months
Title
Inventory of Interpersonal Problems (IIP-64)
Description
64 items self-report measure for interpersonal problems. Severity is scored on a 0-4 scale (range 0-256)
Time Frame
approximately 15 months
Title
Beck Depression Inventory-Second Edition (BDI-II)
Description
21 item self-report measure for depressive symptoms. Severity is scored on a 0-3 scale (range 0-63
Time Frame
approximately 15 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Modum Bad
City
Vikersund
State/Province
Buskerud
ZIP/Postal Code
N-3370
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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The Modum Bad Complex Posttraumatic Stress Disorder Study

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