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The Modum Bad Complex Posttraumatic Stress Disorder Study

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ClinicalTrials.gov Identifier: NCT03509844
Recruitment Status : Recruiting
First Posted : April 26, 2018
Last Update Posted : April 26, 2018
Sponsor:
Information provided by (Responsible Party):
Modum Bad

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.

Condition or disease Intervention/treatment Phase
Post-Traumatic Stress Disorder Behavioral: Psychotherapy Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Outcome is assessed with CAPS-V by research assistants blind to the patients allocation to treatment arms
Primary Purpose: Treatment
Official Title: Comparison of Treatments for Complex Posttraumatic Stress Disorder -a Randomized Controlled Trial
Actual Study Start Date : September 20, 2017
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Clinician-Administered PTSD Scale (CAPS-5) for the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) [ Time Frame: approximatly 15 months ]
    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 :
  1. The PTSD Checklist for DSM-5 (PCL-5) [ Time Frame: approximatly 15 months ]
    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)

  2. Inventory of Interpersonal Problems (IIP-64) [ Time Frame: approximatly 15 months ]
    64 items self-report measure for interpersonal problems. Severity is scored on a 0-4 scale (range 0-256)

  3. Beck Depression Inventory-Second Edition (BDI-II) [ Time Frame: approximatly 15 months ]
    21 item self-report measure for depressive symptoms. Severity is scored on a 0-3 scale (range 0-63



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03509844


Contacts
Contact: Asle Hoffart, PhD. 0047 32749700 asle.hoffart@modum-bad.no
Contact: Terje Tilden, PhD. 0047 32749700 terje.tilden@modum-bad.no

Locations
Norway
Modum Bad Recruiting
Vikersund, Buskerud, Norway, N-3370
Contact: Asle Hoffart, PhD.    0047 32749700    asle.hoffart@modum-bad.no   
Contact: Peter Sele, Psychol.    0047 41684153    peter.sele@modum-bad.no   
Sub-Investigator: Peter Sele, Psychol.         
Principal Investigator: Asle Hoffart, PhD.         
Sub-Investigator: Tuva Øktedalen, PhD.         
Sponsors and Collaborators
Modum Bad

Responsible Party: Modum Bad
ClinicalTrials.gov Identifier: NCT03509844     History of Changes
Other Study ID Numbers: CPTSD-Peter_Sele
First Posted: April 26, 2018    Key Record Dates
Last Update Posted: April 26, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Disease
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Pathologic Processes
Trauma and Stressor Related Disorders
Mental Disorders