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Completed

NCT Number: NCT03509844

The Modum Bad Complex Posttraumatic Stress Disorder Study

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Modum Bad

Vikersund, Buskerud, N-3370, Norway

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Clinician-Administered PTSD Scale (CAPS-5) for the Diagnostic and Statistical Manual of Mental Disorders (DSM-5)

    Time frame: approximately 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 outcomes

  1. The PTSD Checklist for DSM-5 (PCL-5)

    Time frame: approximately 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: approximately 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: approximately 15 months

    21 item self-report measure for depressive symptoms. Severity is scored on a 0-3 scale (range 0-63

Sponsors and collaborators

Lead sponsor

Modum Bad

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Apr 26, 2018
Registry last updated
Mar 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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