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The Modum Bad Complex Posttraumatic Stress Disorder Study

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03509844
Enrollment
96
Registered
2018-04-26
Start date
2017-09-20
Completion date
2021-10-30
Last updated
2023-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-Traumatic Stress Disorder

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).

Interventions

BEHAVIORALPsychotherapy

Three established psychotherapeutic models for treatment of complex posttraumatic stress disorders are compared in a residential care setting. Combination of group and individual sessions.

Sponsors

Modum Bad
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

Outcome is assessed with CAPS-V by research assistants blind to the patients allocation to treatment arms

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Clinician-Administered PTSD Scale (CAPS-5) for the Diagnostic and Statistical Manual of Mental Disorders (DSM-5)approximately 15 months30 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

MeasureTime frameDescription
The PTSD Checklist for DSM-5 (PCL-5)approximately 15 months20 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)approximately 15 months64 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)approximately 15 months21 item self-report measure for depressive symptoms. Severity is scored on a 0-3 scale (range 0-63

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026