The Modum Bad Complex Posttraumatic Stress Disorder Study

M

Modum Bad

Status

Completed

Conditions

Post-Traumatic Stress Disorder

Treatments

Behavioral: Psychotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT03509844
CPTSD-Peter_Sele

Details and patient eligibility

About

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.

Full 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).

Enrollment

96 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

96 participants in 3 patient groups

Prolonged Exposure
Experimental group
Description:
Psychotherapy: 10 weeks, Prolonged Exposure (individual sessions) according to the manual developed by Foa et al., adapted for a residential care setting
Treatment:
Behavioral: Psychotherapy
STAIR
Experimental group
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
Treatment:
Behavioral: Psychotherapy
STAIR/NT
Experimental group
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.
Treatment:
Behavioral: Psychotherapy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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