Effectiveness Trial of Temperament Based Therapy With Support (TBT-S)

Last updated: November 21, 2024
Sponsor: Oslo University Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Vomiting

Anorexia

Treatment

Temperament Based Therapy with Support (TBT-S)

Clinical Study ID

NCT06497101
728279
  • Ages > 18
  • All Genders

Study Summary

The main aim of this project is to determine the short and long-term effectiveness of an out-patient treatment for patients with anorexia nervosa. Specifically, we will measure whether TBT-S in addition to treatment as usual (TAU) will be more effective than TAU alone in reducing eating disorder psychopathology. Assessments will be conducted at four timepoints; pre and post TBT-S, and at 3 and 12 months follow-up. Primary outcome measure is eating disorder psychopathology, with the hypothesis that patients receiving TBT-S in addition to TAU will show significantly greater reduction in eating disorder psychopathology from TBT-S treatment admission to 3 month follow-up, compared to controls.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age ≥18, all genders

  • A Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnosed anorexianervosa disorder (F50.0, F50.01, F50.02, also including F50.9 - atypical anorexianervosa)

  • Willingness to have Support(s) participate in treatment

  • Medically stable

Exclusion

Exclusion Criteria:

  • Developmental, intellectual or psychotic disorder

  • Diagnosis of alcohol or drug abuse or dependence in the 3 months prior to the study

  • Receiving in-patient treatment at time of study entry

  • Presence of other psychopathology that might interfere with ability to participatein the study

Study Design

Total Participants: 140
Treatment Group(s): 1
Primary Treatment: Temperament Based Therapy with Support (TBT-S)
Phase:
Study Start date:
November 15, 2024
Estimated Completion Date:
September 01, 2028

Study Description

Participants in the intervention arm will receive five days of TBT-S in addition to treatment as usual. TBT-S is administered to three to six adult anorexia nervosa patients with up to four supports per patient. The treatment structure consists of five consecutive days of treatment, up to 7,5 hours each day. Staff requirements for TBT-S are three clinicians, one dietician and one medical staff. Adults referred to a local psychiatric centre (DPS) for out-patient anorexia nervosa treatment, and their supports, will be eligible to participate in the study.

Connect with a study center

  • Oslo University Hospital, Regional Department for Eating Disorders

    Oslo,
    Norway

    Active - Recruiting

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