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NCT Number: NCT06497101

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oslo University Hospital, Regional Department for Eating Disorders

Oslo, Norway

Location status: Recruiting

Location contact

Kristin Stedal, PhD

CONTACT

[email protected]

+4791321971

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥18, all genders
  • A Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnosed anorexia nervosa disorder (F50.0, F50.01, F50.02, also including F50.9 - atypical anorexia nervosa)
  • Willingness to have Support(s) participate in treatment
  • Medically stable

Exclusion criteria

  • Intellectual developmental disorder or intellectual disability; psychotic disorder or other psychopathology that may affect or prevent participation in the study
  • diagnosed alcohol or other substance use disorder within 3 months prior to study initiation
  • ongoing inpatient treatment at the time of study enrollment (participants currently in inpatient care must be discharged and engaged in outpatient treatment before participating in the TBT-S week

Treatment and study plan

Temperament Based Therapy with Support (TBT-S)

Behavioral

Participants included in the intervention arm will receive TBT-S (5-day treatment) in addition to treatment as usual (TAU)

Other names: TBT-S

Primary outcomes

  1. Eating Disorder Psychopathology

    Time frame: Baseline, after 1 week and at 3 and 12 months follow-up

    Eating Disorders Examination Questionnaire (EDE-Q). Participants report symptomatology on a 7-point Likert scale from 0 (no days) to 6 (everyday). The EDE-Q contains 4 subscales: Restraint, Weight Concern, Eating Concern, and Shape Concern. Subscale scores are calculated by finding the averages of the subscale items. A global score is also calculated by averaging the subscale scores. Scores range from 0 to 6; higher scores indicate higher levels of eating disorder pathology.

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Official study title

Effectiveness of Temperament Based Therapy With Support (TBT-S): A Novel 5-day Treatment for Anorexia Nervosa

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Jul 11, 2024
Registry last updated
Mar 2, 2026

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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