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

Not Applicable

Recruiting

• Conditions: Anorexia Nervosa
• Interventions: Behavioral: Temperament Based Therapy with Support (TBT-S)

• Registration Number: NCT06497101
• Lead Sponsor: Oslo University Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2024-07-04
• Study First Submitted QC: 2024-07-04
• Study First Posted: 2024-07-11
• Status Verified: 2024-11
• Study Start: 2024-11-15
• Last Update Submitted: 2024-11-21
• Last Update Posted: 2024-11-25
• Primary Completion: 2026-12-31
• Study Completion: 2028-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 140

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

• 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 participate in the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Temperament Based Therapy with Support (TBT-S)	Temperament Based Therapy with Support (TBT-S)	TBT-S in addition to treatment as usual

Primary Outcome Measures

Name	Time	Method
Eating Disorder Psychopathology	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.

Trial Locations

Locations (1)

Oslo University Hospital, Regional Department for Eating Disorders; 🇳🇴 Oslo, Norway