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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Anorexia Nervosa
• Intervention / Treatment: Behavioral: Temperament Based Therapy with Support (TBT-S)

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 Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway
    • Recruiting
    • Oslo University Hospital, Regional Department for Eating Disorders
    • Contact: Kristin Stedal, PhD; Phone Number: +4791321971; Email: krsted@ous-hf.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Temperament Based Therapy with Support (TBT-S); TBT-S in addition to treatment as usual	Behavioral: Temperament Based Therapy with Support (TBT-S); Participants included in the intervention arm will receive TBT-S (5-day treatment) in addition to treatment as usual (TAU); Other Names: TBT-S
No Intervention: Treatment as Usual (TAU); Treatment as Usual

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Eating Disorder Psychopathology	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.	Baseline, after 1 week and at 3 and 12 months follow-up

Collaborators and Investigators

• Sponsor: Oslo University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): September 1, 2028

Study Registration Dates

• First Submitted: July 4, 2024
• First Submitted That Met QC Criteria: July 4, 2024
• First Posted (Actual): July 11, 2024

Study Record Updates

• Last Update Posted (Actual): March 2, 2026
• Last Update Submitted That Met QC Criteria: February 26, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Feeding and Eating Disorders; Anorexia Nervosa; Therapeutics; Patient Care; Health Services; Health Care Facilities Workforce and Services; Palliative Care
• Other Study ID Numbers: 728279

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There are no plans to make individual participant data (IPD) available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No