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

NCT06497101 | Recruiting

• 1 other identifier: 728279
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Anorexia Nervosa

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Temperament Based Therapy with Support (TBT-S)

EXPERIMENTAL

TBT-S in addition to treatment as usual

Behavioral: Temperament Based Therapy with Support (TBT-S)

Treatment as Usual (TAU)

NO INTERVENTION

Treatment as Usual

Interventions

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)

Also known as: TBT-S

Temperament Based Therapy with Support (TBT-S)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

Oslo University Hospital, Regional Department for Eating Disorders

Oslo, Norway

RECRUITING

MeSH Terms

Conditions

Anorexia Nervosa

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Researcher

Study Record Dates

• First Submitted: July 4, 2024
• First Posted: July 11, 2024
• Study Start: November 15, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): September 1, 2028
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)