Treatment of Anorexia Nervosa in Children and Adolescents: An Integrated Family Based and Metacognitive Approach (FBT-MCT)

Treatment of Anorexia Nervosa in Children and Adolescents: An Integrated Family-based and Metacognitive Approach

The goal of this study is to evaluate the treatment effects of an integrated treatment called Family-based and Metacognitive therapy for patients with Anorexia Nervosa. In addition, we will evaluate if an active follow-up of the patients will reduce the number of relapses, which is common during the 1 year after discharge. Fifty patients aged 12-18 years old and their parents will be invited to participate in this study and all will receive the same treatment but be randomly allocated to different follow-up conditions. The active follow-up includes 3 sessions of Metacognitive therapy and the passive follow-up includes ordinary follow-up, with no booster sessions. The patients will be assessed at baseline, pre-treatment, post-treatment, and at 6 and 12 months follow-up.

Study Overview

• Status: Active, not recruiting
• Conditions: Anorexia Nervosa
• Intervention / Treatment: Behavioral: Family based therapy- Metacognitive therapy

Detailed Description

The study is an evaluation of a new approach to treating Anorexia Nervosa (F.50.0 and F 50.1) called Family-based and Metacognitive therapy. The treatment integrates both family-based work approach, where the parents learn to be in control of the meal situation and communicate better with their child. The metacognitive treatment approach, is targeting the child to work with its problems with emotional regulation and self-esteem issues, but also their attitudes to body and weight. Our aim is to both address what the overall effect of the treatment will be, but also to test if an active follow-up after discharge will lead to reduced relapse rates in the 12 months after treatment. We will apply the same approach to all included patients (A-B design), but the patients and their parents will be allocated to one of two different conditions for follow-up. The active follow-up involves receiving 3 sessions of metacognitive therapy, whereas the other group gets ordinary follow-up, with no sessions of MCT. All patients are assessed at baseline, pre-treatment, post-treatment, and by 6 and 12 months follow-up. The purpose of the design is to evaluate if the rate of relapse during the first year after discharge can be reduced

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Trøndelag
    • Trondheim, Trøndelag, Norway, 7006
      • St.Olavs Hospital HF

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Primary diagnosis of F 50.0 and F 50.1

Exclusion Criteria:

• Psychotic symptoms
• Severe somatic illness
• Mental retardation or developmental disorder
• Bipolar disorder
• Extreme self-mutilation or acute suicidal risks
• Does not speak or understand Norwegian

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
Active Comparator: Active follow-up; The patients will recieve 3 sessions of MCT	Behavioral: Family based therapy- Metacognitive therapy; Family based therapy and Metacognitive therapy
Active Comparator: Passive follow-up; The group receives no sessions during follow-up	Behavioral: Family based therapy- Metacognitive therapy; Family based therapy and Metacognitive therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Mass Index	Body mass index	18 months

Collaborators and Investigators

• Sponsor: Norwegian University of Science and Technology
• Collaborators: St. Olavs Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2023
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: August 24, 2023
• First Submitted That Met QC Criteria: November 15, 2023
• First Posted (Actual): November 18, 2023

Study Record Updates

• Last Update Posted (Actual): June 22, 2025
• Last Update Submitted That Met QC Criteria: June 17, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Feeding and Eating Disorders; Anorexia; Anorexia Nervosa
• Other Study ID Numbers: 255677

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No