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NCT Number: NCT06139770

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St.Olavs hospital HF

Trondheim, Trøndelag, 7006, Norway

About this study

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

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Family based therapy- Metacognitive therapy

Behavioral

Family based therapy and Metacognitive therapy

Primary outcomes

  1. Body Mass Index

    Time frame: 18 months

    Body mass index

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • St. Olavs Hospital

Registry information

Official study title

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

Acronym: FBT-MCT

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Nov 18, 2023
Registry last updated
Jun 22, 2025

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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