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

NCT06139770 | Active Not Recruiting

• 1 other identifier: 255677
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anorexia Nervosa

Outcome Measures

Primary Outcomes (1)

• Body Mass Index

  Body mass index

  18 months

Study Arms (2)

Active follow-up

ACTIVE COMPARATOR

The patients will recieve 3 sessions of MCT

Behavioral: Family based therapy- Metacognitive therapy

Passive follow-up

ACTIVE COMPARATOR

The group receives no sessions during follow-up

Behavioral: Family based therapy- Metacognitive therapy

Interventions

Family based therapy- Metacognitive therapy BEHAVIORAL

Family based therapy and Metacognitive therapy

Active follow-up; Passive follow-up

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Primary diagnosis of F 50.0 and F 50.1

You may not qualify if:

• 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

Sponsors & Collaborators

• Norwegian University of Science and Technology: lead
• St. Olavs Hospital: collaborator

Study Sites (1)

St.Olavs hospital HF

Trondheim, Trøndelag, 7006, Norway

Location

MeSH Terms

Conditions

Anorexia Nervosa

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The patients will receive the same treatment (FBT/MCT) including their parents, and by post treatment the patients will be randomised to two types of follow-up. One group of the patients will be allocated to active follow-up, receiving 3 booster sessions during the 12 months follow-up, and the second group will be followed-up as usual.

Study Record Dates

• First Submitted: August 24, 2023
• First Posted: November 18, 2023
• Study Start: November 1, 2023
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 22, 2025

Record last verified: 2025-06

Locations

NO (1)