Treatment of Anorexia Nervosa in Children and Adolescents... | NCT06139770

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

NCT06139770

Sponsor

Norwegian University of Science and Technology

Status

Active, not recruiting

Last Update Posted

Jun 22, 2025Actual

Enrollment

48Estimated

Phase

Not Applicable

Conditions

Anorexia Nervosa

Interventions

Family based therapy- Metacognitive therapy

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2023Actual

Primary Completion Date

Dec 1, 2025Estimated

Completion Date

Dec 1, 2026Estimated

First Submitted Date

Aug 24, 2023

First Submission Date that Met QC Criteria

Nov 15, 2023

First Posted Date

Nov 18, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 17, 2025

Last Update Posted Date

Jun 22, 2025Actual

Name	Class
St. Olavs Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

48Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Family based therapy- Metacognitive therapy	Behavioral	Family based therapy and Metacognitive therapy	Active follow-up Passive follow-up

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St.Olavs hospital HF		Trondheim	Trøndelag	7006	Norway

Condition Browse Module

MeSH Terms

ID	Term
D000856	Anorexia Nervosa

Ancestor Terms

ID	Term
D001068	Feeding and Eating Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Model Description

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.