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

Sponsor

Norwegian University of Science and Technology (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT06139770

Collaborator

St. Olavs Hospital (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anorexia Nervosa	Behavioral: Family based therapy- Metacognitive therapy	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

48 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.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.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2025

Anticipated Study Completion Date :

Dec 1, 2026

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Body Mass Index [18 months]
Body mass index

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St.Olavs hospital HF	Trondheim	Trøndelag	Norway	7006

Sponsors and Collaborators

Norwegian University of Science and Technology
St. Olavs Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Norwegian University of Science and Technology

ClinicalTrials.gov Identifier:

NCT06139770

Other Study ID Numbers:

255677

First Posted:

Nov 18, 2023

Last Update Posted:

Nov 18, 2023

Last Verified:

Nov 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Anorexia

Anorexia Nervosa

Study Results

No Results Posted as of Nov 18, 2023