Anorexia NervosaFBT-MCTNCT06139770
Treatment of Anorexia Nervosa in Children and Adolescents: An Integrated Family Based and Metacognitive Approach
A study testing Family based Metacognitive Therapy. in people with Anorexia Nervosa, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- Family based Metacognitive Therapy.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteNorway
- Study dates
- 1 Nov 2023to 1 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Primary diagnosis of F 50.0 and F 50.1
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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 6 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 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
- Conditions
- Anorexia Nervosa
- Being tested
- Family based Metacognitive Therapy.
- Medical subject headings
- Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family based Metacognitive Therapy.Behavioural
FB-MCT is a integration of Family-Based Therapy and Metacognitive therapy for adolescents and parents, using principles from both FBT and MCT.
| Study group | Role | What they receive |
|---|---|---|
| Family based Metacognitive therapy | Experimental | Family based Metacognitive therapy is a treatment combining family based therapy prinsiples with Metacognitive therapy. FB-MCT integrates parental support for refeeding with metacognitive work on worry, rumination, body checking and thought control strategies Receives: Behavioral: Family based Metacognitive Therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Mass Index
Body mass index
Measured: Through study completion on an average of 1 year.
Percentage Expected Body Weight (PEBW)
PEBW was used as the principal measure of weight restoration because it accounts for age, sex, and height and is therefore developmentally appropriate for adolescents. PEBW expresses observed weight as a percentage of the expected weight derived from age- and sex-adjusted growth standards. A value of 100% represents expected body weight for that sex and age. Weight remission was defined as achieving ≥95% PEBW.
Measured: Through study completaion on an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start1 Nov 2023
- Primary completion1 May 2026
- Study completion1 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06139770
- Sponsor's protocol ID
- 255677
- Acronym
- FBT-MCT
- Status last verified
- Oct 2026
- First submitted
- 24 Aug 2023
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Anorexia Nervosa in Children and Adolescents: An Integrated Family-based and Metacognitive Approach
- ClinicalTrials.gov ID
- NCT06139770
- Acronym / sponsor ID
- FBT-MCT / 255677
- Conditions
- Anorexia Nervosa
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 May 2026 (actual)
- Study completion
- 1 Aug 2026 (actual)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 6 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 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Family based Metacognitive therapy | Experimental | Behavioral: Family based Metacognitive Therapy.Family based Metacognitive therapy is a treatment combining family based therapy prinsiples with Metacognitive therapy. FB-MCT integrates parental support for refeeding with metacognitive work on worry, rumination, body checking and thought control strategies |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Primary diagnosis of F 50.0 and F 50.1
Key exclusion criteria (6 listed)
- Psychotic symptoms
- Severe somatic illness
- Mental retardation or developmental disorder
- Bipolar disorder
- Extreme self-mutilation or acute suicidal risks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family based Metacognitive Therapy.FB-MCT is a integration of Family-Based Therapy and Metacognitive therapy for adolescents and parents, using principles from both FBT and MCT. | Behavioural | Family based Metacognitive therapy |
Primary outcome
Body Mass Index
Time frame: Through study completion on an average of 1 year.
Body mass index
Percentage Expected Body Weight (PEBW)
Time frame: Through study completaion on an average of 1 year
PEBW was used as the principal measure of weight restoration because it accounts for age, sex, and height and is therefore developmentally appropriate for adolescents. PEBW expresses observed weight as a percentage of the expected weight derived from age- and sex-adjusted growth standards. A value of 100% represents expected body weight for that sex and age. Weight remission was defined as achieving ≥95% PEBW.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family based Metacognitive Therapy. in people with Anorexia Nervosa, run by Norwegian University of Science and Technology at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Mass Index (time frame: Through study completion on an average of 1 year.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.