Anorexia NervosaARCS-FBTNCT05748457
Akershus University Hospital Retrospective Cohort Study of Family Based Treatment
An observational study of Anorexia Nervosa and Atypical Anorexia Nervosa, run by University Hospital, Akershus at 1 site in Norway.
Trial summary
The goal of this observational study is to compare short and long-term effects of manualised Family Based Treatment for adolescent anorexia nervosa to those of non-manualised family therapy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Anorexia Nervosa, Atypical Anorexia Nervosa
- What is being tested?
- Non-manualised family therapy. and Family Based Treatment
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 28 participants
- Where
- 1 siteNorway
- Study dates
- 27 Mar 2023to 29 Aug 2024
- Phase
- Observational
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Patients initiating treatment during the years 2015-2020 with the eating disorder team at Nedre Romerike outpatient clinic at Akershus university hospital, Department of child and adolescent mental health services.
Who may be able to join
- Clinical diagnosis of F50.0 Anorexia nervosa or F50.1 Atypical anorexia nervosa according to the International Classification of Diseases-10.
Who cannot join
- Patient was treated during the years 2018-2020 and FBT was never initiated according to patient health records.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Changes in Outcomes of Treatment for Adolescent Anorexia Nervosa After Implementation of Family Based Treatment in a Norwegian Child and Adolescent Mental Health Service: A Retrospective Cohort Study With Prospective Follow-up
The goal of this observational study is to compare short and long-term effects of manualised Family Based Treatment for adolescent anorexia nervosa to those of non-manualised family therapy. The study will approach former patients who were treated before and after Family Based Therapy was adopted in an outpatient clinic, and extract data from electronic health records and public registries.
Read the detailed description
A two-group retrospective exploratory cohort study with longitudinal follow-up comparing adolescents with anorexia nervosa treated with generic family therapy to those treated with the manualised Family Based Treatment (FBT). The primary aim is to investigate whether adoption of FBT has led to faster normalisation of weight and lower rates of eating disorder in early adulthood. Secondary aims are to investigate whether implementation of FBT has changed the time to discharge, heterogeneity of patient weight change across treatment, rates of adverse events, rates of readmission, patient experiences of the treatment, long term functional outcomes and mortality. Data are extracted from patient health records, reported by participants and extracted from public registries.
- Conditions
- Anorexia Nervosa, Atypical Anorexia Nervosa
- Being tested
- Non-manualised family therapy., Family Based Treatment
- Medical subject headings
- Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-manualised family therapy.Behavioural
Family therapy provided by qualified therapists without reference to a specific therapy manual.
Family Based TreatmentBehavioural
Family therapy implemented according to the published "Treatment manual for anorexia nervosa: A family-based approach" by Lock \& Le Grange (2nd edition, 2015).
| Study group | Role | What they receive |
|---|---|---|
| 2015-2017 | Patients treated for anorexia nervosa in the years 2015-2017 at Nedre Romerike outpatient clinic, Department of child and adolescent mental health services, Akershus university hospital. Receives: Behavioral: Non-manualised family therapy. | |
| 2018-2020 | Patients treated for anorexia nervosa in the years 2018-2020 at Nedre Romerike outpatient clinic, Department of child and adolescent mental health services, Akershus university hospital. Receives: Behavioral: Family Based Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to weight restoration
Number of days from start of treatment to a weight measurement placing the patient at or above 95% of expected body weight (50. percentile) for age and sex given Norwegian population norms.
Measured: Assessed retrospectively at enrolment.
Secondary outcomes (6)
Time to discharge from treatment
Number of days from start of treatment to the date of discharge from the outpatient clinic.
Measured: Assessed retrospectively at enrolment.
Time to readmission to treatment
Number of days from start of treatment to any date of readmission to the outpatient clinic.
Measured: Assessed retrospectively at enrolment.
Mortality
Death from any cause.
Measured: Assessed 5, 10, 15 and 20 years post treatment.
Level of education
Highest level of education achieved, obtained from national registries.
Measured: Assessed 5, 10, 15 and 20 years post treatment.
Employment status and welfare benefits
Employment status or receipt of welfare benefits, obtained from national registries.
Measured: Assessed 5, 10, 15 and 20 years post treatment.
Treatment for eating disorder in adulthood
Treatment in specialist mental health services for any eating disorder.
Measured: Assessed 5, 10, 15 and 20 years post treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2023
- Study start27 Mar 2023
- Primary completion29 Aug 2024
- Study completion29 Aug 2024
Why it stopped: The proportion of eligible participants consenting was too low (21%) too draw any conclusions.
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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Akershus
- Sponsor type
- University, hospital or other
- Collaborators
- Rådgivning om Spiseforstyrrelser
- Responsible party
- Principal investigator, Erling W. Rognli, University Hospital, Akershus
- Investigators
- Erling W Rognli, PhD, Principal investigator, University Hospital, Akershus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05748457
- Sponsor's protocol ID
- 2021_182
- Acronym
- ARCS-FBT
- Status last verified
- Aug 2024
- First submitted
- 16 Feb 2023
- Last updated
- 3 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data cannot be shared for legal reasons.
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Outcomes of Treatment for Adolescent Anorexia Nervosa After Implementation of Family Based Treatment in a Norwegian Child and Adolescent Mental Health Service: A Retrospective Cohort Study With Prospective Follow-up
- ClinicalTrials.gov ID
- NCT05748457
- Acronym / sponsor ID
- ARCS-FBT / 2021_182
- Conditions
- Anorexia Nervosa, Atypical Anorexia Nervosa
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The proportion of eligible participants consenting was too low (21%) too draw any conclusions.
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University Hospital, AkershusUniversity, hospital or other
- Collaborators
- Rådgivning om Spiseforstyrrelser
- Study start
- 27 Mar 2023 (actual)
- Primary completion
- 29 Aug 2024 (actual)
- Study completion
- 29 Aug 2024 (actual)
- First posted
- 28 Feb 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 observational study is to compare short and long-term effects of manualised Family Based Treatment for adolescent anorexia nervosa to those of non-manualised family therapy. The study will approach former patients who were treated before and after Family Based Therapy was adopted in an outpatient clinic, and extract data from electronic health records and public registries.
Detailed description
A two-group retrospective exploratory cohort study with longitudinal follow-up comparing adolescents with anorexia nervosa treated with generic family therapy to those treated with the manualised Family Based Treatment (FBT). The primary aim is to investigate whether adoption of FBT has led to faster normalisation of weight and lower rates of eating disorder in early adulthood. Secondary aims are to investigate whether implementation of FBT has changed the time to discharge, heterogeneity of patient weight change across treatment, rates of adverse events, rates of readmission, patient experiences of the treatment, long term functional outcomes and mortality. Data are extracted from patient health records, reported by participants and extracted from public registries.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2015-2017 | – | Behavioral: Non-manualised family therapy.Patients treated for anorexia nervosa in the years 2015-2017 at Nedre Romerike outpatient clinic, Department of child and adolescent mental health services, Akershus university hospital. |
| 2018-2020 | – | Behavioral: Family Based TreatmentPatients treated for anorexia nervosa in the years 2018-2020 at Nedre Romerike outpatient clinic, Department of child and adolescent mental health services, Akershus university hospital. |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients initiating treatment during the years 2015-2020 with the eating disorder team at Nedre Romerike outpatient clinic at Akershus university hospital, Department of child and adolescent mental health services.
Key inclusion criteria (1 listed)
- Clinical diagnosis of F50.0 Anorexia nervosa or F50.1 Atypical anorexia nervosa according to the International Classification of Diseases-10.
Key exclusion criteria (1 listed)
- Patient was treated during the years 2018-2020 and FBT was never initiated according to patient health records.
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 |
|---|---|---|
| Non-manualised family therapy.Family therapy provided by qualified therapists without reference to a specific therapy manual. | Behavioural | 2015-2017 |
| Family Based TreatmentFamily therapy implemented according to the published "Treatment manual for anorexia nervosa: A family-based approach" by Lock \& Le Grange (2nd edition, 2015). | Behavioural | 2018-2020 |
Primary outcome
Time to weight restoration
Time frame: Assessed retrospectively at enrolment.
Number of days from start of treatment to a weight measurement placing the patient at or above 95% of expected body weight (50. percentile) for age and sex given Norwegian population norms.
6 secondary outcomes
Time to discharge from treatment
Time frame: Assessed retrospectively at enrolment.
Time to readmission to treatment
Time frame: Assessed retrospectively at enrolment.
Mortality
Time frame: Assessed 5, 10, 15 and 20 years post treatment.
Level of education
Time frame: Assessed 5, 10, 15 and 20 years post treatment.
Employment status and welfare benefits
Time frame: Assessed 5, 10, 15 and 20 years post treatment.
Treatment for eating disorder in adulthood
Time frame: Assessed 5, 10, 15 and 20 years post treatment.
Results and safety
The study was stopped early (reason given: The proportion of eligible participants consenting was too low (21%) too draw any conclusions.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2024.
- Individual participant dataSharing planned: No. Individual participant data cannot be shared for legal reasons.
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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.
Erling W Rognli, PhD principal investigator
University Hospital, Akershus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anorexia Nervosa and Atypical Anorexia Nervosa, run by University Hospital, Akershus 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 1 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: stopped early, as of the sponsor's last update on 3 Sep 2024. 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 was stopped early (reason given: The proportion of eligible participants consenting was too low (21%) too draw any conclusions.). Results are not available in the source record.
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?
Time to weight restoration (time frame: Assessed retrospectively at enrolment.). 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 3 Sep 2024.