Eating DisordersNCT05734573
The Effectiveness of Eating Disorder Treatment
A study testing Family-based treatment in people with Eating Disorders, run by Helsinki University Central Hospital.
Trial summary
Family-based treatment (FBT), a form of family therapy for eating disorders (ED) in young patients, has proven to be effective in numerous large-scale studies. This study aims to evaluate outcomes of the treatment for anorexia nervosa (AN) in a 'real-world' setting in a specialized outpatient clinic in Helsinki… Read more about this study
- Who is it for?
- Ages 13 to 18 years, women only
- Conditions the study is for
- Eating Disorders
- What is being tested?
- Family-based treatment
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2013to 31 Dec 2022
- 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 13 to 18 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Clinical diagnosis of Anorexia nervosa
- Admitted to FBT at the Eating Disorder Unit from June 1, 2013, through December 31, 2017
Who cannot join
- No exclusions
About this study
Official title: Effects of Family-based Treatment on Adolescent Outpatients Treated for Anorexia Nervosa in the Eating Disorder Unit of Helsinki University Hospital
Family-based treatment (FBT), a form of family therapy for eating disorders (ED) in young patients, has proven to be effective in numerous large-scale studies. This study aims to evaluate outcomes of the treatment for anorexia nervosa (AN) in a 'real-world' setting in a specialized outpatient clinic in Helsinki, Finland. Fifty-two young female patients seen for treatment between June 2013 and December 2017 were included in the study. Demographic and treatment characteristics, weight, and ED symptoms before and after treatment are reported
Read the detailed description
Aim: The naturalistic outcome of outpatient FBT for adolescent AN was investigated.
Methods: Fifty-two female patients and their families who received FBT at a tertiary eating disorders unit participated in the study. Data on their pre-treatment parameters, treatment details, and condition at the end of treatment (EOT) was collected from their medical records
- Conditions
- Eating Disorders
- Being tested
- Family-based treatment
- Medical subject headings
- Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family-based treatmentBehavioural
FBT is carried out by a family therapist who has received FBT training. The duration of FBT is commonly 6-12 months, in most cases comprising 10-20 sessions. At the beginning of treatment, there are weekly sessions; later in treatment, the sessions are less frequent. The patient and their family meet their psychiatrist every four to six weeks, and the family therapist also takes part in these meetings. The treatment is implemented in accordance with the FBT treatment manual.
What is being measured
The primary outcome is the main question the study is designed to answer.
% of patients with body weight normalization in treatment
Rate of patients with a normal body weight defined as a BMI over 18.5 at the end of treatment was calculated.
Measured: Treatment period, aprox. 1 year
% of patients with eating disorder symptoms at the end of treatment
The data of any eating disorder symptoms detected by a psychiatrist at the end of treatment were collected from the medical records, and the incidence was calculated.
Measured: Treatment period, aprox. 1 year
% of patients in need for a further treatment after the intervention
Rate of patients who still needed treatment after the FBT intervention from was assessed at the end of treatment. The data were obtained from the medical files of the patients.
Measured: Treatment period, aprox. 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start1 Jun 2013
- Primary completion31 Dec 2017
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Eating DisordersStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Svetlana Oshukova, Helsinki University Central Hospital
- Investigators
- Jaana Suokas, Dos, Study director, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05734573
- Sponsor's protocol ID
- 653/13/01/03/2015/1
- Status last verified
- Feb 2023
- First submitted
- 8 Jan 2023
- Last updated
- 21 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The dataset generated for the study is not publicly available due to privacy restrictions. The data are available on request from the principal investigator
Publications
Jones M, Volker U, Lock J, Taylor CB, Jacobi C. Family-based early intervention for anorexia nervosa. Eur Eat Disord Rev. 2012 May;20(3):e137-43. doi: 10.1002/erv.2167. Epub 2012 Mar 22.
PubMed 22438094Lock J. Family therapy for eating disorders in youth: current confusions, advances, and new directions. Curr Opin Psychiatry. 2018 Nov;31(6):431-435. doi: 10.1097/YCO.0000000000000451.
PubMed 30063479Lock J, Le Grange D. Family-based treatment: Where are we and where should we be going to improve recovery in child and adolescent eating disorders. Int J Eat Disord. 2019 Apr;52(4):481-487. doi: 10.1002/eat.22980. Epub 2018 Dec 6.
PubMed 30520532Oshukova S, Suokas J, Nordberg M, Algars M. Effects of family-based treatment on adolescent outpatients treated for anorexia nervosa in the Eating Disorder Unit of Helsinki University Hospital. J Eat Disord. 2023 Sep 11;11(1):154. doi: 10.1186/s40337-023-00879-9.
PubMed 37697396
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Family-based Treatment on Adolescent Outpatients Treated for Anorexia Nervosa in the Eating Disorder Unit of Helsinki University Hospital
- ClinicalTrials.gov ID
- NCT05734573
- Acronym / sponsor ID
- 653/13/01/03/2015/1
- Conditions
- Eating Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- 1 Jun 2013 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 21 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.
Family-based treatment (FBT), a form of family therapy for eating disorders (ED) in young patients, has proven to be effective in numerous large-scale studies. This study aims to evaluate outcomes of the treatment for anorexia nervosa (AN) in a 'real-world' setting in a specialized outpatient clinic in Helsinki, Finland. Fifty-two young female patients seen for treatment between June 2013 and December 2017 were included in the study. Demographic and treatment characteristics, weight, and ED symptoms before and after treatment are reported
Detailed description
Aim: The naturalistic outcome of outpatient FBT for adolescent AN was investigated.
Methods: Fifty-two female patients and their families who received FBT at a tertiary eating disorders unit participated in the study. Data on their pre-treatment parameters, treatment details, and condition at the end of treatment (EOT) was collected from their medical records
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 13 to 18 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of Anorexia nervosa
- Admitted to FBT at the Eating Disorder Unit from June 1, 2013, through December 31, 2017
Key exclusion criteria (1 listed)
- No exclusions
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 treatmentFBT is carried out by a family therapist who has received FBT training. The duration of FBT is commonly 6-12 months, in most cases comprising 10-20 sessions. At the beginning of treatment, there are weekly sessions; later in treatment, the sessions are less frequent. The patient and their family meet their psychiatrist every four to six weeks, and the family therapist also takes part in these meetings. The treatment is implemented in accordance with the FBT treatment manual. | Behavioural | – |
Primary outcome
% of patients with body weight normalization in treatment
Time frame: Treatment period, aprox. 1 year
Rate of patients with a normal body weight defined as a BMI over 18.5 at the end of treatment was calculated.
% of patients with eating disorder symptoms at the end of treatment
Time frame: Treatment period, aprox. 1 year
The data of any eating disorder symptoms detected by a psychiatrist at the end of treatment were collected from the medical records, and the incidence was calculated.
% of patients in need for a further treatment after the intervention
Time frame: Treatment period, aprox. 1 year
Rate of patients who still needed treatment after the FBT intervention from was assessed at the end of treatment. The data were obtained from the medical files of the patients.
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 21 Feb 2023.
- Background: PubMed 22438094Jones M, Volker U, Lock J, Taylor CB, Jacobi C. Family-based early intervention for anorexia nervosa. Eur Eat Disord Rev. 2012 May;20(3):e137-43. doi: 10.1002/erv.2167. Epub 2012 Mar 22.
- Background: PubMed 30063479Lock J. Family therapy for eating disorders in youth: current confusions, advances, and new directions. Curr Opin Psychiatry. 2018 Nov;31(6):431-435. doi: 10.1097/YCO.0000000000000451.
- Background: PubMed 30520532Lock J, Le Grange D. Family-based treatment: Where are we and where should we be going to improve recovery in child and adolescent eating disorders. Int J Eat Disord. 2019 Apr;52(4):481-487. doi: 10.1002/eat.22980. Epub 2018 Dec 6.
- Derived from this study: PubMed 37697396Oshukova S, Suokas J, Nordberg M, Algars M. Effects of family-based treatment on adolescent outpatients treated for anorexia nervosa in the Eating Disorder Unit of Helsinki University Hospital. J Eat Disord. 2023 Sep 11;11(1):154. doi: 10.1186/s40337-023-00879-9.
- Individual participant dataSharing planned: No. The dataset generated for the study is not publicly available due to privacy restrictions. The data are available on request from the principal investigator
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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.
Jaana Suokas, Dos study director
Helsinki University Central Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Family-based treatment in people with Eating Disorders, run by Helsinki University Central Hospital.
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 2 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: finished, as of the sponsor's last update on 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
% of patients with body weight normalization in treatment (time frame: Treatment period, aprox. 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05734573, which also lists 4 linked publications.
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 21 Feb 2023.