Anorexia in AdolescenceHTEDNCT05418075
Evaluation of the Effectiveness of Add-on Hometreatment to Family Based Therapy in Adolescent Anorexia Nervosa.
A study testing Psychotherapy in people with Anorexia in Adolescence, run by Psychiatric University Hospital, Zurich at 1 site in Switzerland.
Trial summary
The project serves to evaluate a new treatment method with outreach services as a supplement to family-based therapy in the treatment of children and adolescents with eating disorders. Read more about this study
- Who is it for?
- Ages 12 to 20 years
- Conditions the study is for
- Anorexia in Adolescence
- What is being tested?
- Psychotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Feb 2022to 31 Dec 2024
- 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 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children and adolescents aged 12 -20 years.
- Successful registrations in the special consultation for eating disorders at the Clinic for Child and Adolescent Psychiatry and Psychotherapy (KJPP) of the Psychiatric University Hospital (PUK) Zurich.
- Diagnosis of anorexia nervosa or atypical anorexia nervosa (ICD-10 F50.00/ F50.01/ F50.1)
- Existing informed consent of patients* (14 years and older) and parents or legal guardians (12-14 years).
- IQ over 75
- Resident in the canton of Zurich
- Good knowledge of German
Who cannot join
- No written consent
- Children under 12 years
- Other forms of eating disorders apart from anorexia nervosa or atypical anorexia nervosa.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Psychiatrische Universitätsklilnik Zürich
Zurich, 8032
Nicole Flütsch, M.Sc., 0434992626 ext. +41, nicole.fluetsch@uzh.ch
About this study
Official title: Evaluation of the Effectiveness of Add-on Hometreatment to Family Based Therapy in Adolescent Anorexia Nervosa. A Randomised Controlled Clinical Trial
The project serves to evaluate a new treatment method with outreach services as a supplement to family-based therapy in the treatment of children and adolescents with eating disorders.
The project is intended to help identify different family structures and which families will benefit most from the new outreach service of home-based treatment.
- Conditions
- Anorexia in Adolescence
- Being tested
- Psychotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsychotherapyOther
If the families agree to participate in the study, they are randomly assigned to a treatment group. In each of the three groups, they are treated with FBT in a weekly session. In the two comparison groups, Hometreatment or MBSR are offered in addition to FBT, with two consultations per week in each case.
| Study group | Role | What they receive |
|---|---|---|
| Home Treatment as add on to Familiy-based Treatment | Experimental | Not described Receives: Other: Psychotherapy |
| Familiy-based Treatment | Active comparator | Not described Receives: Other: Psychotherapy |
| Mindfulness based stress reduction training | Active comparator | Not described Receives: Other: Psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptomatic improvement
Change of the reported BMI; Weight in Kg and Height in cm will be combined to report BMI in kg/m^2
Measured: 3 months
Symptomatic improvement
Change of the Eating Disorder Examination Interview (EDE) total score analyze using a linear random coefficient regressions model
Measured: 3 months
Symptomatic improvement
Change of the Eating Disorder Inventory (EDI) total score analyze using a linear random coefficient regressions model
Measured: 3 months
Secondary outcomes (2)
State of health improvement
Change of the Perceived stress scale (PSS) total score measering level of perceived stress and change of the total score in Brief dyadic scale of expressed emotion (BDSEE) measering level of expressed emotion.
Measured: 3 months
Remission rate
Remission is definde as a Body weight within 15% deviation of the normal weight and clinically unremarkable values in the EDE and EDI
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2022
- Study start1 Feb 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anorexia in AdolescenceStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Psychiatric University Hospital, Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05418075
- Sponsor's protocol ID
- HTED 2021-01706
- Acronym
- HTED
- Status last verified
- Jun 2022
- First submitted
- 5 Jan 2022
- Last updated
- 14 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Besse-Flutsch N, Buhlmann C, Fabijani N, Ruschetti GG, Smigielski L, Pauli D. Home treatment as an add-on to family-based treatment for adolescents with anorexia nervosa compared with standard family-based treatment and home-based stress reduction training: study protocol for a randomized clinical trial. J Eat Disord. 2023 Aug 14;11(1):135. doi: 10.1186/s40337-023-00861-5.
PubMed 37580810
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Add-on Hometreatment to Family Based Therapy in Adolescent Anorexia Nervosa. A Randomised Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05418075
- Acronym / sponsor ID
- HTED / HTED 2021-01706
- Conditions
- Anorexia in Adolescence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Psychiatric University Hospital, ZurichUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 14 Jun 2022 (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 project serves to evaluate a new treatment method with outreach services as a supplement to family-based therapy in the treatment of children and adolescents with eating disorders.
The project is intended to help identify different family structures and which families will benefit most from the new outreach service of home-based treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Home Treatment as add on to Familiy-based Treatment | Experimental | Other: Psychotherapy |
| Familiy-based Treatment | Active comparator | Other: Psychotherapy |
| Mindfulness based stress reduction training | Active comparator | Other: Psychotherapy |
Who may qualify
- Ages
- 12 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Children and adolescents aged 12 -20 years.
- Successful registrations in the special consultation for eating disorders at the Clinic for Child and Adolescent Psychiatry and Psychotherapy (KJPP) of the Psychiatric University Hospital (PUK) Zurich.
- Diagnosis of anorexia nervosa or atypical anorexia nervosa (ICD-10 F50.00/ F50.01/ F50.1)
- Existing informed consent of patients* (14 years and older) and parents or legal guardians (12-14 years).
- IQ over 75
Key exclusion criteria (3 listed)
- No written consent
- Children under 12 years
- Other forms of eating disorders apart from anorexia nervosa or atypical anorexia nervosa.
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 |
|---|---|---|
| PsychotherapyIf the families agree to participate in the study, they are randomly assigned to a treatment group. In each of the three groups, they are treated with FBT in a weekly session. In the two comparison groups, Hometreatment or MBSR are offered in addition to FBT, with two consultations per week in each case. | Other | Familiy-based Treatment, Home Treatment as add on to Familiy-based Treatment, Mindfulness based stress reduction training |
Primary outcome
Symptomatic improvement
Time frame: 3 months
Change of the reported BMI; Weight in Kg and Height in cm will be combined to report BMI in kg/m^2
Symptomatic improvement
Time frame: 3 months
Change of the Eating Disorder Examination Interview (EDE) total score analyze using a linear random coefficient regressions model
Symptomatic improvement
Time frame: 3 months
Change of the Eating Disorder Inventory (EDI) total score analyze using a linear random coefficient regressions model
2 secondary outcomes
State of health improvement
Time frame: 3 months
Remission rate
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2022.
- Derived from this study: PubMed 37580810Besse-Flutsch N, Buhlmann C, Fabijani N, Ruschetti GG, Smigielski L, Pauli D. Home treatment as an add-on to family-based treatment for adolescents with anorexia nervosa compared with standard family-based treatment and home-based stress reduction training: study protocol for a randomized clinical trial. J Eat Disord. 2023 Aug 14;11(1):135. doi: 10.1186/s40337-023-00861-5.
- Individual participant dataSharing planned: Undecided
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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.
Psychiatrische Universitätsklilnik Zürich
Zurich, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychotherapy in people with Anorexia in Adolescence, run by Psychiatric University Hospital, Zurich at 1 site in Switzerland.
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 7 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 14 Jun 2022. 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 Switzerland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptomatic improvement (time frame: 3 months). 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 NCT05418075, which also lists 1 linked publication.
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 14 Jun 2022.