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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05418075
Other study ID # HTED 2021-01706
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 1, 2022
Est. completion date December 31, 2024

Study information

Verified date June 2022
Source Psychiatric University Hospital, Zurich
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 90
Est. completion date December 31, 2024
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 12 Years to 20 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - No written consent - Children under 12 years - Other forms of eating disorders apart from anorexia nervosa or atypical anorexia nervosa.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Psychotherapy
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.

Locations

Country Name City State
Switzerland Psychiatrische Universitätsklilnik Zürich Zürich

Sponsors (1)

Lead Sponsor Collaborator
Psychiatric University Hospital, Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Symptomatic improvement Change of the reported BMI; Weight in Kg and Height in cm will be combined to report BMI in kg/m^2 3 months
Primary Symptomatic improvement Change of the Eating Disorder Examination Interview (EDE) total score analyze using a linear random coefficient regressions model 3 months
Primary Symptomatic improvement Change of the Eating Disorder Inventory (EDI) total score analyze using a linear random coefficient regressions model 3 months
Secondary 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. 3 months
Secondary 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 12 months
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