Evaluation of the Effectiveness of Add-on Hometreatment to Family Based Therapy in Adolescent Anorexia Nervosa.

Anorexia in Adolescence Clinical Trial

— HTED  

Official title:

Evaluation of the Effectiveness of Add-on Hometreatment to Family Based Therapy in Adolescent Anorexia Nervosa. A Randomised Controlled Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05418075
• Other study ID #: HTED 2021-01706
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Anorexia
• Anorexia in Adolescence
• Anorexia Nervosa

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