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

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.

Study Overview

• Status: Recruiting
• Conditions: Anorexia in Adolescence
• Intervention / Treatment: Other: Psychotherapy

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Zürich, Switzerland, 8032
    • Recruiting
    • Psychiatrische Universitätsklilnik Zürich
    • Contact: Nicole Flütsch, M.Sc.; Phone Number: +41 0434992626; Email: nicole.fluetsch@uzh.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 20 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Home Treatment as add on to Familiy-based Treatment	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.
Active Comparator: Familiy-based Treatment	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.
Active Comparator: Mindfulness based stress reduction training	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Symptomatic improvement	Change of the Eating Disorder Examination Interview (EDE) total score analyze using a linear random coefficient regressions model	3 months
Symptomatic improvement	Change of the Eating Disorder Inventory (EDI) total score analyze using a linear random coefficient regressions model	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Psychiatric University Hospital, Zurich

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: January 5, 2022
• First Submitted That Met QC Criteria: June 10, 2022
• First Posted (Actual): June 14, 2022

Study Record Updates

• Last Update Posted (Actual): June 14, 2022
• Last Update Submitted That Met QC Criteria: June 10, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Feeding and Eating Disorders; Anorexia; Anorexia Nervosa
• Other Study ID Numbers: HTED 2021-01706

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No