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

Primary Purpose

Anorexia in Adolescence

Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Psychotherapy
Sponsored by
Psychiatric University Hospital, Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anorexia in Adolescence

Eligibility Criteria

12 Years - 20 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Psychiatrische Universitätsklilnik ZürichRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Home Treatment as add on to Familiy-based Treatment

Familiy-based Treatment

Mindfulness based stress reduction training

Arm Description

Outcomes

Primary Outcome Measures

Symptomatic improvement
Change of the reported BMI; Weight in Kg and Height in cm will be combined to report BMI in kg/m^2
Symptomatic improvement
Change of the Eating Disorder Examination Interview (EDE) total score analyze using a linear random coefficient regressions model
Symptomatic improvement
Change of the Eating Disorder Inventory (EDI) total score analyze using a linear random coefficient regressions model

Secondary Outcome Measures

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.
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

Full Information

First Posted
January 5, 2022
Last Updated
June 10, 2022
Sponsor
Psychiatric University Hospital, Zurich
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1. Study Identification

Unique Protocol Identification Number
NCT05418075
Brief Title
Evaluation of the Effectiveness of Add-on Hometreatment to Family Based Therapy in Adolescent Anorexia Nervosa.
Acronym
HTED
Official Title
Evaluation of the Effectiveness of Add-on Hometreatment to Family Based Therapy in Adolescent Anorexia Nervosa. A Randomised Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Psychiatric University Hospital, Zurich

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorexia in Adolescence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Home Treatment as add on to Familiy-based Treatment
Arm Type
Experimental
Arm Title
Familiy-based Treatment
Arm Type
Active Comparator
Arm Title
Mindfulness based stress reduction training
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Psychotherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Symptomatic improvement
Description
Change of the reported BMI; Weight in Kg and Height in cm will be combined to report BMI in kg/m^2
Time Frame
3 months
Title
Symptomatic improvement
Description
Change of the Eating Disorder Examination Interview (EDE) total score analyze using a linear random coefficient regressions model
Time Frame
3 months
Title
Symptomatic improvement
Description
Change of the Eating Disorder Inventory (EDI) total score analyze using a linear random coefficient regressions model
Time Frame
3 months
Secondary Outcome Measure Information:
Title
State of health improvement
Description
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.
Time Frame
3 months
Title
Remission rate
Description
Remission is definde as a Body weight within 15% deviation of the normal weight and clinically unremarkable values in the EDE and EDI
Time Frame
12 months

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Psychiatrische Universitätsklilnik Zürich
City
Zürich
ZIP/Postal Code
8032
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicole Flütsch, M.Sc.
Phone
0434992626
Ext
+41
Email
nicole.fluetsch@uzh.ch

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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