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

NCT ID: NCT05418075

Last Updated: 2022-06-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-01

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Anorexia in Adolescence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Home Treatment as add on to Familiy-based Treatment

Group Type EXPERIMENTAL

Psychotherapy

Intervention Type OTHER

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.

Familiy-based Treatment

Group Type ACTIVE_COMPARATOR

Psychotherapy

Intervention Type OTHER

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.

Mindfulness based stress reduction training

Group Type ACTIVE_COMPARATOR

Psychotherapy

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

12 Years

Maximum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Psychiatric University Hospital, Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Psychiatrische Universitätsklilnik Zürich

Zurich, , Switzerland

Site Status RECRUITING

Countries

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Switzerland

Facility Contacts

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Nicole Flütsch, M.Sc.

Role: primary

0434992626 ext. +41

References

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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.

Reference Type DERIVED
PMID: 37580810 (View on PubMed)

Other Identifiers

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HTED 2021-01706

Identifier Type: -

Identifier Source: org_study_id

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