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

NCT05418075 | Unknown

• 1 other identifier: HTED 2021-01706
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Anorexia in Adolescence

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• State of health improvement

  3 months

• Remission rate

  12 months

Study Arms (3)

Home Treatment as add on to Familiy-based Treatment

EXPERIMENTAL

Other: Psychotherapy

Familiy-based Treatment

ACTIVE COMPARATOR

Other: Psychotherapy

Mindfulness based stress reduction training

ACTIVE COMPARATOR

Other: Psychotherapy

Interventions

Psychotherapy 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; Home Treatment as add on to Familiy-based Treatment; Mindfulness based stress reduction training

Eligibility Criteria

• Age: 12 Years - 20 Years
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• No written consent
• Children under 12 years
• Other forms of eating disorders apart from anorexia nervosa or atypical anorexia nervosa.

Sponsors & Collaborators

• Psychiatric University Hospital, Zurich: lead

Study Sites (1)

Psychiatrische Universitätsklilnik Zürich

Zurich, 8032, Switzerland

RECRUITING

Related Publications (1)

• 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.

  PMID: 37580810 DERIVED

MeSH Terms

Interventions

Psychotherapy

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2022
• First Posted: June 14, 2022
• Study Start: February 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: June 14, 2022

Record last verified: 2022-06

Locations

CH (1)