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

Study Overview
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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.

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

Conditions
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Anorexia in Adolescence

Intervention / Treatment
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* Other: Psychotherapy


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Home Treatment as add on to Familiy-based Treatment<br> | Other: Psychotherapy<br>* 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.<br>|
| Active Comparator: Familiy-based Treatment<br> | Other: Psychotherapy<br>* 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.<br>|
| Active Comparator: Mindfulness based stress reduction training<br> | Other: Psychotherapy<br>* 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.<br>|

What is the study measuring?
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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 |