Anorexia nervosa Mental and Behavioural Disorders Anorexia nervosa
Conditions
Interventions
Day treatment and inpatient treatment includes:
1. Medical management as required
2. Physiotherapy
3. Occupational therapy
4. Nutritional counselling
5. Nutritional therapy (e.g. eating according to
patients will now also be followed-up in week 130 (1.5 years after the primary outcome).
Sponsors
German Federal Ministry of Education and Research (Bundesministerium Für Bildung und Forschung [BMBF]) (Germany)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Amendments as of 23/07/2010: As of the above date, point one below was updated as follows: 1. Female patients between 11 and 18 years Initial information at time of registration: 1. Female patients between 12 and 18 years 2. At first admission to hospital treatment for AN according to Diagnostic and Statistical Manual of mental disorders - fourth edition (DSM-IV) criteria as assessed by the Structured Interview for Anorexic and Bulimic disorders (SIAB) (Fichter et al. 1998) 3. Reasonable distance from residence to hospital: less than 60 minutes by bus/train 4. Written informed consent of the patient and - if necessary - of her legal guardian 5. All patients have passed a somatical stabilisation of three weeks in an inpatient setting prior to randomisation
Exclusion criteria
Exclusion criteria: 1. Any psychotic or personality disorder 2. Current alcohol or other substance abuse disorder 3. Self-injury behaviours as assessed by a structured diagnostic interview (Kiddie-Schedule for Affective Disorders and Schizophrenia [SADS], Delmo et al. 2001) 4. Insufficient ability to understand German (patients and parents) 5. Intelligence Quotient (IQ) less than 85
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 05/02/2013: Difference between BMI at admission, after one year and after two and a half years. Discontinuation of day treatment will be penalised appropriately. All treatment studies of AN have investigated weight gain during treatment and weight gain and weight maintenance after achievement of a target weight as major goals in the treatment of AN (e.g. British, American and German guidelines). BMI can be easily and objectively assessed even by general practitioners in case of relocations. Previous primary outcome measures until 05/02/2013: Difference between BMI after one year and at admission. Discontinuation of day treatment will be penalised appropriately. All treatment studies of AN have investigated weight gain during treatment and weight gain and weight maintenance after achievement of a target weight as major goals in the treatment of AN (e.g. British, American and German guidelines). BMI can be easily and objectively assessed even by general practitioners in case of relocations. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 05/02/2013: The clinical claim in favour of day treatment will only be supported in the case of the rejection of the null hypothesis based on the primary outcome measure. However, due to limited follow-up time, even in this case additional outcome variables will be analysed to support the clinical claim. The descriptive outcome measures comprise: 1. Difference between BMI after one year and at admission 2. Morgan-Russell criteria 3. BMI percentile 4. Improvement of eating disorder psychopathology (self report: Eating Disorder Inventory - 2 [EDI-2], structured interview: SIAB) 5. Depressive symptoms (patients: Depressionsinventar für Kinder und Jugendliche [Depression Inventory for Children and Adolescents] [DIKJ], parents: Beck Depression Inventory [BDI]) 6. Obsessive-compulsive symptoms (Children?s Yale-Brown Obsessive Compulsive Scale [CY-BOCS]) 7. General psychopathology (Symptoms CheckList [SCL-90-R56]) 8. Burden of parents (Brief Symptom Inventory [BSI]) At one-year follow-up additionally: 1. The number of relapses (hospitalisations) 2. Quality of life 3. Days of hospital treatment upon achievement of target weight At two and half-year follow-up: 1. The number of relapses (hospitalisations) 2. Quality of life 3. Days of hospital treatment upon achievement of target weight 4. Treatment satisfaction All psychometric outcome measures will be derived from validated and internationally used questionnaires and interviews. Previous secondary outcome measures until 05/02/2013: The clinical claim in favour of day treatment will only be supported in the case of the rejection of the null hypothesis based on the primary outcome measure. However, due to limited follow-up time, even in this case additional outcome variables will be analysed to support the clinical claim. The descriptive outcome measures comprise: 1. Difference between BMI after one year and at admission 2. Morgan-Russell criteria 3. BMI percentile 4. Improve | — |
Countries
Germany
Outcome results
None listed