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Treatment of childhood and adolescent Anorexia Nervosa: Day treatment versus Inpatient treatment
ISRCTN ISRCTN67783402
DOI 10.1186/ISRCTN67783402
ClinicalTrials.gov identifier
EudraCT number
Public title Treatment of childhood and adolescent Anorexia Nervosa: Day treatment versus Inpatient treatment
Scientific title
Acronym ANDI
Serial number at source N/A
Study hypothesis The effect of 12 weeks of day patient treatment is not different (non-inferior) from inpatient treatment of the same length in terms of weight gain after one year concerning adolescents with non-chronic Anorexia Nervosa (AN).

As of 23/07/2010 this record was updated to include an extended anticipated end date; the initial anticipated end date at the time of registration was 31/12/2009. Additionally, recruitment is now completed. All other changes can be found in the relevant field with the above update date.

Please note that as of 05/02/2013, the following changes were made to the record:
1. The target number of participants was updated from 170 to 176
2. The anticipated end date was updated from 31/12/2012 to 31/10/2012
Lay summary Lay summary under review 3
Ethics approval Local Ethics Committee (Ethik-Kommission at the Medical Faculty of the Rheinisch-Westfälischen Technischen Hochschule Aachen [RWTH Aachen]) approved on the 24th January 2007 (ref: 127/06)
Study design Multicentre prospective randomised non-inferiority trial
Countries of recruitment Germany
Disease/condition/study domain Anorexia Nervosa
Participants - 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
Participants - 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
Anticipated start date 01/10/2006
Anticipated end date 31/10/2012
Status of trial Completed
Patient information material
Target number of participants 176 recruited in six hospitals
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 a plan, model eating, eating in a restaurant, guided family meals)
6. Weight management with flexible operant conditional behavioural program to support a weekly weight gain of 500-1000 gr/week up to the achievement of target weight (15 to 20th Body Mass Index [BMI] percentile)
7. Group therapy for eating disorders
8. Individual psychotherapy psychotherapy (Cognitive-Behavioural Therapy [CBT])
9. Family-based therapy

Outpatient treatment includes:
1. Re-admission contract
2. One to two weekly individual psychotherapy including weight management and nutritional counselling (anorexia nervosa oriented CBT according to the evaluated manual-based outpatient program from Pike et al. 2003 adapted to adolescents)
3. Four-weekly family-based interventions (one hour/session) until week 52 (one-year follow-up)

Added 23/07/2010:
As of the above update date, a new follow-up was added to this record; patients will now also be followed-up in week 130 (1.5 years after the primary outcome).
Primary outcome measure(s) 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 outcome measure(s) 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. 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

All psychometric outcome measures will be derived from validated and internationally used questionnaires and interviews.
Sources of funding German Federal Ministry of Education and Research (Bundesministerium Für Bildung und Forschung [BMBF]) (Germany)
Trial website
Publications 2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24439238
Contact name Prof  Beate  Herpertz-Dahlmann
  Address Universitätsklinikum Aachen
Department of Child and Adolescent Psychiatry and Psychotherapy
Neuenhofer Weg 21
  City/town Aachen
  Zip/Postcode 52074
  Country Germany
  Tel +49 (0)241 808 8737
  Fax +49 (0)241 808 2544
  Email bherpertz-dahlmann@ukaachen.de
Sponsor German Federal Ministry of Education and Research (Bundesministerium Für Bildung und Forschung [BMBF]) (Germany)
  Address Heinemannstr. 2
  City/town Bonn
  Zip/Postcode 53175
  Country Germany
  Tel +49 (0)18 88 57 0
  Fax +49 (0)18 88 57 83 601
  Email bmbf@bmbf.bund.de
  Sponsor website: http://www.bmbf.de/
Date applied 31/07/2006
Last edited 24/04/2014
Date ISRCTN assigned 18/01/2007
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