Condition category
Mental and Behavioural Disorders
Date applied
31/07/2006
Date assigned
18/01/2007
Last edited
17/12/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Lay summary under review 3

Trial website

Contact information

Type

Scientific

Primary contact

Prof Beate Herpertz-Dahlmann

ORCID ID

Contact details

Universitätsklinikum Aachen
Department of Child and Adolescent Psychiatry and Psychotherapy
Neuenhofer Weg 21
Aachen
52074
Germany
+49 (0)241 808 8737
bherpertz-dahlmann@ukaachen.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Treatment of childhood and adolescent Anorexia Nervosa: Day treatment versus Inpatient treatment

Acronym

ANDI

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

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

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

Anorexia Nervosa

Intervention

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).

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

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 measures

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.

Overall trial start date

01/10/2006

Overall trial end date

31/10/2012

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Child

Gender

Female

Target number of participants

176 recruited in six hospitals

Participant 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

Recruitment start date

01/10/2006

Recruitment end date

31/10/2012

Locations

Countries of recruitment

Germany

Trial participating centre

Universitätsklinikum Aachen
Aachen
52074
Germany

Sponsor information

Organisation

German Federal Ministry of Education and Research (Bundesministerium Für Bildung und Forschung [BMBF]) (Germany)

Sponsor details

Heinemannstr. 2
Bonn
53175
Germany
+49 (0)18 88 57 0
bmbf@bmbf.bund.de

Sponsor type

Government

Website

http://www.bmbf.de/

Funders

Funder type

Government

Funder name

German Federal Ministry of Education and Research (Bundesministerium Für Bildung und Forschung [BMBF]) (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24439238
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24238469

Publication citations

  1. Results

    Herpertz-Dahlmann B, Schwarte R, Krei M, Egberts K, Warnke A, Wewetzer C, Pfeiffer E, Fleischhaker C, Scherag A, Holtkamp K, Hagenah U, Bühren K, Konrad K, Schmidt U, Schade-Brittinger C, Timmesfeld N, Dempfle A, Day-patient treatment after short inpatient care versus continued inpatient treatment in adolescents with anorexia nervosa (ANDI): a multicentre, randomised, open-label, non-inferiority trial., Lancet, 2014, 383, 9924, 1222-1229, doi: 10.1016/S0140-6736(13)62411-3.

Additional files

Editorial Notes