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Focal psychodynamic psychotherapy, cognitive-behavioural therapy and treatment as usual in outpatients with anorexia nervosa
ISRCTN ISRCTN72809357
DOI 10.1186/ISRCTN72809357
ClinicalTrials.gov identifier
EudraCT number
Public title Focal psychodynamic psychotherapy, cognitive-behavioural therapy and treatment as usual in outpatients with anorexia nervosa
Scientific title
Acronym ANTOP (Anorexia Nervosa Treatment of OutPatients)
Serial number at source 01GV0624
Study hypothesis Compared to treatment as usual, both specific manualised psychotherapeutic outpatient interventions show a significantly better outcome in gain in body mass index (BMI) at the end of treatment.
Lay summary Not provided at time of registration
Ethics approval Ethics Board of the Faculty of Medicine, University Hospital Tuebingen, approved on 21/02/2007 (ref: 440/2006)
Study design Multicentre prospective randomised superiority trial with 3 parallel arms
Countries of recruitment Germany
Disease/condition/study domain Anorexia nervosa
Participants - inclusion criteria 1. Anorexia nervosa (AN) and subsyndromal AN (lacking 1 diagnostic criterion according to Diagnostic and Statistical Manual of Mental Disorders [DSM] IV such as amenorrhoea or body image disturbance)
2. Female
3. Aged 18 years or older
4. Body mass index (BMI) between 15.0 and 18.5 kg/m^2
5. Signed consent form
Participants - exclusion criteria 1. Current substance abuse
2. Current neuroleptic medication
3. Current suicidal ideation
4. Psychotic disorder
5. Bipolar disorder
6. Serious unstable medical problems
7. Primary somatic illness
8. Pregnancy or lactation
9. Ongoing psychotherapy
10. Participation in other trials
Anticipated start date 01/10/2006
Anticipated end date 31/12/2009
Status of trial Completed
Patient information material
Target number of participants 237
Interventions Participants will be randomised into one of the three arms:

1. Focal psychodynamic psychotherapy: 40 outpatient individual therapy sessions over 10 months according to a manual
2. Cognitive-behavioural therapy: 40 outpatient individual therapy sessions over 10 months according to a manual
3. Treatment as usual (control intervention): Patients are provided with a list of local psychotherapists

They will be assessed at the study centre after 4 and 10 months and at 13-month follow-up. GP consultation once a month.
Primary outcome measure(s) Current information as of 04/02/2009:
Body mass index (BMI) at the end of the treatment (10 months after randomisation; T2). In the statistical analysis, the BMI at T2 willl be adjusted for the baseline BMI at T0.

Initial information at time of registration:
Individual changes in BMI between beginning and end of treatment, assessed at 4 and 10 months and at 13-month follow-up.
Secondary outcome measure(s) 1. Morgan-Russell criteria
2. General psychopathology
3. Eating disorders psychopathology
4. Depression (Structured Clinical Interview for DSM-IV [SCID-I], Structured Inventory for Anorexic and Bulimic Syndromes [SIAB-EX], PHQ-D [The "Patient Health Questionnaire"])
5. Quality of life (the 36-item Short Form health survey [SF-36])

Added as of 04/02/2009:
6. Process measure: therapeutic alliance (Helping Alliance Questionnaire [HAQ])
Sources of funding German Federal Ministry of Education and Research (BMBF) (Germany)
Trial website http://www.medizin.uni-tuebingen.de/psychosomatik/
Publications 2009 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/19389245
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24131861
Contact name Prof  Stephan  Zipfel
  Address University Hospital Tuebingen
Department of Psychological Medicine and Psychotherapy
Osianderstrasse 5
  City/town Tuebingen
  Zip/Postcode 72076
  Country Germany
  Tel +49 (0)7071/29-86719
  Fax +49 (0)7071/29-4541
  Email stephan.zipfel@med.uni-tuebingen.de
Sponsor German Federal Ministry of Education and Research (BMBF) (Germany)
  Address Deutsches Zentrum für Luft- und Raumfahrt (DLR) e.V.
Heinrich-Konen-Strasse 1
  City/town Bonn
  Zip/Postcode 53227
  Country Germany
  Email martin.goller@dlr.de
Date applied 23/02/2007
Last edited 25/10/2013
Date ISRCTN assigned 01/05/2007
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