Condition category
Mental and Behavioural Disorders
Date applied
23/02/2007
Date assigned
01/05/2007
Last edited
25/10/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.medizin.uni-tuebingen.de/psychosomatik/

Contact information

Type

Scientific

Primary contact

Prof Stephan Zipfel

ORCID ID

Contact details

University Hospital Tuebingen
Department of Psychological Medicine and Psychotherapy
Osianderstrasse 5
Tuebingen
72076
Germany
+49 (0)7071/29-86719
stephan.zipfel@med.uni-tuebingen.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

01GV0624

Study information

Scientific title

Acronym

ANTOP (Anorexia Nervosa Treatment of OutPatients)

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.

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

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

Anorexia nervosa

Intervention

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.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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 measures

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])

Overall trial start date

01/10/2006

Overall trial end date

31/12/2009

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

237

Participant 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

Recruitment start date

01/10/2006

Recruitment end date

31/12/2009

Locations

Countries of recruitment

Germany

Trial participating centre

University Hospital Tuebingen
Tuebingen
72076
Germany

Sponsor information

Organisation

German Federal Ministry of Education and Research (BMBF) (Germany)

Sponsor details

Deutsches Zentrum für Luft- und Raumfahrt (DLR) e.V.
Heinrich-Konen-Strasse 1
Bonn
53227
Germany
martin.goller@dlr.de

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

German Federal Ministry of Education and Research (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

2009 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/19389245
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24131861

Publication citations

  1. Protocol

    Wild B, Friederich HC, Gross G, Teufel M, Herzog W, Giel KE, de Zwaan M, Schauenburg H, Schade-Brittinger C, Schäfer H, Zipfel S, The ANTOP study: focal psychodynamic psychotherapy, cognitive-behavioural therapy, and treatment-as-usual in outpatients with anorexia nervosa--a randomized controlled trial., Trials, 2009, 10, 23, doi: 10.1186/1745-6215-10-23.

  2. Results

    Zipfel S, Wild B, Groß G, Friederich HC, Teufel M, Schellberg D, Giel KE, de Zwaan M, Dinkel A, Herpertz S, Burgmer M, Löwe B, Tagay S, von Wietersheim J, Zeeck A, Schade-Brittinger C, Schauenburg H, Herzog W, , Focal psychodynamic therapy, cognitive behaviour therapy, and optimised treatment as usual in outpatients with anorexia nervosa (ANTOP study): randomised controlled trial., Lancet, 2014, 383, 9912, 127-137, doi: 10.1016/S0140-6736(13)61746-8.

Additional files

Editorial Notes