Plain English Summary
Not provided at time of registration
Study website
Contact information
Type
Scientific
Contact name
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/CTIS number
IRAS number
ClinicalTrials.gov number
Secondary identifying numbers
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(s)
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
Study setting(s)
Other
Study 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
Primary outcome measure
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 study start date
01/10/2006
Overall study end date
31/12/2009
Reason abandoned (if study stopped)
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(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
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
Study 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
ROR
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
Individual participant data (IPD) Intention to share
No
IPD sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 23/04/2009 | Yes | No | |
| Results article | results | 11/01/2014 | Yes | No |