Focal psychodynamic psychotherapy, cognitive-behavioural therapy and treatment as usual in outpatients with anorexia nervosa

ISRCTN ISRCTN72809357
DOI https://doi.org/10.1186/ISRCTN72809357
Secondary identifying numbers 01GV0624
Submission date
23/02/2007
Registration date
01/05/2007
Last edited
25/10/2013
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Prof Stephan Zipfel
Scientific

University Hospital Tuebingen
Department of Psychological Medicine and Psychotherapy
Osianderstrasse 5
Tuebingen
72076
Germany

Phone +49 (0)7071/29-86719
Email stephan.zipfel@med.uni-tuebingen.de

Study information

Study designMulticentre prospective randomised superiority trial with 3 parallel arms
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Scientific title
Study acronymANTOP (Anorexia Nervosa Treatment of OutPatients)
Study objectivesCompared 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)
Health condition(s) or problem(s) studiedAnorexia nervosa
InterventionParticipants 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 typeOther
Primary outcome measureCurrent 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 measures1. 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 date01/10/2006
Completion date31/12/2009

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexFemale
Target number of participants237
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/10/2006
Date of final enrolment31/12/2009

Locations

Countries of recruitment

  • Germany

Study participating centre

University Hospital Tuebingen
Tuebingen
72076
Germany

Sponsor information

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

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

Email martin.goller@dlr.de
ROR logo "ROR" https://ror.org/04pz7b180

Funders

Funder type

Government

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

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