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

ISRCTN	ISRCTN72809357
DOI	https://doi.org/10.1186/ISRCTN72809357
Protocol serial number	01GV0624
Sponsor	German Federal Ministry of Education and Research (BMBF) (Germany)
Funder	German Federal Ministry of Education and Research (BMBF) (Germany)

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

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

Primary study design	Interventional
Study design	Multicentre prospective randomised superiority trial with 3 parallel arms
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	ANTOP (Anorexia Nervosa Treatment of OutPatients)
Study objectives	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)
Health condition(s) or problem(s) studied	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(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.
Key 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])
Completion date	31/12/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target sample size at registration	237
Key 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
Key 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
Date of first enrolment	01/10/2006
Date of final enrolment	31/12/2009

Locations

Countries of recruitment

Germany

Study participating centre

University Hospital Tuebingen

Tuebingen
72076
Germany

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	11/01/2014		Yes	No
Protocol article	protocol	23/04/2009		Yes	No
Study website	Study website	11/11/2025	11/11/2025	No	Yes