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
Contact information
Prof Stephan Zipfel
Scientific
Scientific
University Hospital Tuebingen
Department of Psychological Medicine and Psychotherapy
Osianderstrasse 5
Tuebingen
72076
Germany
| Phone | +49 (0)7071/29-86719 |
|---|---|
| stephan.zipfel@med.uni-tuebingen.de |
Study information
| 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 |
| 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 | 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 |
| Completion date | 31/12/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 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
72076
Germany
Sponsor information
German Federal Ministry of Education and Research (BMBF) (Germany)
Government
Government
Deutsches Zentrum für Luft- und Raumfahrt (DLR) e.V.
Heinrich-Konen-Strasse 1
Bonn
53227
Germany
| martin.goller@dlr.de | |
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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 |
