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Process and outcome of day clinic and inpatient psychotherapy in severe bulimia nervosa: a randomised-controlled trial
ISRCTN ISRCTN30183796
DOI 10.1186/ISRCTN30183796
ClinicalTrials.gov identifier
EudraCT number
Public title Process and outcome of day clinic and inpatient psychotherapy in severe bulimia nervosa: a randomised-controlled trial
Scientific title
Acronym N/A
Serial number at source ZE 520/4-1
Study hypothesis 1. 3 month follow-up:
1.1. Inpatients will suffer from more relapses after discharge (bulimic
symptoms)
1.2. Inpatients will show less feelings of specific self-efficiacy compared
with day clinic patients between discharge and 3-month-follow-up
1.3. Day clinic patients will show some improvement in social adjustment whereas after inpatient treatment there will be no change

2. 12 month follow up:
2.1. Both groups will show comparable results in general and specific
pathology
2.2. Day clinic patients will show more improvements in social adjustment
2.3. Day clinic patients will be more satisfied with treatment in retrospect
Lay summary
Ethics approval Not provided at time of registration
Study design Randomised controlled trial
Countries of recruitment Germany
Disease/condition/study domain Severe bulimia nervosa
Participants - inclusion criteria 1. Bulimia nervosa: International Statistical Classification of Diseases and Related Health Problems, tenth revision (ICD 10) / Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM IV)
2. Age >17
3. Indication for day clinic/inpatient treatment
3.1. failure of outpatient psychotherapy
3.2. chronicity
3.3. severe symptom expression
3.4. severe comorbidity
Participants - exclusion criteria 1. Severe, acute somatic complications
2. Psychosis
3. Severe addiction (detoxification is needed)
4. Acute suicidality
5. Clinic can not be reached within a reasonable time (>60 minutes travel time)
Anticipated start date 01/01/2003
Anticipated end date 31/03/2006
Status of trial Completed
Patient information material
Target number of participants 60
Interventions 3 month of day clinic or inpatient treatment (multimodal treatment) with the same treatment elements in similar quantity in both conditions (individual and group therapy, work with eating diaries, rounds, art therapy, body therapy etc.). The treatment concept is psychodynamic, integrating cognitive-behavioral and family-oriented elements.
Primary outcome measure(s) 1. Eating- Disorder-Inventory (EDI-II) (scale 2: bulimia)
2. Symptom-Check-List (SCL-90-R)
3. Global Severity Index (GSI)
4. Self-Efficiacy-Questionnaire; Social Adjustment Scale (SAS) (total score)
Secondary outcome measure(s) Not provided at time of registration
Sources of funding German Research Foundation (Deutsche Forschungsgemeinschaft) (DFG) (Germany) - (ref: ZE 520/4-1_
Trial website
Publications 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19270470
Contact name Dr  Almut  Zeeck
  Address Dept. of Psychosomatic Medicine and Psychotherapy
University of Freiburg
Hauptstrasse 8
  City/town Freiburg
  Zip/Postcode 79104
  Country Germany
  Tel +49 (0)761 2706806
  Fax +49 (0)761 2706885
  Email almut.zeeck@uniklinik-freiburg.de
Sponsor German Research Foundation (Deutsche Forschungsgemeinschaft) (DFG) (Germany)
  Address Kennedyallee 40
  City/town Bonn
  Zip/Postcode 53170
  Country Germany
  Tel +49 (0)228 8852824
  Fax +49 (0)228 8852777
  Email astrid.golla@dfg.de
  Sponsor website: http://www.dfg.de/
Date applied 30/05/2005
Last edited 29/09/2009
Date ISRCTN assigned 23/08/2005
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