Condition category
Mental and Behavioural Disorders
Date applied
30/05/2005
Date assigned
23/08/2005
Last edited
29/09/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Almut Zeeck

ORCID ID

Contact details

Dept. of Psychosomatic Medicine and Psychotherapy
University of Freiburg
Hauptstrasse 8
Freiburg
79104
Germany
+49 (0)761 2706806
almut.zeeck@uniklinik-freiburg.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ZE 520/4-1

Study information

Scientific title

Acronym

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

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Severe bulimia nervosa

Intervention

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.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

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 measures

Not provided at time of registration

Overall trial start date

01/01/2003

Overall trial end date

31/03/2006

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

60

Participant 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)

Recruitment start date

01/01/2003

Recruitment end date

31/03/2006

Locations

Countries of recruitment

Germany

Trial participating centre

Dept. of Psychosomatic Medicine and Psychotherapy
Freiburg
79104
Germany

Sponsor information

Organisation

German Research Foundation (Deutsche Forschungsgemeinschaft) (DFG) (Germany)

Sponsor details

Kennedyallee 40
Bonn
53170
Germany
+49 (0)228 8852824
astrid.golla@dfg.de

Sponsor type

Research organisation

Website

http://www.dfg.de/

Funders

Funder type

Research organisation

Funder name

German Research Foundation (Deutsche Forschungsgemeinschaft) (DFG) (Germany) - (ref: ZE 520/4-1_

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19270470

Publication citations

  1. Results

    Zeeck A, Weber S, Sandholz A, Wetzler-Burmeister E, Wirsching M, Hartmann A, Inpatient versus day clinic treatment for bulimia nervosa: a randomized trial., Psychother Psychosom, 2009, 78, 3, 152-160, doi: 10.1159/000206869.

Additional files

Editorial Notes