Process and outcome of day clinic and inpatient psychotherapy in severe bulimia nervosa: a randomised-controlled trial
| ISRCTN | ISRCTN30183796 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN30183796 |
| Protocol serial number | ZE 520/4-1 |
| Sponsor | German Research Foundation (Deutsche Forschungsgemeinschaft) (DFG) (Germany) |
| Funder | German Research Foundation (Deutsche Forschungsgemeinschaft) (DFG) (Germany) - (ref: ZE 520/4-1_ |
- Submission date
- 30/05/2005
- Registration date
- 23/08/2005
- Last edited
- 29/09/2009
- 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
Dr Almut Zeeck
Scientific
Scientific
Dept. of Psychosomatic Medicine and Psychotherapy
University of Freiburg
Hauptstrasse 8
Freiburg
79104
Germany
| Phone | +49 (0)761 2706806 |
|---|---|
| almut.zeeck@uniklinik-freiburg.de |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
1. Eating- Disorder-Inventory (EDI-II) (scale 2: bulimia) |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/03/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 60 |
| Key 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 |
| Key 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) |
| Date of first enrolment | 01/01/2003 |
| Date of final enrolment | 31/03/2006 |
Locations
Countries of recruitment
- Germany
Study participating centre
Dept. of Psychosomatic Medicine and Psychotherapy
Freiburg
79104
Germany
79104
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 | 01/08/2009 | Yes | No |
