Bulimia nervosa (eating disorders) Mental and Behavioural Disorders Bulimia nervosa
Conditions
Interventions
Current interventions as of 17/04/2014, according to the study protocol approved in July 2007:
1. Nine-month Internet-based aftercare program in addition to Treatment As Usual (TAU)
2. Treatment As Us
Sponsors
Federal Ministry of Education and Research (Germany)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Age at least 16 years 2. Informed consent by patient and - if necessary - by her legal guardian 3. Female 4. Diagnosis of bulimia nervosa (BN) according to DSM-IV-TR at the time of admission to inpatient treatment 5. Successful completion of inpatient treatment as defined by at least 50% reduction in binge eating and purging during the last two weeks prior to discharge from inpatient treatment
Exclusion criteria
Exclusion criteria: 1. Mental or physical condition that does not allow the patient's participation in the trial 2. Acute psychosis, chronic organic or schizophrenic psychosis 3. Severe suicidal ideation or behaviour 4. Premature discharge from inpatient treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 17/04/2014, according to the study protocol approved in July 2007: The primary efficacy endpoint will be the percentage of patients abstinent from core bulimia nervosa behaviors at the end of the treatment (9 months). Abstinence is defined as the absence of binge eating and inappropriate compensatory behaviour (e.g., vomiting) for at least two months at post-intervention. Previous primary outcome measures: The primary efficacy endpoint will be the frequency of relapses at the end of the treatment (12 month). Relapses are defined as the presence of binging and/or inappropriate compensatory behaviour (i.e. including vomiting) at least twice per week for three months during the 12 month follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 17/04/2014, according to the study protocol approved in July 2007: 1. Abstinence from core bulimia nervosa behaviours at follow-up (18 months after randomization) 2. Eating disorder diagnoses (as measured by Structured Inventory for Anorexic and Bulimic Syndromes) at the end of treatment and follow-up 3. Changes in eating disorder related behaviours and attitudes (as measured by Eating Disorder Inventory and Eating Disorder Examination Questionnaire) between baseline and end-of-treatment/follow-up 4. Changes in general psychopathology (as measured by global severity index of the BSI) between baseline and end-of-treatment/follow-up 5. Changes in depressive symptoms (as measured by BDI) between baseline and end-of-treatment/follow-up 6. Changes in impulsiveness (as measured by Barrat Impulsiveness Scale) between baseline and end-of-treatment/follow-up 7. Changes in self-esteem (as measured by Rosenberg Self Esteem Scale) between baseline and end-of-treatment/follow-up Previous secondary outcome measures: 1. Expert interviews for the assessment of primary and secondary outcomes (T0, T1, T3): 1.1. Structured Inventory for Anorexic and Bulimic Syndromes (SIAB-EX) 1.2. Psychiatric Status Rating (PSR) 1.3. Structured Clinical Interview for DSM-IV (SCID-I) 2. Self-rating instruments (T0, T1, T2a-e, T3): 2.1. Eating Disorder Inventory (EDI-2) 2.2. SIAB-S self-rating 2.3. Symptom-Checklist (SCL-56) 2.4. Barrett Impulsiveness Scale (BIS-11) | — |
Countries
Germany
Outcome results
None listed