Eating Disorders
Conditions
Interventions
Enhanced cognitive behavior Therapy for eating disorder, focused form, 20 sessions.
Treatment as usual (TAU): Usual psycho-social treatment for eating disorders including diagnosis, assessment, establ
Sponsors
International University of Health and Welfare
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Persons diagnosed with bulimia nervosa based on DSM-5 criteria. 2. Body mass index (BMI) is greater than 17.5 and less than 40.0 at screening. 3. Persons who are living in Japan and able to speak and write in Japanese. 4. Persons who can understand the purpose and content of this trial and give voluntary written informed consent.
Exclusion criteria
Exclusion criteria: 1. Persons who have previously received CBT, IPT or similar structured psychotherapy. 2. Persons suffering from major psychiatric diseases such as schizophrenia, bipolar disorder, substance abuse-related disorder, or somatic diseases that could interfere with implementation of ED focused CBT. 3. Persons who were taking psychotropic medications except for antidepressants, anxiolytics and sleep inducers. 4. Persons who have intellectual disability. 5. Imminent suicidal ideation. 6. Pregnant or lactating women. 7. Persons who anticipate difficulty attending sessions and assessments as scheduled. 8. Any other person whom the principal investigator has determined to be unsuitable as a participant of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is to achieve the following two criteria at the same time at the end of intervention (at 20 weeks after start of intervention). 1.The frequency of episode of binge eating and the frequency of inappropriate compensatory behaviors both are, on average, less than once a week for the previous four weeks. 2.Self-evaluation is not unduly influenced by either shape or weight. The outcome is assessed by the Japanese version of the Eating Disorder Examination (EDE). 3.Body Mass Index(BMI)>17.5kg/m2. | — |
Secondary
| Measure | Time frame |
|---|---|
| The important secondary outcome is to meet the same criteria as the primary outcome at 40 weeks. 1. The Japanese version of Eating Disorder Examination (EDE) 2. The Japanese version of the Eating Disorder Examination-Questionnaire (EDE-Q) 3. Beck Depression Inventory-Second Edition (BDI-2) 4. State-Trait Anxiety Inventory (STAI) 5. The Japanese version of Clinical Impairment Assessment Questionnaire (CIA) 6. Symptom checklist 90-Revised (SCL-90-R) 7. General Functioning Subscale of the McMaster Family Assessment Device (GF-FAD) 8. Expectation and satisfaction to treatment assessed by Visual Analogue Scale 9. Patient characteristics information | — |
Countries
Japan
Contacts
Public ContactTetsuya Ando
International University of Health and Welfare Hospital Department of Psychosomatic Internal Medicine
Outcome results
None listed