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Randomized Control Trial of Cognitive Behavior Therapy for Bulimia Nervosa

Not Applicable
Conditions
Eating Disorders
Registration Number
JPRN-UMIN000031625
Lead Sponsor
International University of Health and Welfare
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up continuing
Sex
All
Target Recruitment
39
Inclusion Criteria

Not provided

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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
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 Outcome Measures
NameTimeMethod
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
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