Unique ID issued by UMIN | UMIN000031625 |
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Receipt number | R000036066 |
Scientific Title | Randomized Control Trial of Cognitive Behavior Therapy for Bulimia Nervosa |
Date of disclosure of the study information | 2018/03/07 |
Last modified on | 2024/04/17 13:32:20 |
Randomized Control Trial of Cognitive Behavior Therapy for Bulimia Nervosa
RCT of Cognitive Behavior Therapy for Bulimia Nervosa
Randomized Control Trial of Cognitive Behavior Therapy for Bulimia Nervosa
RCT of Cognitive Behavior Therapy for Bulimia Nervosa
Japan |
Eating Disorders
Psychosomatic Internal Medicine | Psychiatry |
Others
NO
To examine the effectiveness of individual eating-disorder-focused cognitive behavioral therapy in patients with bulimia nervosa in Japan.
Efficacy
Confirmatory
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.
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
Interventional
Parallel
Randomized
Individual
Open -but assessor(s) are blinded
Active
YES
NO
Institution is considered as a block.
YES
Central registration
2
Treatment
Behavior,custom |
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, establishing therapeutic relationship, psychoeducation, nutritional guidance, recording eating behavior and behavioral technique (stimulus control method), supportive psychotherapy, family support, group therapy and so on.
18 | years-old | <= |
Not applicable |
Male and Female
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.
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.
140
1st name | Tetsuya |
Middle name | |
Last name | Ando |
International University of Health and Welfare
Department of Psychosomatic Internal Medicine, School of Medicine
286-8686
4-3 Kozunomori, Narita, Chiba, 286-8686, Japan
0476-20-7701
andot@iuhw.ac.jp
1st name | Tetsuya |
Middle name | |
Last name | Ando |
International University of Health and Welfare Hospital
Department of Psychosomatic Internal Medicine
329-2763
537-3 Iguchi, Nasushiobara, Tochigi, 29-2763, Japan
0287-39-3060
andot@iuhw.ac.jp
International University of Health and Welfare
International University of Health and Welfare
Other
International University of Health and Welfare
4-3 Kozunomori, Narita, Chiba, 286-8686, Japan
0476-35-5613
rinri-md@iuhw.ac.jp
NO
九州大学(福岡県)、東北大学(宮城県)、東京大学(東京都)、国立国際医療研究センター病院(東京都)、国立国際医療研究センター国府台病院(千葉県)/Kyushu University,Tohoku University, University of Tokyo, National Center for Global Health and Medicine, Konodai Hospital National Center for Global Health and Medicine.
2018 | Year | 03 | Month | 07 | Day |
Unpublished
39
No longer recruiting
2018 | Year | 02 | Month | 13 | Day |
2017 | Year | 11 | Month | 10 | Day |
2019 | Year | 04 | Month | 05 | Day |
2024 | Year | 03 | Month | 21 | Day |
2018 | Year | 03 | Month | 07 | Day |
2024 | Year | 04 | Month | 17 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036066
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