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UMIN-CTR Clinical Trial |
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Name | UMIN ID |
Recruitment status | Open public recruiting |
Unique ID issued by UMIN | UMIN000031625 |
Receipt No. | 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 | 2021/09/10 |
Basic information | ||
Public title | Randomized Control Trial of Cognitive Behavior Therapy for Bulimia Nervosa | |
Acronym | RCT of Cognitive Behavior Therapy for Bulimia Nervosa | |
Scientific Title | Randomized Control Trial of Cognitive Behavior Therapy for Bulimia Nervosa | |
Scientific Title:Acronym | RCT of Cognitive Behavior Therapy for Bulimia Nervosa | |
Region |
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Condition | |||
Condition | Eating Disorders | ||
Classification by specialty |
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Classification by malignancy | Others | ||
Genomic information | NO |
Objectives | |
Narrative objectives1 | To examine the effectiveness of individual eating-disorder-focused cognitive behavioral therapy in patients with bulimia nervosa in Japan. |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Confirmatory |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | 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. |
Key secondary outcomes | 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 |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | Individual |
Blinding | Open -but assessor(s) are blinded |
Control | Active |
Stratification | YES |
Dynamic allocation | NO |
Institution consideration | Institution is considered as a block. |
Blocking | YES |
Concealment | Central registration |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | Enhanced cognitive behavior Therapy for eating disorder, focused form, 20 sessions. | |
Interventions/Control_2 | 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. | |
Interventions/Control_3 | ||
Interventions/Control_4 | ||
Interventions/Control_5 | ||
Interventions/Control_6 | ||
Interventions/Control_7 | ||
Interventions/Control_8 | ||
Interventions/Control_9 | ||
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key 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. |
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Key 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. |
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Target sample size | 140 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | National Center of Neurology and Psychiatry | ||||||
Division name | Department of Behavioral Medicine, National Institute of Mental Health | ||||||
Zip code | 187-8553 | ||||||
Address | 4-1-1 Ogawahigashi Kodaira, Tokyo 187-8553, Japan | ||||||
TEL | 042-341-2711 | ||||||
andot.ncnp@gmail.com |
Public contact | |||||||
Name of contact person |
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Organization | National Center of Neurology and Psychiatry | ||||||
Division name | Department of Psychosomatic Research, National Institute of Mental Health | ||||||
Zip code | 042-341-2711 | ||||||
Address | 4-1-1 Ogawahigashi Kodaira, Tokyo 187-8553, Japan | ||||||
TEL | 042-341-2711 | ||||||
Homepage URL | |||||||
ando-t@ncnp.go.jp |
Sponsor | |
Institute | National Center of Neurology and Psychiatry |
Institute | |
Department |
Funding Source | |
Organization | National Center of Neurology and Psychiatry |
Organization | |
Division | |
Category of Funding Organization | Other |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | National Center of Neurology and Psychiatry |
Address | 4-1-1 Ogawahigashi Kodaira, Tokyo 187-8551, Japan |
Tel | 042-341-2711 |
ml_rinrijimu@ncnp.go.jp |
Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
Org. issuing International ID_1 | |
Study ID_2 | |
Org. issuing International ID_2 | |
IND to MHLW |
Institutions | |
Institutions | 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.
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Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
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Baseline Characteristics | |
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Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Open public recruiting | ||||||
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Management information | |||||||
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Last modified on |
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Link to view the page | |
URL(English) | https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036066 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |