UMIN-CTR Clinical Trial

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	Japan

Condition
Condition	Eating Disorders
Classification by specialty	Psychosomatic Internal Medicine Psychiatry
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	Behavior,custom
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	18 years-old <=
Age-upper limit	Not applicable
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.
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.
Target sample size	140

Research contact person
Name of lead principal investigator	1st name Tetsuya Middle name Last name Ando
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
Email	andot.ncnp@gmail.com

Public contact
Name of contact person	1st name Tetsuya Middle name Last name Ando
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
Email	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
Email	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.

Other administrative information
Date of disclosure of the study information	2018 Year 03 Month 07 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2018 Year 02 Month 13 Day
Date of IRB	2017 Year 11 Month 10 Day
Anticipated trial start date	2019 Year 04 Month 05 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 03 Month 07 Day
Last modified on	2021 Year 09 Month 10 Day

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

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