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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 2019/05/21

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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
Middle name
Last name Tetsuya Ando
Organization National Center of Neurology and Psychiatry
Division name Department of Psychosomatic Research, National Institute of Mental Health
Zip code
Address 4-1-1 Ogawahigashi Kodaira, Tokyo 187-8553, Japan
TEL 042-341-2711
Email ando-t@ncnp.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tetsuya Ando
Organization National Center of Neurology and Psychiatry
Division name Department of Psychosomatic Research, National Institute of Mental Health
Zip code
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
Address
Tel
Email

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
2019 Year 05 Month 21 Day


Link to view the page
URL(English) https://upload.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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