UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031625
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 2021/09/10 12:36:30

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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 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 or person

Institute

National Center of Neurology and Psychiatry

Institute

Department

Personal name



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

Value
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