UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effectiveness Study of cognitive behavior therapy guided self-care with bulimia nervosa -an pilot study-
Title of the study (Brief title)	Effectiveness Study of cognitive behavior therapy guided self-care with bulimia nervosa -an pilot study-
Region	Japan

Condition
Condition	Bulimia nervosa, Eating disorder not otherwise specified
Classification by specialty	Psychosomatic Internal Medicine Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine effectiveness and feasibility of cognitive behavioral therapy guided self-care with bulimia nervosa and eating disorder not otherwise specified in Japanese clinical settings
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	abstinence rates from objective bingeing and vomiting
Key secondary outcomes	EDE-Q subscales (E, W, S, R, G) BITE PHQ-9 GAD-7 HADS BMI BDI GAF CGI

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Cognitive behavioral therapy
Interventions/Control_2
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	60 years-old >=
Gender	Male and Female
Key inclusion criteria	Primary diagnosis of bulimia nervosa or eating disorder not otherwise specified
Key exclusion criteria	Individuals with who have histories of substance abuse, active suicidality, severe mental and physical condition, body mass index < 14, global assesment of functioning < 50, pervasive development disorder, intelligence quotient < 80, eating disorder examination questionnaire > 2.8 for health control, mood disorder (major depression, bipolar), and psychiatric disorders associated with substance abuse
Target sample size	25

Research contact person
Name of lead principal investigator	Eiji Shimizu
Organization	Chiba University Graduate School of Medicine
Division name	Research Center for Child Mental Development
Address	1-8-1,Inohana, Chuo-ku, Chiba-shi, Chiba ,260-8670,Japan
TEL	043-226-2975
Email	kenichi.asano@chiba-u.jp

Public contact
Name of contact person	Michiko Nakazato
Organization	Chiba University Graduate School of Medicine
Division name	Research Center for Child Mental Development
Address	1-8-1, inohana, Chuo-ku, Chiba, 260-8675, Japan
TEL	043-226-2975
Homepage URL
Email	nakazato@faculty.chiba-u.jp

Sponsor
Institute	Research Center for Child Mental Development, Chiba University Graduate School of Medicine
Institute
Department

Funding Source
Organization	The Ministry of Health, Labor and Welfare, The Ministry of Education, Culture, Sports,Science and Technology
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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

Other administrative information
Date of disclosure of the study information	2013 Year 07 Month 10 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 06 Month 01 Day
Anticipated trial start date	2012 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://www.ncbi.nlm.nih.gov/pubmed/29695260
Results
Other related information

Management information
Registered date	2013 Year 07 Month 04 Day
Last modified on	2019 Year 01 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012998