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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000039485
Receipt No. R000045023
Scientific Title Guided Internet-based cognitive behavioral therapy for anorexia nervosa: a pilot single-arm study
Date of disclosure of the study information 2020/02/14
Last modified on 2020/02/14

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Basic information
Public title Guided Internet-based cognitive behavioral therapy for anorexia nervosa: a pilot single-arm study
Acronym Guided ICBT for anorexia nrevosa: a pilot feasibility study
Scientific Title Guided Internet-based cognitive behavioral therapy for anorexia nervosa: a pilot single-arm study
Scientific Title:Acronym Guided ICBT for anorexia nrevosa: a pilot feasibility study
Region
Japan

Condition
Condition anorexia nrevosa
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine effectiveness and feasibility of Guided Internet-based cognitive behavioral therapy for patients with anorexia nrevosa
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The change of EDE-Q global score for pre- and post- 12 weeks-treatment
Key secondary outcomes Eating Disorder examination questionnaire (EDE-Q)(Restraint;Eating Concern; Shape Concern; Weight Concern)
Body Checking Questionnaire(BCQ)
Body shape questionnaire(BSQ)
Metacognitions Questionnaire(MCQ-30)
Body Mass Index(BMI)
Menstrual abnormalities
EQ-5D
Client Satisfaction Questionnaire(CSQ)
Working Alliance Inventory Short Form (WAI-SF)
Patient Health Questionnaire-9 (PHQ-9)
Generalized Anxiety Disorder -7 (GAD-7)

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 Guided Internet-Based 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
15 years-old <=
Age-upper limit
65 years-old >=
Gender Female
Key inclusion criteria Patients who met the current diagnosis of anorexia nervosa according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria
Key exclusion criteria Psychotic disorder
Highly likely to attempt suicide
Organic brain complications/disorders
Antisocial personality disorder
Mental retardation
Other severe mental / physical condition
Target sample size 12

Research contact person
Name of lead principal investigator
1st name Jumpei
Middle name
Last name Takahashi
Organization Chiba University
Division name Research center for child mental development
Zip code 260-8677
Address 1-8-1, Inohana, Chuouku, Chiba, Japan
TEL 043-226-2027
Email recruit3@chiba-u.jp

Public contact
Name of contact person
1st name Sayo
Middle name
Last name Hamatani
Organization Chiba University
Division name Research center for child mental development
Zip code 260-8677
Address 1-8-1, Inohana, Chuouku, Chiba, Japan
TEL 043-226-2027
Homepage URL
Email ahna0286@chiba-u.jp

Sponsor
Institute Chiba University
Institute
Department

Funding Source
Organization Japan society for the promotion of science
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Chiba university
Address 1-8-1, Inohana, Chuouku, Chiba, Japan
Tel 0432262616
Email prc-jim@chiba-u.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

Other administrative information
Date of disclosure of the study information
2020 Year 02 Month 14 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
2020 Year 01 Month 06 Day
Date of IRB
2020 Year 01 Month 06 Day
Anticipated trial start date
2020 Year 01 Month 06 Day
Last follow-up date
2020 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 02 Month 14 Day
Last modified on
2020 Year 02 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045023

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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