UMIN-CTR Clinical Trial

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	Completed
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	2020 Year 12 Month 31 Day
Date trial data considered complete	2021 Year 05 Month 07 Day
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 02 Month 14 Day
Last modified on	2021 Year 06 Month 24 Day

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