UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039485
Receipt number 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 2021/06/24 02:26:12

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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 or person

Institute

Chiba University

Institute

Department

Personal name



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

Value
https://center6.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