UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Internet cognitive behavioural therapy for major depressive disorder: a pilot randomized controlled trial
Title of the study (Brief title)	ICBT for major depression - a pilot RCT
Region	Japan

Condition
Condition	Major depressive disorder
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine effectiveness of ICBT for Major depressive disorder
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	BDI-2(Beck Depression Inventory-Second Edition)
Key secondary outcomes	PHQ-9(Patient Health Questionnaire) GAD-7(Generalized Anxiety Disorder) EQ-5D(EuroQol-5D)

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Internet cognitive behavioural therapy
Interventions/Control_2	Usual care
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	65 years-old >=
Gender	Male and Female
Key inclusion criteria	Primary diagnosis of Major Depressive Disorders Subjects with BDI-2 score 14~28 at screening
Key exclusion criteria	psychotic disorder active suicidality organic brain disorder antisocial personality disorder other severe mental / physical condition
Target sample size	30

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, Department of Cognitive Behavioral Physiology
Address	1-8-1,Inohana, Chuo-ku, Chiba-shi, Chiba ,260-8670,Japan
TEL	043-226-2027
Email	eiji@faculty.chiba-u.jp

Public contact
Name of contact person	Remi Noguchi
Organization	Chiba University Graduate School of Medicine
Division name	Research Center for Child Mental Development, Department of Cognitive Behavioral Physiology
Address	1-8-1,Inohana, Chuo-ku, Chiba-shi, Chiba ,260-8670,Japan
TEL	043-226-2027
Homepage URL
Email	remi_noguchi@chiba-u.jp

Sponsor
Institute	Department of Cognitive Behavioral Physiology ,Chiba University Graduate School of Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Research Center for Child Mental Development
Organization
Division
Category of Funding Organization	Other
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	千葉大学医学研究院

Other administrative information
Date of disclosure of the study information	2013 Year 10 Month 30 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2013 Year 07 Month 24 Day
Anticipated trial start date	2013 Year 10 Month 15 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	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 10 Month 29 Day
Last modified on	2016 Year 04 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014138