UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of a 5minutes internet-based cognitive behavioral therapy (iCBT) and easy mindfulness exercise intervention on depressive mood : a large scale randomized controlled trial
Title of the study (Brief title)	Effects of a 5minutes internet-based cognitive behavioral therapy (iCBT) and easy mindfulness exercise intervention on depressive mood : RCT
Region	Japan

Condition
Condition	depressive mood
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine effectiveness of 5minutes ICBT and easy mindfulness exercise for depressive mood
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Center for Epidemiologis Studies Depression Scale
Key secondary outcomes	Patient Health Questionnaire 9 Generalized Anxiety Disoder-7

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	No treatment
Stratification	NO
Dynamic allocation
Institution consideration
Blocking
Concealment	Central registration

Intervention
No. of arms	3
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Maneuver
Interventions/Control_1	5 minute ICBT
Interventions/Control_2	Easy mindfulness exesise
Interventions/Control_3	Waiting
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	20 years-old <=
Age-upper limit	65 years-old >
Gender	Male and Female
Key inclusion criteria	Subjects with CES-D score over the 16 at screening. Subjects with PHQ-9 score over the 5 at screening.
Key exclusion criteria	Relevant reason decided by the CREC investigators. Strong suicidal ideation.
Target sample size	1000

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	Chiba University Graduate School of Medicine Research Center for Child Mental Development, Department of Cognitive Behavioral Physiology d
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	Reseach Institute of Economy, Trade and Industry (RIETI)
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

Other administrative information
Date of disclosure of the study information	2014 Year 10 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 07 Month 29 Day
Anticipated trial start date	2014 Year 10 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	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 09 Month 09 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=R000017564