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Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000012158
Receipt No. R000014138
Scientific Title Internet cognitive behavioural therapy for major depressive disorder: a pilot randomized controlled trial
Date of disclosure of the study information 2013/10/30
Last modified on 2016/04/15

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Basic information
Public title Internet cognitive behavioural therapy for major depressive disorder: a pilot randomized controlled trial
Acronym ICBT for major depression - a pilot RCT
Scientific Title Internet cognitive behavioural therapy for major depressive disorder: a pilot randomized controlled trial
Scientific Title:Acronym 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
1st name
Middle name
Last name Eiji Shimizu
Organization Chiba University Graduate School of Medicine
Division name Research Center for Child Mental Development, Department of Cognitive Behavioral Physiology
Zip code
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
1st name
Middle name
Last name Remi Noguchi
Organization Chiba University Graduate School of Medicine
Division name Research Center for Child Mental Development, Department of Cognitive Behavioral Physiology
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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 No longer recruiting
Date of protocol fixation
2013 Year 07 Month 24 Day
Date of IRB
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

Other
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


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