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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000015591
Receipt No. R000018111
Scientific Title A Randomised Controlled Trial Investigating the Effectiveness of Peer-enhanced Internet Cognitive Behavioral Therapy (P-iCBT) for Adult Depression
Date of disclosure of the study information 2014/11/03
Last modified on 2016/11/14

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Basic information
Public title A Randomised Controlled Trial Investigating the Effectiveness of Peer-enhanced Internet Cognitive Behavioral Therapy (P-iCBT) for Adult Depression
Acronym P-iCBT Study
Scientific Title A Randomised Controlled Trial Investigating the Effectiveness of Peer-enhanced Internet Cognitive Behavioral Therapy (P-iCBT) for Adult Depression
Scientific Title:Acronym P-iCBT Study
Region
Japan

Condition
Condition Depression
Classification by specialty
Psychiatry Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 1)To assess the clinical- and cost- effectiveness of P-iCBT on Japanese adults with depression as compared to standalone iCBT or waiting list
2)To assess the validity and reliability of a smartphone-app for the Autonomic Nervous System's Imbalance Index
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1)Beck Depression Inventory-2 (BDI-2)
Japanese Version
2)The Autonomic Nervous System's
Imbalance Index
Key secondary outcomes 1)
1-1) K6 Japanese Version
1-2) STAI Japanese Version
1-3) SF-12v2 Japanese Version
2) Medical Costs

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Device,equipment Behavior,custom
Interventions/Control_1 Weekly self-help intervention by standalone iCBT over seven weeks
Interventions/Control_2 Weekly self-help intervention by peer-enhanced iCBT over seven weeks
Interventions/Control_3 Wait-list over seven weeks
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
20 years-old <=
Age-upper limit
60 years-old >=
Gender Male and Female
Key inclusion criteria 1) Regular access to the Internet
2) A score of 5 or more on the PHQ-9
3) Ability to both understand and agree
with informed consent in Japanese
4) Availability of iPhone, iPad or iPod
touch,regardless of its ownership, at
three assessment points
Key exclusion criteria 1) Receiving any other CBT intervention
during the trial
2) A score of 21 or more on the PHQ-9
3) Strong suicidal ideation
4) Schizophrenia
5) Dementia
6) Any substance addiction (except
nicotine addiction) during the 12
months prior to the trial
7) (For patients receiving treatment by a
mental health practitioner)
Unavailability of practitioner's
permission for the patient to
participate in the trial
Target sample size 180

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mirai So
Organization Keio University School of Medicine
Division name Department of Neuropsychiatry
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan
TEL +81-(0)3-3353-1211
Email mirai.so@keio.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mirai So
Organization Keio University School of Medicine
Division name Department of Neuropsychiatry
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan
TEL +81-(0)3-3353-1211
Homepage URL
Email mirai.so@keio.jp

Sponsor
Institute Keio University School of Medicine, Department of Neuropsychiatry
Institute
Department

Funding Source
Organization Society for the Promotion of Science
Grant-in-Aid for Scientific Research (26350862)
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Institute of Wellness and Ecological Sciences (Global Research Center for Applied System Science)
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

Other administrative information
Date of disclosure of the study information
2014 Year 11 Month 03 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
2014 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 11 Month 05 Day
Last follow-up date
2015 Year 03 Month 28 Day
Date of closure to data entry
Date trial data considered complete
2015 Year 03 Month 31 Day
Date analysis concluded
2015 Year 05 Month 15 Day

Other
Other related information

Management information
Registered date
2014 Year 11 Month 03 Day
Last modified on
2016 Year 11 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018111

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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