UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Randomised Controlled Trial Investigating the Effectiveness of Peer-enhanced Internet Cognitive Behavioral Therapy (P-iCBT) for Adult Depression
Title of the study (Brief title)	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	Mirai So
Organization	Keio University School of Medicine
Division name	Department of Neuropsychiatry
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	Mirai So
Organization	Keio University School of Medicine
Division name	Department of Neuropsychiatry
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 10 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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