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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000019228
Receipt No. R000022220
Scientific Title A Randomised Controlled Trial Investigating the Effectiveness of AI (Artificial Intelligence)-enhanced Internet Cognitive Behavioral Therapy (AI-ICBT) for Adult Depression
Date of disclosure of the study information 2015/10/04
Last modified on 2018/06/10

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Basic information
Public title A Randomised Controlled Trial Investigating the Effectiveness of AI (Artificial Intelligence)-enhanced Internet Cognitive Behavioral Therapy (AI-ICBT) for Adult Depression
Acronym A trial for the assessment of the effectiveness of AI-ICBT on Japanese adults with depression as compared to standalone ICBT (AI-ICBT study)

Scientific Title A Randomised Controlled Trial Investigating the Effectiveness of AI (Artificial Intelligence)-enhanced Internet Cognitive Behavioral Therapy (AI-ICBT) for Adult Depression
Scientific Title:Acronym A trial for the assessment of the effectiveness of AI-ICBT on Japanese adults with depression as compared to standalone ICBT (AI-ICBT study)

Region
Japan

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

Objectives
Narrative objectives1 To assess the clinical- and cost- effectiveness of AI-ICBT on Japanese adults with depression as compared to standard ICBT without AI function or waiting list
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes PHQ-9 (Patient Health Questionnaire) at baseline and follow-up (7 weeks and 3 months after intervention)
Key secondary outcomes QIDS (Quick Inventory of Depressive Symptomatology), GAD-7 (Generalized Anxiety Disorder 7-item (GAD-7) scale), ODSIS (Overall Depression Severity and Impairment Scale),OASIS (Overall Anxiety Severity And Impairment Scale), SDISS (Sheehan Disability Scale) & Medical costs

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Device,equipment Behavior,custom
Interventions/Control_1 Weekly self-help intervention by AI-enhanced ICBT over seven weeks
Interventions/Control_2 Weekly self-help intervention by standard ICBT without AI function over seven weeks
Interventions/Control_3 Wait-list
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 -Regular access to the Internet
-A score of 5 or more on the PHQ-9
-Ability to both understand and agree
with informed consent in Japanese
Key exclusion criteria -Receiving any other CBT
-Strong suicidal ideation
-Schizophrenia
-Dementia
-Any substance addiction (except nicotine
addiction) during the 12 months prior to
the trial

-(For patients receiving treatment by a
mental health specialist/therapist)
Unavailability of therapist's permission for the patient to participate in the trial
Target sample size 900

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 Department of Neuropsychiatry
TEL +81-(0)3-3353-1211
Homepage URL
Email mirai.so@keio.jp

Sponsor
Institute The Research Institute of Economy, Trade and Industry
Institute
Department

Funding Source
Organization The Research Institute of Economy, Trade and Industry
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor NIKKEI RESEARCH INC.
NEC Solution Innovators, Ltd
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 株式会社 日経リサーチ社
NIKKEI RESEARCH INC.

Other administrative information
Date of disclosure of the study information
2015 Year 10 Month 04 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://www.rieti.go.jp/jp/publications/summary/16110002.html
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 Main results already published
Date of protocol fixation
2015 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 10 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
2016 Year 05 Month 15 Day
Date analysis concluded
2016 Year 06 Month 20 Day

Other
Other related information

Management information
Registered date
2015 Year 10 Month 04 Day
Last modified on
2018 Year 06 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022220

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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