UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019228 |
|---|---|
| Receipt number | 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 | 2026/01/06 11:38:16 |
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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 | Mirai |
| Middle name | |
| Last name | So |
Organization
Keio University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan
TEL
+81-(0)3-3353-1211
mirai.so@keio.jp
Public contact
Name of contact person
| 1st name | Mirai |
| Middle name | |
| Last name | So |
Organization
Keio University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
160-8582
Address
Department of Neuropsychiatry
TEL
+81-(0)3-3353-1211
Homepage URL
ghh13250@gmail.com
Sponsor or person
Institute
The Research Institute of Economy, Trade and Industry
Institute
Department
Personal name
Funding Source
Organization
The Research Institute of Economy, Trade and Industry
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
NIKKEI RESEARCH INC.
NEC Solution Innovators, Ltd
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hiramatsu Memorial Hospital
Address
1-20 Minami 22 Nishi 14, Sapporo, Hokkaido, Japan
Tel
011-561-0708
webmaster@hiramatu-mhp.or.jp
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
https://www.rieti.go.jp/jp/publications/summary/16110002.html
Publication of results
Published
Result
URL related to results and publications
https://www.jmir.org/2026/1/e76902
Number of participants that the trial has enrolled
1187
Results
In ITT, engagement analyses showed a significant group x week interaction, with AI-iCBT participants demonstrating consistently higher odds of weekly participation (odds ratio 1.23, P<.001). Exploratory analyses indicated that activation of the empathic feedback function strongly predicted adherence (odds ratio 9.99, P<.001). In EAS analyses, at followup, only AIiCBT showed a significantly lower proportion of participants with a PHQ-9 score of 10 or more compared with control (difference -0.15, P=.046).
Results date posted
| 2026 | Year | 01 | Month | 02 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2026 | Year | 01 | Month | 05 | Day |
Baseline Characteristics
A total of 1187 participants were eligible and randomly allocated to the AI-iCBT (n=396), iCBT (n=397), or waitlist (n=394) groups (ITT population; see Figure 4 for the CONSORT flow diagram). Baseline demographic and clinical characteristics are summarized in Table 1. The mean age was 43.50 (SD 9.85) years, and 699 (58.8%) of 1187 participants were male. Across the 3 groups, demographic and clinical characteristics were well balanced, with no significant differences in depressive symptom severity (PHQ-9: P=.56; QIDS-J: P=.74). No significant baseline differences were found between the AI-iCBT and iCBT groups, confirming the comparability of the 2 active interventions.
Participant flow
Automated email reminders were sent to participants twice weekly during the 7-week intervention period. Each week, participants in the intervention groups were required to (1) view an online psychoeducational CBT module and (2) perform their allocated (AI-iCBT or iCBT) CR exercise at least once (6 times or more in total). Waitlist participants did not undergo any exercises during this period. All participants were required to complete assessments at baseline, postintervention (week 7), and follow-up (month 3 after postintervention). All intervention and assessment procedures, including attendance and outcome measures, were conducted online.
Adverse events
No serious adverse events were reported.
Outcome measures
All primary and secondary outcomes were analyzed based on the ITT population.The primary outcome was the mean PHQ-9 score, assessed at baseline, week 7 (postintervention), and month 3 (follow-up). Secondary outcomes include (1) proportion of participants with PHQ-9 scores 10 or more. (2) QIDS-J (3) GAD-7 (4) SDS. Engagement outcome included weekly CR exercise attendance rate in the 2 intervention groups. Program satisfaction at week 7 was assessed with the CSQ-8.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 09 | Month | 28 | Day |
Anticipated trial start date
| 2015 | Year | 10 | Month | 05 | Day |
Last follow-up date
| 2016 | Year | 06 | Month | 30 | Day |
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
| 2026 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022220
