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A Randomised Controlled Trial Investigating the Effectiveness of AI (Artificial Intelligence)-enhanced Internet Cognitive Behavioral Therapy (AI-ICBT) for Adult Depression

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000019228
Enrollment
900
Registered
2015-10-04
Start date
2015-10-05
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

Interventions

Weekly self-help intervention by AI-enhanced ICBT over seven weeks Weekly self-help intervention by standard ICBT without AI function over seven weeks Wait-list

Sponsors

The Research Institute of Economy, Trade and Industry
Lead Sponsor
NIKKEI RESEARCH INC. NEC Solution Innovators, Ltd
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
PHQ-9 (Patient Health Questionnaire) at baseline and follow-up (7 weeks and 3 months after intervention)

Secondary

MeasureTime frame
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

Countries

Japan

Contacts

Public ContactMirai So

Keio University School of Medicine Department of Neuropsychiatry

ghh13250@gmail.com+81-(0)3-3353-1211

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026