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Evaluation of the Clinical Usefulness of Measurement-Based and AI-Supported Care in the Treatment of Depression: An Open-Label Randomized Controlled Trial

Evaluation of the Clinical Usefulness of Measurement-Based and AI-Supported Care in the Treatment of Depression: An Open-Label Randomized Controlled Trial - MBAIC Study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000056333
Enrollment
48
Registered
2025-02-14
Start date
2025-03-01
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

Major Depressive Disorder

Interventions

Measurement -Based and AI-supported care along with usual care Treatment as usual

Sponsors

Keio University
Lead Sponsor
Himorogi Psychiatric Institute
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (Patients) 1. Those who meet the diagnostic criteria for depression in DSM-5 2. Those who understand the purpose and content of this study and have obtained written consent from the individual to participate in the study of their own free will (Medical Doctors) 1. Outpatient doctors who are in charge of above patient 2. Those who understand the purpose and content of this study and have obtained written consent from the individual to participate in the study of their own free will

Exclusion criteria

Exclusion criteria: (Patients) 1. Those with a history of severe organic brain lesions or cognitive dysfunction 2. Those with a clinically diagnosed life-threatening or unstable physical condition at the time of screening 3. Those who are unable to visit the hospital more than twice within 3 months of participation in the study 4. Others deemed by the principal investigator to be ineligible for the study (Medical Doctors) N/A

Design outcomes

Primary

MeasureTime frame
Shared Decision Making Scale (SDM-Q-9 or SDM-Q-Doc) score and Client Satisfaction (CSQ-8J) at the time of end of intervention period

Secondary

MeasureTime frame
1. Coincident ratio between patient shared decision making (DSM-Q-9) and physician shared decision making (SDM-Q-Doc) 2. Remission rate of depression 3. Tool issues, frequency of tool use 4. Trust in physicians (TPS) 5. Depressive symptoms (HAMD, MADRS, BDI-II) 6. Satisfaction with the care using the tool (CSQ-8J)

Countries

Japan

Contacts

Public ContactToshiaki Kikuchi

Keio University School of Medicine Department of Neuropsychiatry

t-kick.z3@keio.jp03-5363-3971

Outcome results

None listed

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