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Digital Interventions for Adults with Treatment-Resistant Depression: a Pilot Study

NCT ID: NCT06732089

Last Updated: 2024-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-12-16

Study Completion Date

2026-12-31

Brief Summary

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The goal of this observational study is to learn about remote mental health monitoring technology for adults with treatment-resistant depression. The main question it aims to answer is: are digital mental health monitoring tools (an electronic data capture platform and wearable device (e.g., smartwatch or smart-ring)) feasible to implement alongside clinical treatment for depression? The secondary aim of this study is to inform preliminary clinical parameters for larger, definitive studies.

Participants receiving neuropsychiatric treatment (repetitive transcranial magnetic stimulation, intravenous ketamine, or electroconvulsive therapy) as part of their regular medical care for treatment-resistant depression in the Interventional Psychiatry Program will have their clinical assessment data entered into a digital platform and will wear an accessory-based wearable device for the duration of treatment.

Detailed Description

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This observational study with retrospective data analysis is conducted in patients with treatment-resistant depression (TRD) undergoing neuropsychiatric clinical treatment (rTMS, IVK, or ECT) in the Interventional Psychiatry Program (IPP) at St. Michael's Hospital. Participants will have scores from a self-report assessment of anxiety (GAD-7) and a self-report (PHQ-9) or clinician-administered (MADRS) assessment of depression completed as part of clinical care entered into the Research Electronic Database Capture (REDCap) web-based platform after each treatment session. This will facilitate retrospective analysis of mental health symptom change and treatment response over the course of treatment. Participants will also have the opportunity to wear an accessory-based wearable device (e.g., smartwatch or ring) throughout the course of treatment to passively capture physiological biometrics of physical and mental health (e.g., heart rate, temperature, sleep, activity). This two-year pilot study aims to recruit a total of 200 participants with TRD to retrospectively assess the feasibility and efficacy of integrating remote health sensing and monitoring platforms in psychiatric clinical care.

Conditions

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Major Depressive Disorder (MDD) Major Depressive Episode Treatment-Resistant Major Depressive Disorder

Keywords

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pilot study digital health monitoring wearable device remote measurement-based care treatment-resistant depression observational study feasibility study electronic data capture

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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rTMS

Participants in this group are enrolled to recieve rTMS treatment as part of their clinical care in the Interventional Psychiatry Program.

No interventions assigned to this group

IVK

Participants in this group are enrolled to receive intravenous ketamine (IVK) treatment as part of their clinical care in the Interventional Psychiatry Program.

No interventions assigned to this group

ECT

Participants in this group are enrolled to receive electroconvulsive therapy (ECT) as part of their clinical care in the Interventional Psychiatry Program.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Adults (aged 18+) who are capable of giving informed consent
* Patients meeting diagnostic criteria for major depressive disorder (MDD) without psychotic symptoms according to the DSM-5
* Currently experiencing a major depressive episode (MDE)
* Montgomery-Asperg Depression Rating Scale (MADRS) score greater than 20 at screening
* Patients meeting criteria for treatment-resistant depression (TRD): failure of 2 or more adequate trials of antidepressant therapy of adequate dose and duration during the current episode
* Enrollment in one of the treatment modalities (rTMS, IVK, or ECT) at the Interventional Psychiatry Program at St. Michael's Hospital, Unity Health Toronto
* Ownership of a smartphone (for participants using wearable devices)

Exclusion Criteria

* Individuals without Internet access (required to access study platforms)
* Medication changes, aside from the treatment received through the IPP, one month (28 days) before screening, or during the entire duration of treatment (variable based on treatment arm)
* Participants who do not speak English fluently enough to successfully communicate study information, answer questions accurately, and/or obtain informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Toronto

OTHER

Sponsor Role collaborator

Toronto Metropolitan University

OTHER

Sponsor Role collaborator

Unity Health Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dr. Srihar Krishnan, Ph.D., Peng., F.C.A.E.

Role: STUDY_CHAIR

Toronto Metropolitan University

Dr. Wendy Lou, Ph.D.

Role: STUDY_CHAIR

Dalla Lana School of Public Health, University of Toronto

Locations

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St. Michael's Hospital, Unity Health Toronto

Toronto, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Dr. Venkat Bhat, M.D., F.R.C.P.C.

Role: CONTACT

Phone: 416-360-4000

Email: [email protected]

Dr. Karisa Parkington, Ph.D.

Role: CONTACT

Phone: 416-360-4000

Email: [email protected]

Facility Contacts

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Dr. Venkat Bhat, M.D., F.R.C.P.C.

Role: primary

Dr. Karisa Parkington, Ph.D.

Role: backup

Dr. Reinhard Janssen Aguilar, M.D.

Role: backup

Dr. Alice Rueda, Ph.D.

Role: backup

Gyu Hee Lee, B.Sc.

Role: backup

Fathima Adamsahib, B.Sc., P.A.-C.

Role: backup

Dr. Perry Menzies, M.D., F.R.C.P.C.

Role: backup

References

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Parkington K, Aguilar RJ, Lee GH, Rueda A, Adamsahib F, Al-Hassan M, Famuditimi S, Menzies P, Lin Q, Lou W, Krishnan S, Bhat V. Digital health monitoring for adults with treatment-resistant depression: Observational feasibility study protocol. PLoS One. 2025 Oct 24;20(10):e0333484. doi: 10.1371/journal.pone.0333484. eCollection 2025.

Reference Type DERIVED
PMID: 41134764 (View on PubMed)

Other Identifiers

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Miner's Lamp Foundation

Identifier Type: OTHER

Identifier Source: secondary_id

21-274

Identifier Type: -

Identifier Source: org_study_id