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

NCT06732089 | Recruiting

• 2 other identifiers: 21-274Miner's Lamp Foundation
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Feasibility

  To determine the feasibility of using a web-based digital platform and wearable devices to collect active and passive data, respectively, among adults receiving clinical treatment for treatment-resistant depression. This will be measured by: number of recruitments (minimum threshold of 6-7 participants/month), recruitment rates (relative to invited patient-participants; minimum threshold of 80%), dropout rates (maximum threshold of 30%), reasons for dropout (qualitative), and data completion/adherence rates (minimum threshold of 70%).

  From Screening and Baseline Visit (Day 0) to last treatment day (approximately 2-8 weeks depending on treatment group)

Secondary Outcomes (3)

• Longitudinal Changes in Symptom Presentation

  From Screening and Baseline Visit (Day 0) to last treatment day (approximately 2-8 weeks depending on treatment group)

• Predicting Treatment Response, Remission, and Relapse

  From Screening and Baseline Visit (Day 0) to last treatment day (approximately 2-8 weeks depending on treatment group)

• Personalized Digital Phenotype Profiling (pDPP)

  From Screening and Baseline Visit (Day 0) to last treatment day (approximately 2-8 weeks depending on treatment group)

Study Arms (3)

rTMS

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

IVK

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

ECT

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults suffering from treatment-resistant depression (TRD) who are being treated in the Interventional Psychiatry Program at St. Michael's Hospital, Unity Health Toronto. Patients have a confirmed diagnosis of Major Depressive Disorder (MDD) and are experiencing a Major Depressive Episode (MDE) at the time of enrollment.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Unity Health Toronto: lead
• University of Toronto: collaborator
• Toronto Metropolitan University: collaborator

Study Sites (1)

St. Michael's Hospital, Unity Health Toronto

Toronto, Ontario, M5B 1W8, Canada

RECRUITING

Related Publications (1)

• 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.

  PMID: 41134764 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major; Depressive Disorder, Treatment-Resistant

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

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

  Toronto Metropolitan University

  STUDY CHAIR

• Dr. Wendy Lou, Ph.D.

  Dalla Lana School of Public Health, University of Toronto

  STUDY CHAIR

Central Study Contacts

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

CONTACT

416-360-4000; venkat.bhat@unityhealth.to

Dr. Karisa Parkington, Ph.D.

CONTACT

416-360-4000; karisa.parkington@unityhealth.to

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2024
• First Posted: December 13, 2024
• Study Start: December 16, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 13, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)