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

Determining the Feasibility of Digital Interventions for Adults with Treatment-Resistant Depression

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.

Study Overview

• Status: Recruiting
• Conditions: Major Depressive Disorder (MDD); Major Depressive Episode; Treatment-Resistant Major Depressive Disorder

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Dr. Venkat Bhat, M.D., F.R.C.P.C.; Phone Number: 76404 416-360-4000; Email: venkat.bhat@unityhealth.to
• Study Contact Backup: Name: Dr. Karisa Parkington, Ph.D.; Phone Number: 76228 416-360-4000; Email: karisa.parkington@unityhealth.to

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5B 1W8
      • Recruiting
      • St. Michael's Hospital, Unity Health Toronto
      • Contact: Dr. Venkat Bhat, M.D., F.R.C.P.C.; Phone Number: 76404 416-360-4000; Email: venkat.bhat@unityhealth.to
      • Contact: Dr. Karisa Parkington, Ph.D.; Phone Number: 76228 416-360-4000; Email: karisa.parkington@unityhealth.to
      • Contact: Dr. Reinhard Janssen Aguilar, M.D.
      • Contact: Dr. Alice Rueda, Ph.D.
      • Contact: Gyu Hee Lee, B.Sc.
      • Contact: Fathima Adamsahib, B.Sc., P.A.-C.
      • Contact: Dr. Perry Menzies, M.D., F.R.C.P.C.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Longitudinal Changes in Symptom Presentation	To quantify changes in active (clinical symptoms) and passive (physiological) measures of physical (activity) and mental health (depression, anxiety, sleep) over time. Active data will focus on anxiety and depression symptoms across treatment, as reported on the GAD-7, PHQ-9, and MADRS. Passive data will focus on physiological biometrics (e.g., heart rate, respiration, step count, metabolic equivalency, body temperature, sleep staging, skin conductance response) captured by the wearable devices.	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	To model and predict the likelihood of a patient achieving anxiety/depression treatment response (reduction greater than or equal to 50% on clinical assessment), remission (assessment score less than clinical threshold), and relapse (assessment score greater than clinical threshold after achieving remission) captured through active self-/clinician-administered assessments, based on longitudinal active and passive data.	From Screening and Baseline Visit (Day 0) to last treatment day (approximately 2-8 weeks depending on treatment group)
Personalized Digital Phenotype Profiling (pDPP)	To construct pDPPs (a.k.a. digital fingerprints) for each participant based on longitudinal active and passive data. This will be achieved using machine learning (ML), artificial intelligence (AI), and advanced data analytic principles.	From Screening and Baseline Visit (Day 0) to last treatment day (approximately 2-8 weeks depending on treatment group)

Collaborators and Investigators

• Sponsor: Unity Health Toronto
• Collaborators: University of Toronto; Toronto Metropolitan University
• Investigators: Study Chair: 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 record dates

Study Major Dates

• Study Start (Estimated): December 16, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: December 9, 2024
• First Submitted That Met QC Criteria: December 9, 2024
• First Posted (Estimated): December 13, 2024

Study Record Updates

• Last Update Posted (Estimated): December 13, 2024
• Last Update Submitted That Met QC Criteria: December 9, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: pilot study; observational study; feasibility study; treatment-resistant depression; wearable device; electronic data capture; digital health monitoring; remote measurement-based care
• Additional Relevant MeSH Terms: Mental Disorders; Behavioral Symptoms; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major; Depressive Disorder, Treatment-Resistant
• Other Study ID Numbers: 21-274; Miner's Lamp Foundation (Other Identifier: University of Toronto)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No