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

Phase

N/A

Condition

Depression

Depression (Major/severe)

Treatment

N/A

Clinical Study ID

NCT06732089

21-274

Miner's Lamp Foundation

Ages > 18
All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Adults (aged 18+) who are capable of giving informed consent
Patients meeting diagnostic criteria for major depressive disorder (MDD) withoutpsychotic 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 ormore adequate trials of antidepressant therapy of adequate dose and duration duringthe current episode
Enrollment in one of the treatment modalities (rTMS, IVK, or ECT) at theInterventional Psychiatry Program at St. Michael's Hospital, Unity Health Toronto
Ownership of a smartphone (for participants using wearable devices)

Exclusion

Exclusion Criteria:

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

Study Design

December 16, 2024

December 31, 2026

Study 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.

Connect with a study center

St. Michael's Hospital, Unity Health Toronto
Toronto, Ontario M5B 1W8
Canada
Active - Recruiting

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