Digital Interventions for Adults with Treatment-Resistant Depression: a Pilot Study
Recruiting · NCT06732089 · Observational (researchers observe without assigning treatment) · Lead sponsor: Unity Health Toronto
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
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
Where it is running
1 location listed.
- St. Michael's Hospital, Unity Health Toronto - Toronto, Ontario, Canada