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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUnity Health Toronto

About this trial

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

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

200 Participants
are grouped into 3 trial groups

Sponsors and collaborators

Unity Health Toronto

Lead sponsor

University of Toronto

Collaborator

Toronto Metropolitan University

Collaborator