RecruitingNCT06732089

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

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

Sponsor

Unity Health Toronto

Enrollment

200 participants

Start Date

Dec 16, 2024

Study Type

OBSERVATIONAL

Conditions

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

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This pilot study is testing digital health tools (such as smartphone apps and wearable devices) to support adults undergoing treatment for severe, treatment-resistant depression — including brain stimulation therapies and ketamine infusions — to see if these tools can improve symptom tracking and outcomes. **You may be eligible if...** - You are 18 or older - You have a diagnosis of major depressive disorder (without psychosis) - You are currently experiencing a depressive episode (scoring above 20 on a standard depression rating scale) - Your depression has not responded to at least 2 adequate courses of antidepressant medication - You are enrolled in a treatment program at St. Michael's Hospital, Unity Health Toronto (using rTMS, ketamine, or ECT) - You own a smartphone **You may NOT be eligible if...** - You have a primary diagnosis other than depression (e.g., bipolar disorder, psychosis) - You are not enrolled in a qualified treatment program at the listed site Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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