Digital health tools for adults with treatment-resistant depression
Determining the Feasibility of Digital Interventions for Adults with Treatment-Resistant Depression
Unity Health Toronto · NCT06732089
This study is testing if digital health tools, like apps and wearable devices, can help adults with treatment-resistant depression track their symptoms and treatment responses while they receive care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Unity Health Toronto (other) |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT06732089 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the feasibility of using digital mental health monitoring tools, including an electronic data capture platform and wearable devices, for adults suffering from treatment-resistant depression. Participants undergoing neuropsychiatric treatments such as repetitive transcranial magnetic stimulation, intravenous ketamine, or electroconvulsive therapy will have their clinical assessment data recorded and analyzed. The study will also assess physiological data collected from wearable devices to understand changes in mental health symptoms and treatment responses over time. The goal is to inform future larger studies on the integration of remote health monitoring in psychiatric care.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with major depressive disorder who are currently experiencing a major depressive episode and are enrolled in specific neuropsychiatric treatments.
Not a fit: Patients without internet access or those who have had recent medication changes may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the management of treatment-resistant depression through improved monitoring and personalized care.
How similar studies have performed: While the integration of digital health tools in mental health care is a growing field, this specific approach is relatively novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Toronto, Ontario
- St. Michael's Hospital, Unity Health Toronto — Toronto, Ontario, Canada (RECRUITING)
Study contacts
- Study coordinator: Dr. Venkat Bhat, M.D., F.R.C.P.C.
- Email: venkat.bhat@unityhealth.to
- Phone: 416-360-4000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Major Depressive Disorder, Major Depressive Episode, Treatment-Resistant Major Depressive Disorder, pilot study, digital health monitoring, wearable device, remote measurement-based care, treatment-resistant depression