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

Launched by UNITY HEALTH TORONTO · Dec 9, 2024

Keywords

ClinConnect Summary

This study is looking at how digital tools can help adults who are struggling with severe depression that hasn't improved with standard treatments. Specifically, researchers want to find out if using a smartphone platform and a wearable device, like a smartwatch, can effectively track mental health alongside ongoing medical care. The main aim is to see if these digital tools can be easily integrated into treatment plans for patients receiving therapies like repetitive transcranial magnetic stimulation or intravenous ketamine.

To participate, you need to be an adult over 18 years old, currently experiencing a major depressive episode, and have not responded to at least two previous antidepressant treatments. You'll also need to own a smartphone and be receiving one of the specified treatments at a particular hospital program. If you join, you’ll record your mental health data digitally and wear a device to help gather information throughout your treatment. This study aims to gather information that could lead to larger studies in the future, ultimately helping to improve care for those with difficult-to-treat depression.

Gender

ALL

Eligibility 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