Digital health monitoring for adults with treatment-resistant depression: Observational feasibility study protocol.
Karisa Parkington, Reinhard Janssen Aguilar, Gyu Hee Lee...
https://pubmed.ncbi.nlm.nih.gov/41134764Actively Recruiting
Age: 18Years +
All Genders
ID06732089
Determining the Feasibility of Digital Interventions for Adults with Treatment-Resistant Depression
Led by Unity Health Toronto · Updated on 2024-12-13
200
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
Sponsors
U
Unity Health Toronto
Lead Sponsor
U
University of Toronto
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are exploring the use of digital tools to monitor mental health in adults with treatment-resistant depression. This study aims to find out if wearable devices like smartwatches or smart rings, combined with an electronic data platform, can be effectively used alongside regular clinical treatments such as repetitive transcranial magnetic stimulation (rTMS), intravenous ketamine (IVK), or electroconvulsive therapy (ECT). The study also seeks to gather early clinical data to guide future, larger studies. Participants undergoing neuropsychiatric treatments for depression will have their clinical assessment scores for anxiety and depression recorded on a web-based platform after each treatment session. Additionally, they may wear a wearable device throughout their treatment period to passively collect health data like heart rate, temperature, sleep, and activity. This pilot study plans to recruit 200 adults over two years to evaluate how well these digital monitoring methods work in psychiatric care. During the approximately 2 to 8 weeks of treatment, participants will complete self-report or clinician assessments regularly, and their physiological data will be monitored continuously if they use the wearable device. Researchers will analyze feasibility, changes in symptoms, treatment response, remission, relapse, and personalized digital profiles. The study involves remote data collection and aims to integrate digital health monitoring into standard psychiatric treatment routines, with total participation spanning the treatment duration.
CONDITIONS
Brief Title
Digital Interventions for Adults with Treatment-Resistant Depression: a Pilot Study
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older who can give informed consent
- Diagnosed with major depressive disorder without psychotic symptoms based on DSM-5
- Currently experiencing a major depressive episode
- Montgomery-Asperg Depression Rating Scale (MADRS) score greater than 20 at screening
- Have treatment-resistant depression, defined as failure of 2 or more adequate antidepressant trials during the current episode
- Enrolled in one of the neuropsychiatric treatments (rTMS, intravenous ketamine, or electroconvulsive therapy) at the Interventional Psychiatry Program
- Own a smartphone if using wearable devices
You will not qualify if you...
- No access to the Internet to use study platforms
- Medication changes other than the treatment received through the Interventional Psychiatry Program within one month before screening or during treatment
- Insufficient English proficiency to understand study information, answer questions, or provide informed consent
AI-Screening
AI-Powered Screening
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2
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Monitoring
Duration - Approximately 2 to 8 weeks depending on treatment group
Participants who undergo routine neuropsychiatric treatments (rTMS, intravenous ketamine, or electroconvulsive therapy) as part of clinical care are observed. Symptom assessments and physiological biometrics are collected throughout treatment to evaluate mental health status.
Assessments and wearable device data collection after each treatment session
Trial Site Locations
Total: 1 location
1
St. Michael's Hospital, Unity Health Toronto
Toronto, Ontario, Canada, M5B 1W8
Actively Recruiting
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Research Team
D
Dr. Venkat Bhat, M.D., F.R.C.P.C.
D
Dr. Karisa Parkington, Ph.D.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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