Digital Therapeutics

RECRUITING

Project 1: Determining the feasibility of digital interventions for adults with treatment-resistant depression 

REB Approved: #21-274

Study Coordinator: Dr. Reinhard Janssen Aguilar (reinhard.janssenaguilar@unityhealth.to) 

Study Contact Email: IAMGOLD@unityhealth.to 

Overview:

Approximately one third of patients with major depressive disorder (MDD) do not respond to traditional antidepressant therapies and are considered to have treatment-resistant depression (TRD). Here in the Interventional PsychiatryNeuropsychiatry Program we offer three outpatient treatments for patients living with TRD: repetitive transcranial magnetic stimulation (rTMS), intravenous ketamine (IVK), and electroconvulsive therapy (ECT). Wearable devicesDigital mental health interventionsMHIs that incorporate self-monitoring features, such as web-based EMAs and wearable devices, are well-tolerated in psychiatric populations and have the potential to not only improve clinical outcomes (e.g., depression, anxiety, sleep) but also provide clinicians insights into patients’ symptom trajectories and treatment response, especially when combined with .electronic data capture of measurement-based care. 

The goal of this study is to determine whether it is practical to use a wearable device and synchronous electronic data capture (using REDCap) the DiiG digital suite to collect data about the mental health (depression and anxiety) and physiological biometrics (e.g., heart rate variability, respiration, temperature, activity, sleep) of patients with TRD throughout the course of neuropsychiatric treatment. We will be doing this by having patients complete daily and weekly self-report assessments of mood on the REDCap (Research Electronic Data Capture) platform and continuously wear a smart ring (Oura Ring) throughout the course of their while they are engaging in out-patient treatment in the Interventional Psychiatry Program (rTMS, IVKintravenous ketamine, or ECT)  and having their clinical care team enter measurement-based care measures of depression and anxiety into REDCap after each treatment visitin the Interventional Neuropsychiatry Program. This data will help us: (1) understand the effectiveness of the Interventional PNeuropsychiatry Program; (2) predict if a patient will benefit from this program; and (3) monitor and identify early signs of treatment response (symptom improvements) and depressive relapse (symptom worsening) in patients with TRD.

Eligibility:

  • Primary diagnosis of major depressive disorder (MDD) without psychotic symptoms
  • Failure to respond to 2+ antidepressant therapies (i.e., treatment-resistant depression)
  • Referred to the Interventional Psychiatry Program at St. Michael’s Hospital, Unity Health Toronto for outpatient treatment (rTMS, IVK, or ECT)
  • 18+ years of age
  • Ownership of a smartphone 

Exclusion criteria:

  • Participants involved in experimental interventions (e.g., take-home neurostimulation, nitrous oxide, stellate ganglion block, psilocybin)
  • Poor/unreliable access to Internet/Wifi

Treatment description:

  • The wearable device will unobstrusively passively is digital suite will collect active and passive digital data continuously,physiological biomarkers (e.g., heart rate variability, respiration, temperature, activity, sleep) as patient-users go about their lives in the real world, while patients are enrolled in the Interventional Psychiatry Program.
  • The clinical care team will enter responses to self-report (PHQ-9 and/or GAD-7) and clinician-administered (MADRS) assessments of depression and anxiety completed as part of clinical care, into the REDCap system at the end of each treatment sessionParticipants will complete daily/weekly web-based surveys related to mental health using REDCap.
  • Participants will be offered a wearable device (Oura Ring or Empatica watch), which will monitor physiological features (e.g., body temperature, heart rate, respiratory rate, sleep, physical activity)

Project 2: Physical Activity Programme for Adults with Treatment-Resistant Depression 

REB approved: #23-069

Study contact: PA.TRD@unityhealth.to are we adding study contact for all studies? If so add it to other ones for consistency 

Overview: 

Physical activity (PA) has been associated with improvements in mood and mental health in both clinical and non-clinical populations. Recent research suggests that low doses and enjoyability of PA underlie its protective effect on mental health and well-being. As a result, in this study, we seek to explore the impact of a 4-week remotely delivered individualized one-on-one PA programme in addition to treatment as usual (TAU) on depressive symptoms of participants with treatment-resistant depression (TRD). At this time, we aim to conduct a pilot study with 30 participants wherein 20 will be randomized to the PA group and 10 will be in the control group. 

Inclusion Criteria: 

  • Sedentary adults (engage in less than 60 minutes of moderate-to-vigorous physical activity per week) between the age of 18 and 65 years, inclusive, capable of giving informed consent.
  • Participants meeting diagnostic criteria for major depressive disorder (MDD) without psychotic symptoms according to the Diagnostic and Statistical Manual of Mental Disorders – 5th Ed. (DSM-5) and currently experiencing a major depressive episode (MDE) as confirmed by the Mini International Neuropsychiatric Interview (MINI).
  • A Montgomery-Åsberg Depression Rating Scale (MADRS) total score of ≥ 7 at screening (mild to severe MDE).
  • Failure of at least two trials of antidepressant therapy of adequate dose and duration during the current episode as established by the Antidepressant Treatment History Form (ATHF) and self-report.
  • Receiving treatments congruent with Canadian Network for Mood and Anxiety Treatments (CANMAT) guidelines with no medication changes or no introduction of psychotherapy allowed one month before screening (28 days), during the randomized intervention phase (28 days), and during the follow-up phase (42 days).

Exclusion Criteria:

  • Current symptoms of mania, hypomania, mixed episodes, or psychosis.
  • Have received a diagnosis of alcohol or a substance use disorder within the past 3 months or as confirmed by the MINI. Other secondary psychiatric comorbidities (e.g., anxiety disorders, trauma-related disorders, etc.) will not be excluded.
  • Pregnant females.
  • Acute risk for a cardiovascular event (i.e., cardiovascular event within the past 12 months). 
  • Have any medical contraindications to exercise according to the Physical Activity Readiness Questionnaire (PAR-Q).
  • Self-reported balance, gait, or locomotion difficulties that would preclude participation in a physical activity programme. 
  • Have any other condition that, in the opinion of the investigator(s), would adversely affect the subject’s ability to complete the study or its measures.
  • Have exercise-induced asthma. 
  • Taking medication that interferes with heart rate response to exercise, such as beta blockers.
  • Do not own a smartphone. 
  • Do not have reliable access to the Internet.
  • Have previously received intravenous ketamine treatment in the last 2 months.
  • Non-English-speaking individuals are excluded because the ability to communicate study information, answer questions accurately and completely about the study, and obtain consent are necessary.

Treatment Description

  • Upon confirming eligibility in the study, participants will be randomized to the PA group (PA programme plus TAU) or the control group (no PA programme, only TAU). 
  • All participants will receive an Oura Ring which will collect passive physiological data (e.g. sleep, activity and readiness) throughout the course of the study. 
  • On a daily and weekly basis, participants will complete self-report questionnaires relevant to mental health and quality of life.
  • Participants in the PA group will meet with their program trainer once a week for 4 weeks for a supervised PA session and engage in PA outside of the supervised session. 
  • Participants will be followed up with for 6 weeks after the intervention period.
  • At the end of their participation in the study, participants who were randomized to the control group will have access to at least one session with a program trainer.

Interested in participating in our study? Find out if you are eligible <https://redcap.smh.ca/redcap/surveys/?s=LNDNCDWML8FEJ3MR>