Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04655924
Other study ID # IUSMD 18-04
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 16, 2022
Est. completion date December 31, 2023

Study information

Verified date January 2024
Source Aifred Health Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will determine the safety and potential effectiveness of a digital health platform aimed at improving treatment outcomes for patients with depression by assisting physicians with clinical decision making about depression treatment.


Recruitment information / eligibility

Status Completed
Enrollment 94
Est. completion date December 31, 2023
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Patient Inclusion Criteria: - diagnosed with major depressive disorder by a physician using DSM-V criteria - able to provide informed consent - patients must confirm that they are comfortable being treated for depression by their physician, who may propose a range of treatment options, such as medications or psychotherapies, consistent with best practice guidelines for depression which are included in the application. Physicians will be required, as in usual practice, to explain treatments to patients and patients will be able to give and withdraw consent for treatment in general or for specific treatments as in usual practice. Patient Exclusion Criteria: - bipolar disorder of any type - inability or unwillingness of the individual to give informed consent - inability to manage patient in an outpatient setting (i.e. imminent suicidality) - active major depression is not the main condition being treated (i.e. the patient has depressive symptoms in the context of severe substance abuse or a psychotic disorder, but a primary diagnosis of major depressive episode (MDE) cannot be made or would result in inappropriate care). - inability to use the tool (i.e. patient cannot interface with a mobile phone or computer due to delirium, or another medical condition)* *Note that for patients who do not have access to mobile or desktop devices but are able to use them or to be trained to use them, these will be provided to them at no cost. Physician Inclusion Criteria: - any family doctor/primary care physician or psychiatrist accredited in Canada or the USA who treats patients with depression on at least a monthly basis, as well as residents from these specialities supervised by a participating physician - able to provide informed consent - comfortable prescribing the range of potential treatments which could have probabilities provided for them by the CDA No Physician Exclusion Criteria

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Clinical Decision Support System
Clinical Decision Support System using Measurement-Based Care and Digital Decision Support Platform

Locations

Country Name City State
Canada CIUSSS De Centre Ouest De L'île de Montréal Montréal Quebec
Canada CIUSSS de l'Est-de-l'Île-de-Montréal Montréal Quebec
Canada CIUSSS De L'Ouest de L'île de Montréal Montréal Quebec
Canada McGill University Health Care Centre (MUHC) Montréal Quebec
Canada CAMH: The Centre for Addiction and Mental Health Toronto Ontario
Canada Douglas Mental Health University Institute Verdun Quebec
United States University of Michigan, Michigan Medicine Ann Arbor Michigan
United States Emory University Atlanta Georgia
United States South Florida Veterans Affairs Miami Florida
United States Salem VAMC Salem Virginia
United States VA New Haven, VA Connecticut Healthcare System West Haven Connecticut

Sponsors (2)

Lead Sponsor Collaborator
Aifred Health McGill University

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Other Number of ER visits, admissions, and re-admissions We will examine impact of health resource utilization by comparing rates of visits, admissions, and re-admissions between groups. 3 months
Other Medication Adherence Rates We will asses medication adherence rates, as measured by the Brief Adherence Rating Scale, after each visit for the duration of the study and compare between groups. 3 months
Other Patient Questionnaire Response Rate We will assess the frequency at which patients complete the questionnaires in the digital health platform in both groups. 3 months
Primary Rate of Safety - Adverse Events Adverse and Serious Adverse Events 3 months
Primary Effectiveness in Reduction of Depression Symptoms This is approved as a physician partially-blinded study and, as such, physicians are blinded to the primary outcome. 3 months
Secondary Time to Remission To evaluate time to remission between groups. The hypothesis is that time to remission will be shorter in the active intervention group compared to the active control group. 3 months
Secondary Response Rate To evaluate response rate between groups. The hypothesis is that the response rate (defined as 50% improvement in symptoms) and time to response, will be higher and lower, respectively, in the active intervention group compared to the active control group. 3 months
Secondary Patient Disability with WHODAS rating scale To evaluate between-group differences in patient disability outcomes. The hypothesis is that the physicians in the active intervention arm will produce superior patient outcomes to those physicians using usual guideline-informed practice, in terms of patient function as measured by a rating scale (WHODAS). 3 months
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05777044 - The Effect of Hatha Yoga on Mental Health N/A
Recruiting NCT04680611 - Severe Asthma, MepolizumaB and Affect: SAMBA Study
Recruiting NCT04977232 - Adjunctive Game Intervention for Anhedonia in MDD Patients N/A
Recruiting NCT04043052 - Mobile Technologies and Post-stroke Depression N/A
Completed NCT04512768 - Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy N/A
Recruiting NCT03207828 - Testing Interventions for Patients With Fibromyalgia and Depression N/A
Completed NCT04617015 - Defining and Treating Depression-related Asthma Early Phase 1
Recruiting NCT06011681 - The Rapid Diagnosis of MCI and Depression in Patients Ages 60 and Over
Completed NCT04476446 - An Expanded Access Protocol for Esketamine Treatment in Participants With Treatment Resistant Depression (TRD) Who do Not Have Other Treatment Alternatives Phase 3
Recruiting NCT02783430 - Evaluation of the Initial Prescription of Ketamine and Milnacipran in Depression in Patients With a Progressive Disease Phase 2/Phase 3
Recruiting NCT05563805 - Exploring Virtual Reality Adventure Training Exergaming N/A
Completed NCT04598165 - Mobile WACh NEO: Mobile Solutions for Neonatal Health and Maternal Support N/A
Completed NCT03457714 - Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial
Recruiting NCT05956912 - Implementing Group Metacognitive Therapy in Cardiac Rehabilitation Services (PATHWAY-Beacons)
Completed NCT05588622 - Meru Health Program for Cancer Patients With Depression and Anxiety N/A
Recruiting NCT05234476 - Behavioral Activation Plus Savoring for University Students N/A
Active, not recruiting NCT05006976 - A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study N/A
Enrolling by invitation NCT03276585 - Night in Japan Home Sleep Monitoring Study
Terminated NCT03275571 - HIV, Computerized Depression Therapy & Cognition N/A
Completed NCT03167372 - Pilot Comparison of N-of-1 Trials of Light Therapy N/A