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Trial record 1 of 1 for:    NCT03762460
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Clinical Trial of Enhanced Measurement-Based Care (eMBC)

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ClinicalTrials.gov Identifier: NCT03762460
Recruitment Status : Not yet recruiting
First Posted : December 3, 2018
Last Update Posted : December 3, 2018
Sponsor:
Collaborators:
Vancouver Coastal Health Research Institute
Healthy Minds Canada
Pfizer
Information provided by (Responsible Party):
Raymond Lam, University of British Columbia

Tracking Information
First Submitted Date April 11, 2018
First Posted Date December 3, 2018
Last Update Posted Date December 3, 2018
Estimated Study Start Date January 1, 2019
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 30, 2018)
Prevalence of clinician use of eMBC [ Time Frame: 8 weeks ]
The primary outcome for this feasibility study will be percentage of clinicians who indicate they reviewed eMBC outcome scales with participants (defined by a clinical note in the chart).
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: November 30, 2018)
  • Change in MADRS (Montgomery-Asberg Depression Rating Scale) scores from baseline [ Time Frame: [Time Frame: 8 weeks, 6 months] ]
    Change in symptoms of depression, as rated by clinicians
  • Prevalence of participant use of eMBC tool [ Time Frame: 8 weeks ]
    Percentage of participants who use the eMBC tool (defined as 3 or more uses over the primary follow-up period).
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Clinical Trial of Enhanced Measurement-Based Care (eMBC)
Official Title Pilot Randomized Clinical Trial of Enhanced Measurement-Based Care (eMBC)
Brief Summary This feasibility study investigates the use of enhanced measurement-based care (eMBC) within routine medical treatment for patients with depression in an outpatient psychiatric setting. eMBC will be facilitated using an Internet-based application optimized for mobile devices, such as smartphones and tablets. The study investigates whether patients and their treating clinicians find technology-enabled eMBC to be acceptable and feasible, and whether clinical and functional outcomes improve with use of eMBC, compared to informational online resources for mental health.
Detailed Description

Major Depressive Disorder (MDD) is increasingly recognized as the most common psychiatric disorder and as one of the most common medical diagnoses worldwide.

This research study investigates the feasibility of using an Internet-based application that incorporates a technology-enhanced platform of measurement-based care (eMBC) in routine clinical care for MDD within an outpatient psychiatric setting.

Measurement-based care (MBC) is an evidence-based approach for providing effective clinical care to patients with MDD. MBC utilizes validated rating scales to assess symptom severity, functional impairments, treatment adherence, and side-effect burden to personalize clinical decision-making based on measured outcomes and clinical algorithms. However, despite evidence demonstrating improved outcomes, MBC is still not routinely used by physicians. Barriers to the use of MBC include lack of knowledge of which scales to use, how to incorporate measurements into clinical charting systems, and the extra time needed for repeated assessments.

Our research team developed a web-based application (app) optimized for mobile devices to address the treatment gap in MBC for people with depression, especially those who are working while depressed. This user-friendly app encourages patients to actively participate in MBC by using their smartphones, tablets, or computers to screen, monitor, and manage depressive symptoms and functional outcomes. Results can be easily displayed and printed to share with clinicians, thereby affording health professionals a simple and cost-effective means to integrate eMBC into standard practices and to optimize treatment for MDD at the point of care, without needing additional materials, equipment, or staffing.

To determine both the clinical and practical utility of eMBC, this study will enroll "real-world" patients with few exclusion criteria and undergoing naturalistic treatments so that findings will be generalizable to other clinical settings and practices.

Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Participants will be identified from our outpatient clinic population at the UBC Mood Disorders Centre, a specialized psychiatric program operated by the Vancouver Coastal Health Authority, and located at the Djavad Mowafaghian Centre for Brain Health at the University of British Columbia Hospital in Vancouver, BC, Canada.
Condition Depression
Intervention Other: Enhanced Measurement-Based Care (eMBC)
MBC utilizes validated rating scales to assess symptom severity, functional impairments, treatment adherence, and side-effect burden to personalize clinical decision-making based on measured outcomes and clinical algorithms. This study incorporates a technology-enabled platform of MBC (eMBC) that participants access using a personally-owned smartphone, tablet, or laptop computer.
Study Groups/Cohorts
  • Enhanced Measurement-Based Care (eMBC)
    Participants randomized to this group will use a personally-owned smartphone, tablet, or laptop computer to access the online eMBC platform.
    Intervention: Other: Enhanced Measurement-Based Care (eMBC)
  • Information website (control)
    Participants randomized to this group will receive information about online resources for mental health
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: November 30, 2018)
60
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 31, 2020
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. age 19-65 and capable of informed consent;
  2. diagnosis of MDD by the Diagnostic and Statistical Manual, Fifth Edition (DSM-5) criteria as determined by the clinic psychiatrist (and if needed confirmed through the Mini International Neuropsychiatric Interview);
  3. at least moderate depression as defined by QIDS-SR score of 10 or higher on the Quick Inventory for Depressive Symptomatology, Self-Rated (QIDS-SR);
  4. access to an Internet-enabled computer or mobile device; and
  5. able to read and understand English sufficiently to use the eMBC platform

Exclusion Criteria:

  1. active psychotic or substance use disorder; or
  2. severe suicidality as judged by the psychiatrist.
Sex/Gender
Sexes Eligible for Study: All
Ages 19 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Cindy Woo 604-822-7627 cindy.woo@ubc.ca
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT03762460
Other Study ID Numbers H17-02786
V17-02786 ( Other Identifier: Vancouver Coastal Health Research Institute )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Raymond Lam, University of British Columbia
Study Sponsor University of British Columbia
Collaborators
  • Vancouver Coastal Health Research Institute
  • Healthy Minds Canada
  • Pfizer
Investigators
Principal Investigator: Raymond W Lam, MD, FRCPC University of British Columbia
PRS Account University of British Columbia
Verification Date November 2018