Clinical Trial of Enhanced Measurement-Based Care (eMBC)
NCT03762460
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Adult Trials: 18+ Years
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
1. active psychotic or substance use disorder; or
2. severe suicidality as judged by the psychiatrist.
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| Descriptive Information | |||||
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| 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 |
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| 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 | 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:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 19 Years to 65 Years (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts |
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| 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 |
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| IPD Sharing Statement |
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| Responsible Party | Raymond Lam, University of British Columbia | ||||
| Study Sponsor | University of British Columbia | ||||
| Collaborators |
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| Investigators |
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| PRS Account | University of British Columbia | ||||
| Verification Date | November 2018 | ||||