Clinical trial NCT03762460: A Pilot Study of eHealth Tools in a Tertiary-care Setting
Official title: Pilot Randomized Clinical Trial of eHealth Tools
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Measurement-Based Care
e-Mental Health
Functional Outcomes
Occupational Functioning
Cognition
Mobile Technology
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Vancouver Coastal Health Research Institute
name: Healthy Minds Canada
name: Pfizer
First posted: 2018-12-03
Enrollment: 60
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This feasibility study investigates the use of eHealth tools within routine medical treatment for patients with depression in an outpatient psychiatric setting. The study investigates whether patients find a mobile-optimized online eHealth tool to be acceptable and feasible, and whether clinical and functional outcomes improve with use of the online eHealth tool, 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.

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 eHealth tool 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 MBC into standard practices and to optimize treatment for MDD at the point of care, without needing additional materials, equipment, or staffing.

This research study investigates the feasibility of using a mobile-optimized online eHealth tool to support MBC in routine clinical care for MDD within an outpatient psychiatric setting.

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.

Note: As of April, 2020 (before recruitment started), because of the pandemic the study protocol was changed to be fully virtual, with a change in the primary outcome to a patient feasibility outcome.

Eligibility criteria: Inclusion Criteria:

1. age 19-65 and capable of informed consent;
2. diagnosis of major depressive episode (MDE) by the Diagnostic and Statistical Manual, Fifth Edition (DSM-5) criteria as determined by the clinic psychiatrist;
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.

Primary outcomes:
measure: Feasibility-of-use outcome: Percentage of patients who use the eHealth tool (MoodFx) 3 or more times over the 6-month period
timeFrame: 6 months
Secondary outcomes:
measure: Change scores on the Quick Inventory of Depressive Symptomatology (QIDS-SR) from baseline to follow up at 8 weeks and 6 months.
timeFrame: 8 weeks and 6 months
measure: Change scores on the Patient Health Questionnaire (PHQ-9) from baseline to follow up at 8 weeks and 6 months.
timeFrame: 8 weeks and 6 months
measure: Change scores on the Generalized Anxiety Disorder scale (GAD-7) from baseline to follow up at 8 weeks and 6 months.
timeFrame: 8 weeks and 6 months
measure: Change scores on the Sheehan Disability Scale (SDS) from baseline to follow up at 8 weeks and 6 months.
timeFrame: 8 weeks and 6 months
measure: Change scores on the Lam Employment Absence and Productivity Scale (LEAPS) from baseline to follow up at 8 weeks and 6 months.
timeFrame: 8 weeks and 6 months
measure: Change scores on the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) from baseline to follow up at 8 weeks and 6 months.
timeFrame: 8 weeks and 6 months
measure: Change scores on the Euro-QOL-5Lscale (EQ-5D-5L) from baseline to follow up at 8 weeks and 6 months.
timeFrame: 8 weeks and 6 months
measure: Satisfaction with eHealth tool as measured by the System Usability Scale.
timeFrame: 6 months
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: UBC Mood Disorders Centre
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Raymond W Lam, MD
role: PRINCIPAL_INVESTIGATOR
References: