A Pilot Study of eHealth Tools in a Tertiary-care Setting

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pilot Randomized Clinical Trial of eHealth Tools

Conditions
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Depression

Intervention / Treatment
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* Other: Online eHealth tool
* Other: Informational website


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 19-65 and capable of informed consent; diagnosis of major depressive episode (MDE) by the Diagnostic and Statistical Manual, Fifth Edition (DSM-5) criteria as determined by the clinic psychiatrist; 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); access to an Internet-enabled computer or mobile device; and able to read and understand English sufficiently to use the eMBC platform Exclusion Criteria: active psychotic or substance use disorder; or severe suicidality as judged by the psychiatrist.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Online eHealth Tool<br>Participants randomized to this group will use a personally-owned smartphone, tablet, or computer to access the online eHealth tool. | Other: Online eHealth tool<br>* Mobile-optimized online eHealth tool to support MBC.<br>|
| Placebo Comparator: Informational website (control)<br>Participants randomized to this group will receive information about online resources for mental health | Other: Informational website<br>* Participants randomized to this group will receive information about online resources for mental health<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility-of-use outcome: Percentage of patients who use the eHealth tool (MoodFx) 3 or more times over the 6-month period | Percentage of patients who use the eHealth tool (MoodFx), defined as 3 or more uses over the 6-month follow up period | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change scores on the Quick Inventory of Depressive Symptomatology (QIDS-SR) from baseline to follow up at 8 weeks and 6 months. | The Quick Inventory of Depressive Symptomatology (QIDS-SR) is a self-report scale to assess symptoms of depression and consists of 16 items, 9 of which contribute to a summed total score (i.e., only the highest score of items 1-4, 6-9, and 15-16 are counted towards the total score). Higher scores indicate more severe symptoms, with individual item scores ranging from 0-3 and total scores ranging from 0-27. | 8 weeks and 6 months | 
| Change scores on the Patient Health Questionnaire (PHQ-9) from baseline to follow up at 8 weeks and 6 months. | The Patient Health Questionnaire (PHQ-9) is a brief, self-rated scale assessing symptoms of depression. The scale consists of 9 items rated on a scale from 0-3, with higher scores indicating more severe symptoms. Item scores are summed to yield a total score, range 0-27. | 8 weeks and 6 months | 
| Change scores on the Generalized Anxiety Disorder scale (GAD-7) from baseline to follow up at 8 weeks and 6 months. | The Generalized Anxiety Disorder scale (GAD-7) is a brief, self-rated scale assessing symptoms of generalized anxiety. The scale consists of 7 items rated on a scale from 0-3, with higher scores indicating more severe symptoms. Item scores are summed to yield a total score, range 0-21. | 8 weeks and 6 months | 
| Change scores on the Sheehan Disability Scale (SDS) from baseline to follow up at 8 weeks and 6 months. | The Sheehan Disability Scale (SDS) is a brief self-report scale assessing functional impairment in three inter-related domains: work/school, social and home/family life. The user rates the extent to which work/school, social life and home life or family responsibilities are impaired by his or her symptoms on a 11 point visual analog scale (range 0-10). Higher scores indicate greater impairment. | 8 weeks and 6 months | 
| Change scores on the Lam Employment Absence and Productivity Scale (LEAPS) from baseline to follow up at 8 weeks and 6 months. | The Lam Employment Absence and Productivity Scale (LEAPS) is a brief self-rated scale to assess patients' work functioning. The LEAPS consists of 10 items rated on a 5-point scale from 0-4, with higher scores indicating greater impairment. Item scores are summed to yield a total score, range 0-28. | 8 weeks and 6 months | 
| 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. | The Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) is a 16 item self-administered questionnaire assessing life satisfaction over the past week. Each question is rated on a 5 point scale from 1 (Very Poor) to 5 (Very Good). Scores from the individual items are added together and reported as percentage maximum possible score. | 8 weeks and 6 months | 
| Change scores on the Euro-QOL-5Lscale (EQ-5D-5L) from baseline to follow up at 8 weeks and 6 months. | The Euro-QOL scale (EQ-5D) is a standardised self-report instrument for measuring generic health status. It consists of 5 items evaluating rated on a 5-level scale from no impairments to complete impairment. The 5 rating levels can be quantified as ranging from 0 to 4, with higher scores indicating higher impairment. Total score ranges from 0 to 20. | 8 weeks and 6 months | 
| Satisfaction with eHealth tool as measured by the System Usability Scale. | The System Usability Scale is a 10-item survey that evaluates user satisfaction with online tools, applications, etc. Each item is rated on a 5-point scale (from 0-4), with higher scores indicating greater satisfaction. Item scores may be added together to yield scores ranging from 0-40, and then multiplied by 2.5 for scores ranging from 0-100. (Note these scores are not percentages or percentiles. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Measurement-Based Care, e-Mental Health, Functional Outcomes, Occupational Functioning, Cognition, Mobile Technology