Meru Health Program Versus Waitlist Control for Adults With Depression
Randomized Controlled Trial of the Meru Health Program Versus Waitlist Control for Adults With Depression
Study Overview
Detailed Description
Title: Randomized Controlled Trial of the Meru Health Program versus Waitlist Control for Adults with Depression
Study Description: This is a randomized controlled trial (RCT) of the Meru Health Program (MHP) versus a waitlist (WL) control group, which will be offered access to the MHP after the waitlist period (12 weeks) is over, for adults with depression.
Objectives*:
Primary Objective: To compare changes in depressive symptoms and reduction in clinically significant depression at the end of the program and compare between those in the MHP group versus WL group
Secondary Objectives: To compare changes in anxiety, worker productivity, burnout symptoms, resilience, insomnia, quality of life, days spent engaging with the program per week and hours spent in various program activities per week between those in the MHP group versus WL group
Endpoints*:
Primary Endpoint: Depressive symptoms and adverse events at 12 weeks
Secondary Endpoints: Anxiety, worker productivity, burnout, resilience, insomnia, and quality of life at 12 weeks; days spent engaging with program per week and hours spent in various program activities per week, program satisfaction, therapist rating, system usability scale..
Study Population: Patients aged 18 or older presenting to the Meru Health Program with depression (defined as having a PHQ-9 score of 10 or higher at baseline)
Description of Sites/Facilities Enrolling Participants: MHP online clinic
Description of Study Intervention/Experimental Manipulation: The Meru Health Program (MHP) is a 12-week mobile health app delivered via Smartphone that includes components of several evidence-based treatments (Cognitive Behavioral Therapy, Behavioral Activation Therapy, Mindfulness Meditation) and also several promising therapies (heart rate variability-biofeedback [HRVB], nutritional psychiatry, sleep training) that is overseen by a licensed clinical therapist. This study will test the MHP versus a WL control group, of which patients enrolled will be offered access to the MHP after 12 weeks in the WL control group, to compare groups on depressive symptom outcomes and, secondarily, on other mood and behavioral outcomes, engagement, and patient satisfaction outcomes.
Study Duration*: 1 year
Participant Duration: 12 weeks
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Colorado
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Denver, Colorado, United States, 80014
- Online
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 18 years or older
- Own a Smartphone
- PHQ-9>9
- Lives in Colorado
Exclusion Criteria:
- Screen positive for a psychotic disorder, bipolar disorder, alcohol or drug use disorder, or suicidal plans
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Meru Health Program
The Meru Health Program (MHP) is a 12-week online mobile digital mental health clinic delivered via Smartphone app that includes components of several evidence-based treatments (Cognitive Behavioral Therapy, Behavioral Activation Therapy, Mindfulness Meditation) and also several promising therapies (heart rate variability-biofeedback [HRVB], nutritional psychiatry, sleep training) and a group support component that is overseen by a licensed clinical therapist.
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Each week of the 12 week program follows a different theme.
Patients and therapists interact asynchronously after their initial Zoom-based intake call.
Psychiatrists and medical doctors are available for consults if needed.
Other Names:
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No Intervention: Waitlist
12 week waitlist
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Depression
Time Frame: 12 weeks
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Mean change in Patient Health Questionnaire-9 item depression scale during the program.
Scores range from 0 to 27, with higher scores indicative of more depression.
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12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Anxiety
Time Frame: 12 weeks
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Mean change in Generalized Anxiety Disorder-7 item anxiety scale during the program.
Scores range from 0 to 21, with higher scores indicative of more anxiety.
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12 weeks
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Burnout
Time Frame: 12 weeks
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Percent of participants with change in burnout during program.
A validated, single item burnout score measure will be used.
Burnout is assessed through an item with 5-level responses and categorized as "yes" (>=3) or "no" (<3) on a 5 point scale ranging from 1 (no symptoms of burnout) to 5 (completely burned out).
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12 weeks
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Worker Productivity and Activity Impairment
Time Frame: 12 weeks
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The 6-item WPAI will be used to quantify changes in baseline to 12-week (post-program) scores on 4 subscales of worker productivity and activity impairment: absenteeism, presenteeism, overall worker productivity impairment, and impairment in activities of daily living, which each range from 0 (no impairment) to 100% (fully impaired)
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12 weeks
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Resilience
Time Frame: 12 weeks
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Mean change in scores on the Resilience Scale score, which has a minimum of 25 (lowest resilience) and 175 (highest resilience).
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12 weeks
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Insomnia
Time Frame: 12 weeks
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The Insomnia Severity Scale will be used to assess mean changes made during the program.
The ISS has a minimum of 0 (no insomnia) to 28 (very severe insomnia)
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12 weeks
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Quality of life as measured by the EQ-5D
Time Frame: 12 weeks
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The EQ-5D will be used to evaluate mean changes in quality of life for each of the 5 subscales of the EQ-5D, which range from (no difficulties) to 3 (a lot of difficulty)
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12 weeks
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Patient-reported adverse events
Time Frame: during the 12-week intervention
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The proportion of patients reporting at least one adverse event during the study period will be calculated.
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during the 12-week intervention
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Patient-reported program satisfaction
Time Frame: 12 weeks
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The mean patient satisfaction on a single item question asking about overall satisfaction with the program will be used to calculate mean satisfaction (minimum 1, maxium 5)
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12 weeks
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Therapist rating
Time Frame: 12 weeks
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The mean therapist rating assessed via a single item question asking about overall satisfaction with the program will be used to calculate mean satisfaction (minimum 1, maxium 5)
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12 weeks
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System usability
Time Frame: 12 weeks
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The mean rating of system usability will be calculated from a single-item question with responses that range from 1 (lowest usability) to 5 (maximum usability)
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12 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Valerie F Hoffman, PhD, MPH, Meru Health, Inc.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- #20-MERU-107
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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