Meru Health Program Versus Waitlist Control for Adults With Depression
NCT ID: NCT04738084
Last Updated: 2023-07-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2020-08-21
2021-12-30
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
Meru Health Program
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.
Waitlist
12 week waitlist
No interventions assigned to this group
Interventions
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Meru Health Program
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Own a Smartphone
* PHQ-9\>9
* Lives in Colorado
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
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Meru Health, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Valerie F Hoffman, PhD, MPH
Role: PRINCIPAL_INVESTIGATOR
Meru Health, Inc.
Locations
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Online
Denver, Colorado, United States
Countries
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References
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Forman-Hoffman VL, Sihvonen S, Wielgosz J, Kuhn E, Nelson BW, Peiper NC, Gould CE. Therapist-supported digital mental health intervention for depressive symptoms: A randomized clinical trial. J Affect Disord. 2024 Mar 15;349:494-501. doi: 10.1016/j.jad.2024.01.057. Epub 2024 Jan 9.
Other Identifiers
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#20-MERU-107
Identifier Type: -
Identifier Source: org_study_id
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