Randomized Controlled Trial of the Meru Health Program Versus Waitlist Control for Adults With Depression
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Meru Health, Inc.
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Depression
Study Overview
Brief Summary
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. The Meru Health Program (MHP) is a 12-week mobile mental health intervention 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) that is overseen by a licensed clinical therapist.
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
Data analyst will be blind to study group
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •18 years or older
- •Own a Smartphone
- •Lives in Colorado
Exclusion Criteria
- •Screen positive for a psychotic disorder, bipolar disorder, alcohol or drug use disorder, or suicidal plans
Arms & Interventions
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.
Intervention: Meru Health Program (Behavioral)
Waitlist
12 week waitlist
Outcomes
Primary Outcomes
Depression
Time Frame: 12 weeks
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.
Secondary Outcomes
- Anxiety(12 weeks)
- Quality of life as measured by the EQ-5D(12 weeks)
- Resilience(12 weeks)
- Worker Productivity and Activity Impairment(12 weeks)
- Insomnia(12 weeks)
- Burnout(12 weeks)
- Patient-reported adverse events(during the 12-week intervention)