Meru Health Program Versus Waitlist Control for Adults With Depression
- Conditions
- Depression
- Interventions
- Behavioral: Meru Health Program
- Registration Number
- NCT04738084
- Lead Sponsor
- Meru Health, Inc.
- 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
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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- 18 years or older
- Own a Smartphone
- PHQ-9>9
- Lives in Colorado
- Screen positive for a psychotic disorder, bipolar disorder, alcohol or drug use disorder, or suicidal plans
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Meru Health Program 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.
- Primary Outcome Measures
Name Time Method Depression 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 Outcome Measures
Name Time Method Anxiety 12 weeks 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.
Quality of life as measured by the EQ-5D 12 weeks 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)
Resilience 12 weeks Mean change in scores on the Resilience Scale score, which has a minimum of 25 (lowest resilience) and 175 (highest resilience).
Worker Productivity and Activity Impairment 12 weeks 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)
Insomnia 12 weeks 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)
Burnout 12 weeks 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).
Patient-reported adverse events during the 12-week intervention The proportion of patients reporting at least one adverse event during the study period will be calculated.
Trial Locations
- Locations (1)
Online
🇺🇸Denver, Colorado, United States