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

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.

Study Overview

• Status: Completed
• Conditions: Depression
• Intervention / Treatment: Behavioral: Meru Health Program

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: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80014
      • Online

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: 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 Names: Ascend
No Intervention: Waitlist; 12 week waitlist

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression	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.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety	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.	12 weeks
Burnout	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).	12 weeks
Worker Productivity and Activity Impairment	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)	12 weeks
Resilience	Mean change in scores on the Resilience Scale score, which has a minimum of 25 (lowest resilience) and 175 (highest resilience).	12 weeks
Insomnia	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)	12 weeks
Quality of life as measured by the EQ-5D	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)	12 weeks
Patient-reported adverse events	The proportion of patients reporting at least one adverse event during the study period will be calculated.	during the 12-week intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-reported program satisfaction	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)	12 weeks
Therapist rating	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)	12 weeks
System usability	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)	12 weeks

Collaborators and Investigators

• Sponsor: Meru Health, Inc.
• Investigators: Principal Investigator: Valerie F Hoffman, PhD, MPH, Meru Health, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 21, 2020
• Primary Completion (Actual): April 15, 2021
• Study Completion (Actual): December 30, 2021

Study Registration Dates

• First Submitted: January 24, 2021
• First Submitted That Met QC Criteria: January 29, 2021
• First Posted (Actual): February 4, 2021

Study Record Updates

• Last Update Posted (Actual): July 13, 2023
• Last Update Submitted That Met QC Criteria: July 12, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: depression; anxiety; digital health intervention
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: #20-MERU-107

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No