Meru Health Program Versus Waitlist Control for Adults With Depression

Depression Clinical Trial

Official title:

Randomized Controlled Trial of the Meru Health Program Versus Waitlist Control for Adults With Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04738084
• Other study ID #: #20-MERU-107
• Status: Completed
• Phase: N/A
• Start date: August 21, 2020
• Est. completion date: December 30, 2021

Study information

• Verified date: July 2023
• Source: Meru Health, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 30, 2021
• Est. primary completion date: April 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

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.

Locations

Country	Name	City	State
United States	Online	Denver	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Meru Health, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	Resilience	Mean change in scores on the Resilience Scale score, which has a minimum of 25 (lowest resilience) and 175 (highest resilience).	12 weeks
Secondary	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
Secondary	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
Secondary	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