Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Meru Health Program Versus Waitlist Control for Adults With Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04738084
Recruitment Status : Active, not recruiting
First Posted : February 4, 2021
Last Update Posted : May 27, 2021
Sponsor:
Information provided by (Responsible Party):
Meru Health, Inc.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Depression Behavioral: Meru Health Program Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients randomized to one of two groups, the Meru Health Program which is a 12 week program or a 12-week waitlist control group
Masking: Single (Outcomes Assessor)
Masking Description: Data analyst will be blind to study group
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of the Meru Health Program Versus Waitlist Control for Adults With Depression
Actual Study Start Date : August 21, 2020
Actual Primary Completion Date : April 15, 2021
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Name: Ascend
No Intervention: Waitlist
12 week waitlist


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Anxiety [ Time Frame: 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.

  2. Burnout [ Time Frame: 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).

  3. Worker Productivity and Activity Impairment [ Time Frame: 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)

  4. Resilience [ Time Frame: 12 weeks ]
    Mean change in scores on the Resilience Scale score, which has a minimum of 25 (lowest resilience) and 175 (highest resilience).

  5. Insomnia [ Time Frame: 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)

  6. Quality of life as measured by the EQ-5D [ Time Frame: 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)

  7. Patient-reported adverse events [ Time Frame: during the 12-week intervention ]
    The proportion of patients reporting at least one adverse event during the study period will be calculated.


Other Outcome Measures:
  1. Patient-reported program satisfaction [ Time Frame: 12 weeks ]
    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)

  2. Therapist rating [ Time Frame: 12 weeks ]
    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)

  3. System usability [ Time Frame: 12 weeks ]
    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)


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04738084


Locations
Layout table for location information
United States, Colorado
Online
Denver, Colorado, United States, 80014
Sponsors and Collaborators
Meru Health, Inc.
Investigators
Layout table for investigator information
Principal Investigator: Valerie F Hoffman, PhD, MPH Meru Health, Inc.
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Meru Health, Inc.
ClinicalTrials.gov Identifier: NCT04738084    
Other Study ID Numbers: #20-MERU-107
First Posted: February 4, 2021    Key Record Dates
Last Update Posted: May 27, 2021
Last Verified: May 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Meru Health, Inc.:
depression
anxiety
digital health intervention
Additional relevant MeSH terms:
Layout table for MeSH terms
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders