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Completed

NCT Number: NCT04738084

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.

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Key information

Conditions

Depression Anxiety Disorders Behavior Behavioral Symptoms Mental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Online

Denver, Colorado, 80014, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Meru Health Program

Behavioral

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

Primary outcomes

  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 outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Meru Health, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 4, 2021
Registry last updated
Jul 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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