Clinical trial NCT04738084: Meru Health Program Versus Waitlist Control for Adults With Depression
Official title: Randomized Controlled Trial of the Meru Health Program Versus Waitlist Control for Adults With Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: depression
anxiety
digital health intervention
Lead sponsor: Meru Health, Inc.
Sponsor class: INDUSTRY
First posted: 2021-02-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

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

Eligibility 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

Primary outcomes:
measure: Depression
timeFrame: 12 weeks
Secondary outcomes:
measure: Anxiety
timeFrame: 12 weeks
measure: Burnout
timeFrame: 12 weeks
measure: Worker Productivity and Activity Impairment
timeFrame: 12 weeks
measure: Resilience
timeFrame: 12 weeks
measure: Insomnia
timeFrame: 12 weeks
measure: Quality of life as measured by the EQ-5D
timeFrame: 12 weeks
measure: Patient-reported adverse events
timeFrame: during the 12-week intervention
Other outcomes:
measure: Patient-reported program satisfaction
timeFrame: 12 weeks
measure: Therapist rating
timeFrame: 12 weeks
measure: System usability
timeFrame: 12 weeks
Locations:
city: Denver
country: United States
facility: Online
state: Colorado
Study officials:
affiliation: Meru Health, Inc.
name: Valerie F Hoffman, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: