NCT04738084

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable depression

Timeline
Completed

Started Aug 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 21, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 4, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2021

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

July 13, 2023

Status Verified

July 1, 2023

Enrollment Period

8 months

First QC Date

January 24, 2021

Last Update Submit

July 12, 2023

Conditions

Depression

Keywords

depressionanxietydigital health intervention

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Anxiety

    12 weeks

  • Burnout

    12 weeks

  • Worker Productivity and Activity Impairment

    12 weeks

  • Resilience

    12 weeks

  • Insomnia

    12 weeks

  • +2 more secondary outcomes

Other Outcomes (3)

  • Patient-reported program satisfaction

    12 weeks

  • Therapist rating

    12 weeks

  • System usability

    12 weeks

Study Arms (2)

Meru Health Program

EXPERIMENTAL

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

Waitlist

NO INTERVENTION

12 week waitlist

Interventions

Meru Health ProgramBEHAVIORAL

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.

Also known as: Ascend
Meru Health Program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years or older
  • Own a Smartphone
  • PHQ-9\>9
  • Lives in Colorado

You may not qualify if:

  • Screen positive for a psychotic disorder, bipolar disorder, alcohol or drug use disorder, or suicidal plans

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Online

Denver, Colorado, 80014, United States

Location

Related Publications (1)

  • Forman-Hoffman VL, Sihvonen S, Wielgosz J, Kuhn E, Nelson BW, Peiper NC, Gould CE. Therapist-supported digital mental health intervention for depressive symptoms: A randomized clinical trial. J Affect Disord. 2024 Mar 15;349:494-501. doi: 10.1016/j.jad.2024.01.057. Epub 2024 Jan 9.

    PMID: 38211747DERIVED

MeSH Terms

Conditions

DepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Study Officials

  • Valerie F Hoffman, PhD, MPH

    Meru Health, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Data analyst will be blind to study group
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Patients randomized to one of two groups, the Meru Health Program which is a 12 week program or a 12-week waitlist control group
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2021

First Posted

February 4, 2021

Study Start

August 21, 2020

Primary Completion

April 15, 2021

Study Completion

December 30, 2021

Last Updated

July 13, 2023

Record last verified: 2023-07

Locations

US(1)