Meru Health Ascend Mobile Intervention for Depression in Middle Aged and Older Adults

March 8, 2021 updated by: Christine Gould, Palo Alto Veterans Institute for Research

Evaluation of Meru Health Ascend Mobile Intervention for Depression in Middle Aged and Older Adults

Using technology to deliver depression interventions is one way could alleviate the public health burden of depression. The study is testing a mobile app intervention program for depression that uses cognitive behavioral skills and mindfulness. This study seeks to obtain feedback on the intervention and refine the intervention and then test the intervention in a larger study. The mobile app intervention called the Meru Health Ascend program consists of the app and therapist support via messaging within the app.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The Meru Health Ascend program is a guided self-management program that uses a mobile application to deliver content of the intervention. A licensed therapist (Meru Health employed) provides support to participants as needed and reviews practice logs within the app.The 8-week program teaches cognitive behavioral techniques and mindfulness skills with the aim of improving the user's mental health. The platform provides informational videos, skills practices, group discussion, and messaging with the therapist. The Meru Health program enrolls participants in treatment groups that work through the program at the same time and can provide support to on another on the discussion board within the app.

We are conducting two studies in middle aged and older adults with elevated depressive symptoms to evaluate the Meru Health Ascend program. In the first study (study 1), we will examine the feasibility of the intervention in individuals aged 40 years or older with elevated depression symptoms using an iterative case series. Specifically, we will examine the usability of app and materials, dropout and reasons for dropout, and user perceptions of the program.

We will then conduct a proof-of-concept study (study 2) using a nonrandomized pre-post design to examine whether individuals achieve clinically significant reductions in depressive symptoms.

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94304
        • VA Palo Alto Health Care System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 120 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Owns a smart phone, resides in California, PHQ-9 score greater than or equal to 10, stable dose of medication (if taking psychotropic), able to read and understand English.

Exclusion Criteria:

  • Psychotic disorder, possible cognitive impairment, evidence of problematic drinking behavior, active suicide ideation with a plan, active psychological treatment, bipolar disorder (study 2 only)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Meru Health Ascend Program

The Meru Health Ascend Program is an 8-week mobile application (app) based intervention that teaches cognitive-behavioral and mindfulness skills. The intervention also includes a group discussion board with the other participants in the intervention group and therapist support via chat within the app.

Study 2 is examining a revised version of the Meru Health Ascend Program that is 12 weeks long and incorporates sleep and nutrition information in addition to the 8-week program.
Behavioral: Meru Health Ascend Program
Cognitive-behavioral skills, mindfulness

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in depressive symptoms
Time Frame: Change from baseline to 8 weeks/posttreatment for study 1; change from baseline to 12 weeks for study 2
The Patient Health Questionnaire 9-item (PHQ-9) is a measure that assesses 9 depressive symptoms with scores ranging from 0 to 27. Higher scores indicate more severe depressive symptomatology.
Change from baseline to 8 weeks/posttreatment for study 1; change from baseline to 12 weeks for study 2

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in anxiety symptoms
Time Frame: Change from baseline to 8 weeks/posttreatment for study 1; change from baseline to 12 weeks for study 2
The Generalized Anxiety Disorder 7-item (GAD-7) is a seven item measure of anxiety symptoms with scores ranging from 0 to 21. Higher scores indicate more severe anxiety symptomatology.
Change from baseline to 8 weeks/posttreatment for study 1; change from baseline to 12 weeks for study 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Palo Alto Veterans Institute for Research

Collaborators

Stanford University
Meru Health, Inc.

Investigators

  • Principal Investigator: Christine E Gould, PhD, VA Palo Alto Health Care System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 12, 2018

Primary Completion (ACTUAL)

January 15, 2021

Study Completion (ACTUAL)

January 15, 2021

Study Registration Dates

First Submitted

August 28, 2018

First Submitted That Met QC Criteria

August 28, 2018

First Posted (ACTUAL)

August 29, 2018

Study Record Updates

Last Update Posted (ACTUAL)

March 10, 2021

Last Update Submitted That Met QC Criteria

March 8, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GOU0003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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