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

NCT ID: NCT03652948

Last Updated: 2021-03-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-12

Study Completion Date

2021-01-15

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Depression Depressive Symptoms

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Study 1: 8 week mobile app based intervention using cognitive behavioral and mindfulness skills Study 2: 12 week mobile app based intervention (8 week intervention+4 weeks focused on sleep and nutrition)
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Meru Health Ascend Program

Intervention Type BEHAVIORAL

Cognitive-behavioral skills, mindfulness

Interventions

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Meru Health Ascend Program

Cognitive-behavioral skills, mindfulness

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

40 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Meru Health, Inc.

INDUSTRY

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role collaborator

Palo Alto Veterans Institute for Research

OTHER

Sponsor Role lead

Responsible Party

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Christine Gould

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christine E Gould, PhD

Role: PRINCIPAL_INVESTIGATOR

VA Palo Alto Health Care System

Locations

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VA Palo Alto Health Care System

Palo Alto, California, United States

Site Status

Countries

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United States

Other Identifiers

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GOU0003

Identifier Type: -

Identifier Source: org_study_id

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