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Completed

NCT Number: NCT03652948

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.

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Key information

Age range

40 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

VA Palo Alto Health Care System

Palo Alto, California, 94304, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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)

Treatment and study plan

Meru Health Ascend Program

Behavioral

Cognitive-behavioral skills, mindfulness

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Palo Alto Veterans Institute for Research

Other

Collaborators

  • Meru Health, Inc.
  • Stanford University

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Aug 29, 2018
Registry last updated
Mar 10, 2021

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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