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

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ClinicalTrials.gov Identifier: NCT03652948
Recruitment Status : Recruiting
First Posted : August 29, 2018
Last Update Posted : April 16, 2019
Sponsor:
Collaborators:
Meru Health
Stanford University
Information provided by (Responsible Party):
Christine Gould, Palo Alto Veterans Institute for Research

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Depression Depressive Symptoms Behavioral: Meru Health Ascend Program Phase 2 Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Intervention Model: Single Group Assignment
Intervention Model Description: 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)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Meru Health Ascend Mobile Intervention for Depression in Middle Aged and Older Adults
Actual Study Start Date : July 12, 2018
Estimated Primary Completion Date : July 30, 2020
Estimated Study Completion Date : July 30, 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03652948


Contacts
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Contact: Christine E Gould, PhD 650-493-5000 ext 68899 christine.gould@va.gov

Locations
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United States, California
VA Palo Alto Health Care System Recruiting
Palo Alto, California, United States, 94304
Contact: Christine Gould, PhD    650-493-5000 ext 68899    christine.gould@va.gov   
Principal Investigator: Christine E Gould, PhD         
Sub-Investigator: Ruth O'Hara, PhD         
Sponsors and Collaborators
Palo Alto Veterans Institute for Research
Meru Health
Stanford University
Investigators
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Principal Investigator: Christine E Gould, PhD VA Palo Alto Health Care System

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Responsible Party: Christine Gould, Principal Investigator, Palo Alto Veterans Institute for Research
ClinicalTrials.gov Identifier: NCT03652948     History of Changes
Other Study ID Numbers: GOU0003
First Posted: August 29, 2018    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Christine Gould, Palo Alto Veterans Institute for Research:
mobile app
middle age adults
older adults

Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders