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

Sponsor
Palo Alto Veterans Institute for Research (Other)
Overall Status
Completed
CT.gov ID
NCT03652948
Collaborator
Meru Health, Inc. (Industry), Stanford University (Other)
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Study Details

Study Description

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
  • 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
70 participants
Allocation:
N/A
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)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 :
Jul 12, 2018
Actual Primary Completion Date :
Jan 15, 2021
Actual Study Completion Date :
Jan 15, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. change in depressive symptoms [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 120 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 VA Palo Alto Health Care System Palo Alto California United States 94304

Sponsors and Collaborators

  • Palo Alto Veterans Institute for Research
  • Meru Health, Inc.
  • Stanford University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Christine Gould, Principal Investigator, Palo Alto Veterans Institute for Research
ClinicalTrials.gov Identifier:
NCT03652948
Other Study ID Numbers:
  • GOU0003
First Posted:
Aug 29, 2018
Last Update Posted:
Mar 10, 2021
Last Verified:
Mar 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Christine Gould, Principal Investigator, Palo Alto Veterans Institute for Research
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 10, 2021