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Clinical Trials/NCT03652948
NCT03652948
Completed
Phase 2

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

Palo Alto Veterans Institute for Research1 site in 1 country70 target enrollmentJuly 12, 2018

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Depression
Sponsor
Palo Alto Veterans Institute for Research
Enrollment
70
Locations
1
Primary Endpoint
change in depressive symptoms
Status
Completed
Last Updated
5 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
July 12, 2018
End Date
January 15, 2021
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Christine Gould

Principal Investigator

Palo Alto Veterans Institute for Research

Eligibility 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)

Outcomes

Primary Outcomes

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

  • change in anxiety symptoms(Change from baseline to 8 weeks/posttreatment for study 1; change from baseline to 12 weeks for study 2)

Study Sites (1)

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