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

Study Overview
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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.

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

Conditions
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Depression, Depressive Symptoms

Intervention / Treatment
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* Behavioral: Meru Health Ascend Program


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Meru Health Ascend Program<br>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<br>* Cognitive-behavioral skills, mindfulness<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in depressive symptoms | 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. | Change from baseline to 8 weeks/posttreatment for study 1; change from baseline to 12 weeks for study 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in anxiety symptoms | 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. | Change from baseline to 8 weeks/posttreatment for study 1; change from baseline to 12 weeks for study 2 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mobile app, middle age adults, older adults