Technology Enabled Services to Enhance Depression Care

Study Overview
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Brief Summary
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This study will compare two digital mental health interventions (DMHIs). One DMHI will use an app called Vira (which is a product developed and managed by Ksana Health), along with low intensity coaching provided via phone and both SMS text and in-app messaging. The other DMHI will provide a broad range of information on how to manage symptoms of depression, anxiety, and stress. The DMHI will be evaluated with patients receiving care from Rush University Medical Center's primary care and family medicine clinics, which serve racially, ethnically, and economically diverse communities; evaluations may also be extended beyond Rush patients.

Detailed Description
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Depression and anxiety are common and impose a tremendous societal burden in terms of cost, morbidity, quality of life, and mortality. Yet, few people are able to obtain adequate or appropriate treatment. This trial will compare the ability of two digital mental health interventions (DMHIs) to reduce depression and anxiety. One DMHI, called Mood Education App, provides information on depression and a broad range of strategies that are effective in improving symptoms. The other app, called VIRA, uses smartphone sensors to identify a few behavioral markers, including mobility patterns, physical activity, and sleep. The results of these sensed behavioral markers are used to give the participant behavior change recommendations through the Vira app that are expected to result in symptom improvement. The DMHI will include low intensity coaching, which includes one or more brief phone calls and communication via SMS text and in-app messaging. Both treatments are 8-weeks long. The trial will be conducted within Rush University Medical Center's primary care and family medicine clinics, although recruitment be expanded beyond these clinics.

Official Title
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Technology Enabled Services to Enhance Depression Care

Conditions
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Depression, Anxiety

Intervention / Treatment
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* Device: VIRA App
* Device: Mood Education App


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: US Citizen/ Resident 13 years or older English Speaking Owns an Android or iPhone smartphone with an up-to-date operating system Has used a smartphone in the last 7 days PHQ-8 greater than or equal to 10 and/or GAD-7 greater than or equal to 10 Exclusion Criteria: Children under the age of 13 Severe suicidality (as defined by presence of a plan + intent to act on that plan)

Ages Eligible for Study
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Minimum Age: 13 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Controlled Trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sensor-enabled digital mental health intervention (DMHI)<br>Patients randomized to sensor-enabled DMHI condition will use Ksana Health's Vira mobile therapy platform with support from a study coach | Device: VIRA App<br>* Support from coach and using the VIRA app<br>|
| Experimental: Experimental: Control Treatment (CT)<br>Participants randomized to the CT condition will use a Mood Education App designed by researchers at the University of Virginia to deliver psychoeducational content to help people self-manage symptoms of depression, anxiety, and stress. | Device: Mood Education App<br>* Support from mood education app<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Health Questionaire-9 (PHQ-9) | The PHQ-9 measures depression symptom severity on a scale of 0-27, with higher scores indicating greater symptom severity. | 12 weeks | 
| Generalized Anxiety Disorder-7 (GAD-7) | The GAD-7 measures anxiety symptom severity on a scale of 0-21, with higher scores indicating greater symptoms severity | 12 weeks |