Technology Enabled Services to Enhance Depression Care

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-10

Study Completion Date

2023-09-30

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.

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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.

Conditions

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Depression Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized Controlled Trial

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sensor-enabled digital mental health intervention (DMHI)

Patients randomized to sensor-enabled DMHI condition will use Ksana Health's "Vira" mobile therapy platform with support from a study coach

Group Type EXPERIMENTAL

VIRA App

Intervention Type OTHER

Support from coach and using the VIRA app

Experimental: Control Treatment (CT)

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.

Group Type EXPERIMENTAL

Mood Education App

Intervention Type OTHER

Support from mood education app

Interventions

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VIRA App

Support from coach and using the VIRA app

Intervention Type OTHER

Mood Education App

Support from mood education app

Intervention Type OTHER

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