Technology Enabled Services to Enhance Depression Care

Northwestern University

Status: Completed

Conditions: Depression; Anxiety

Treatments: Other: Mood Education App; Other: VIRA App

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05406791

1P50MH119029-01A1 (U.S. NIH Grant/Contract)

STU#:00211887

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 130 patients

Sex: All

Ages: 13+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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130 participants in 2 patient groups

Sensor-enabled digital mental health intervention (DMHI)

Experimental group

Description:

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

Treatment:

Other: VIRA App

Experimental: Control Treatment (CT)

Experimental group

Description:

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.

Treatment:

Other: Mood Education App