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.

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.

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)

Data will be shared through the NIMH Data Archive

Data will be available 1 year after completion of the study.

Approval by NIMH Data Archive

Adverse event data were collected up to 12 weeks

Adverse events were monitored via assessments completed by participants (completed by all arms), application user feedback interviews (intervention arm-only), and interactions with the coaches (intervention arm-only). Questions regarding suicidal ideation were explicitly asked only on assessment questions (PHQ-9). The open-ended nature of interviews and coach interaction allowed for expression of suicidal thoughts or behaviors and as a result was monitored for indications of adverse events.