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OpenTrials
Completed

NCT Number: NCT05406791

Technology Enabled Services to Enhance Depression Care

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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Key information

Age range

13 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rush University Medical Center Department of Psychiatry & Behavioral Sciences

Chicago, Illinois, 60612, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

VIRA App

Other

Support from coach and using the VIRA app

Mood Education App

Other

Support from mood education app

Primary outcomes

  1. Patient Health Questionaire-9 (PHQ-9)

    Time frame: 12 weeks

    The PHQ-9 measures depression symptom severity on a scale of 0-27, with higher scores indicating greater symptom severity.

  2. Generalized Anxiety Disorder-7 (GAD-7)

    Time frame: 12 weeks

    The GAD-7 measures anxiety symptom severity on a scale of 0-21, with higher scores indicating greater symptoms severity

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • National Institute of Mental Health (NIMH)
  • Rush University

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 6, 2022
Registry last updated
Apr 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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