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.

Study Overview

• Status: Completed
• Conditions: Depression; Anxiety
• Intervention / Treatment: Other: VIRA App; Other: Mood Education App

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 130
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center Department of Psychiatry & Behavioral Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Other: VIRA App; Support from coach and using the VIRA app
Experimental: 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.	Other: Mood Education App; Support from mood education app

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: National Institute of Mental Health (NIMH); Rush University
• Investigators: Principal Investigator: David C Mohr, PhD, Northwestern University

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2022
• Primary Completion (Actual): September 30, 2023
• Study Completion (Actual): September 30, 2023

Study Registration Dates

• First Submitted: June 1, 2022
• First Submitted That Met QC Criteria: June 1, 2022
• First Posted (Actual): June 6, 2022

Study Record Updates

• Last Update Posted (Actual): April 9, 2025
• Last Update Submitted That Met QC Criteria: April 8, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Behavioral Symptoms; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: STU#:00211887; 1P50MH119029-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be shared through the NIMH Data Archive
• IPD Sharing Time Frame: Data will be available 1 year after completion of the study.
• IPD Sharing Access Criteria: Approval by NIMH Data Archive

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No