NCT05406791

Technology Enabled Services to Enhance Depression Care

Completed NA Results posted Last updated 9 April 2025

What this trial tests

NA trial testing VIRA App in Depression in 130 participants. Completed in 30 September 2023.

Timeline

10 June 2022

Primary endpoint
30 September 2023

30 September 2023

Quick facts

Lead sponsor	Northwestern University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	130
Start date	10 June 2022
Primary completion	30 September 2023
Estimated completion	30 September 2023
Sites	1 location across United States

Drugs / interventions tested

• VIRA App
• Mood Education App

Conditions studied

• Depression — all drugs for Depression →
• Anxiety — all drugs for Anxiety →

Sponsor

Northwestern University

Who can join

13 and older, any sex, with Depression or Anxiety. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Patient Health Questionaire-9 (PHQ-9) Primary · 12 weeks

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

Baseline

Group	Value	95% CI
Sensor-enabled Digital Mental Health Intervention (DMHI)	13.2	11.6 – 14.8
Experimental: Control Treatment (CT)	12.4	10.8 – 14.0

Week 4

Group	Value	95% CI
Sensor-enabled Digital Mental Health Intervention (DMHI)	10.0	8.3 – 11.6
Experimental: Control Treatment (CT)	9.4	7.8 – 11.1

Week 8

Group	Value	95% CI
Sensor-enabled Digital Mental Health Intervention (DMHI)	9.5	7.8 – 11.2
Experimental: Control Treatment (CT)	9.2	7.6 – 10.8

Week 12

Group	Value	95% CI
Sensor-enabled Digital Mental Health Intervention (DMHI)	8.7	6.8 – 10.5
Experimental: Control Treatment (CT)	7.9	6.2 – 9.5

Generalized Anxiety Disorder-7 (GAD-7) Primary · 12 weeks

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

Baseline

Group	Value	95% CI
Sensor-enabled Digital Mental Health Intervention (DMHI)	11.7	10.2 – 13.2
Experimental: Control Treatment (CT)	12.2	10.7 – 13.7

Week 4

Group	Value	95% CI
Sensor-enabled Digital Mental Health Intervention (DMHI)	8.8	7.3 – 10.3
Experimental: Control Treatment (CT)	9.8	8.3 – 11.3

Week 8

Group	Value	95% CI
Sensor-enabled Digital Mental Health Intervention (DMHI)	8.2	6.5 – 9.9
Experimental: Control Treatment (CT)	9.3	7.8 – 11.0

Week 12

Group	Value	95% CI
Sensor-enabled Digital Mental Health Intervention (DMHI)	7.5	5.7 – 9.4
Experimental: Control Treatment (CT)	7.4	5.9 – 9.0

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. A personal sensing technology enabled service versus a digital psychoeducation control for primary care patients with depression and anxiety: a pilot randomized controlled trial.
   Stiles-Shields C, Reyes KM, Lakhtakia T, Smith SR, et al · · 2024 · cited 7× · PMID 39563248 · DOI 10.1186/s12888-024-06284-z