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N/A Completed N=130 Randomized Treatment

Technology Enabled Services to Enhance Depression Care

Source: ClinicalTrials.gov NCT05406791 ↗
Enrolled (actual)
130
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcomePrimary: Patient Health Questionaire-9 (PHQ-9) — 13.2; 12.4; 10.0; 9.4 score on a scale

Summary

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
Patient Health Questionaire-9 (PHQ-9)
13.2; 12.4; 10.0; 9.4; 9.5; 9.2
PRIMARY
Generalized Anxiety Disorder-7 (GAD-7)
11.7; 12.2; 8.8; 9.8; 8.2; 9.3

Eligibility Criteria

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)
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05406791). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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