NCT05406791

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable depression

Timeline
Completed

Started Jun 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 1, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 6, 2022

Completed
4 days until next milestone

Study Start

First participant enrolled

June 10, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

April 9, 2025

Completed
Last Updated

April 9, 2025

Status Verified

April 1, 2025

Enrollment Period

1.3 years

First QC Date

June 1, 2022

Results QC Date

January 29, 2025

Last Update Submit

April 8, 2025

Conditions

DepressionAnxiety

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

Sensor-enabled digital mental health intervention (DMHI)

EXPERIMENTAL

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

Experimental: Control Treatment (CT)

EXPERIMENTAL

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

Interventions

VIRA AppOTHER

Support from coach and using the VIRA app

Sensor-enabled digital mental health intervention (DMHI)
Mood Education AppOTHER

Support from mood education app

Experimental: Control Treatment (CT)

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • US Citizen/ Resident
  • 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

You may not qualify if:

  • Children under the age of 13
  • Severe suicidality (as defined by presence of a plan + intent to act on that plan)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rush University Medical Center Department of Psychiatry & Behavioral Sciences

Chicago, Illinois, 60612, United States

Location

Related Publications (1)

  • Stiles-Shields C, Reyes KM, Lakhtakia T, Smith SR, Barnas OE, Gray EL, Krause CJ, Kruzan KP, Kwasny MJ, Mir Z, Panjwani S, Rothschild SK, Sanchez-Johnsen L, Winquist NW, Lattie EG, Allen NB, Reddy M, Mohr DC. A personal sensing technology enabled service versus a digital psychoeducation control for primary care patients with depression and anxiety: a pilot randomized controlled trial. BMC Psychiatry. 2024 Nov 19;24(1):828. doi: 10.1186/s12888-024-06284-z.

    PMID: 39563248DERIVED

MeSH Terms

Conditions

DepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Results Point of Contact

Title
Colleen Stiles-Shields, PhD
Organization
University of Illinois at Chicago
ecss@uic.edu
312-413-1128

Study Officials

  • David C Mohr, PhD

    Northwestern University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized Controlled Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 1, 2022

First Posted

June 6, 2022

Study Start

June 10, 2022

Primary Completion

September 30, 2023

Study Completion

September 30, 2023

Last Updated

April 9, 2025

Results First Posted

April 9, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will share

Data will be shared through the NIMH Data Archive

Time Frame
Data will be available 1 year after completion of the study.
Access Criteria
Approval by NIMH Data Archive
More information

Locations

US(1)