Technology Enabled Services to Enhance Depression Care

Sponsor
Northwestern University (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05406791
Collaborator
Rush University (Other)
130
1
2
21.7
6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: VIRA App
  • Device: Mood Education App
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
130 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized Controlled TrialRandomized Controlled Trial
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Technology Enabled Services to Enhance Depression Care
Actual Study Start Date :
Jun 10, 2022
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Mar 31, 2024

Arms and Interventions

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

Device: 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.

Device: Mood Education App
Support from mood education app

Outcome Measures

Primary Outcome Measures

  1. Patient Health Questionaire-9 (PHQ-9) [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) [12 weeks]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
13 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Rush University Medical Center Department of Psychiatry & Behavioral Sciences Chicago Illinois United States 60612

Sponsors and Collaborators

  • Northwestern University
  • Rush University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
David Mohr, Principal Investigator, Northwestern University
ClinicalTrials.gov Identifier:
NCT05406791
Other Study ID Numbers:
  • STU#:00211887
First Posted:
Jun 6, 2022
Last Update Posted:
Jul 19, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 19, 2022