Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05406791 |
Other study ID # |
STU#:00211887 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
June 10, 2022 |
Est. completion date |
September 30, 2023 |
Study information
Verified date |
February 2024 |
Source |
Northwestern University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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.