Technology Enabled Services to Enhance Depression Care

Depression Clinical Trial

Official title:

Technology Enabled Services to Enhance Depression Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05406791
• Other study ID #: STU#:00211887
• Status: Completed
• Phase: N/A
• 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
• 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Anxiety
• Depression
• Depressive Disorder

Intervention

Device:
• VIRA App
Support from coach and using the VIRA app
• Mood Education App
Support from mood education app

Locations

Country	Name	City	State
United States	Rush University Medical Center Department of Psychiatry & Behavioral Sciences	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	Rush University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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