Technology Enabled Services to Enhance Depression Care
Primary Purpose
Depression, Anxiety
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
VIRA App
Mood Education App
Sponsored by
About this trial
This is an interventional treatment trial for Depression
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)
Sites / Locations
- Rush University Medical Center Department of Psychiatry & Behavioral Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Sensor-enabled digital mental health intervention (DMHI)
Experimental: Control Treatment (CT)
Arm Description
Patients randomized to sensor-enabled DMHI condition will use Ksana Health's "Vira" mobile therapy platform with support from a study coach
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.
Outcomes
Primary Outcome Measures
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.
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
Secondary Outcome Measures
Full Information
NCT ID
NCT05406791
First Posted
June 1, 2022
Last Updated
June 30, 2023
Sponsor
Northwestern University
Collaborators
Rush University
1. Study Identification
Unique Protocol Identification Number
NCT05406791
Brief Title
Technology Enabled Services to Enhance Depression Care
Official Title
Technology Enabled Services to Enhance Depression Care
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 10, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
Collaborators
Rush University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Controlled Trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
130 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sensor-enabled digital mental health intervention (DMHI)
Arm Type
Experimental
Arm Description
Patients randomized to sensor-enabled DMHI condition will use Ksana Health's "Vira" mobile therapy platform with support from a study coach
Arm Title
Experimental: Control Treatment (CT)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
VIRA App
Intervention Description
Support from coach and using the VIRA app
Intervention Type
Device
Intervention Name(s)
Mood Education App
Intervention Description
Support from mood education app
Primary Outcome Measure Information:
Title
Patient Health Questionaire-9 (PHQ-9)
Description
The PHQ-9 measures depression symptom severity on a scale of 0-27, with higher scores indicating greater symptom severity.
Time Frame
12 weeks
Title
Generalized Anxiety Disorder-7 (GAD-7)
Description
The GAD-7 measures anxiety symptom severity on a scale of 0-21, with higher scores indicating greater symptoms severity
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David C Mohr, PhD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rush University Medical Center Department of Psychiatry & Behavioral Sciences
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be shared through the NIMH Data Archive
IPD Sharing Time Frame
Data will be available 1 year after completion of the study.
IPD Sharing Access Criteria
Approval by NIMH Data Archive
IPD Sharing URL
https://nda.nih.gov/
Learn more about this trial
Technology Enabled Services to Enhance Depression Care
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