Trial Outcomes & Findings for Technology Enabled Services to Enhance Depression Care (NCT NCT05406791)
NCT ID: NCT05406791
Last Updated: 2025-04-09
Results Overview
The PHQ-9 measures depression symptom severity on a scale of 0-27, with higher scores indicating greater symptom severity.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
130 participants
Primary outcome timeframe
12 weeks
Results posted on
2025-04-09
Participant Flow
Recruitment took place between June 2022 and June 2023. Patients were recruited in-person from clinic-based sites and through community events (e.g., back-to-school fairs, wellness events); the electronic health record (EHR; MyChart/Epic); social media and other platforms; and through subject recruitment registries.
Of 258 individuals assessed for eligibility, 130 met inclusion criteria and were randomized to treatment groups.
Participant milestones
| Measure |
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
VIRA App: Support from coach and using the VIRA app
|
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.
Mood Education App: Support from mood education app
|
|---|---|---|
|
Overall Study
STARTED
|
65
|
65
|
|
Overall Study
COMPLETED
|
52
|
55
|
|
Overall Study
NOT COMPLETED
|
13
|
10
|
Reasons for withdrawal
| Measure |
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
VIRA App: Support from coach and using the VIRA app
|
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.
Mood Education App: Support from mood education app
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
13
|
10
|
Baseline Characteristics
Technology Enabled Services to Enhance Depression Care
Baseline characteristics by cohort
| Measure |
Sensor-enabled Digital Mental Health Intervention (DMHI)
n=65 Participants
Patients randomized to sensor-enabled DMHI condition will use Ksana Health's "Vira" mobile therapy platform with support from a study coach
VIRA App: Support from coach and using the VIRA app
|
Experimental: Control Treatment (CT)
n=65 Participants
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.
Mood Education App: Support from mood education app
|
Total
n=130 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
62 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
124 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
30 years
n=5 Participants
|
33 years
n=7 Participants
|
32 years
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
52 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Non-binary
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Transgender
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
53 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
106 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
53 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
18 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
35 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
65 participants
n=5 Participants
|
65 participants
n=7 Participants
|
130 participants
n=5 Participants
|
|
Education
Some high school or less
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Education
High School Graduate/ GED
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Education
Vocational/Technical Degree, Associate's Degree, or Some College
|
18 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Education
Bachelor's Degree
|
18 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Education
Post-Bachelors Education
|
19 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Education
Prefer not to answer
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Marital Status
Divorced
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Marital Status
Living with Partner
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Marital Status
Married
|
17 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Marital Status
Separated
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Marital Status
Single
|
37 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
|
Marital Status
Widowed
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Household Income
Less than $10,000
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Household Income
$10,000 - $19,999
|
4 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Household Income
$20,000 - $39,999
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Household Income
$40,000 - $59,999
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Household Income
$60,000 - $99,999
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Household Income
$100,000 +
|
20 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Household Income
Don't know
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Household Income
Prefer not to answer
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksThe PHQ-9 measures depression symptom severity on a scale of 0-27, with higher scores indicating greater symptom severity.
Outcome measures
| Measure |
Sensor-enabled Digital Mental Health Intervention (DMHI)
n=65 Participants
Patients randomized to sensor-enabled DMHI condition will use Ksana Health's "Vira" mobile therapy platform with support from a study coach
VIRA App: Support from coach and using the VIRA app
|
Experimental: Control Treatment (CT)
n=65 Participants
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.
Mood Education App: Support from mood education app
|
|---|---|---|
|
Patient Health Questionaire-9 (PHQ-9)
Baseline
|
13.2 score on a scale
Interval 11.6 to 14.8
|
12.4 score on a scale
Interval 10.8 to 14.0
|
|
Patient Health Questionaire-9 (PHQ-9)
Week 4
|
10.0 score on a scale
Interval 8.3 to 11.6
|
9.4 score on a scale
Interval 7.8 to 11.1
|
|
Patient Health Questionaire-9 (PHQ-9)
Week 8
|
9.5 score on a scale
Interval 7.8 to 11.2
|
9.2 score on a scale
Interval 7.6 to 10.8
|
|
Patient Health Questionaire-9 (PHQ-9)
Week 12
|
8.7 score on a scale
Interval 6.8 to 10.5
|
7.9 score on a scale
Interval 6.2 to 9.5
|
PRIMARY outcome
Timeframe: 12 weeksThe GAD-7 measures anxiety symptom severity on a scale of 0-21, with higher scores indicating greater symptoms severity
Outcome measures
| Measure |
Sensor-enabled Digital Mental Health Intervention (DMHI)
n=65 Participants
Patients randomized to sensor-enabled DMHI condition will use Ksana Health's "Vira" mobile therapy platform with support from a study coach
VIRA App: Support from coach and using the VIRA app
|
Experimental: Control Treatment (CT)
n=65 Participants
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.
Mood Education App: Support from mood education app
|
|---|---|---|
|
Generalized Anxiety Disorder-7 (GAD-7)
Baseline
|
11.7 score on a scale
Interval 10.2 to 13.2
|
12.2 score on a scale
Interval 10.7 to 13.7
|
|
Generalized Anxiety Disorder-7 (GAD-7)
Week 4
|
8.8 score on a scale
Interval 7.3 to 10.3
|
9.8 score on a scale
Interval 8.3 to 11.3
|
|
Generalized Anxiety Disorder-7 (GAD-7)
Week 8
|
8.2 score on a scale
Interval 6.5 to 9.9
|
9.3 score on a scale
Interval 7.8 to 11.0
|
|
Generalized Anxiety Disorder-7 (GAD-7)
Week 12
|
7.5 score on a scale
Interval 5.7 to 9.4
|
7.4 score on a scale
Interval 5.9 to 9.0
|
Adverse Events
Sensor-enabled Digital Mental Health Intervention (DMHI)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Experimental: Control Treatment (CT)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Colleen Stiles-Shields, PhD
University of Illinois at Chicago
Phone: 312-413-1128
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place