Anxiety, Depression
Conditions
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.
Interventions
OTHERVIRA App
Support from coach and using the VIRA app
OTHERMood Education App
Support from mood education app
Sponsors
Rush University
National Institute of Mental Health (NIMH)
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized Controlled Trial
Eligibility
Sex/Gender
ALL
Age
13 Years to No maximum
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
Of 258 individuals assessed for eligibility, 130 met inclusion criteria and were randomized to treatment groups.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 65 |
| 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 | 65 |
| Total | 130 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 13 | 10 |
Baseline characteristics
| Characteristic | Sensor-enabled Digital Mental Health Intervention (DMHI) | Experimental: Control Treatment (CT) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 3 Participants | 3 Participants | 6 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 62 Participants | 62 Participants | 124 Participants |
| Age, Continuous | 30 years | 33 years | 32 years |
| Education Bachelor's Degree | 18 Participants | 17 Participants | 35 Participants |
| Education High School Graduate/ GED | 6 Participants | 5 Participants | 11 Participants |
| Education Post-Bachelors Education | 19 Participants | 24 Participants | 43 Participants |
| Education Prefer not to answer | 0 Participants | 1 Participants | 1 Participants |
| Education Some high school or less | 4 Participants | 3 Participants | 7 Participants |
| Education Vocational/Technical Degree, Associate's Degree, or Some College | 18 Participants | 15 Participants | 33 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 12 Participants | 16 Participants | 28 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 53 Participants | 48 Participants | 101 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Household Income $100,000 + | 20 Participants | 23 Participants | 43 Participants |
| Household Income $10,000 - $19,999 | 4 Participants | 9 Participants | 13 Participants |
| Household Income $20,000 - $39,999 | 7 Participants | 5 Participants | 12 Participants |
| Household Income $40,000 - $59,999 | 7 Participants | 2 Participants | 9 Participants |
| Household Income $60,000 - $99,999 | 14 Participants | 14 Participants | 28 Participants |
| Household Income Don't know | 4 Participants | 6 Participants | 10 Participants |
| Household Income Less than $10,000 | 6 Participants | 3 Participants | 9 Participants |
| Household Income Prefer not to answer | 3 Participants | 3 Participants | 6 Participants |
| Marital Status Divorced | 2 Participants | 0 Participants | 2 Participants |
| Marital Status Living with Partner | 8 Participants | 10 Participants | 18 Participants |
| Marital Status Married | 17 Participants | 15 Participants | 32 Participants |
| Marital Status Separated | 0 Participants | 2 Participants | 2 Participants |
| Marital Status Single | 37 Participants | 37 Participants | 74 Participants |
| Marital Status Widowed | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 5 Participants | 10 Participants |
| Race (NIH/OMB) Black or African American | 18 Participants | 15 Participants | 33 Participants |
| Race (NIH/OMB) More than one race | 6 Participants | 9 Participants | 15 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) White | 35 Participants | 33 Participants | 68 Participants |
| Region of Enrollment United States | 65 participants | 65 participants | 130 participants |
| Sex: Female, Male Female | 53 Participants | 53 Participants | 106 Participants |
| Sex: Female, Male Male | 12 Participants | 12 Participants | 24 Participants |
| Sex/Gender, Customized Female | 52 Participants | 49 Participants | 101 Participants |
| Sex/Gender, Customized Male | 12 Participants | 12 Participants | 24 Participants |
| Sex/Gender, Customized Non-binary | 0 Participants | 4 Participants | 4 Participants |
| Sex/Gender, Customized Transgender | 1 Participants | 0 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 65 | 0 / 65 |
| other Total, other adverse events | 0 / 65 | 0 / 65 |
| serious Total, serious adverse events | 0 / 65 | 0 / 65 |
Outcome results
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
Time frame: 12 weeks
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Sensor-enabled Digital Mental Health Intervention (DMHI) | Generalized Anxiety Disorder-7 (GAD-7) | Baseline | 11.7 score on a scale |
| Sensor-enabled Digital Mental Health Intervention (DMHI) | Generalized Anxiety Disorder-7 (GAD-7) | Week 4 | 8.8 score on a scale |
| Sensor-enabled Digital Mental Health Intervention (DMHI) | Generalized Anxiety Disorder-7 (GAD-7) | Week 8 | 8.2 score on a scale |
| Sensor-enabled Digital Mental Health Intervention (DMHI) | Generalized Anxiety Disorder-7 (GAD-7) | Week 12 | 7.5 score on a scale |
| Experimental: Control Treatment (CT) | Generalized Anxiety Disorder-7 (GAD-7) | Week 12 | 7.4 score on a scale |
| Experimental: Control Treatment (CT) | Generalized Anxiety Disorder-7 (GAD-7) | Baseline | 12.2 score on a scale |
| Experimental: Control Treatment (CT) | Generalized Anxiety Disorder-7 (GAD-7) | Week 8 | 9.3 score on a scale |
| Experimental: Control Treatment (CT) | Generalized Anxiety Disorder-7 (GAD-7) | Week 4 | 9.8 score on a scale |
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.
Time frame: 12 weeks
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Sensor-enabled Digital Mental Health Intervention (DMHI) | Patient Health Questionaire-9 (PHQ-9) | Baseline | 13.2 score on a scale |
| Sensor-enabled Digital Mental Health Intervention (DMHI) | Patient Health Questionaire-9 (PHQ-9) | Week 8 | 9.5 score on a scale |
| Sensor-enabled Digital Mental Health Intervention (DMHI) | Patient Health Questionaire-9 (PHQ-9) | Week 4 | 10.0 score on a scale |
| Sensor-enabled Digital Mental Health Intervention (DMHI) | Patient Health Questionaire-9 (PHQ-9) | Week 12 | 8.7 score on a scale |
| Experimental: Control Treatment (CT) | Patient Health Questionaire-9 (PHQ-9) | Week 4 | 9.4 score on a scale |
| Experimental: Control Treatment (CT) | Patient Health Questionaire-9 (PHQ-9) | Baseline | 12.4 score on a scale |
| Experimental: Control Treatment (CT) | Patient Health Questionaire-9 (PHQ-9) | Week 12 | 7.9 score on a scale |
| Experimental: Control Treatment (CT) | Patient Health Questionaire-9 (PHQ-9) | Week 8 | 9.2 score on a scale |