DepressionNCT05406791
Technology Enabled Services to Enhance Depression Care
A study testing VIRA App and Mood Education App in people with Depression and Anxiety, run by Northwestern University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Depression, Anxiety
- What is being tested?
- VIRA App and Mood Education App
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jun 2022to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Children under the age of 13
- Severe suicidality (as defined by presence of a plan + intent to act on that plan)
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center Department of Psychiatry & Behavioral Sciences
Chicago, Illinois, 60612
About this study
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.
Read the 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.
- Conditions
- Depression, Anxiety
- Being tested
- VIRA App, Mood Education App
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIRA AppOther
Support from coach and using the VIRA app
Mood Education AppOther
Support from mood education app
| Study group | Role | What they receive |
|---|---|---|
| Sensor-enabled digital mental health intervention (DMHI) | Experimental | Patients randomized to sensor-enabled DMHI condition will use Ksana Health's "Vira" mobile therapy platform with support from a study coach Receives: Other: VIRA App |
| Experimental: Control Treatment (CT) | Experimental | 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. Receives: Other: Mood Education App |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
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
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2022
- Study start10 Jun 2022
- Primary completion30 Sep 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Rush University, National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, David Mohr, Northwestern University
- Investigators
- David C Mohr, PhD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05406791
- Sponsor's protocol ID
- STU#:00211887
- Other IDs
- 1P50MH119029-01A1
- Status last verified
- Apr 2025
- First submitted
- 1 Jun 2022
- Last updated
- 9 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared through the NIMH Data Archive
Publications
Stiles-Shields C, Reyes KM, Lakhtakia T, Smith SR, Barnas OE, Gray EL, Krause CJ, Kruzan KP, Kwasny MJ, Mir Z, Panjwani S, Rothschild SK, Sanchez-Johnsen L, Winquist NW, Lattie EG, Allen NB, Reddy M, Mohr DC. A personal sensing technology enabled service versus a digital psychoeducation control for primary care patients with depression and anxiety: a pilot randomized controlled trial. BMC Psychiatry. 2024 Nov 19;24(1):828. doi: 10.1186/s12888-024-06284-z.
PubMed 39563248
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technology Enabled Services to Enhance Depression Care
- ClinicalTrials.gov ID
- NCT05406791
- Acronym / sponsor ID
- STU#:00211887
- Conditions
- Depression, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Rush University, National Institute of Mental Health (NIMH)
- Study start
- 10 Jun 2022 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 6 Jun 2022 (actual)
- Results
- Posted 9 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Sensor-enabled digital mental health intervention (DMHI) | Experimental | Other: VIRA AppPatients randomized to sensor-enabled DMHI condition will use Ksana Health's "Vira" mobile therapy platform with support from a study coach |
| Experimental: Control Treatment (CT) | Experimental | Other: Mood Education AppParticipants 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. |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Children under the age of 13
- Severe suicidality (as defined by presence of a plan + intent to act on that plan)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VIRA AppSupport from coach and using the VIRA app | Other | Sensor-enabled digital mental health intervention (DMHI) |
| Mood Education AppSupport from mood education app | Other | Experimental: Control Treatment (CT) |
Primary outcome
Patient Health Questionaire-9 (PHQ-9)
Time frame: 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)
Time frame: 12 weeks
The GAD-7 measures anxiety symptom severity on a scale of 0-21, with higher scores indicating greater symptoms severity
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39563248Stiles-Shields C, Reyes KM, Lakhtakia T, Smith SR, Barnas OE, Gray EL, Krause CJ, Kruzan KP, Kwasny MJ, Mir Z, Panjwani S, Rothschild SK, Sanchez-Johnsen L, Winquist NW, Lattie EG, Allen NB, Reddy M, Mohr DC. A personal sensing technology enabled service versus a digital psychoeducation control for primary care patients with depression and anxiety: a pilot randomized controlled trial. BMC Psychiatry. 2024 Nov 19;24(1):828. doi: 10.1186/s12888-024-06284-z.
- Individual participant dataSharing planned: Yes. Data will be shared through the NIMH Data Archive
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David C Mohr, PhD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VIRA App and Mood Education App in people with Depression and Anxiety, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Health Questionaire-9 (PHQ-9) (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05406791, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2025.