Remote vs. In-PersonNCT07854301
Remote vs. In-Person Study Evaluation (RISE) Trials: RISE Above Depression (Trial 2 of 3)
A study testing mobile health application (Moodivate) in people with Remote vs. In-Person and Remote Visits, run by State University of New York at Buffalo at 1 site in United States.
Trial summary
The study will employ a randomized, parallel-group design with two-stage randomization. After an initial brief screen for basic eligibility, participants will be randomized (within site) to either Remote (R) or In-Person (IP) Intake Groups. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Remote vs. In-Person, Remote Visits, In-person Visits
- What is being tested?
- mobile health application (Moodivate)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2026to May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Common to all 3 RCTs:
- age18+ years
- stable mailing address (for mailing study packets if assigned to Remote Intake and/or Remote Treatment/Assessment) within accessible range (1.5 hours) of each study site (per self report)
- able to read, speak \& verbally comprehend English
- currently own an iOS- or Android-compatible smartphone
- have a valid e-mail address that is checked regularly (at least once per day) or have regular access to text messages (to access follow-up assessments)
- Specific to RCT 2:
- Elevated depressive symptoms, defined as a score of > 10 on the Patient Health Questionnaire-9 (PHQ-9) f) Report willingness to utilize a mobile app for the treatment for depressed mood (response of "yes" on yes/no item)
Who cannot join
- Common to All 3 RCTs:
- consumption of >28 alcohol-containing drinks per week
- suicide attempt with at least some wish to die in past 3 months
- mental illness (such as schizophrenia, bipolar disorder, or major depression) that led to hospitalization in the past 30 days
- unable/unwilling to provide informed consent or follow directions, inappropriately responsive, based on staff observations
- Specific to RCT2:
- Current suicidal ideation at study screening, defined as a response of ≥ 1 on item nine ("Thoughts that you would be better off dead, or of hurting yourself") of the PHQ-9
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: Remote vs. In-Person Study Evaluation (RISE) Above Depression
The study will employ a randomized, parallel-group design with two-stage randomization. After an initial brief screen for basic eligibility, participants will be randomized (within site) to either Remote (R) or In-Person (IP) Intake Groups. During the Intake, detailed consent and eligibility assessment will be completed. Participants who are eligible at the Intake will be randomized (within site and Intake Group) to R or IP Treatment and Assessment Groups. Participants will be followed for 3 months.
- Conditions
- Remote vs. In-Person, Remote Visits, In-person Visits
- Being tested
- mobile health application (Moodivate)
- Keywords
- Remote vs. In-Person methods
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mobile health application (Moodivate)Behavioural
All participants receive the mobile health application "Moodivate".
| Study group | Role | What they receive |
|---|---|---|
| REMOTE intake AND REMOTE treatment/assessment | Other | In this arm, ppts have been randomly assigned to a REMOTE INTAKE eligibility/baseline visit, and subsequently randomized to 5 REMOTE treatment/assessment visits. Receives: Behavioral: mobile health application (Moodivate) |
| REMOTE intake BUT IN-PERSON treatment/assessment | Other | In this arm, ppts have been randomly assigned to a REMOTE INTAKE eligibility/baseline visit, and subsequently randomized to 5 IN-PERSON treatment/assessment visits. Receives: Behavioral: mobile health application (Moodivate) |
| IN-PERSON intake, BUT REMOTE treatment/assessment | Other | In this arm, ppts have been randomly assigned to an IN-PERSON INTAKE eligibility/baseline visit, and subsequently randomized to 5 REMOTE treatment/assessment visits. Receives: Behavioral: mobile health application (Moodivate) |
| IN-PERSON intake AND IN-PERSON treatment/assessment | Other | In this arm, ppts have been randomly assigned to an IN-PERSON INTAKE eligibility/baseline visit, and subsequently randomized to 5 IN-PERSON treatment/assessment visits. Receives: Behavioral: mobile health application (Moodivate) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accrual efficiency/Pre-treatment visits
Calculated from visit milestones. Percentage of screen-eligible participants who attend the Intake Visit after randomization to Remote vs In-Person Intake. Additional accrual metrics include 1) Intake-to-Treatment/Assessment Visit 1 completion and 2) Overall pre-treatment accrual (Brief Screen to Treatment/Assessment Visit 1
Measured: ~1 month
Trial Quality: Retention
Retention will be assessed using visit milestone data to determine whether each participant achieved each T/A Visit (Visits 2-5) following T/A initiation at T/A Visit 1. We will calculate a continuous metric of retention (0-4; the number of visits completed) for each participant, supplemented by visit-specific data to provide a detailed examination of the time course and overall amount of retention.
Measured: ~3 months
Trial Quality: Treatment utilization
Participant engagement with the Moodivate mobile application pulled directly from the Moodivate analytics data. The primary outcome will be the percentage of days in which the app was used (from T/A 1 until T/A 5). Additional secondary outcomes include: the number of sessions of app use, average time per session, and total time using the app, as well as fidelity metrics (number of goals created and the number of activities created, scheduled, and completed).
Measured: ~3 months (assessed from T/A1 [when app is distributed] through T/A5)
Trial quality: Biospecimen completion rates
The number of saliva samples completed/returned for Treatment/Assessment visits 1-5 that each participant attended. Remote participants return samples by mail; to count as completed/returned, the mailed package must be postmarked within 7 days of the visit.
Measured: ~3 months (assessed at T/A Visits 1,2, 3, 4, and 5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionMay 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Remote vs. In-PersonStudies of the same condition, open and under way.
- More trials run by State University of New York at BuffaloThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, parallel-group design. The study employs a two-stage adaptive biased-coin randomization technique. The initial randomization will be generated using a stratified biased coin design with an allocation probability of 0.75 and a randomization list within each stratum will be generated for both Stage I (randomization to remote vs in-person Intake) and Stage II (randomization to remote vs. in-person Treatment/Assessment visits). To optimize the balance in cell sizes across the 4 treatment conditions, the allocation probabilities will be adjusted at 3 study milestones (once 25%, 50%, and 75% of the target sample of 100 participants attend Treatment/Assessment Visit 1). Specifically, the allocation probability will be modified based on the imbalance in the number of participants across conditions who have attended Treatment/Assessment Visit 1.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University of South Carolina, National Center for Advancing Translational Sciences (NCATS), Wake Forest University Health Sciences
- Responsible party
- Principal investigator, Larry Hawk, Ph.D., State University of New York at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07854301
- Sponsor's protocol ID
- STUDY00010275
- Other IDs
- 4UH3TR004797
- Status last verified
- Sep 2026
- First submitted
- 26 Sep 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan to make available the full de-identified data set with metadata through the NAHDAP, a NIDA-funded platform for data sharing/archiving, with a topical focus on behavioral health data. NAHDAP operates under the umbrella of the ICPSR, based at the University of Michigan. Per the ICPSR website, the ICPSR is "the largest social science data archive in the world".
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote vs. In-Person Study Evaluation (RISE) Above Depression
- ClinicalTrials.gov ID
- NCT07854301
- Acronym / sponsor ID
- STUDY00010275
- Conditions
- Remote vs. In-Person, Remote Visits, In-person Visits
- Keywords
- Remote vs. In-Person methods
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Collaborators
- Medical University of South Carolina, National Center for Advancing Translational Sciences (NCATS), Wake Forest University Health Sciences
- Study start
- Nov 2026 (estimated)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 2 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will employ a randomized, parallel-group design with two-stage randomization. After an initial brief screen for basic eligibility, participants will be randomized (within site) to either Remote (R) or In-Person (IP) Intake Groups. During the Intake, detailed consent and eligibility assessment will be completed. Participants who are eligible at the Intake will be randomized (within site and Intake Group) to R or IP Treatment and Assessment Groups. Participants will be followed for 3 months.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Randomized, parallel-group design. The study employs a two-stage adaptive biased-coin randomization technique. The initial randomization will be generated using a stratified biased coin design with an allocation probability of 0.75 and a randomization list within each stratum will be generated for both Stage I (randomization to remote vs in-person Intake) and Stage II (randomization to remote vs. in-person Treatment/Assessment visits). To optimize the balance in cell sizes across the 4 treatment conditions, the allocation probabilities will be adjusted at 3 study milestones (once 25%, 50%, and 75% of the target sample of 100 participants attend Treatment/Assessment Visit 1). Specifically, the allocation probability will be modified based on the imbalance in the number of participants across conditions who have attended Treatment/Assessment Visit 1.
| Arm | Type | Receives |
|---|---|---|
| REMOTE intake AND REMOTE treatment/assessment | Other | Behavioral: mobile health application (Moodivate)In this arm, ppts have been randomly assigned to a REMOTE INTAKE eligibility/baseline visit, and subsequently randomized to 5 REMOTE treatment/assessment visits. |
| REMOTE intake BUT IN-PERSON treatment/assessment | Other | Behavioral: mobile health application (Moodivate)In this arm, ppts have been randomly assigned to a REMOTE INTAKE eligibility/baseline visit, and subsequently randomized to 5 IN-PERSON treatment/assessment visits. |
| IN-PERSON intake, BUT REMOTE treatment/assessment | Other | Behavioral: mobile health application (Moodivate)In this arm, ppts have been randomly assigned to an IN-PERSON INTAKE eligibility/baseline visit, and subsequently randomized to 5 REMOTE treatment/assessment visits. |
| IN-PERSON intake AND IN-PERSON treatment/assessment | Other | Behavioral: mobile health application (Moodivate)In this arm, ppts have been randomly assigned to an IN-PERSON INTAKE eligibility/baseline visit, and subsequently randomized to 5 IN-PERSON treatment/assessment visits. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- age18+ years
- stable mailing address (for mailing study packets if assigned to Remote Intake and/or Remote Treatment/Assessment) within accessible range (1.5 hours) of each study site (per self report)
- able to read, speak \& verbally comprehend English
- currently own an iOS- or Android-compatible smartphone
- have a valid e-mail address that is checked regularly (at least once per day) or have regular access to text messages (to access follow-up assessments)
Key exclusion criteria (7 listed)
- consumption of >28 alcohol-containing drinks per week
- suicide attempt with at least some wish to die in past 3 months
- mental illness (such as schizophrenia, bipolar disorder, or major depression) that led to hospitalization in the past 30 days
- unable/unwilling to provide informed consent or follow directions, inappropriately responsive, based on staff observations
- Current suicidal ideation at study screening, defined as a response of ≥ 1 on item nine ("Thoughts that you would be better off dead, or of hurting yourself") of the PHQ-9
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 |
|---|---|---|
| mobile health application (Moodivate)All participants receive the mobile health application "Moodivate". | Behavioural | IN-PERSON intake AND IN-PERSON treatment/assessment, IN-PERSON intake, BUT REMOTE treatment/assessment, REMOTE intake AND REMOTE treatment/assessment, REMOTE intake BUT IN-PERSON treatment/assessment |
Primary outcome
Accrual efficiency/Pre-treatment visits
Time frame: ~1 month
Calculated from visit milestones. Percentage of screen-eligible participants who attend the Intake Visit after randomization to Remote vs In-Person Intake. Additional accrual metrics include 1) Intake-to-Treatment/Assessment Visit 1 completion and 2) Overall pre-treatment accrual (Brief Screen to Treatment/Assessment Visit 1
Trial Quality: Retention
Time frame: ~3 months
Retention will be assessed using visit milestone data to determine whether each participant achieved each T/A Visit (Visits 2-5) following T/A initiation at T/A Visit 1. We will calculate a continuous metric of retention (0-4; the number of visits completed) for each participant, supplemented by visit-specific data to provide a detailed examination of the time course and overall amount of retention.
Trial Quality: Treatment utilization
Time frame: ~3 months (assessed from T/A1 [when app is distributed] through T/A5)
Participant engagement with the Moodivate mobile application pulled directly from the Moodivate analytics data. The primary outcome will be the percentage of days in which the app was used (from T/A 1 until T/A 5). Additional secondary outcomes include: the number of sessions of app use, average time per session, and total time using the app, as well as fidelity metrics (number of goals created and the number of activities created, scheduled, and completed).
Trial quality: Biospecimen completion rates
Time frame: ~3 months (assessed at T/A Visits 1,2, 3, 4, and 5)
The number of saliva samples completed/returned for Treatment/Assessment visits 1-5 that each participant attended. Remote participants return samples by mail; to count as completed/returned, the mailed package must be postmarked within 7 days of the visit.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- This website describes all 3 RISE trials and provides protocols, consent forms, and measures.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. We plan to make available the full de-identified data set with metadata through the NAHDAP, a NIDA-funded platform for data sharing/archiving, with a topical focus on behavioral health data. NAHDAP operates under the umbrella of the ICPSR, based at the University of Michigan. Per the ICPSR website, the ICPSR is "the largest social science data archive in the world".
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mobile health application (Moodivate) in people with Remote vs. In-Person and Remote Visits, run by State University of New York at Buffalo 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 8 inclusion and 7 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: opening soon, as of the sponsor's last update on 3 Nov 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Larry W. Hawk, PhD (716-645-0192, lhawk@buffalo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accrual efficiency/Pre-treatment visits (time frame: ~1 month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Nov 2026.