Remote vs. In-Person Study Evaluation (RISE) Trials: RISE Above Depression (Trial 2 of 3)

NCT07854301 | Not Yet Recruiting

• 2 other identifiers: STUDY000102754UH3TR004797
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief 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. 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

Keywords

Remote vs. In-Person methods

Outcome Measures

Primary Outcomes (4)

• 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

  ~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.

  ~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 number of sessions of app use. Additional secondary outcomes include: 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).

  ~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.

  ~3 months (assessed at T/A Visits 1,2, 3, 4, and 5)

Study Arms (4)

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.

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.

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.

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.

Behavioral: mobile health application (Moodivate)

Interventions

mobile health application (Moodivate) BEHAVIORAL

All participants receive the mobile health application "Moodivate".

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

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• e) 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• State University of New York at Buffalo: lead
• Medical University of South Carolina: collaborator
• Wake Forest University Health Sciences: collaborator
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (2)

University at Buffalo

Buffalo, New York, 14260, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Related Links

• This website describes all 3 RISE trials and provides protocols, consent forms, and measures.

Central Study Contacts

Larry W. Hawk, PhD

CONTACT

716-645-0192; lhawk@buffalo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Model Details: 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.

Study Record Dates

• First Submitted: September 26, 2026
• First Posted: October 2, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: October 2, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: The study protocol and informed consent form will be shared at risetrials.org by 12/31/26. Consistent with NIH and Institute of Medicine recommendations, the data will be deposited no later than the publication of the primary study data or one year after each RCTs completion, whichever comes first. There is no planned end date.
• Access Criteria: The study protocol and informed consent form will be shared at risetrials.org by 12/31/26. Data submitted for archiving/sharing will be consistent with Inter-university Consortium for Political and Social Research (ICPSR) and the National Addiction and HIV Data Archive Program (NAHDAP) data standards and data stewardship policies and will contain no personal identifiers. Typically, the data are publicly available via a unique digital object identifier (DOI).

Locations

US (2)