Health TrialsbyHealthPanel

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

ConditionsRemote vs. In-PersonRemote VisitsIn-person Visits
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorState University of New York at Buffalo

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • mobile health application (Moodivate)

    Behavioral

    All participants receive the mobile health application "Moodivate".

Treatment groups

100 Participants
are divided into 4 treatment groups
Group A: REMOTE intake AND REMOTE treatment/assessmentOther 1 intervention
Group B: REMOTE intake BUT IN-PERSON treatment/assessmentOther 1 intervention
Group C: IN-PERSON intake, BUT REMOTE treatment/assessmentOther 1 intervention
Group D: IN-PERSON intake AND IN-PERSON treatment/assessmentOther 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
~1 month
2

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.

Time frame
~3 months
3

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).

Time frame
~3 months (assessed from T/A1 [when app is distributed] through T/A5)
4

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.

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

State University of New York at Buffalo

Lead sponsor

Medical University of South Carolina

Collaborator

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Wake Forest University Health Sciences

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: