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

2 november 2026 bijgewerkt door: Larry Hawk, Ph.D., State University of New York at Buffalo

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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

100

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Verenigde Staten
    • South Carolina
      • Charleston, South Carolina, Verenigde Staten, 29425
        • Medical University of South Carolina

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 99 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

INCLUSION CRITERIA:

Common to all 3 RCTs:

  1. age18+ years
  2. 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)
  3. able to read, speak & verbally comprehend English
  4. currently own an iOS- or Android-compatible smartphone
  5. 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)

EXCLUSION CRITERIA:

Common to All 3 RCTs:

  1. consumption of >28 alcohol-containing drinks per week

  2. suicide attempt with at least some wish to die in past 3 months

  3. mental illness (such as schizophrenia, bipolar disorder, or major depression) that led to hospitalization in the past 30 days

  4. unable/unwilling to provide informed consent or follow directions, inappropriately responsive, based on staff observations

    Specific to RCT2:

  5. 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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ander
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Ander: REMOTE intake AND REMOTE treatment/assessment

In this arm, ppts have been randomly assigned to a REMOTE INTAKE eligibility/baseline visit, and subsequently randomized to 5 REMOTE treatment/assessment visits.
Gedragsmatig: mobile health application (Moodivate)

All participants receive the mobile health application "Moodivate".
Ander: REMOTE intake BUT IN-PERSON treatment/assessment

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.
Gedragsmatig: mobile health application (Moodivate)

All participants receive the mobile health application "Moodivate".
Ander: IN-PERSON intake, BUT REMOTE treatment/assessment

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.
Gedragsmatig: mobile health application (Moodivate)

All participants receive the mobile health application "Moodivate".
Ander: IN-PERSON intake AND IN-PERSON treatment/assessment

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.
Gedragsmatig: mobile health application (Moodivate)

All participants receive the mobile health application "Moodivate".

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Trial Quality: Retention
Tijdsspanne: ~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.
~3 months
Accrual efficiency/Pre-treatment visits
Tijdsspanne: ~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
~1 month
Trial Quality: Treatment utilization
Tijdsspanne: ~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).
~3 months (assessed from T/A1 [when app is distributed] through T/A5)
Trial quality: Biospecimen completion rates
Tijdsspanne: ~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.
~3 months (assessed at T/A Visits 1,2, 3, 4, and 5)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

State University of New York at Buffalo

Medewerkers

Medical University of South Carolina
Wake Forest University Health Sciences
National Center for Advancing Translational Sciences (NCATS)

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 november 2026

Primaire voltooiing (Geschat)

1 mei 2028

Studie voltooiing (Geschat)

1 mei 2028

Studieregistratiedata

Eerst ingediend

26 september 2026

Eerst ingediend dat voldeed aan de QC-criteria

26 september 2026

Eerst geplaatst (Werkelijk)

2 oktober 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

3 november 2026

Laatste update ingediend die voldeed aan QC-criteria

2 november 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • STUDY00010275
  • 4UH3TR004797 (Subsidie/contract van de Amerikaanse NIH)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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".

IPD-tijdsbestek voor delen

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.

IPD-toegangscriteria voor delen

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).

IPD delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • ICF

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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