Remote vs. In-Person Study Evaluation (RISE) Trials: RISE Above Depression (Trial 2 of 3)
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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Larry W. Hawk, PhD
- Numero di telefono: 716-645-0192
- Email: lhawk@buffalo.edu
Luoghi di studio
-
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South Carolina
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Charleston, South Carolina, Stati Uniti, 29425
- Medical University of South Carolina
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-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
INCLUSION CRITERIA:
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)
EXCLUSION CRITERIA:
Common to All 3 RCTs:
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consumption of >28 alcohol-containing drinks per week
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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
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unable/unwilling to provide informed consent or follow directions, inappropriately responsive, based on staff observations
Specific to RCT2:
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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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Altro
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Altro: 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. |
All participants receive the mobile health application "Moodivate". |
|
Altro: 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. |
All participants receive the mobile health application "Moodivate". |
|
Altro: 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. |
All participants receive the mobile health application "Moodivate". |
|
Altro: 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. |
All participants receive the mobile health application "Moodivate". |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Trial Quality: Retention
Lasso di tempo: ~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
Lasso di tempo: ~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
Lasso di tempo: ~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
Lasso di tempo: ~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)
|
Collaboratori e investigatori
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- STUDY00010275
- 4UH3TR004797 (Sovvenzione/contratto NIH degli Stati Uniti)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
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".
Periodo di condivisione IPD
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.
Criteri di accesso alla condivisione IPD
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).
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- ICF
Informazioni su farmaci e dispositivi, documenti di studio
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