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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Larry W. Hawk, PhD
- Número de teléfono: 716-645-0192
- Correo electrónico: lhawk@buffalo.edu
Ubicaciones de estudio
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South Carolina
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Charleston, South Carolina, Estados Unidos, 29425
- Medical University of South Carolina
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
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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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Otro: 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". |
|
Otro: 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". |
|
Otro: 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". |
|
Otro: 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". |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Trial Quality: Retention
Periodo de tiempo: ~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
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Accrual efficiency/Pre-treatment visits
Periodo de tiempo: ~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
|
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Trial Quality: Treatment utilization
Periodo de tiempo: ~3 months (assessed from T/A1 [when app is distributed] through T/A5)
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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)
|
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Trial quality: Biospecimen completion rates
Periodo de tiempo: ~3 months (assessed at T/A Visits 1,2, 3, 4, and 5)
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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)
|
Colaboradores e Investigadores
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- STUDY00010275
- 4UH3TR004797 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan 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".
Marco de tiempo para compartir 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.
Criterios de acceso compartido de 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 de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- CIF
Información sobre medicamentos y dispositivos, documentos del estudio
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