- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07759973
Neurocomputational Dynamics of Cooperation (COBRA)
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Michelle M Berry, MPS
- Número de teléfono: 424-380-1194
- Correo electrónico: berrymic@pitt.edu
Copia de seguridad de contactos de estudio
- Nombre: Amanda Collier, BS
- Número de teléfono: 412-901-2938
- Correo electrónico: collieral@upmc.edu
Ubicaciones de estudio
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Pennsylvania
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Pittsburgh, Pennsylvania, Estados Unidos, 15213
- University of Pittsburgh, Bellefield Towers
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Contacto:
- Michelle M Berry, MPS
- Número de teléfono: 424-380-1194
- Correo electrónico: berrymic@pitt.edu
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Contacto:
- Amanda Collier, BS
- Número de teléfono: 412-901-2938
- Correo electrónico: collieral@upmc.edu
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Investigador principal:
- Timothy A Allen, PhD
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Sub-Investigador:
- Alexandre Dombrovski, MD
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Online cohort inclusion criteria:
- English fluency
- US residency
- Owner of a desktop or laptop computer
- Adult aged 18-100
Online cohort exclusion criteria:
- Participants who have participated in an earlier version of the study
- Inability to consent
- Self-reported history of neurological disorder or brain damage
- Self-endorsed history of psychosis or mania
Clinical cohort inclusion criteria:
- Adult aged 20-60 years old
- English fluency
- Owner of a smartphone with celluar data
Clinical cohort exclusion criteria:
- Inability to consent
- Self-reported history of neurological disorder or brain damage
- Clinician-rated psychosis or mania in the last 6 months
- Current intoxication or withdrawal
- Estimated IQ < 70
- fMRI safety concerns
- Pregnancy
- Lack of stable psychiatric treatment (e.g., medication dosage, therapy modality) for the previous two months
Informant inclusion criteria:
- Adult aged 18+ years old
- English fluency
- Owner of a smartphone with celluar data
- Must have 4+ interactions/week with the participant for at least 6 months prior to study baseline
Informant exclusion criteria:
- Lack of a smartphone with cellular data at study baseline
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Online Cohort
The online cohort will include 718 adults ages 18-100 who will complete 1) a battery of behavioral tasks designed to assess social learning and mentalizing abilities, and 2) self-report measures assessing personality, externalizing symptoms, interpersonal functioning, and psychopathology.
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In the primary study task, participants engage in a modified iterative trust game.
Participant choices earn feedback in the form of monetary gains or losses.
All participants are debriefed on the motivation behind study task at the end of their visit.
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Experimental: Clinical Cohort
The study will enroll up to 416 clinical-cohort participants, with an anticipated final eligible sample of 239 adults ages 20-60 who will complete 1) a structured clinical interview and neuropsychological assessments, 2) self-report measures assessing personality, externalizing symptoms, interpersonal functioning, and psychopathology, 3) lab-based tasks designed to assess social learning and mentalizing abilities while monitoring physiological responding with Biopac, 4) task-based fMRI, 5) 21-day ecological momentary assessment (EMA) protocol, and 6) additional self-report questionnaires at three yearly follow-ups.
The investigators expect to enroll 416 participants for the start of the protocol to yield 239 final eligible participants to complete fMRI and EMA.
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In the primary study task, participants engage in a modified iterative trust game.
The task is completed in the fMRI scanner and takes about 35 minutes.
Participant choices earn feedback in the form of monetary gains or losses.
All participants are debriefed on the motivation behind the task at the end of their visit.
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Sin intervención: Informants
Additionally, 2 informants (ages 18+) for each participant will be recruited to complete self-report measures, one of whom will also enroll in EMA.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Participant-level Coaxing Score
Periodo de tiempo: During behavioral task visit at study baseline (clinical cohort) or during single online study session (online cohort)
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Participant coaxing behavior will be measured during the primary social learning task.
Coaxing will be operationalized as the difference in the participant's return rate between exchange and secrecy modes on trials in which the coplayer decides not to share.
In exchange mode, the participant knows whether the coplayer chose to share or keep the monetary incentive before indicating whether they would return it.
In secrecy mode, the participant must make the return decision before learning the coplayer's choice.
The coaxing score is calculated as the exchange-mode return rate minus the secrecy-mode return rate.
Scores range from -1 to 1, with positive values indicating greater strategic coaxing and 0 indicating no difference between modes.
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During behavioral task visit at study baseline (clinical cohort) or during single online study session (online cohort)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Mean Informant-rated Momentary Manipulativeness
Periodo de tiempo: Post-baseline 21-day EMA period within year 1 of the study
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Manipulativeness will be assessed using the study-specific Interpersonal Dynamics EMA Battery.
The informant-rated manipulativeness scale contains 3 items, each rated from 1 ("strongly disagree") to 5 ("strongly agree").
At each assessment, responses to the 3 items will be averaged to produce a momentary manipulativeness score that ranges from 1 to 5. Higher scores indicate greater informant-rated manipulativeness.
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Post-baseline 21-day EMA period within year 1 of the study
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Latent Mentalizing Factor
Periodo de tiempo: Baseline
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A latent mentalizing factor will be derived using CFA, with participants' scores on three social cognition tasks serving as indicators.
The latent factor will be standardized to a mean of 0 and standard deviation of 1 in the study sample and therefore has no fixed theoretical minimum or maximum.
Higher factor scores indicate greater mentalizing ability.
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Baseline
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Interpersonal Stress
Periodo de tiempo: At 12, 24, and 36 months after baseline
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Interpersonal stress will be assessed using the marital- or partner-relationship and other-relationship life domains of the Stress and Adversity Inventory for Adults.
At each follow-up, the frequency scores for stressors in these two domains will be averaged to produce an interpersonal stress score.
The score ranges from a minimum of 0 stressors, with no limit on reported stressor maximums.
Higher scores indicate more frequent exposure to interpersonal relationship stressors.
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At 12, 24, and 36 months after baseline
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Timothy A Allen, PhD, University of Pittsburgh
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- STUDY25050217
- R01MH140901 (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
Individual participant data (IPD) will be shared via the National Institute of Mental Health Data Archive (NDA) in accordance with National Institutes of Health (NIH) Data Management and Sharing Policy. Data will be de-identified and made available to qualified researchers upon request after publication of primary results or completion of the study, as outlined in the NIH-approved Data Sharing Plan.
Task code will be posted on GitHub and/or OSF.
Marco de tiempo para compartir IPD
All data will be deposited to NDA starting 12 months after the award begins and will be deposited every six months thereafter following the usual NDA data submission dates.
IPD and supporting information will be available when the award ends (anticipated 06/30/2031). NDA will make decisions about how long to preserve the data, but that data archive has not deleted any deposited data up to now.
Criterios de acceso compartido de IPD
Deidentified data will be findable for the research community through the NDA Collection that will be established when this application is funded. For all publications, an NDA study will be created. Each of those studies is assigned a digital object identifier (DOI). This data DOI will be referenced in the publication to allow the research community easy access to the exact data used in the publication.
To request access to the data, qualified researchers will use the standard processes at NDA, and the NDA Data Access Committee will decide which requests to grant. The standard NDA data access process allows access for one year and is renewable.
Tipo de información de apoyo para compartir IPD
- CÓDIGO_ANALÍTICO
Información sobre medicamentos y dispositivos, documentos del estudio
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