Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

Neurocomputational Dynamics of Cooperation (COBRA)

6 de agosto de 2026 actualizado por: Timothy Allen, University of Pittsburgh
The purpose of this study is to understand brain function, how people make decisions when they interact with others, and how brain function and behavior relate to personality traits.

Descripción general del estudio

Descripción detallada

Problems in cooperating with others define antagonism, a transdiagnostic dimension of psychopathology expressed in personality and externalizing disorders. People high on antagonism are prone to aggressive, callous, and exploitative behaviors that damage relationships and incur substantial costs in the form of productivity loss, substance misuse, and criminality. While clinical theories link antagonism to deficits in social cognition, it is hard to deny that exploiting others requires an understanding of their mind. This apparent contradiction can be resolved by distinguishing between two facets of antagonism: callousness and exploitativeness. Prior work by the investigators and preliminary data inform the hypothesis that exploitativeness reflects an enhanced capacity to learn about the mental states and behaviors of others coupled with an increased sensitivity to personal, rather than shared, rewards. In contrast, callousness reflects a broader insensitivity to social feedback. The investigators hypothesize that these dissociable social learning processes are instantiated in canonical circuits that expanded during anthropogenesis to support mentalizing and self-directed thought. These learning signals, which track behaviorally salient features of the social environment, are integrated in the posterior hub of the default network (DN) where they drive adaptive cooperation. This study proposes to test these hypotheses in two samples elevated on antagonism. At the behavioral level, participants are characterized using a battery of personality and psychopathology measures, social and reward-based decision-making tasks, and corresponding hierarchically estimated reinforcement learning (RL) models (Aim 1). In a model-based functional magnetic resonance imaging (fMRI) study, model-derived learning signals and facets of antagonism are linked to underlying neural activity during cooperative decision-making (Aim 2). Leveraging the multi-timescale design of our study, the investigators plan to relate neurocomputational signatures of callousness and exploitativeness to mentalizing abilities, multi-informant reports of momentary interpersonal behavior, and prospective stress generation. Certain elements of study design are withheld from this record to protect the scientific integrity of the study design.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

1612

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

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

    • Pennsylvania
      • Pittsburgh, Pennsylvania, Estados Unidos, 15213
        • University of Pittsburgh, Bellefield Towers
        • Contacto:
          • Michelle M Berry, MPS
          • Número de teléfono: 424-380-1194
          • Correo electrónico: berrymic@pitt.edu
        • Contacto:
          • Amanda Collier, BS
          • Número de teléfono: 412-901-2938
          • Correo electrónico: collieral@upmc.edu
        • Investigador principal:
          • Timothy A Allen, PhD
        • Sub-Investigador:
          • Alexandre Dombrovski, MD

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

Sí

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

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿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
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.
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.
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.
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.
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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Participant-level Coaxing Score
Periodo de tiempo: During behavioral task visit at study baseline (clinical cohort) or during single online study session (online cohort)
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.
During behavioral task visit at study baseline (clinical cohort) or during single online study session (online cohort)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Mean Informant-rated Momentary Manipulativeness
Periodo de tiempo: Post-baseline 21-day EMA period within year 1 of the study
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.
Post-baseline 21-day EMA period within year 1 of the study
Latent Mentalizing Factor
Periodo de tiempo: Baseline
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.
Baseline
Interpersonal Stress
Periodo de tiempo: At 12, 24, and 36 months after baseline
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.
At 12, 24, and 36 months after baseline

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Timothy A Allen, PhD, University of Pittsburgh

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de septiembre de 2026

Finalización primaria (Estimado)

30 de junio de 2031

Finalización del estudio (Estimado)

30 de junio de 2031

Fechas de registro del estudio

Enviado por primera vez

6 de agosto de 2026

Primero enviado que cumplió con los criterios de control de calidad

6 de agosto de 2026

Publicado por primera vez (Actual)

12 de agosto de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

12 de agosto de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

6 de agosto de 2026

Última verificación

1 de agosto de 2026

Más información

Términos relacionados con este estudio

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)?

SÍ

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

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Suscribir