- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07759973
Neurocomputational Dynamics of Cooperation (COBRA)
Study Overview
Status
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Michelle M Berry, MPS
- Phone Number: 424-380-1194
- Email: berrymic@pitt.edu
Study Contact Backup
- Name: Amanda Collier, BS
- Phone Number: 412-901-2938
- Email: collieral@upmc.edu
Study Locations
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15213
- University of Pittsburgh, Bellefield Towers
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Contact:
- Michelle M Berry, MPS
- Phone Number: 424-380-1194
- Email: berrymic@pitt.edu
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Contact:
- Amanda Collier, BS
- Phone Number: 412-901-2938
- Email: collieral@upmc.edu
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Principal Investigator:
- Timothy A Allen, PhD
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Sub-Investigator:
- Alexandre Dombrovski, MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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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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No Intervention: 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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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Participant-level Coaxing Score
Time Frame: 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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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Mean Informant-rated Momentary Manipulativeness
Time Frame: 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
Time Frame: 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
Time Frame: 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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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Timothy A Allen, PhD, University of Pittsburgh
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY25050217
- R01MH140901 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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.
IPD Sharing Time Frame
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.
IPD Sharing Access Criteria
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.
IPD Sharing Supporting Information Type
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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