NCT07759973

Brief Summary

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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,612

participants targeted

Target at P75+ for not_applicable

Timeline
59mo left

Started Sep 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 6, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 12, 2026

Completed
20 days until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2031

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2031

Last Updated

August 12, 2026

Status Verified

August 1, 2026

Enrollment Period

4.8 years

First QC Date

August 6, 2026

Last Update Submit

August 6, 2026

Conditions

Keywords

Mental HealthMulti-informant EMANeuroimagingfMRIInformantMulti-methodEcological Momentary AssessmentSelf-reportLongitudinal

Outcome Measures

Primary Outcomes (1)

  • Participant-level Coaxing Score

    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)

Secondary Outcomes (3)

  • Mean Informant-rated Momentary Manipulativeness

    Post-baseline 21-day EMA period within year 1 of the study

  • Latent Mentalizing Factor

    Baseline

  • Interpersonal Stress

    At 12, 24, and 36 months after baseline

Study Arms (3)

Online Cohort

EXPERIMENTAL

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.

Behavioral: Social Learning Task Battery, Online Cohort

Clinical Cohort

EXPERIMENTAL

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.

Behavioral: Social Learning Task Battery, Clinical Cohort

Informants

NO INTERVENTION

Additionally, 2 informants (ages 18+) for each participant will be recruited to complete self-report measures, one of whom will also enroll in EMA.

Interventions

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.

Clinical Cohort

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.

Online Cohort

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • English fluency
  • US residency
  • Owner of a desktop or laptop computer
  • Adult aged 18-100

You may not qualify if:

  • 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
  • Adult aged 20-60 years old
  • English fluency
  • Owner of a smartphone with celluar data
  • 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
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh, Bellefield Towers

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Personality DisordersPsychological Well-Being

Condition Hierarchy (Ancestors)

Mental DisordersPersonal SatisfactionBehavior

Study Officials

  • Timothy A Allen, PhD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michelle M Berry, MPS

CONTACT

Amanda Collier, BS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: The study involves three arms: the Clinical Cohort, Online Cohort, and Informants. The Clinical and Online cohorts will receive the intervention, a Social Learning task battery, while informants will provide observational data and will receive no intervention. The Clinical and Online cohorts will each complete a version of the Social Learning task battery specific to their group assignment.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 6, 2026

First Posted

August 12, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

June 30, 2031

Study Completion (Estimated)

June 30, 2031

Last Updated

August 12, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
ANALYTIC CODE
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.
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.

Locations