Decision-Making in Schizophrenia: A Combined Neuroimaging and Experience Sampling Study

NCT06745479 | Recruiting

• 2 other identifiers: Pro2023001193R21MH135329-01A1
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if attention and ways of thinking impact decision-making and brain processes related to decision-making in people with schizophrenia or schizoaffective disorder relative to people without either condition. It will also learn how brain functioning during decision-making relates to real-world decisions made during daily life. The main questions it aims to answer are:

• Does paying attention to specific information impact decision-making and brain processes?
• Does thinking in a certain way according to specific 'thinking strategies' improve brain processes related to decision-making?
• Does brain functioning during decision-making relate to real-world choices to engage in activities? Researchers will compare brain functioning and decision-making on computer tasks of gambling after participants have been trained to use a positive thinking strategy. They will compare what is different in the brain and behavior when participants use this strategy and when they do not. Participants will also answer brief surveys about activities and feelings for a week in their daily lives. Participants will:
• Complete several hours of clinical interviewing, cognitive tests, and surveys of about symptoms, experiences, and personality
• Complete computer tasks about gambling decisions during MRI brain scanning and while having their visual attention measured using eye-tracking
• Complete brief surveys about their activities and feelings 5 times a day for 1 week using a cell phone. Each survey only take several minutes.

Conditions

Schizophrenia; Schizoaffective Disorder; Control Subjects

Keywords

Cognitive Strategy; Emotion Regulation; Psychosis; Schizophrenia; functional MRI

Outcome Measures

Primary Outcomes (2)

• Nucleus Accumbens Brain Activation

  Brain activation in the nucleus accumbens (ventral striatum) measured via functional magnetic resonance imaging (fMRI) on trials that are preceded by the cognitive regulation strategy relative to trials without the cognitive regulation strategy.

  Single timeframe during 1.5 hours of MRI scanning and behavioral task completion.

• Gambling Choice Behavior

  Risky reward pursuit, defined as gamble choices on trials that are preceded by the cognitive regulation strategy relative to trials without the cognitive regulation strategy.

  Single timeframe during 1.5 hours of MRI scanning and behavioral task completion.

Secondary Outcomes (1)

• Brain Activation and Functional Connectivity

  Single timeframe during 1.5 hours of MRI scanning and behavioral task completion

Study Arms (1)

Single Arm

EXPERIMENTAL

There is only 1 arm in this study. In this arm of the study, participants are instructed to implement a cognitive strategy (i.e., way of thinking) during 1/2 of the trials of a behavioral, gambling task. On the other 1/2 of the trials they behave naturally without implementing the cognitive strategy.

Behavioral: Positive Emotion Upregulation

Interventions

Positive Emotion Upregulation BEHAVIORAL

Participants will identify personal goals or activities that they would like to engage in more and describe these goals/activities in a written format with research staff. Participants will then complete a gambling task during functional MRI scanning. Prior to making some gambling decisions, participants are instructed to mentally imagine achieving a goal or engaging in an enjoyable activity. Prior to the other decisions participants are instructed to respond naturally (i.e., not use the cognitive strategy).

Single Arm

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• The following criteria apply to all subjects:
• Between ages of 18-50.
• Have capacity to provide informed consent
• Fluent communication in English
• Willingness and ability to follow study requirements, as evidenced by an ability to provide written or virtual informed consent and read, and complete, study procedures.
• Cognitive ability to understand tasks and estimated IQ greater than 70.
• The following criteria apply to subjects with schizophrenia:
• \. Primary diagnosis of schizophrenia or schizoaffective disorder
• The following additional criteria apply to subjects without schizophrenia:

You may not qualify if:

• The following criteria apply to all subjects:
• Self-disclosed or noticeable intoxication from alcohol or illicit drugs (e.g., arriving to participate in the study drunk/high)
• Self-disclosure of consistent current substance use other than nicotine, alcohol, or cannabis (e.g. cocaine, heroin).
• Many-year history of severely disordered substance use other than nicotine/tobacco (determined via interview)
• Significant physical health disorder, robust physical health conditions, neurological disease/disorder (e.g., Parkinson's, history of strokes).
• History of traumatic brain injury, head injury resulting in loss of consciousness for an extended duration or with noted neurobehavioral consequences.
• Electroconvulsive therapy within one month of participation.
• History of seizures or epilepsy.
• Currently untreated or unstable psychiatric and medical conditions.
• Intellectual disability
• Contra indications for MR imaging (detailed below)
• The following additional criteria apply to subjects without schizophrenia:
• Pervasive history of problematic substance use (other than nicotine, alcohol, and mild-moderate cannabis use) as defined by meeting DSM-5 criteria for a substance use disorder.
• Diagnosis of, or first-degree relative with, significant psychiatric disorder (e.g., bipolar disorder, psychotic disorder, or Cluster A personality disorder).

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Center for Advanced Human Brain Imaging Research

Piscataway, New Jersey, 08854, United States

RECRUITING

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Emotional Regulation

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Self-Control; Social Behavior; Behavior

Study Officials

• David Zald, PhD

  Rutgers University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pariya Chanthasensack, BS

CONTACT

732-235-6438; CANL@rwjms.rutgers.edu

John Purcell, PhD

CONTACT

732-235-6438; jrp345@rwjms.rutgers.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Henry Rutgers Term Professor of Psychiatry

Study Record Dates

• First Submitted: December 17, 2024
• First Posted: December 20, 2024
• Study Start: January 7, 2025
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be uploaded in accordance with National Data Archive (NDA) data upload timelines and procedures.
• Access Criteria: Data will be accessible via the National Data Archive (NDA) according to established data request procedures.

Locations

US (1)