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

Promoting Adaptive Decision-Making in Schizophrenia Through Improved Evidence Integration: A Combined Neuroimaging and Experience Sampling Study

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.

Study Overview

• Status: Recruiting
• Conditions: Schizophrenia; Schizoaffective Disorder; Control Subjects
• Intervention / Treatment: Behavioral: Positive Emotion Upregulation

Detailed Description

This study aims to identify how attention and different ways of thinking impact decision making and brain activity. We are specifically examining how these factors differ between individuals with schizophrenia or schizoaffective disorder and individuals who do not have these conditions. We are also investigating how brain functioning during decision-making tasks correlates with real-world decisions recorded in everyday life. This ongoing study utilizes functional MRI brain imaging, eye-tracking, and daily event-sampling self-reports to identify whether there are differences in decision-making tendencies between groups of participants.

• Study Type: Interventional
• Enrollment (Estimated): 74
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pariya Chanthasensack, BS; Phone Number: 732-235-6438; Email: CANL@rwjms.rutgers.edu
• Study Contact Backup: Name: John Purcell, PhD; Phone Number: 732-235-6438; Email: jrp345@rwjms.rutgers.edu

Study Locations

• United States
  • New Jersey
    • Piscataway, New Jersey, United States, 08854
      • Recruiting
      • Center for Advanced Human Brain Imaging Research
      • Contact: Pariya Chanthasensack, BS; Phone Number: 732-235-6438; Email: CANL@rwjms.rutgers.edu
      • Contact: John R Purcell, PhD; Phone Number: 732-235-6438; Email: jrp345@rwjms.rutgers.edu
      • Principal Investigator: David H Zald, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria

The following criteria apply to all subjects:

1. Between ages of 18-50.
2. Have capacity to provide informed consent
3. Fluent communication in English
4. 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.
5. Cognitive ability to understand tasks and estimated IQ greater than 70.

The following criteria apply to subjects with schizophrenia:

1. Primary diagnosis of schizophrenia or schizoaffective disorder

The following additional criteria apply to subjects without schizophrenia:

1. Inclusion based on subject matched to psychiatric group based on age, sex, race/ethnicity, and education level.

Exclusion Criteria

The following criteria apply to all subjects:

1. Self-disclosed or noticeable intoxication from alcohol or illicit drugs (e.g., arriving to participate in the study drunk/high)
2. Self-disclosure of consistent current substance use other than nicotine, alcohol, or cannabis (e.g. cocaine, heroin).
3. Many-year history of severely disordered substance use other than nicotine/tobacco (determined via interview)
4. Significant physical health disorder, robust physical health conditions, neurological disease/disorder (e.g., Parkinson's, history of strokes).
5. History of traumatic brain injury, head injury resulting in loss of consciousness for an extended duration or with noted neurobehavioral consequences.
6. Electroconvulsive therapy within one month of participation.
7. History of seizures or epilepsy.
8. Currently untreated or unstable psychiatric and medical conditions.
9. Intellectual disability
10. Contra indications for MR imaging (detailed below)

The following additional criteria apply to subjects without schizophrenia:

1. 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.
2. Diagnosis of, or first-degree relative with, significant psychiatric disorder (e.g., bipolar disorder, psychotic disorder, or Cluster A personality disorder).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Single Arm; 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; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Brain Activation and Functional Connectivity	Brain activation and functional connectivity in areas across the whole brain 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

Collaborators and Investigators

• Sponsor: Rutgers, The State University of New Jersey
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: David Zald, PhD, Rutgers University

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2025
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: December 17, 2024
• First Submitted That Met QC Criteria: December 17, 2024
• First Posted (Actual): December 20, 2024

Study Record Updates

• Last Update Posted (Actual): March 11, 2026
• Last Update Submitted That Met QC Criteria: March 9, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Schizophrenia; Psychosis; functional MRI; Emotion Regulation; Cognitive Strategy
• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Behavior; Social Behavior; Self-Control; Schizophrenia; Psychotic Disorders; Emotional Regulation
• Other Study ID Numbers: Pro2023001193; R21MH135329-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Unless consent is withdrawn by participants at the individual level, data will be uploaded to the National Data Archive (NDA) in accordance with their timelines, data cataloguing criteria, and rules for data access requests.
• IPD Sharing Time Frame: Data will be uploaded in accordance with National Data Archive (NDA) data upload timelines and procedures.
• IPD Sharing Access Criteria: Data will be accessible via the National Data Archive (NDA) according to established data request procedures.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No