Recruiting

Observational Study

Sponsor:

Rutgers, The State University of New Jersey

Code:

NCT06745479

Conditions

Schizophrenia

Schizoaffective Disorder

Control Subjects

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Accepted

Interventions

Positive Emotion Upregulation

Study Details

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

Study ID

NCT06745479

Start date

Jan 7, 2025

Status verified date

Mar, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Apr 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Accepted

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 Design

Enrollment

74 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

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.

Interventions

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).

Primary outcome measure

  • Nucleus Accumbens Brain Activation [ Time Frame: Single timeframe during 1.5 hours of MRI scanning and behavioral task completion. ]
  • Gambling Choice Behavior [ Time Frame: Single timeframe during 1.5 hours of MRI scanning and behavioral task completion. ]

Central Contacts and Locations

Central contacts

Locations

Center for Advanced Human Brain Imaging Research

Recruiting

Piscataway, New Jersey, United States, 08854

Contacts

Principal Investigator:

David H Zald, PhD

More Information

Sponsor

Rutgers, The State University of New Jersey

Last update posted

Mar 11, 2026

Last verified

Mar, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Rutgers, The State University of New Jersey on 2026-03-11.