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

Rutgers The State University of New Jersey

Status: Enrolling

Conditions: Schizophrenia; Schizoaffective Disorder; Control Subjects

Treatments: Behavioral: Positive Emotion Upregulation

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06745479

Pro2023001193

R21MH135329-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 74 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

The following criteria apply to all subjects:

1. Between ages of 18-45.
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 or alcohol) 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).

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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74 participants in 1 patient group

Single Arm

Experimental group

Description:

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.

Treatment:

Behavioral: Positive Emotion Upregulation