Clinical trial NCT06745479: Decision-Making in Schizophrenia: a Combined Neuroimaging and Experience Sampling Study
Official title: Promoting Adaptive Decision-Making in Schizophrenia Through Improved Evidence Integration: a Combined Neuroimaging and Experience Sampling Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Schizophrenia
Schizoaffective Disorder
Control Subjects
Keywords: Cognitive Strategy
Emotion Regulation
Psychosis
Schizophrenia
functional MRI
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2024-12-20
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: Inclusion Criteria:

The following inclusion 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 additional inclusion criteria apply to subjects with schizophrenia/schizoaffective disorder:

1) Primary diagnosis of schizophrenia or schizoaffective disorder

The following additional inclusion 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 exclusion 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. History of electroconvulsive therapy
7. History of seizures or epilepsy.
8. Currently untreated or unstable psychiatric and medical conditions.
9. Intellectual disability
10. Contra indications for MR imaging

The following additional exclusion 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).

Primary outcomes:
measure: Nucleus Accumbens Brain Activation
timeFrame: Single timeframe during 1.5 hours of MRI scanning and behavioral task completion.
measure: Gambling Choice Behavior
timeFrame: Single timeframe during 1.5 hours of MRI scanning and behavioral task completion.
Secondary outcomes:
measure: Brain Activation and Functional Connectivity
timeFrame: Single timeframe during 1.5 hours of MRI scanning and behavioral task completion
Other outcomes:
Locations:
city: Piscataway
country: United States
facility: Center for Advanced Human Brain Imaging Research
state: New Jersey
Study officials:
affiliation: Rutgers University
name: David Zald, PhD
role: PRINCIPAL_INVESTIGATOR
References: