SchizophreniaNCT06745479
Decision-Making in Schizophrenia: A Combined Neuroimaging and Experience Sampling Study
A study testing Positive Emotion Upregulation in people with Schizophrenia and Schizoaffective Disorder, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder, Control Subjects
- What is being tested?
- Positive Emotion Upregulation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jan 2025to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Center for Advanced Human Brain Imaging Research
Piscataway, New Jersey, 08854
Pariya Chanthasensack, BS, 732-235-6438, CANL@rwjms.rutgers.edu
John R Purcell, PhD, 732-235-6438, jrp345@rwjms.rutgers.edu
About this study
Official title: 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?
Read more
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.
Read the 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.
- Conditions
- Schizophrenia, Schizoaffective Disorder, Control Subjects
- Being tested
- Positive Emotion Upregulation
- Keywords
- Cognitive Strategy, Emotion Regulation, Psychosis, Schizophrenia, functional MRI
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive Emotion UpregulationBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Positive Emotion Upregulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Single timeframe during 1.5 hours of MRI scanning and behavioral task completion.
Secondary outcomes (1)
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.
Measured: Single timeframe during 1.5 hours of MRI scanning and behavioral task completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2024
- Study start7 Jan 2025
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, David Harold Zald, Ph.D., Rutgers, The State University of New Jersey
- Investigators
- David Zald, PhD, Principal investigator, Rutgers University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06745479
- Sponsor's protocol ID
- Pro2023001193
- Other IDs
- R21MH135329-01A1
- Status last verified
- Mar 2026
- First submitted
- 17 Dec 2024
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Adaptive Decision-Making in Schizophrenia Through Improved Evidence Integration: A Combined Neuroimaging and Experience Sampling Study
- ClinicalTrials.gov ID
- NCT06745479
- Acronym / sponsor ID
- Pro2023001193
- Conditions
- Schizophrenia, Schizoaffective Disorder, Control Subjects
- Keywords
- Cognitive Strategy, Emotion Regulation, Psychosis, Schizophrenia, functional MRI
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 7 Jan 2025 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 20 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Behavioral: Positive Emotion UpregulationThere 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Positive Emotion UpregulationParticipants 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). | Behavioural | Single Arm |
Primary outcome
Nucleus Accumbens Brain Activation
Time frame: Single timeframe during 1.5 hours of MRI scanning and behavioral task completion.
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.
Gambling Choice Behavior
Time frame: Single timeframe during 1.5 hours of MRI scanning and behavioral task completion.
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.
1 secondary outcome
Brain Activation and Functional Connectivity
Time frame: Single timeframe during 1.5 hours of MRI scanning and behavioral task completion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David Zald, PhD principal investigator
Rutgers University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positive Emotion Upregulation in people with Schizophrenia and Schizoaffective Disorder, run by Rutgers, The State University of New Jersey at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pariya Chanthasensack, BS (732-235-6438, CANL@rwjms.rutgers.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nucleus Accumbens Brain Activation (time frame: Single timeframe during 1.5 hours of MRI scanning and behavioral task completion.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.