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临床试验/NCT06745479
NCT06745479
招募中
不适用

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

Rutgers, The State University of New Jersey2 个研究点 分布在 1 个国家目标入组 74 人2025年1月7日

概览

阶段
不适用
干预措施
Positive Emotion Upregulation
疾病 / 适应症
Schizophrenia
发起方
Rutgers, The State University of New Jersey
入组人数
74
试验地点
2
主要终点
Nucleus Accumbens Brain Activation
状态
招募中
最后更新
上个月

概览

简要总结

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.

详细描述

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.

注册库
clinicaltrials.gov
开始日期
2025年1月7日
结束日期
2027年6月30日
最后更新
上个月
研究类型
Interventional
研究设计
Single Group
性别
All

研究者

责任方
Principal Investigator
主要研究者

David Harold Zald, Ph.D.

Henry Rutgers Term Professor of Psychiatry

Rutgers, The State University of New Jersey

入排标准

入选标准

  • The following criteria apply to all subjects:
  • Between ages of 18-
  • 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
  • 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.

排除标准

  • 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.
  • Electroconvulsive therapy within one month of participation.
  • History of seizures or epilepsy.
  • Currently untreated or unstable psychiatric and medical conditions.
  • Intellectual disability

研究组 & 干预措施

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.

干预措施: Positive Emotion Upregulation

结局指标

主要结局

Nucleus Accumbens Brain Activation

时间窗: 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

时间窗: 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.

次要结局

  • Brain Activation and Functional Connectivity(Single timeframe during 1.5 hours of MRI scanning and behavioral task completion)

研究点 (2)

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