State Representation in Early Psychosis 2 (STEP2)
This observational study will examine behavioral and electroencephalography measures related to state representation in individuals with early psychosis and healthy control participants.
Participants will complete clinical interviews, self-report measures, cognitive assessments, computerized behavioral tasks, and EEG assessments. The study will evaluate performance and computed parameters from the Translational Orientation Pattern Expectancy task and Translational Bandit Task, along with EEG variables related to cognitive control, reward processing, and neural synchrony.
The study aims to better understand heterogeneity in early psychosis and identify neurocognitive and neurophysiologic markers that may inform future precision psychiatry approaches.
調査の概要
状態
詳細な説明
State Representation in Early Psychosis 2 is an observational study of individuals with early psychosis and healthy control participants. The study is part of an NIH Silvio O. Conte Center for Translational Mental Health Research grant and is designed to examine behavioral and neural markers of state representation processes in early psychosis.
The study will enroll individuals with early psychosis and demographically similar healthy controls. Participants will complete interviews, self-report measures, behavioral tasks, cognitive assessments, and electroencephalography assessments. The study focuses on computational and EEG measures related to state estimation, state maintenance, and state learning.
Participants will complete variants of two computerized tasks: the Translational Orientation Pattern Expectancy task and the Translational Bandit Task. EEG will be collected while participants complete these tasks and during resting state. EEG variables of interest include P300, reward positivity, phase synchrony, spectral power density slope, and prefrontal/parietal theta.
Clinical and functional measures will also be collected, including measures of psychiatric symptoms, functioning, motivation, pleasure, discrimination, disability, depression, anxiety, and general cognitive ability. The study will compare early psychosis participants with healthy control participants and evaluate how behavioral, computational, EEG, cognitive, clinical, and functional measures relate to heterogeneity in early psychosis.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Grace Owens
- 電話番号：(612) 741-2826
- メール：step2study@umn.edu
研究場所
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Minnesota
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Minneapolis、Minnesota、アメリカ、55455
- 募集
- University of Minnesota Ambulatory Research Center
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コンタクト：
- Grace Owens
- 電話番号：612-741-2826
- メール：owens387@umn.edu
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主任研究者：
- Scott Sponheim, PhD, LP
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Minneapolis、Minnesota、アメリカ、55455
- 募集
- University of Minnesota Department of Psychology
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コンタクト：
- Grace Owens
- 電話番号：612-741-2826
- メール：owens387@umn.edu
-
主任研究者：
- Scott Sponheim, PhD, LP
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
The study population includes individuals with early psychosis and demographically similar healthy control participants. Early psychosis participants will have a clinical diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, psychosis NOS, bipolar disorder with psychosis, or major depressive disorder with psychosis. Healthy control participants will be recruited from the community and must not meet DSM-5 criteria for psychotic or bipolar disorder or have a first-degree family history of psychotic or bipolar disorder. Participants will be 15 to 45 years old and will complete clinical interviews, self-report measures, cognitive assessments, computerized behavioral tasks, and EEG assessments.
説明
Inclusion Criteria:
All participants:
- Aged between 15 and 45 years
- English proficiency, as determined by staff observation and participant self-report
- Estimated IQ at or above 70, as estimated by cognitive assessments
- Estimated visual acuity at 20/40, as estimated by the visual acuity test
Early Psychosis participants:
- Clinical diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, psychosis NOS, bipolar disorder with psychosis, or major depressive disorder with psychosis
- Age 35 years or younger, or age 36 to 45 years with onset of psychotic symptoms within the previous 5 years
- Achieved clinical stability, defined as outpatient status for at least one month prior to study participation
Exclusion Criteria:
All participants:
- Unable or unwilling to provide informed consent
- Unable to demonstrate adequate decisional capacity, in the judgment of the consenting study staff member
- Illiterate
- Previous clinically significant head injury or prolonged unconsciousness, as determined by the investigators
- Meets criteria for severe substance or alcohol use disorder within 3 months of behavioral assessment
- Presence of any major medical condition that, in the opinion of the investigators, would impede participation or put the participant at additional risk
- Has participated in significant formal cognitive training programs, as determined by the investigators
- Meets criteria for clinical risk of suicidal behavior
Early Psychosis participants:
- Presence of a major neurological disorder
Healthy Control participants:
- Meets DSM-5 criteria for psychotic or bipolar disorder
- Has a first-degree family history of psychotic or bipolar disorder
- Presence of a major neurological disorder
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：COHORT
- 時間の展望：PROSPECTIVE
コホートと介入
グループ/コホート |
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Early Psychosis Participants
Participants with a clinical diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, psychosis NOS, bipolar disorder with psychosis, or major depressive disorder with psychosis. Participants will complete clinical interviews, self-report measures, cognitive/computerized tasks, and EEG assessments. |
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Healthy Control Participants
Community control participants without psychotic or bipolar disorder and without a first-degree family history of psychotic or bipolar disorder. Participants will complete clinical interviews, self-report measures, cognitive/computerized tasks, and EEG assessments. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Combined TOPX and TBT State Representation Parameter Score
時間枠：Baseline study assessment, up to 8 weeks
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Performance and computed parameters from the Translational Orientation Pattern Expectancy task and Translational Bandit Task will be combined to evaluate state estimation, state maintenance, and state learning processes. The Translational Orientation Pattern Expectancy task is a cognitive control task used to evaluate dysregulated expectancy through responses to expected and unexpected stimuli. The Translational Bandit Task is a reward learning task used to evaluate responses to rewards. Together, task-derived parameters will be combined into model-derived parameter scores reflecting state estimation, state maintenance, and state learning. Unit: model-derived parameter score |
Baseline study assessment, up to 8 weeks
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P300 Amplitude During AX-CPT Task
時間枠：Baseline study assessment, up to 8 weeks
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P300 will be assessed during the AX-CPT task as a parietally maximal positive-going event-related potential component occurring approximately 300 to 600 milliseconds after stimulus presentation. Cue-locked P300 responses to A versus B cues and probe-locked P300 responses to AX versus AY probes will be used to assess attention allocation and context/state representation during proactive and reactive cognitive control. Unit: Microvolts |
Baseline study assessment, up to 8 weeks
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Reward Positivity Amplitude During Translational Bandit Task
時間枠：Baseline study assessment, up to 8 weeks
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Reward positivity will be assessed during the Translational Bandit Task as a frontocentrally maximal event-related potential component occurring approximately 250 to 350 milliseconds after reward versus non-reward feedback. Reward positivity will be used to assess reward sensitivity and reinforcement learning. Unit: Microvolts |
Baseline study assessment, up to 8 weeks
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Resting-State EEG Phase Synchrony
時間枠：Baseline study assessment, up to 8 weeks
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Phase synchrony will be assessed during resting-state EEG using measures of the consistency of phase relationships between electrode sites, such as phase-locking value or weighted phase-lag index. Resting-state EEG will include eyes-closed and eyes-open conditions and will be used to assess coordination of neural activity across distributed brain regions. Unit: phase-locking value |
Baseline study assessment, up to 8 weeks
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Resting-State EEG Spectral Power Density Slope
時間枠：Baseline study assessment, up to 8 weeks
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The slope of spectral power density will be assessed during resting-state EEG as the aperiodic, 1/f-like component of the power spectrum. The slope will be estimated after separating periodic oscillatory activity from the aperiodic component and will be used to assess cortical excitation/inhibition balance and arousal state. Unit: aperiodic exponent |
Baseline study assessment, up to 8 weeks
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Prefrontal and Parietal Theta Power
時間枠：Baseline study assessment, up to 8 weeks
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Prefrontal and parietal theta activity will be assessed using electroencephalography during computerized tasks and resting state as a neurophysiologic measure related to cognitive control and state representation. Unit: decibels |
Baseline study assessment, up to 8 weeks
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Minnesota Symptoms Severity Questionnaire Score
時間枠：Baseline study assessment, up to 8 weeks
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Physical and mental well-being symptoms will be assessed using the 29-item Minnesota Symptoms Severity questionnaire. Items are scored from 1, absent, to 5, occurring nearly every day. Higher scores indicate higher frequency of physical and mental health symptoms. Unit: points |
Baseline study assessment, up to 8 weeks
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Scale for the Assessment of Negative Symptoms Score
時間枠：Baseline study assessment, up to 8 weeks
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Negative symptoms will be assessed using the Scale for the Assessment of Negative Symptoms. Items are scored from 0, absent, to 5, severe. Higher scores indicate greater negative symptom severity. Unit: points |
Baseline study assessment, up to 8 weeks
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Scale for the Assessment of Positive Symptoms Score
時間枠：Baseline study assessment, up to 8 weeks
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Positive symptoms will be assessed using the Scale for the Assessment of Positive Symptoms. Items are scored from 0, absent, to 5, severe. Higher scores indicate greater positive symptom severity. Unit: points |
Baseline study assessment, up to 8 weeks
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Brief Psychiatric Rating Scale Score
時間枠：Baseline study assessment, up to 8 weeks
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Psychiatric symptoms will be assessed using the Brief Psychiatric Rating Scale. The scale assesses 24 psychiatric symptom constructs, with items scored from 1, absent, to 7, extremely severe. Higher scores indicate greater psychiatric symptom severity. Unit: Points |
Baseline study assessment, up to 8 weeks
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Schizotypal Personality Questionnaire-Brief Revised Score
時間枠：Baseline study assessment, up to 8 weeks
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Schizotypal traits will be assessed using the 32-item Schizotypal Personality Questionnaire-Brief Revised. Items are scored from 0, strongly disagree, to 4, strongly agree. Higher scores indicate greater schizotypal trait severity. Unit: Points |
Baseline study assessment, up to 8 weeks
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Intersectional Discrimination Index Score
時間枠：Baseline study assessment, up to 8 weeks
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Experiences of discrimination will be assessed using the 31-item Intersectional Discrimination Index. The measure uses multiple item response scales to assess experiences of, and worries about, discrimination. Higher scores indicate more frequent or more intense experiences or concerns related to discrimination. Unit: Points |
Baseline study assessment, up to 8 weeks
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Motivation and Pleasure Scale-Self Report Score
時間枠：Baseline study assessment, up to 8 weeks
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Motivation and pleasure will be assessed using the 15-item Motivation and Pleasure Scale-Self Report. Items are scored from 0 to 4. Lower scores indicate greater deficits in motivation and pleasure. Unit: Points |
Baseline study assessment, up to 8 weeks
|
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World Health Organization Disability Assessment Schedule Score
時間枠：Baseline study assessment, up to 8 weeks
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Disability will be assessed using the 15-item World Health Organization Disability Assessment Schedule. Items are scored from 1, none, to 5, extreme or cannot do. Higher scores indicate greater disability. Unit: Points |
Baseline study assessment, up to 8 weeks
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Global Functioning Social Scale Score
時間枠：Baseline study assessment, up to 8 weeks
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Social functioning will be assessed using the Global Functioning Social scale. Scores range from 1, extreme social isolation, to 10, superior social functioning. Lower scores indicate worse social functioning. Unit: Points |
Baseline study assessment, up to 8 weeks
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Test My Brain Matrix Reasoning Score
時間枠：Baseline study assessment, up to 8 weeks
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Fluid cognitive ability and nonverbal reasoning will be assessed using the Matrix Reasoning assessment from Test My Brain. Unit: Points |
Baseline study assessment, up to 8 weeks
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Test My Brain Digit Symbol Matching Score
時間枠：Baseline study assessment, up to 8 weeks
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Processing speed and visual short-term memory will be assessed using the Digit Symbol Matching assessment from Test My Brain. Unit: Points |
Baseline study assessment, up to 8 weeks
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Test My Brain Verbal Paired Associates Memory Score
時間枠：Baseline study assessment, up to 8 weeks
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Verbal memory and episodic memory will be assessed using the Verbal Paired Associates Memory assessment from Test My Brain. Unit: points |
Baseline study assessment, up to 8 weeks
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Test My Brain Multiracial Emotion Recognition Score
時間枠：Baseline study assessment, up to 8 weeks
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Face emotion perception and emotion identification will be assessed using the Multiracial Emotion Recognition assessment from Test My Brain. Unit: Points |
Baseline study assessment, up to 8 weeks
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Wechsler Test of Adult Reading Score
時間枠：Baseline study assessment, up to 8 weeks
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Verbal intelligence will be assessed using the Wechsler Test of Adult Reading. Unit: Points |
Baseline study assessment, up to 8 weeks
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Global Functioning Role Scale Score
時間枠：Baseline study assessment, up to 8 weeks
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Role functioning will be assessed using the Global Functioning Role scale. Scores range from 1, extremely poor role functioning, to 10, superior role functioning. Lower scores indicate worse occupational or role functioning. Unit: Points |
Baseline study assessment, up to 8 weeks
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Scott Sponheim, PhD, LP、University of Minnesota
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- STUDY00024589
- CON000000112940 (その他の識別子：National Institute of Mental Health)
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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