- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07834203
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.
Descripción general del estudio
Estado
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Grace Owens
- Número de teléfono: (612) 741-2826
- Correo electrónico: step2study@umn.edu
Ubicaciones de estudio
-
-
Minnesota
-
Minneapolis, Minnesota, Estados Unidos, 55455
- Reclutamiento
- University of Minnesota Ambulatory Research Center
-
Contacto:
- Grace Owens
- Número de teléfono: 612-741-2826
- Correo electrónico: owens387@umn.edu
-
Investigador principal:
- Scott Sponheim, PhD, LP
-
Minneapolis, Minnesota, Estados Unidos, 55455
- Reclutamiento
- University of Minnesota Department of Psychology
-
Contacto:
- Grace Owens
- Número de teléfono: 612-741-2826
- Correo electrónico: owens387@umn.edu
-
Investigador principal:
- Scott Sponheim, PhD, LP
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
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.
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: COHORT
- Perspectivas temporales: PROSPECTIVE
Cohortes e Intervenciones
Grupo / Cohorte |
|---|
|
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. |
|
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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Combined TOPX and TBT State Representation Parameter Score
Periodo de tiempo: Baseline study assessment, up to 8 weeks
|
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
|
|
P300 Amplitude During AX-CPT Task
Periodo de tiempo: Baseline study assessment, up to 8 weeks
|
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
|
|
Reward Positivity Amplitude During Translational Bandit Task
Periodo de tiempo: Baseline study assessment, up to 8 weeks
|
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
|
|
Resting-State EEG Phase Synchrony
Periodo de tiempo: Baseline study assessment, up to 8 weeks
|
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
|
|
Resting-State EEG Spectral Power Density Slope
Periodo de tiempo: Baseline study assessment, up to 8 weeks
|
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
|
|
Prefrontal and Parietal Theta Power
Periodo de tiempo: Baseline study assessment, up to 8 weeks
|
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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Minnesota Symptoms Severity Questionnaire Score
Periodo de tiempo: Baseline study assessment, up to 8 weeks
|
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
|
|
Scale for the Assessment of Negative Symptoms Score
Periodo de tiempo: Baseline study assessment, up to 8 weeks
|
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
|
|
Scale for the Assessment of Positive Symptoms Score
Periodo de tiempo: Baseline study assessment, up to 8 weeks
|
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
|
|
Brief Psychiatric Rating Scale Score
Periodo de tiempo: Baseline study assessment, up to 8 weeks
|
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
|
|
Schizotypal Personality Questionnaire-Brief Revised Score
Periodo de tiempo: Baseline study assessment, up to 8 weeks
|
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
|
|
Intersectional Discrimination Index Score
Periodo de tiempo: Baseline study assessment, up to 8 weeks
|
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
|
|
Motivation and Pleasure Scale-Self Report Score
Periodo de tiempo: Baseline study assessment, up to 8 weeks
|
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
|
|
World Health Organization Disability Assessment Schedule Score
Periodo de tiempo: Baseline study assessment, up to 8 weeks
|
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
|
|
Global Functioning Social Scale Score
Periodo de tiempo: Baseline study assessment, up to 8 weeks
|
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
|
|
Test My Brain Matrix Reasoning Score
Periodo de tiempo: Baseline study assessment, up to 8 weeks
|
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
|
|
Test My Brain Digit Symbol Matching Score
Periodo de tiempo: Baseline study assessment, up to 8 weeks
|
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
|
|
Test My Brain Verbal Paired Associates Memory Score
Periodo de tiempo: Baseline study assessment, up to 8 weeks
|
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
|
|
Test My Brain Multiracial Emotion Recognition Score
Periodo de tiempo: Baseline study assessment, up to 8 weeks
|
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
|
|
Wechsler Test of Adult Reading Score
Periodo de tiempo: Baseline study assessment, up to 8 weeks
|
Verbal intelligence will be assessed using the Wechsler Test of Adult Reading. Unit: Points |
Baseline study assessment, up to 8 weeks
|
|
Global Functioning Role Scale Score
Periodo de tiempo: Baseline study assessment, up to 8 weeks
|
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
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Scott Sponheim, PhD, LP, University of Minnesota
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- STUDY00024589
- CON000000112940 (Otro identificador: National Institute of Mental Health)
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .