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El ensayo clínico NCT07203027 para Ansiedad, Trastornos de ansiedad está aún no recluta. Consulte la vista de tarjeta del Radar de Ensayos Clínicos y las herramientas de descubrimiento de IA para conocer todos los detalles. O haga cualquier pregunta aquí. | ||
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Quantifying Multi-step Avoidance in Anxiety 163
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El ensayo clínico NCT07203027 es un estudio observacional para Ansiedad, Trastornos de ansiedad. Su estado actual es: aún no recluta. Se prevé iniciar el reclutamiento el 1 de enero de 2027 hasta completar 163 participantes. Dirigido por la Universidad Emory, se espera que finalice el 1 de junio de 2030. Los datos se actualizaron por última vez en ClinicalTrials.gov el 2 de octubre de 2025.
Resumen
This study aims to learn more about avoidance behavior in people with anxiety, using mathematical models of decision-making processes and decoded neural signals of threat imminence.
Researchers are investigating anxiety-related behavior and brain function in people with and without anxiety. Investigators are also looking at how behavior and brain function during tasks in the lab relate to avoidance in their daily li...
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Current learning theories of anxiety propose that disrupted fear learning underlie anxiety disorders. This suggests that treatments like exposure therapy work by changing learned threat values. However, empirical data does not support these models where changes in fear conditioning lead to symptom changes and later reductions of avoidance behavior. Instead, recent findings suggest that avoidance behavior can be a mec...Mostrar más
Título oficial
Quantifying Neural Signatures of Multi-step Avoidance Behavior in Anxiety
Condiciones médicas
AnsiedadTrastornos de ansiedadOtros ID del estudio
- STUDY00009403
- 1R01MH139780 (Subvención/contrato NIH (EE. UU.))
Número del NCT
Inicio del estudio (real)
2027-01
Última actualización
2025-10-02
Fecha de finalización (estimada)
2030-06
Inscripción (prevista)
163
Tipo de estudio
Observacional
Estado general
Aún no recluta
Palabras clave
Avoidance behavior
Fear learning
Fear learning
Brazos / Intervenciones
| Grupo de participantes | Intervención/Tratamiento |
|---|---|
Anxiety and impairing levels of avoidance Participants are screened for anxiety and impairing levels of avoidance and will complete questionnaires, a clinical interview, behavioral tasks, scanning, ecological momentary assessment (EMA), and passive sensing. Participants will complete four visits total. | Behavioral Tasks with imaging Participants will complete the MDP task only during 3 separate fMRI scanning sessions.
After each session, they will complete one week of ambulatory assessment of real-world avoidance behavior (self-reported avoidance behavior) via Emory Qualtrics surveys. In a fourth scanning session, the brain signature of threat imminence constructed in the first set of participants (Aim 1) will be used to predict and modify avoi...Mostrar más |
Resultado primario
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
Ecological momentary assessment (EMA) | Participants will complete one week of ecological momentary assessment (EMA) to assess real-world avoidance behaviors after each of the scanning visits. The proportion of assessments where participants report engaging in avoidance behavior in the last hour will be assessed. Changes in the proportion of assessments where avoidance is reported will be used to measure changes in avoidance severity. | Baseline, week 1, week 2, week 3, and week 4 |
Avoidance Severity Based on Location Entropy | Avoidance severity will be assessed using passive sensing of daily location patterns after each fMRI scanning visit. Participants will complete one week of passive sensing of location (using phone-based GPS measures) to assess real-world avoidance behaviors after each of the scanning visits. Changes in location entropy, representing the distribution of unique locations visited per day, will be used to measure changes in avoidance severity. Lower entropy values will indicate greater avoidance severity, while higher values will indicate less avoidance. | Baseline, week 1, week 2, week 3, and week 4 |
Change in Location Entropy | Location entropy, defined as the distribution of unique locations visited per day, will be measured using one week of passive phone-based GPS monitoring after each fMRI scanning visit. This measure reflects variability in movement patterns and real-world avoidance behaviors. | Baseline, week 1, week 2, week 3, and week 4 |
Asistente de participación
Criterios de elegibilidad
Criterios de edad
Adulto
Edad mínima
22 Years
Criterios de sexo
Todos
Admisión de voluntarios sanos
Sí
- Ability to comprehend written and spoken English
- Ability to provide informed consent
- Estimated intelligence quotient (IQ) >70.
- Clinically significant anxiety symptoms (scoring above clinical cutoff on at least one Inventory of Depression and Anxiety Symptoms (IDAS) anxiety-related subscale and/or OASIS total)
- Significant anxiety-related avoidance (scoring 2 or above on a 0-4 scale, indicating at least "occasional" avoidance) on the avoidance-related question on the Overall Anxiety Severity and Impairment Scale (OASIS)
- Functional impairment, defined as at least moderate impairment in one WHO Disability Assessment Schedule (WHODAS 2.0) domain related to anxiety.
- Individuals younger than 22 or older than 55,
- Individuals with an IQ < 70,
- A lifetime history of neurological disorder or brain damage,
- Contraindications for undergoing MRI scanning,
- A lifetime history or diagnosis of psychosis or bipolar disorder,
- Current substance use intoxication or withdrawal,
- Severe risk of suicide, or
- Recent (<3 months) changes in psychotropic medicine or psychotherapy treatment,
- Ineligible at the PI's discretion, are excluded.
Parte responsable del estudio
Vanessa M. Brown, Investigador principal, Assistant Professor, Emory University
Contactos centrales del estudio
Contacto: Vanessa M. Brown, PhD, 404-727-5454, [email protected]
2 Centros del estudio en 1 países
Georgia
Emory College, Atlanta, Georgia, 30322, United States
Facility for Education and Research in Neuroscience (FERN), Atlanta, Georgia, 30322, United States