Charles Bonnet Syndrome in Low Vision Patients (CBS)
Charles Bonnet Syndrome (CBS): Prevalence and Characteristics of Visual Hallucinations. Psychological Profile of the Visually Impaired Patient With CBS
Descripción general del estudio
Estado
Condiciones
Descripción detallada
As part of our clinical practice, screening questionnaires will be used to assess the mental health and psychological profile of enrolled patients:
PHQ-9 (Patient Health Questionnaire): A 9-question tool for screening depression, with scores ranging from 0-27 to assess depression severity. Scores above 5 require referral to a clinical psychologist; scores 15+ suggest psychiatric evaluation.
GAD-7 (General Anxiety Disorder): A 7-item tool to screen for generalized anxiety disorder, with scores from 0-21. Scores 10+ require clinical psychologist referral, and 15+ indicate the need for psychiatric evaluation.
SCL-90R (Symptom Checklist-90): A 90-item questionnaire assessing a range of psychological symptoms, including depression, anxiety, and aggression, rated on a Likert scale from 0 to 4.
NEI VFQ25 (National Eye Institute Visual Function Questionnaire): A tool to assess the quality of life related to vision.
GSES (Generalized Self-Efficacy Scale):A 10-item scale to measure perceived self-efficacy and coping mechanisms for stressful life events, rated on a 4-point Likert scale.
PSS (Perceived Stress Scale):A tool to measure how individuals perceive their life as stressful, focusing on unpredictability, uncontrollability, and overwhelm.
GHQ-12 (General Health Questionnaire-12):A 12-item questionnaire to identify general mental health problems, focusing on the past two weeks.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
Roma, Italia, 00168
- fondazione Policlinico Universitario A. Gemelli IRCCS, Polo Nazionale Ipovisione
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Best corrected visual acuity between 1/20 (1.0 LogMAR) and 3.2/10 (0.5 LogMAR) in cases of central vision impairment.
- Residual binocular visual field ≤ 60% in cases of peripheral vision impairment.
- Patients with age-related macular degeneration, Stargardt's disease, or glaucoma.
- Age between 40 and 70 years.
- Signed informed consent.
Exclusion Criteria:
- Age under 40 years.
- Clear cognitive impairments that reduce patient reliability.
- Psychiatric disorders.
- Refusal to sign informed consent to participate in the study.
- Mental State Examination (MMSE) score below 22.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Prevalence of the Charles Bonnet Syndrome
Periodo de tiempo: From baseline through study completion, up to 24 months.
|
Prevalence of Charles Bonnet Syndrome, calculated as the ratio between the number of visually impaired patients affected by CBS and the total number of patients attending the visual rehabilitation center, multiplied by 100 (%).
|
From baseline through study completion, up to 24 months.
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Generalized Anxiety Disorder-7 (GAD-7). 7 items score.
Periodo de tiempo: 3 hours
|
Scale range: 0 to 21 Interpretation: higher scores indicate a worse outcome (greater severity of anxiety symptoms) Cut-off: greater than 5
|
3 hours
|
|
Change in Patient Health Questionnaire-9 (PHQ-9). 9 Items score
Periodo de tiempo: 3 hours
|
Scale range: 0 to 27 Interpretation: higher scores indicate a worse outcome (greater severity of depressive symptoms) Cut-off: greater than 5
|
3 hours
|
|
Change in Symptom Checklist-90 (SCL-90) . 90 items score
Periodo de tiempo: 3 hours
|
Scale range: 0 to 4 (mean score across items) Interpretation: higher scores indicate a worse outcome (greater psychological distress) Cut-off: greater than 1.5
|
3 hours
|
|
Change in Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25). 25 items score
Periodo de tiempo: 3 hours
|
Scale range: 0 to 100 Interpretation: higher scores indicate a better outcome (better visual function and quality of life) Cut-off: less than 60
|
3 hours
|
|
Change in General Self-Efficacy Scale (GSES) score.
Periodo de tiempo: 3 hours
|
Scale range: 10 to 40 Interpretation: higher scores indicate a better outcome (greater perceived self-efficacy) Cut-off: less than 30
|
3 hours
|
|
Change in Perceived Stress Scale (PSS) score.
Periodo de tiempo: 3 hours
|
Scale range: 0 to 40 Interpretation: higher scores indicate a worse outcome (greater perceived stress) Cut-off: less than 15
|
3 hours
|
Colaboradores e Investigadores
Investigadores
- Investigador principal: Stefania Fortini, MD, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- ID 6502
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. .