Charles Bonnet Syndrome (CBS): Prevalence and Characteristics of Visual Hallucinations. Psychological Profile of the Visually Impaired Patient With CBS
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 640
- 试验地点
- 1
- 主要终点
- Prevalence of the Charles Bonnet Syndrome
研究概览
简要总结
Among patients with chronic and degenerative ocular diseases that cause visual limitations, the presence of Charles Bonnet Syndrome (CBS) may be detected as a comorbidity. CBS is as a phenomenon of complex visual hallucinations occurring in individuals with reduced visual function, in the absence of cognitive alterations, psychiatric and/or neurological conditions. It is estimated that 15.8% of patients with age-related macular degeneration and 13.5% among glaucoma patients have CBS. Prevalence rates vary widely, and this may depend on inconsistent diagnostic criteria, variability in the questions used to determine if an individual has visual hallucinations, and the reluctance of people to admit to having strange visions for fear of being considered mentally ill. Visual hallucinations can be invasive and debilitating, compromising mental health, quality of life, and rehabilitation in visually impaired individuals. Patients may experience confusion, anxiety, anger, paranoia, and social isolation. Regarding psychological aspects, about a third of patients report experiencing distress and fear,higher anxiety and social dysfunction particularly during the initial onset of symptoms and in the terminal stage of the disease.Screening questionnaires will be used.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Prevalence of the Charles Bonnet Syndrome
时间窗: 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 (%).
次要结局
- Change in Generalized Anxiety Disorder-7 (GAD-7). 7 items score.(3 hours)
- Change in Patient Health Questionnaire-9 (PHQ-9). 9 Items score(3 hours)
- Change in Symptom Checklist-90 (SCL-90) . 90 items score(3 hours)
- Change in Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25). 25 items score(3 hours)
- Change in General Self-Efficacy Scale (GSES) score.(3 hours)
- Change in Perceived Stress Scale (PSS) score.(3 hours)