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临床试验/NCT06914076
NCT06914076进行中(未招募)不适用

Evaluating The Effectiveness Of Structured Psychosocial Counseling On Mental Health And Functional Independence In Individuals With Low Vision

Superior University1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2025年3月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
28
试验地点
1
主要终点
DASS 21

研究概览

简要总结

Vision impairments affect 2.2 billion people worldwide, including 36 million who are blind and 217 million with moderate-to-severe visual impairment. In the US, age-related vision loss is a leading cause of disability among older adults.

详细描述

With increasing longevity, global blindness rates are expected to triple, and moderate-to-severe vision impairment rates to double in 30 years. The study aims to assess the effects of structured psychosocial counseling on mental health (depression, anxiety) and functional independence in individuals with low vision. Additionally, it seeks to evaluate the overall impact on quality of life (QoL) following the counseling intervention. A randomized controlled trial will be conducted at Superior University Lahore.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Individuals aged 18 to 80 years.
  • •Both male and female
  • •Individuals diagnosed with low vision, defined as a visual acuity of less than 6/18 but equal to or better than 3/60 in the better eye with best correction.
  • •Individuals having visual acuity 6/60, Counting fingers or light perception.
  • •Individuals experiencing symptoms of depression or anxiety as assessed through a validated screening tool.
  • •Individuals reporting reduced functional independence in daily activities due to low vision.

排除标准

  • •Unable to provide informed consent.
  • •Diagnosed with severe psychiatric disorders such as schizophrenia, bipolar disorder, or severe post-traumatic stress disorder.
  • •Existing involvement in similar counseling programs.
  • •Presence of medical conditions or disabilities.
  • •Pregnant individuals if pregnancy-related complications or responsibilities could interfere with participation in the intervention.

研究组 & 干预措施

Structured Psychosocial Counseling

Experimental

干预措施: Structured Psychosocial Counseling (Combination Product)

Standard Care

Active Comparator

干预措施: Standard Care (Diagnostic Test)

结局指标

主要结局

DASS 21

时间窗: 12 Months

The DASS-21 uses the following categories to interpret scores: Normal: 0-9 (Depression), 0-7 (Anxiety), 0-14 (Stress) Mild: 10-13 (Depression), 8-9 (Anxiety), 15-18 (Stress) Moderate: 14-20 (Depression), 10-14 (Anxiety), 19-25 (Stress) Severe: 21-27 (Depression), 15-19 (Anxiety), 26-33 (Stress) Extremely Severe: 28+ (Depression), 20+ (Anxiety), 34+ (Stress)

LVQoL Questionare

时间窗: 12 Months

Total Score Interpretation: * 25-50: Good quality of life * 51-75: Moderate quality of life * 76-100: Poor quality of life * 101-125: Very poor quality of life

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Muhammad Naveed Babur

Principal Investigator

Superior University

研究点 (1)

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