Developing Evidence-Based Cognitive Approaches to Improve Adjustment to Vision Loss
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Change from Baseline in Mean Adaption to Vision Loss (AVL) Scale Score
研究概览
简要总结
The goal of this study is to develop and pilot test a therapeutic strategy combining cognitive behavioral therapy (CBT) with mindfulness practices tailored for individuals adjusting to vision loss. The study will begin with focus groups to inform the design of the intervention. Participants will complete brief surveys on their background and experiences with vision loss prior to attending a focus group, and some may be invited to a second session to provide additional feedback before preliminary testing begins. In the pilot phase, participants will attend weekly group therapy sessions using the developed intervention and complete assessments before and after the program, including questions about vision status, demographics, and experiences with vision loss.
详细描述
The goal of this study is to develop and pilot test an 8-week cognitive behavioral therapy (CBT) & mindfulness curriculum tailored for people adjusting to vision loss. Development of the curriculum during the initial phase of this research will include a thorough review of the literature, input from participant groups, and insights from an expert panel. An initial draft of the curriculum will be developed based on the findings from the literature review. 30-40 Participants will have the opportunity to attend up to two focus group sessions to provide feedback and input on content relevance, feasibility, and acceptability of the curriculum. In the pilot testing phase, 15-20 participants will attend eight weekly group therapy sessions held either in-person or virtually using the developed curriculum and will complete assessments before and after the program. These assessments will include questions about your vision, demographics, and experiences with vision loss, as well as collecting baseline and post-intervention measures prior to undergoing the 8-week pilot testing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults who are at least 18 years old
- •Experiencing varying degrees of vision loss (e.g. mild, moderate, severe)
- •Willingness to participate in the focus group or pilot testing and provide feedback
排除标准
- •Individuals with severe cognitive impairment affecting participation
- •Congenital blindness
- •Recent or current participation in another clinical trial study or medical intervention that may interfere with study results
- •Documented or self-reported health condition that may interfere with the outcomes of this study.
- •Deemed unfit to participate in the study by the site investigator
- •Unwilling and/or unable to participate or provide consent
研究组 & 干预措施
Pilot Testing - Assessing Feasibility and Acceptability
Participants will be testing an 8-week therapeutic strategy combining cognitive behavioral therapy (CBT) with mindfulness practices tailored for people adjusting to vision loss in a group therapy setting and complete assessments before and after completing the program.
干预措施: Integrated Cognitive Behavioral Therapy (CBT) & Mindfulness Group Intervention for Adjustment to Vision Loss (Behavioral)
结局指标
主要结局
Change from Baseline in Mean Adaption to Vision Loss (AVL) Scale Score
时间窗: Assessed at baseline and following the 8-week intervention period
The AVL is a 24-item self-report questionnaire rated on a 5-point Likert scale. Items assess emotional and psychosocial adjustment to vision loss. Scores range from 1 to 5, with higher scores indicating better adaptation. Some items are reverse-scored.
次要结局
- Change from Baseline in Mean Generalized Anxiety Disorder (GAD-7) Score(Assessed at baseline and following the 8-week intervention period)
- Change from Baseline in Mean Patient Health Questionnaire (PHQ-9) Score(Assessed at baseline and following the 8-week intervention period)
研究者
Patricia Grant, Ph.D.
Chief Research Officer
The Chicago Lighthouse