Treating Psychosocial Distress in Glaucoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Change in vision-related quality-of-life (QoL)
研究概览
简要总结
In this study, using three phases, the investigators will use an iterative development approach to refine a behavioral intervention for managing concomitant psychosocial distress in glaucoma. Phase 1: The investigators will begin by developing a baseline intervention using strategies from Acceptance and Commitment Therapy (ACT), and delivered using a mobile application. Phase 2: The investigators will refine the baseline intervention for glaucoma patients using qualitative interviews conducted with primary open-angle glaucoma (POAG) patients with psychosocial distress (N=20), and health professionals (N=5). Phase 3: Finally, the investigators will measure acceptability and feasibility of the refined intervention through a single-armed pilot study (N=25). The investigators hypothesize that the refined intervention will yield an acceptable and feasible intervention in a POAG patient population, setting the stage for a future efficacy study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •diagnosed with mild, moderate, or severe chronic glaucoma (e.g., POAG),
- •had a visual field within the past year at the main Duke Eye Center,
- •been prescribed pressure lowering eye drop medication,
- •at least mild distress (based on PHQ-4),
- •18 years old,
- •able to understand, speak, and read English, and
- •be able to provide informed consent.
排除标准
- •diagnosed with borderline glaucoma or as a glaucoma suspect,
- •had a glaucoma surgery in past month (e.g., trabeculectomy, glaucoma drainage device/tube),
- •visual acuity of worse than 20/70 in the better seeing eye,
- •diagnosed with a major medical conditions (e.g., cancer, or another visual disorder, like macular degeneration),
- •diagnosed with a psychiatric conditions (e.g., schizophrenia, bipolar disorder), and
- •reported or suspected cognitive impairment indicated by provider or chart review.
研究组 & 干预措施
VISION-ACT: Acceptance commitment therapy via a mobile-application
The arm will pilot a behavioral intervention to treat psychosocial distress in patients with glaucoma using acceptance commitment therapy (ACT) delivered via a mobile-application, called VISION-ACT. The intervention will be developed and refined using qualitative feedback from glaucoma patients and healthcare stakeholders.
干预措施: Acceptance commitment therapy (Behavioral)
结局指标
主要结局
Change in vision-related quality-of-life (QoL)
时间窗: Measures will be administered at baseline (A1), immediately post-intervention (A2), and 1-month post treatment assessment (A3).
Measured using the National Eye Institute (NEI)- Visual Functioning Questionnaire (VFQ) 9. The scale ranges from 0-100 with higher values indicating higher vision-related QoL.
Change in health-related QoL
时间窗: Measures will be administered at baseline (A1), immediately post-intervention (A2), and 1-month post treatment assessment (A3).
Measured using the CDC Health-Related Quality-of-Life 4-Item Scale. For our outcome we will use the self-rated scale from Poor to Excellent, which has a scale from 1-5, with higher values indicating higher QoL.
Change in psychosocial distress
时间窗: Measures will be administered at baseline (A1), immediately post-intervention (A2), and 1-month post treatment assessment (A3).
Measured using the Hospital Anxiety and Depression Scale (HADS). The scale ranges from 0-42 with higher values indicating higher distress.
次要结局
- Change in psychological flexibility(Measures will be administered at baseline (A1), immediately post-intervention (A2), and 1-month post treatment assessment (A3).)
- Change in disease acceptance(Measures will be administered at baseline (A1), immediately post-intervention (A2), and 1-month post treatment assessment (A3).)
- Change in self-efficacy(Measures will be administered at baseline (A1), immediately post-intervention (A2), and 1-month post treatment assessment (A3).)
- Change in mindfulness(Measures will be administered at baseline (A1), immediately post-intervention (A2), and 1-month post treatment assessment (A3).)
- Change in perceived social support(Measures will be administered at baseline (A1), immediately post-intervention (A2), and 1-month post treatment assessment (A3).)