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临床试验/NCT04184726
NCT04184726已完成不适用

Mindfulness Based Cognitive Therapy Modified for Visual Symptoms: MBCT-vision

Guy's and St Thomas' NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2020年1月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
22
试验地点
1
主要终点
change in severity of visual symptoms

研究概览

简要总结

This is a research study on Mindfulness-Based Cognitive Therapy for visual symptoms (MBCT-vision), to treat patients with debilitating symptoms of visual snow (VS) and is associated visual symptoms, severe light sensitivity (i.e. photophobia) and migrainous visual aura.

Participants will receive an intervention of an 8-week MBCT course modified for visual symptoms, which will involve 8 weeks of once weekly group sessions and home practice between sessions.

详细描述

This is a research study on Mindfulness-Based Cognitive Therapy for visual symptoms (MBCT-vision), to treat patients with debilitating symptoms of visual snow (VS) and its associated visual symptoms, severe light sensitivity (i.e. photophobia) and migrainous visual aura.

VS is a condition of persistent flickering dots, like that of an out-of-focus analog television screen, affecting the whole visual field. There can be associated visual symptoms such as after-images, and trailing of images. No clinical trials for treatment have been done for VS. Instead, treatment data comes from patient case reports.

Photophobia describes discomfort or pain to light stimulation. Causes include eye surface issues, migraine, or of an unknown trigger, and can be persistent despite optimum management of underlying causes.

Patients with migrainous visual aura may have troublesome visual disturbances despite optimum migraine treatment.

Previous studies have shown that dysfunction in brain pathways contribute to the above conditions.

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
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with visual snow or associated visual symptoms; photophobia for at least 3 months
  • Patients with migrainous visual aura occurring >4 episodes a month for at least 3 months

排除标准

  • Patient with a current severe depressive or psychotic episode
  • Patient with severe difficulties in emotional regulation
  • Patient unable to provide informed consent for participation
  • Patient with insufficient understanding of spoken English (due to need to participate in group discussions)

结局指标

主要结局

change in severity of visual symptoms

时间窗: week 9 and 20

change in severity of visual symptoms pre- and post-intervention, comparing scores on Likert scale, ranging from 0/10 (no symptoms) to 10/10 (extremely severe symptoms)

次要结局

  • qualitative assessment of MBCT-vision(week 9)
  • change in Clinical Outcomes in Routine Evaluation (CORE-10) scores(week 9 and 20)
  • change in Five-Facet Mindfulness Questionnaire (FFMQ) scores(week 9 and 20)
  • functional MRI(week 20)
  • change in World Health Organisation (WHO) wellbeing index scores(week 9 and 20)
  • compliance (session attendance and completion of daily practice)(week 9)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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