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Clinical Trials/NCT04184726
NCT04184726CompletedNot Applicable

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

Guy's and St Thomas' NHS Foundation Trust1 site in 1 country22 target enrollmentStarted: January 9, 2020Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
22
Locations
1
Primary Endpoint
change in severity of visual symptoms

Study Overview

Brief Summary

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.

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
16 Years to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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

Exclusion Criteria

  • •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)

Arms & Interventions

MBCT-vision

Experimental

8 x once weekly group sessions, and home practice between sessions

Intervention: Mindfulness Based Cognitive Therapy (Behavioral)

Outcomes

Primary Outcomes

change in severity of visual symptoms

Time Frame: 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)

Secondary Outcomes

  • change in World Health Organisation (WHO) wellbeing index scores(week 9 and 20)
  • 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)
  • compliance (session attendance and completion of daily practice)(week 9)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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