Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04184726 |
Other study ID # |
266101 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
January 9, 2020 |
Est. completion date |
September 30, 2022 |
Study information
Verified date |
January 2022 |
Source |
Guy's and St Thomas' NHS Foundation Trust |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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.
Mindfulness-Based Cognitive Therapy is a treatment that combines evidence-based approaches of
Mindfulness-Based Stress Reduction and Cognitive Behavioural Therapy (CBT). MBCT is an
established 8-week programme designed to develop skills of mindfulness and CBT strategies in
individuals, through weekly small-group sessions and structured daily practice between
sessions.
Studies on MBCT and mindfulness-based interventions have shown improvements in psychological
resilience; physical health including immune function; and neural changes associated with
psychological wellbeing.
The investigators propose that MBCT, modified to incorporate aspects relevant to persistent
and distressing visual symptoms (MBCT-vision), can improve these debilitating symptoms by
modifying dysfunctional neural pathways and equip patients with skills that promote
psychological resilience and improve coping with residual symptoms.
For this study, the investigators will assess the use of MBCT-vision in patients with visual
snow or associated visual symptoms, migrainous visual aura or photophobia. This will be the
first study of a mindfulness-based intervention in this population.