An interventional study of Mindfulness Based Cognitive Therapy in Visual Snow Syndrome, Trailing Phenomenon and Photophobia, sponsored by Guy's and St Thomas' NHS Foundation Trust. Completed at 1 site in United Kingdom. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2023-09-18.
Sponsored by Guy's and St Thomas' NHS Foundation Trust · Not applicable, Interventional, and Treatment
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.
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.
43 studies on the registry are indexed under Photophobia; 13 are open to participants now.
This study's enrollment of 22 is below the median of 43 across 36 interventional studies indexed under Photophobia.
Browse Photophobia studies →Guy's and St Thomas' NHS Foundation Trust is the lead sponsor of 295 studies on the registry; 80 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
8 x once weekly group sessions, and home practice between sessions
Behavioral: Mindfulness Based Cognitive Therapy
mindfulness and cognitive behavioural therapy techniques taught in group sessions meeting once weekly for 8 weeks, and home practice between sessions.
Also known as: MBCT
change in severity of visual symptoms
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)
Time frame: week 9 and 20
change in World Health Organisation (WHO) wellbeing index scores
change in WHO wellbeing index, comparing pre- and post- intervention scores. WHO wellbeing index range from 0-25, with higher scores representing increased wellbeing.
Time frame: week 9 and 20
change in Clinical Outcomes in Routine Evaluation (CORE-10) scores
change in CORE-10 scores, comparing pre- and post- intervention. CORE-10 scores range from 0-40 with higher scores indicating more distress.
Time frame: week 9 and 20
change in Five-Facet Mindfulness Questionnaire (FFMQ) scores
change in Five-Facet Mindfulness Questionnaire scores, comparing pre- and post- intervention. FFMQ scores range from 39-195 where higher scores represent more mindfulness
Time frame: week 9 and 20
compliance (session attendance and completion of daily practice)
participant compliance from attendance record for MBCT-vision weekly sessions and self-report compliance with daily home practice
Time frame: week 9
qualitative assessment of MBCT-vision
participant feedback on the design of MBCT-vision via structured qualitative interview
Time frame: week 9
functional MRI
changes to functional MRI comparing baseline to week 20 - this has been added for participants recruited in the second and third cohort
Time frame: week 20
Plan to share: No
No publications or documents are linked to this record.
Ran from Jan 2020 to primary completion in Dec 2021, 23 months.
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This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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