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Mindfulness Based Cognitive Therapy Modified for Visual Symptoms (MBCT-vision)

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04184726
Acronym
MBCT-vision
Enrollment
22
Registered
2019-12-04
Start date
2020-01-09
Completion date
2022-09-30
Last updated
2023-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Photophobia, Trailing Phenomenon, Visual Aura, Visual Snow Syndrome

Keywords

Mindfulness, Mindfulness Based Cognitive Therapy

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. 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.

Interventions

BEHAVIORALMindfulness Based Cognitive Therapy

mindfulness and cognitive behavioural therapy techniques taught in group sessions meeting once weekly for 8 weeks, and home practice between sessions.

Sponsors

Guy's and St Thomas' NHS Foundation Trust
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

MBCT-vision intervention

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
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)

Design outcomes

Primary

MeasureTime frameDescription
change in severity of visual symptomsweek 9 and 20change 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

MeasureTime frameDescription
change in Clinical Outcomes in Routine Evaluation (CORE-10) scoresweek 9 and 20change in CORE-10 scores, comparing pre- and post- intervention. CORE-10 scores range from 0-40 with higher scores indicating more distress.
change in Five-Facet Mindfulness Questionnaire (FFMQ) scoresweek 9 and 20change in Five-Facet Mindfulness Questionnaire scores, comparing pre- and post- intervention. FFMQ scores range from 39-195 where higher scores represent more mindfulness
change in World Health Organisation (WHO) wellbeing index scoresweek 9 and 20change in WHO wellbeing index, comparing pre- and post- intervention scores. WHO wellbeing index range from 0-25, with higher scores representing increased wellbeing.
qualitative assessment of MBCT-visionweek 9participant feedback on the design of MBCT-vision via structured qualitative interview
functional MRIweek 20changes to functional MRI comparing baseline to week 20 - this has been added for participants recruited in the second and third cohort
compliance (session attendance and completion of daily practice)week 9participant compliance from attendance record for MBCT-vision weekly sessions and self-report compliance with daily home practice

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026