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NCT Number: NCT04184726

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Mindfulness Based Cognitive Therapy

Behavioral

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

Other names: MBCT

Primary outcomes

  1. 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

  1. change in World Health Organisation (WHO) wellbeing index scores

    Time frame: week 9 and 20

    change in WHO wellbeing index, comparing pre- and post- intervention scores. WHO wellbeing index range from 0-25, with higher scores representing increased wellbeing.

  2. change in Clinical Outcomes in Routine Evaluation (CORE-10) scores

    Time frame: week 9 and 20

    change in CORE-10 scores, comparing pre- and post- intervention. CORE-10 scores range from 0-40 with higher scores indicating more distress.

  3. change in Five-Facet Mindfulness Questionnaire (FFMQ) scores

    Time frame: week 9 and 20

    change in Five-Facet Mindfulness Questionnaire scores, comparing pre- and post- intervention. FFMQ scores range from 39-195 where higher scores represent more mindfulness

  4. compliance (session attendance and completion of daily practice)

    Time frame: week 9

    participant compliance from attendance record for MBCT-vision weekly sessions and self-report compliance with daily home practice

  5. qualitative assessment of MBCT-vision

    Time frame: week 9

    participant feedback on the design of MBCT-vision via structured qualitative interview

  6. functional MRI

    Time frame: week 20

    changes to functional MRI comparing baseline to week 20 - this has been added for participants recruited in the second and third cohort

Sponsors and collaborators

Lead sponsor

Guy's and St Thomas' NHS Foundation Trust

Other

Registry information

Official study title

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

Acronym: MBCT-vision

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Dec 4, 2019
Registry last updated
Sep 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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