Clinical trial NCT04184726: Mindfulness Based Cognitive Therapy Modified for Visual Symptoms (MBCT-vision)
Official title: Mindfulness Based Cognitive Therapy Modified for Visual Symptoms: MBCT-vision
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Visual Snow Syndrome
Trailing Phenomenon
Photophobia
Visual Aura
Keywords: Mindfulness
Mindfulness Based Cognitive Therapy
Lead sponsor: Guy's and St Thomas' NHS Foundation Trust
Sponsor class: OTHER
First posted: 2019-12-04
Enrollment: 22
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: MBCT-vision intervention
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: change in severity of visual symptoms
timeFrame: week 9 and 20
Secondary outcomes:
measure: change in World Health Organisation (WHO) wellbeing index scores
timeFrame: week 9 and 20
measure: change in Clinical Outcomes in Routine Evaluation (CORE-10) scores
timeFrame: week 9 and 20
measure: change in Five-Facet Mindfulness Questionnaire (FFMQ) scores
timeFrame: week 9 and 20
measure: compliance (session attendance and completion of daily practice)
timeFrame: week 9
measure: qualitative assessment of MBCT-vision
timeFrame: week 9
measure: functional MRI
timeFrame: week 20
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Guys & St Thomas' NHS Foundation Trust
Study officials:
affiliation: Guys & St Thomas'
name: Sui H Wong, MD
role: PRINCIPAL_INVESTIGATOR
References: