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

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.

Study Overview

• Status: Completed
• Conditions: Visual Snow Syndrome; Photophobia; Trailing Phenomenon; Visual Aura
• Intervention / Treatment: Behavioral: Mindfulness Based Cognitive Therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom
    • Guys & St Thomas' NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MBCT-vision; 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.; Other Names: MBCT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	week 9 and 20

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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	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	week 9
qualitative assessment of MBCT-vision	participant feedback on the design of MBCT-vision via structured qualitative interview	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	week 20

Collaborators and Investigators

• Sponsor: Guy's and St Thomas' NHS Foundation Trust
• Investigators: Principal Investigator: Sui H Wong, MD, Guys & St Thomas'

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2020
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): September 30, 2022

Study Registration Dates

• First Submitted: November 26, 2019
• First Submitted That Met QC Criteria: November 29, 2019
• First Posted (Actual): December 4, 2019

Study Record Updates

• Last Update Posted (Actual): September 18, 2023
• Last Update Submitted That Met QC Criteria: September 15, 2023
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Mindfulness; Mindfulness Based Cognitive Therapy
• Additional Relevant MeSH Terms: Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Sensation Disorders; Vision Disorders; Photophobia
• Other Study ID Numbers: 266101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No