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

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ClinicalTrials.gov Identifier: NCT04184726
Recruitment Status : Completed
First Posted : December 4, 2019
Last Update Posted : September 18, 2023
Sponsor:
Information provided by (Responsible Party):
Guy's and St Thomas' NHS Foundation Trust

Study Description
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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.


Condition or disease Intervention/treatment Phase
Visual Snow Syndrome Trailing Phenomenon Photophobia Visual Aura Behavioral: Mindfulness Based Cognitive Therapy Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: MBCT-vision intervention
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mindfulness Based Cognitive Therapy Modified for Visual Symptoms: MBCT-vision
Actual Study Start Date : January 9, 2020
Actual Primary Completion Date : December 31, 2021
Actual Study Completion Date : September 30, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: MBCT


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04184726


Locations
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United Kingdom
Guys & St Thomas' NHS Foundation Trust
London, United Kingdom
Sponsors and Collaborators
Guy's and St Thomas' NHS Foundation Trust
Investigators
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Principal Investigator: Sui H Wong, MD Guys & St Thomas'
More Information
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Responsible Party: Guy's and St Thomas' NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT04184726    
Other Study ID Numbers: 266101
First Posted: December 4, 2019    Key Record Dates
Last Update Posted: September 18, 2023
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Guy's and St Thomas' NHS Foundation Trust:
Mindfulness
Mindfulness Based Cognitive Therapy
Additional relevant MeSH terms:
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Photophobia
Vision Disorders
Sensation Disorders
 Neurologic Manifestations
Nervous System Diseases
Eye Diseases