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

Primary Purpose

Visual Snow Syndrome, Trailing Phenomenon, Photophobia

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Mindfulness Based Cognitive Therapy
Sponsored by
Guy's and St Thomas' NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Visual Snow Syndrome focused on measuring Mindfulness, Mindfulness Based Cognitive Therapy

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Guys & St Thomas' NHS Foundation Trust

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MBCT-vision

Arm Description

8 x once weekly group sessions, and home practice between sessions

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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.
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.
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
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
qualitative assessment of MBCT-vision
participant feedback on the design of MBCT-vision via structured qualitative interview
functional MRI
changes to functional MRI comparing baseline to week 20 - this has been added for participants recruited in the second and third cohort

Full Information

First Posted
November 26, 2019
Last Updated
September 15, 2023
Sponsor
Guy's and St Thomas' NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT04184726
Brief Title
Mindfulness Based Cognitive Therapy Modified for Visual Symptoms (MBCT-vision)
Acronym
MBCT-vision
Official Title
Mindfulness Based Cognitive Therapy Modified for Visual Symptoms: MBCT-vision
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
January 9, 2020 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
September 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guy's and St Thomas' NHS Foundation Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Visual Snow Syndrome, Trailing Phenomenon, Photophobia, Visual Aura
Keywords
Mindfulness, Mindfulness Based Cognitive Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
MBCT-vision intervention
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MBCT-vision
Arm Type
Experimental
Arm Description
8 x once weekly group sessions, and home practice between sessions
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness Based Cognitive Therapy
Other Intervention Name(s)
MBCT
Intervention Description
mindfulness and cognitive behavioural therapy techniques taught in group sessions meeting once weekly for 8 weeks, and home practice between sessions.
Primary Outcome Measure Information:
Title
change in severity of visual symptoms
Description
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)
Time Frame
week 9 and 20
Secondary Outcome Measure Information:
Title
change in World Health Organisation (WHO) wellbeing index scores
Description
change in WHO wellbeing index, comparing pre- and post- intervention scores. WHO wellbeing index range from 0-25, with higher scores representing increased wellbeing.
Time Frame
week 9 and 20
Title
change in Clinical Outcomes in Routine Evaluation (CORE-10) scores
Description
change in CORE-10 scores, comparing pre- and post- intervention. CORE-10 scores range from 0-40 with higher scores indicating more distress.
Time Frame
week 9 and 20
Title
change in Five-Facet Mindfulness Questionnaire (FFMQ) scores
Description
change in Five-Facet Mindfulness Questionnaire scores, comparing pre- and post- intervention. FFMQ scores range from 39-195 where higher scores represent more mindfulness
Time Frame
week 9 and 20
Title
compliance (session attendance and completion of daily practice)
Description
participant compliance from attendance record for MBCT-vision weekly sessions and self-report compliance with daily home practice
Time Frame
week 9
Title
qualitative assessment of MBCT-vision
Description
participant feedback on the design of MBCT-vision via structured qualitative interview
Time Frame
week 9
Title
functional MRI
Description
changes to functional MRI comparing baseline to week 20 - this has been added for participants recruited in the second and third cohort
Time Frame
week 20

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sui H Wong, MD
Organizational Affiliation
Guys & St Thomas'
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guys & St Thomas' NHS Foundation Trust
City
London
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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