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

Sponsor
Guy's and St Thomas' NHS Foundation Trust (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04184726
Collaborator
(none)
22
1
1
32.7
0.7

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Mindfulness Based Cognitive Therapy
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
22 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
MBCT-vision interventionMBCT-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 :
Jan 9, 2020
Actual Primary Completion Date :
Dec 31, 2021
Anticipated Study Completion Date :
Sep 30, 2022

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. change in severity of visual symptoms [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 [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 [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 [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) [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 [week 9]

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

    6. functional MRI [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

    Criteria

    Ages Eligible for Study:
    16 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Guys & St Thomas' NHS Foundation Trust London United Kingdom

    Sponsors and Collaborators

    • Guy's and St Thomas' NHS Foundation Trust

    Investigators

    • Principal Investigator: Sui H Wong, MD, Guys & St Thomas'

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Guy's and St Thomas' NHS Foundation Trust
    ClinicalTrials.gov Identifier:
    NCT04184726
    Other Study ID Numbers:
    • 266101
    First Posted:
    Dec 4, 2019
    Last Update Posted:
    Jan 26, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 26, 2022