NCT04184726

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 26, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 4, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

January 9, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

September 18, 2023

Status Verified

January 1, 2022

Enrollment Period

2 years

First QC Date

November 26, 2019

Last Update Submit

September 15, 2023

Conditions

Visual Snow SyndromeTrailing PhenomenonPhotophobiaVisual Aura

Keywords

MindfulnessMindfulness Based Cognitive Therapy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • change in World Health Organisation (WHO) wellbeing index scores

    week 9 and 20

  • change in Clinical Outcomes in Routine Evaluation (CORE-10) scores

    week 9 and 20

  • change in Five-Facet Mindfulness Questionnaire (FFMQ) scores

    week 9 and 20

  • compliance (session attendance and completion of daily practice)

    week 9

  • qualitative assessment of MBCT-vision

    week 9

  • +1 more secondary outcomes

Study Arms (1)

MBCT-vision

EXPERIMENTAL

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

Behavioral: Mindfulness Based Cognitive Therapy

Interventions

Mindfulness Based Cognitive TherapyBEHAVIORAL

mindfulness and cognitive behavioural therapy techniques taught in group sessions meeting once weekly for 8 weeks, and home practice between sessions.

Also known as: MBCT
MBCT-vision

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guys & St Thomas' NHS Foundation Trust

London, United Kingdom

Location

Related Publications (1)

  • Wong SH, Pontillo G, Kanber B, Prados F, Wingrove J, Yiannakas M, Davagnanam I, Gandini Wheeler-Kingshott CAM, Toosy AT. Visual Snow Syndrome Improves With Modulation of Resting-State Functional MRI Connectivity After Mindfulness-Based Cognitive Therapy: An Open-Label Feasibility Study. J Neuroophthalmol. 2024 Mar 1;44(1):112-118. doi: 10.1097/WNO.0000000000002013. Epub 2023 Nov 15.

    PMID: 37967050DERIVED

MeSH Terms

Conditions

visual snow syndromePhotophobiaEpilepsy, Partial, Sensory

Interventions

Mindfulness-Based Cognitive Therapy

Condition Hierarchy (Ancestors)

Vision DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesEye DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsEpilepsies, PartialEpilepsyBrain DiseasesCentral Nervous System Diseases

Intervention Hierarchy (Ancestors)

MindfulnessCognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Sui H Wong, MD

    Guys & St Thomas'

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: MBCT-vision intervention
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 26, 2019

First Posted

December 4, 2019

Study Start

January 9, 2020

Primary Completion

December 31, 2021

Study Completion

September 30, 2022

Last Updated

September 18, 2023

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)