Visual Snow SyndromeMBCT-visionNCT04184726
Mindfulness Based Cognitive Therapy Modified for Visual Symptoms (MBCT-vision)
A study testing Mindfulness Based Cognitive Therapy in people with Visual Snow Syndrome and Trailing Phenomenon, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Visual Snow Syndrome, Trailing Phenomenon, Photophobia
- What is being tested?
- Mindfulness Based Cognitive Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 Jan 2020to 30 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Visual Snow Syndrome, Trailing Phenomenon, Photophobia, Visual Aura
- Being tested
- Mindfulness Based Cognitive Therapy
- Keywords
- Mindfulness, Mindfulness Based Cognitive Therapy
- Medical subject headings
- visual snow syndrome, Photophobia, Epilepsy, Partial, Sensory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Based Cognitive TherapyBehavioural
Also called MBCT
mindfulness and cognitive behavioural therapy techniques taught in group sessions meeting once weekly for 8 weeks, and home practice between sessions.
| Study group | Role | What they receive |
|---|---|---|
| MBCT-vision | Experimental | 8 x once weekly group sessions, and home practice between sessions Receives: Behavioral: Mindfulness Based Cognitive Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: week 9 and 20
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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
Measured: 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
Measured: week 9
qualitative assessment of MBCT-vision
participant feedback on the design of MBCT-vision via structured qualitative interview
Measured: 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
Measured: week 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2019
- Study start9 Jan 2020
- Primary completion31 Dec 2021
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Visual Snow SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- MBCT-vision intervention
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sui H Wong, MD, Principal investigator, Guys & St Thomas'
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04184726
- Sponsor's protocol ID
- 266101
- Acronym
- MBCT-vision
- Status last verified
- Jan 2022
- First submitted
- 26 Nov 2019
- Last updated
- 18 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37967050
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness Based Cognitive Therapy Modified for Visual Symptoms: MBCT-vision
- ClinicalTrials.gov ID
- NCT04184726
- Acronym / sponsor ID
- MBCT-vision / 266101
- Conditions
- Visual Snow Syndrome, Trailing Phenomenon, Photophobia, Visual Aura
- Keywords
- Mindfulness, Mindfulness Based Cognitive Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Study start
- 9 Jan 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 4 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- MBCT-vision intervention
| Arm | Type | Receives |
|---|---|---|
| MBCT-vision | Experimental | Behavioral: Mindfulness Based Cognitive Therapy8 x once weekly group sessions, and home practice between sessions |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness Based Cognitive TherapyAlso: MBCTmindfulness and cognitive behavioural therapy techniques taught in group sessions meeting once weekly for 8 weeks, and home practice between sessions. | Behavioural | MBCT-vision |
Primary outcome
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)
6 secondary outcomes
change in World Health Organisation (WHO) wellbeing index scores
Time frame: week 9 and 20
change in Clinical Outcomes in Routine Evaluation (CORE-10) scores
Time frame: week 9 and 20
change in Five-Facet Mindfulness Questionnaire (FFMQ) scores
Time frame: week 9 and 20
compliance (session attendance and completion of daily practice)
Time frame: week 9
qualitative assessment of MBCT-vision
Time frame: week 9
functional MRI
Time frame: week 20
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2023.
- Derived from this study: PubMed 37967050Wong 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.
- Individual participant dataSharing planned: No
Related trials for Visual Snow Syndrome
Recruiting
Investigating Brain Function in People With and Without Visual Snow Syndrome Using Adaptation to Visual Stimuli
Visual Snow Syndrome, Migraine
RecruitingObservational study
High-field MR Imaging in Migraine, Visual Snow and Epilepsy
Migraine, Epilepsy
Recruiting
Study of Visual Perception Phenomena: Phosphene Mapping Induced by TMS and Its Relationship With Eye Movements
Visual Snow Syndrome, Color Blindness
Not yet recruiting
MBCT-vision VSS RCT
Visual Snow Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sui H Wong, MD principal investigator
Guys & St Thomas'
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Based Cognitive Therapy in people with Visual Snow Syndrome and Trailing Phenomenon, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in severity of visual symptoms (time frame: week 9 and 20). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04184726, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2023; AzTrials last refreshed its copy on 26 Oct 2026.