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

Photophobia Clinical Trial

— MBCT-vision  

Official title:

Mindfulness Based Cognitive Therapy Modified for Visual Symptoms: MBCT-vision

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04184726
• Other study ID #: 266101
• Status: Completed
• Phase: N/A
• Start date: January 9, 2020
• Est. completion date: September 30, 2022

Study information

• Verified date: January 2022
• Source: Guy's and St Thomas' NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: September 30, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Photophobia
• Trailing Phenomenon
• Visual Aura
• Visual Snow Syndrome

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Guys & St Thomas' NHS Foundation Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
Guy's and St Thomas' NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	week 9 and 20
Secondary	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.	week 9 and 20
Secondary	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	week 9 and 20
Secondary	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	week 9
Secondary	qualitative assessment of MBCT-vision	participant feedback on the design of MBCT-vision via structured qualitative interview	week 9
Secondary	functional MRI	changes to functional MRI comparing baseline to week 20 - this has been added for participants recruited in the second and third cohort	week 20