MBCT-vision VSS RCT

  • Research type

    Research Study

  • Full title

    MBCT-vision as a treatment for Visual Snow Syndrome: a Randomised Controlled Trial

  • IRAS ID

    328749

  • Contact name

    Sui Wong

  • Contact email

    sui.wong@gstt.nhs.uk

  • Sponsor organisation

    Guy's & St Thomas' NHS Foundation Trust

  • Clinicaltrials.gov Identifier

    NCT06018103

  • Duration of Study in the UK

    2 years, 11 months, 30 days

  • Research summary

    Visual Snow Syndrome (VSS) is a neurological condition where affected people see flickering dots across their whole visual field, & may have other symptoms such as light sensitivity, after-images, trailing of images, & tinnitus. Functional Magnetic Resonance Imaging (fMRI) studies in VSS have shown brain network dysregulation involving the visual pathway. There is currently no evidence-based validated treatment for VSS, therefore the current standard of care is no treatment.

    This research trial is to test the treatment of an intensive mindfulness programme, using the Mindfulness Based Cognitive Therapy customised for visual symptoms (MBCT-vision) programme, for people with Visual Snow Syndrome. MBCT-vision is a group learning programme, where people meet once weekly for 8 weeks. During these once weekly sessions, they learn mindfulness practices. The group discussions about the mindfulness practices introduces cognitive behavioural skills. Participants are given daily home practices between these weekly group learning sessions. We completed a study (IRAS 266101) showing MBCT-vision was a feasible treatment for VSS.

    This clinical trial is a 'randomised controlled trial'(RCT), where the effectiveness of a treatment is evaluated by comparison between two groups. We are recruiting people with VSS. Participants will be randomly allocated to one of two groups: one group receives MBCT-vision; while another group received standard care only for 5 months. The second group is called a waiting-list control group, whereby after 5 months, they will receive MBCT-vision treatment. The study will be conducted from single centre at a tertiary care hospital and the MBCT-vision is delivered online.

    The key outcome of interest is severity of Visual Snow Syndrome on a 0-10 visual analogue scale. Other outcome measures will be collected to understand the effect of MBCT-vision, including quality of life and psychological wellbeing.

  • REC name

    North of Scotland Research Ethics Committee 2

  • REC reference

    23/NS/0101

  • Date of REC Opinion

    4 Oct 2023

  • REC opinion

    Further Information Favourable Opinion