MBCT-vision VSS RCT

NCT06018103 | Not Yet Recruiting

• 1 other identifier: 328749
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

Visual Snow Syndrome (VSS) is a neurological condition with bran network dysregulation involving the visual pathway. This is a research trial comparing the effect of an 8-week mindfulness-based intervention via a group-learning course, the MBCT-vision programme, to treat Visual Snow Syndrome, compared to people on a standard care (wait-list control). Participants will be randomly allocated to either the Treatment group (MBCT-vision), or the Control group (wait-list control). After a waiting period, people allocated to the Control group will also be offered the MBCT-vision treatment. The primary outcome is to compare the severity of the visual symptoms on a 0 to 10 scale between the two groups.

Conditions

Visual Snow Syndrome

Keywords

Visual Snow Syndrome; Mindfulness

Outcome Measures

Primary Outcomes (1)

• Severity of visual symptoms of Visual Snow Syndrome on a 0-10 VAS

  Severity of VSS visual symptoms

  5 months

Secondary Outcomes (4)

• Psychological wellbeing on the World Health Organisation (WHO) wellbeing index scores

  5 months

• Psychological distress on the Clinical Outcomes in Routine Evaluation (CORE-10) scores

  5-months

• Impact of Visual Snow Syndrome symptoms on daily life on 0-10 scale

  5-months

• Work and Social Adjustment Scale

  5-months

Study Arms (2)

Treatment

EXPERIMENTAL

8-week online group learning course of the MBCT-vision programme

Behavioral: MBCT-vision

Control

NO INTERVENTION

wait-list control (standard care, no research intervention)

Interventions

MBCT-vision BEHAVIORAL

8-week mindfulness group learning course, using Mindfulness Based Cognitive Therapy customised for visual symptoms (MBCT-vision). Participants meet once weekly only, with daily home practice between sessions.

Treatment

Eligibility Criteria

• Age: 16 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• People with VSS according to the ICHD-3 criteria; previously diagnosed by a Neurologist, Ophthalmologist or Neuro-Ophthalmologist

You may not qualify if:

• Patients with co-morbid conditions affecting vision
• Patients with a current severe depressive or psychotic episode as determined by the psychologist
• Patients with severe difficulties in emotional regulation as determined by the psychologist
• Patients unable to provide informed consent for participation
• Patients with insufficient understanding of spoken English (due to need to participate in group discussions)
• Patients who have previously completed MBCT or similar mindfulness interventions
• Persons aged \<16 or \>80 years
• Family or household member of a similar age (+/- 8years) to a participant with VSS recruited into the MBCT-vision VSS RCT study
• Person with no symptoms of VSS
• Person who self-declares as fit and well with no current medical conditions including anxiety or migraine
• Person unable to provide informed consent
• Person with other co-morbid medical or psychological conditions
• Person aged \<16 or \>80years

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead

MeSH Terms

Conditions

visual snow syndrome

Study Officials

• Sui Wong, MD

  Guy's and St Thomas' NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sui Wong, MD

CONTACT

020 7188 4885; research@MBCT-vision.co.uk

Abigail Orr

CONTACT

020 7188 4885; EyeResearch@gstt.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Statistician performing the analysis will be masked. It is not possible to mask the participant nor the investigator due to the nature of the intervention (group learning programme on mindfulness)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Control Trial of two groups: Treatment (MBCT-vision), or Control (wait-list, standard of care)

Study Record Dates

• First Submitted: August 25, 2023
• First Posted: August 30, 2023
• Study Start: January 1, 2024
• Primary Completion: July 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 31, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share