Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2025-12-24 @ 7:38 PM
NCT ID:
NCT06018103
Eligibility Criteria:
Inclusion Criteria:
* People with VSS according to the ICHD-3 criteria; previously diagnosed by a Neurologist, Ophthalmologist or Neuro-Ophthalmologist
Exclusion Criteria:
* 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
An exploratory sub-study on the change in metabolomics will recruit healthy controls, inclusion criteria:
Healthy Control Inclusion Criteria
* 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
Healthy Control Exclusion Criteria
* Person unable to provide informed consent
* Person with other co-morbid medical or psychological conditions
* Person aged \<16 or \>80years
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
16 Years
Maximum Age:
80 Years
Study:
NCT06018103
Study Brief:
Protocol Section:
NCT06018103