Health TrialsbyHealthPanel

MBCT-vision VSS RCT

ConditionVisual Snow Syndrome
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16-80
SponsorGuy's and St Thomas' NHS Foundation Trust

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 groups

60 Participants
are divided into 2 treatment groups
Group A: TreatmentExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

Severity of VSS visual symptoms

Time frame
5 months

Secondary outcomes

1

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

WHO-5 wellbeing index

Time frame
5 months
2

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

CORE-10 scores

Time frame
5-months
3

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

VSS impact

Time frame
5-months
4

Work and Social Adjustment Scale

impact of VSS on work and social function

Time frame
5-months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Guy's and St Thomas' NHS Foundation Trust

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: