xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06018103</url>
    </required_header>
    <id_info>
      <org_study_id>328749</org_study_id>
      <nct_id>NCT06018103</nct_id>
    </id_info>
    <brief_title>MBCT-vision VSS RCT</brief_title>
    <official_title>MBCT-vision to Treat Visual Snow Syndrome: a Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Guy's and St Thomas' NHS Foundation Trust</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Guy's and St Thomas' NHS Foundation Trust</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Visual Snow Syndrome (VSS) is a neurological condition with bran network dysregulation&#xD;
        involving the visual pathway. This is a research trial comparing the effect of an 8-week&#xD;
        mindfulness-based intervention via a group-learning course, the MBCT-vision programme, to&#xD;
        treat Visual Snow Syndrome, compared to people on a standard care (wait-list control).&#xD;
        Participants will be randomly allocated to either the Treatment group (MBCT-vision), or the&#xD;
        Control group (wait-list control). After a waiting period, people allocated to the Control&#xD;
        group will also be offered the MBCT-vision treatment. The primary outcome is to compare the&#xD;
        severity of the visual symptoms on a 0 to 10 scale between the two groups.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Visual Snow Syndrome (VSS) is a neurological condition where affected people see flickering&#xD;
        dots across their whole visual field, &amp; may have other symptoms such as light sensitivity,&#xD;
        after-images, trailing of images, &amp; tinnitus. Functional Magnetic Resonance Imaging (fMRI)&#xD;
        studies in VSS have shown brain network dysregulation involving the visual pathway. There is&#xD;
        currently no evidence-based validated treatment for VSS, therefore the current standard of&#xD;
        care is no treatment.&#xD;
  &#xD;
        This research trial is to test the treatment of an intensive mindfulness programme, using the&#xD;
        Mindfulness Based Cognitive Therapy customised for visual symptoms (MBCT-vision) programme,&#xD;
        for people with Visual Snow Syndrome. MBCT-vision is a group learning programme, where people&#xD;
        meet once weekly for 8 weeks. During these once weekly sessions, they learn mindfulness&#xD;
        practices. The group discussions about the mindfulness practices introduces cognitive&#xD;
        behavioural skills. Participants are given daily home practices between these weekly group&#xD;
        learning sessions. We completed a study (ClinicalTrials.gov identifier NCT04184726) showing&#xD;
        MBCT-vision was a feasible treatment for VSS.&#xD;
  &#xD;
        This clinical trial is a 'randomized controlled trial'(RCT), where the effectiveness of a&#xD;
        treatment is evaluated by comparison between two groups. We are recruiting people with VSS.&#xD;
        Participants will be randomly allocated to one of two groups: one group receives MBCT-vision;&#xD;
        while another group received standard care only for 5 months. The second group is called a&#xD;
        waiting-list control group, whereby after 5 months, they will receive MBCT-vision treatment.&#xD;
        The study will be conducted from single centre at a tertiary care hospital and the&#xD;
        MBCT-vision is delivered online.&#xD;
  &#xD;
        The key outcome of interest is severity of Visual Snow Syndrome on a 0-10 visual analogue&#xD;
        scale. Other outcome measures will be collected to understand the effect of MBCT-vision,&#xD;
        including quality of life and psychological wellbeing.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">January 2024</start_date>
    <completion_date type="Anticipated">December 2026</completion_date>
    <primary_completion_date type="Anticipated">July 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Randomized Control Trial of two groups: Treatment (MBCT-vision), or Control (wait-list, standard of care)</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
      <masking_description>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)</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Severity of visual symptoms of Visual Snow Syndrome on a 0-10 VAS</measure>
      <time_frame>5 months</time_frame>
      <description>Severity of VSS visual symptoms</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Psychological wellbeing on the World Health Organisation (WHO) wellbeing index scores</measure>
      <time_frame>5 months</time_frame>
      <description>WHO-5 wellbeing index</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Psychological distress on the Clinical Outcomes in Routine Evaluation (CORE-10) scores</measure>
      <time_frame>5-months</time_frame>
      <description>CORE-10 scores</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Impact of Visual Snow Syndrome symptoms on daily life on 0-10 scale</measure>
      <time_frame>5-months</time_frame>
      <description>VSS impact</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Work and Social Adjustment Scale</measure>
      <time_frame>5-months</time_frame>
      <description>impact of VSS on work and social function</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Visual Snow Syndrome</condition>
    <arm_group>
      <arm_group_label>Treatment</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>8-week online group learning course of the MBCT-vision programme</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>wait-list control (standard care, no research intervention)</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>MBCT-vision</intervention_name>
      <description>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.</description>
      <arm_group_label>Treatment</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  People with VSS according to the ICHD-3 criteria; previously diagnosed by a&#xD;
               Neurologist, Ophthalmologist or Neuro-Ophthalmologist&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with co-morbid conditions affecting vision&#xD;
  &#xD;
            -  Patients with a current severe depressive or psychotic episode as determined by the&#xD;
               psychologist&#xD;
  &#xD;
            -  Patients with severe difficulties in emotional regulation as determined by the&#xD;
               psychologist&#xD;
  &#xD;
            -  Patients unable to provide informed consent for participation&#xD;
  &#xD;
            -  Patients with insufficient understanding of spoken English (due to need to participate&#xD;
               in group discussions)&#xD;
  &#xD;
            -  Patients who have previously completed MBCT or similar mindfulness interventions&#xD;
  &#xD;
            -  Persons aged &lt;16 or &gt;80 years&#xD;
  &#xD;
          An exploratory sub-study on the change in metabolomics will recruit healthy controls,&#xD;
          inclusion criteria:&#xD;
  &#xD;
          Healthy Control Inclusion Criteria&#xD;
  &#xD;
            -  Family or household member of a similar age (+/- 8years) to a participant with VSS&#xD;
               recruited into the MBCT-vision VSS RCT study&#xD;
  &#xD;
            -  Person with no symptoms of VSS&#xD;
  &#xD;
            -  Person who self-declares as fit and well with no current medical conditions including&#xD;
               anxiety or migraine&#xD;
  &#xD;
          Healthy Control Exclusion Criteria&#xD;
  &#xD;
            -  Person unable to provide informed consent&#xD;
  &#xD;
            -  Person with other co-morbid medical or psychological conditions&#xD;
  &#xD;
            -  Person aged &lt;16 or &gt;80years&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>16 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Sui Wong, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Guy's and St Thomas' NHS Foundation Trust</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Sui Wong, MD</last_name>
      <phone>020 7188 4885</phone>
      <email>research@MBCT-vision.co.uk</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Abigail Orr</last_name>
      <phone>020 7188 4885</phone>
      <email>EyeResearch@gstt.nhs.uk</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 25, 2023</study_first_submitted>
    <study_first_submitted_qc>August 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 2023</study_first_posted>
    <last_update_submitted>August 30, 2023</last_update_submitted>
    <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 31, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Visual Snow Syndrome</keyword>
    <keyword>Mindfulness</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Syndrome</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>anonymised numeric data to be shared upon reasonable request from qualified researcher after review by Eye Research Governance and data transfer agreement</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06018103
  org study id: 328749
  nct id: NCT06018103
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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 (ClinicalTrials.gov identifier NCT04184726) showing
        MBCT-vision was a feasible treatment for VSS.
  
        This clinical trial is a 'randomized 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.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Randomized Control Trial of two groups: Treatment (MBCT-vision), or Control (wait-list, standard of care)
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  masking description: 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)
  measure: Severity of visual symptoms of Visual Snow Syndrome on a 0-10 VAS
  time frame: 5 months
  description: Severity of VSS visual symptoms
  measure: Psychological wellbeing on the World Health Organisation (WHO) wellbeing index scores
  time frame: 5 months
  description: WHO-5 wellbeing index
  measure: Psychological distress on the Clinical Outcomes in Routine Evaluation (CORE-10) scores
  time frame: 5-months
  description: CORE-10 scores
  measure: Impact of Visual Snow Syndrome symptoms on daily life on 0-10 scale
  time frame: 5-months
  description: VSS impact
  measure: Work and Social Adjustment Scale
  time frame: 5-months
  description: impact of VSS on work and social function
  arm group label: Treatment
  arm group type: Experimental
  description: 8-week online group learning course of the MBCT-vision programme
  arm group label: Control
  arm group type: No Intervention
  description: wait-list control (standard care, no research intervention)
  intervention type: Behavioral
  intervention name: MBCT-vision
  description: 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.
  arm group label: Treatment
  criteria: 
  gender: All
  minimum age: 16 Years
  maximum age: 80 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Sui Wong, MD
  role: Principal Investigator
  affiliation: Guy's and St Thomas' NHS Foundation Trust
  last name: Sui Wong, MD
  phone: 020 7188 4885
  email: research@MBCT-vision.co.uk
  last name: Abigail Orr
  phone: 020 7188 4885
  email: EyeResearch@gstt.nhs.uk
  responsible party type: Sponsor
  mesh term: Syndrome
  sharing ipd: No
  ipd description: anonymised numeric data to be shared upon reasonable request from qualified researcher after review by Eye Research Governance and data transfer agreement