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Mindfulness Based Cognitive Therapy Modified for Visual Symptoms (MBCT-vision) (MBCT-vision)

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ClinicalTrials.gov Identifier: NCT04184726
Recruitment Status : Recruiting
First Posted : December 4, 2019
Last Update Posted : June 16, 2020
Sponsor:
Information provided by (Responsible Party):
Guy's and St Thomas' NHS Foundation Trust

Tracking Information
First Submitted Date  ICMJE November 26, 2019
First Posted Date  ICMJE December 4, 2019
Last Update Posted Date June 16, 2020
Actual Study Start Date  ICMJE January 9, 2020
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 4, 2019)
change in severity of visual symptoms [ Time Frame: week 9 and 20 ]
change in severity of visual symptoms pre- and post-intervention, comparing scores on Likert scale, ranging from 0/10 (no symptoms) to 10/10 (extremely severe symptoms)
Original Primary Outcome Measures  ICMJE
 (submitted: November 29, 2019)
severity of visual symptoms [ Time Frame: week 9 and 20 ]
change in severity of visual symptoms pre- and post-intervention, comparing scores on Likert scale, ranging from 0/10 (no symptoms) to 10/10 (extremely severe symptoms)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 4, 2019)
  • change in World Health Organisation (WHO) wellbeing index scores [ Time Frame: week 9 and 20 ]
    change in WHO wellbeing index, comparing pre- and post- intervention scores. WHO wellbeing index range from 0-25, with higher scores representing increased wellbeing.
  • change in Clinical Outcomes in Routine Evaluation (CORE-10) scores [ Time Frame: week 9 and 20 ]
    change in CORE-10 scores, comparing pre- and post- intervention. CORE-10 scores range from 0-40 with higher scores indicating more distress.
  • change in Five-Facet Mindfulness Questionnaire (FFMQ) scores [ Time Frame: week 9 and 20 ]
    change in Five-Facet Mindfulness Questionnaire scores, comparing pre- and post- intervention. FFMQ scores range from 39-195 where higher scores represent more mindfulness
  • compliance (session attendance and completion of daily practice) [ Time Frame: week 9 ]
    participant compliance from attendance record for MBCT-vision weekly sessions and self-report compliance with daily home practice
  • qualitative assessment of MBCT-vision [ Time Frame: week 9 ]
    participant feedback on the design of MBCT-vision via structured qualitative interview
Original Secondary Outcome Measures  ICMJE
 (submitted: November 29, 2019)
  • psychological measures [ Time Frame: week 9 and 20 ]
    change in psychological measures on questionnaires (WHO wellbeing and CORE-10), comparing pre- and post- intervention scores
  • mindfulness measures [ Time Frame: week 9 and 20 ]
    change in mindfulness measures on questionnaires (Five-Facet Mindfulness Questionnaire), comparing pre- and post- intervention scores
  • qualitative assessment of MBCT-vision [ Time Frame: week 9 ]
    participant feedback on the design of MBCT-vision via structured qualitative interview
  • compliance [ Time Frame: week 9 ]
    participant compliance with attendance record for MBCT-vision weekly sessions and self-report compliance with daily home practice
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mindfulness Based Cognitive Therapy Modified for Visual Symptoms (MBCT-vision)
Official Title  ICMJE Mindfulness Based Cognitive Therapy Modified for Visual Symptoms: MBCT-vision
Brief Summary

This is a research study on Mindfulness-Based Cognitive Therapy for visual symptoms (MBCT-vision), to treat patients with debilitating symptoms of visual snow (VS) and is associated visual symptoms, severe light sensitivity (i.e. photophobia) and migrainous visual aura.

Participants will receive an intervention of an 8-week MBCT course modified for visual symptoms, which will involve 8 weeks of once weekly group sessions and home practice between sessions.

Detailed Description

This is a research study on Mindfulness-Based Cognitive Therapy for visual symptoms (MBCT-vision), to treat patients with debilitating symptoms of visual snow (VS) and its associated visual symptoms, severe light sensitivity (i.e. photophobia) and migrainous visual aura.

VS is a condition of persistent flickering dots, like that of an out-of-focus analog television screen, affecting the whole visual field. There can be associated visual symptoms such as after-images, and trailing of images. No clinical trials for treatment have been done for VS. Instead, treatment data comes from patient case reports.

Photophobia describes discomfort or pain to light stimulation. Causes include eye surface issues, migraine, or of an unknown trigger, and can be persistent despite optimum management of underlying causes.

Patients with migrainous visual aura may have troublesome visual disturbances despite optimum migraine treatment.

Previous studies have shown that dysfunction in brain pathways contribute to the above conditions.

Mindfulness-Based Cognitive Therapy is a treatment that combines evidence-based approaches of Mindfulness-Based Stress Reduction and Cognitive Behavioural Therapy (CBT). MBCT is an established 8-week programme designed to develop skills of mindfulness and CBT strategies in individuals, through weekly small-group sessions and structured daily practice between sessions.

Studies on MBCT and mindfulness-based interventions have shown improvements in psychological resilience; physical health including immune function; and neural changes associated with psychological wellbeing.

The investigators propose that MBCT, modified to incorporate aspects relevant to persistent and distressing visual symptoms (MBCT-vision), can improve these debilitating symptoms by modifying dysfunctional neural pathways and equip patients with skills that promote psychological resilience and improve coping with residual symptoms.

For this study, the investigators will assess the use of MBCT-vision in patients with visual snow or associated visual symptoms, migrainous visual aura or photophobia. This will be the first study of a mindfulness-based intervention in this population.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
MBCT-vision intervention
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Visual Snow Syndrome
  • Trailing Phenomenon
  • Photophobia
  • Visual Aura
Intervention  ICMJE Behavioral: Mindfulness Based Cognitive Therapy
mindfulness and cognitive behavioural therapy techniques taught in group sessions meeting once weekly for 8 weeks, and home practice between sessions.
Other Name: MBCT
Study Arms  ICMJE Experimental: MBCT-vision
8 x once weekly group sessions, and home practice between sessions
Intervention: Behavioral: Mindfulness Based Cognitive Therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 29, 2019)
36
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2020
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with visual snow or associated visual symptoms; photophobia for at least 3 months
  • Patients with migrainous visual aura occurring >4 episodes a month for at least 3 months

Exclusion Criteria:

  • Patient with a current severe depressive or psychotic episode
  • Patient with severe difficulties in emotional regulation
  • Patient unable to provide informed consent for participation
  • Patient with insufficient understanding of spoken English (due to need to participate in group discussions)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: MBCT-vision admin 02071887188 MBCTvision@gstt.nhs.uk
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04184726
Other Study ID Numbers  ICMJE 266101
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Guy's and St Thomas' NHS Foundation Trust
Study Sponsor  ICMJE Guy's and St Thomas' NHS Foundation Trust
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sui H Wong, MD Guys & St Thomas'
PRS Account Guy's and St Thomas' NHS Foundation Trust
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP