Low Vision, One Eye, Unspecified EyeLow Vision Blindness
Investigational drug(s) / intervention(s)
MeditationHealth Enhancement Program
Meditation: This therapy will be delivered using the hospital approved Microsoft TEAMS platform by trained, certified non-clinician teachers. 25 irreversible age-related vision loss patients and their 25 caregivers in the MEDITATION arm will be trained for 2 consecutive days (2 hours/day) in the first week, followed by 1-hour weekly reinforcement sessions for 11 weeks. Participants will learn how to respond to experiences that arise in meditation, will discuss what enhances or detracts from effective meditation, and review methods for meditating at home. Weekly reinforcement sessions will include 33 minutes of guided meditation practice, and then focus on participants' experiences with meditation during the week, additional observations, and a review of relevant knowledge to support their home practice. Each of these follow-up sessions will include a 33-minute guided meditation session. Participants will also be encouraged to practice daily at home for 33 minutes per session.
Health Enhancement Program: HEP was designed and used as a manualized active control in meditation-based intervention trials. We have tailored HEP to be structurally equivalent to MEDITATION intervention, with similar-sized groups, meeting for 2 days for 2 hours, and then one 60-75-minute follow up session weekly for the subsequent 11 follow ups. Participants allocated to HEP will be completing the same amount of home practice as MEDITATION, and will be asked to complete weekly practice logs. Participants will learn about health promotion, including the benefits of a lifestyle of healthy diet, music, recreation, and exercise, but will not learn breathing techniques, or meditation. In HEP, which is provided according to specific guidelines for administration, participants get the support of a group and facilitator, and talk through and try to implement positive health-enhancing life changes.
Study summary
Investigators aim to assess the feasibility of delivering two augmentation interventions, Meditation and a Health Enhancement Program, for potentially enhancing the quality of life and mental health of Irreversible Age-Related Vision Loss (IARVL) patients and/or their caregivers.
Eligibility
Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
Inclusion Criteria:
* Patients with irreversible age-related vision loss (IARVL) and have ongoing significant disability and/or their caregivers who agree to consent.
* IARVL patients between age 60 to 85 years or caregivers between 18 to 85 years.
* Deemed competent to provide individual consent to participate.
* Speak and understand English without requirement for interpretation or assistance.
* Have no significant self-reported or physician diagnosed mental health disorder other than depressive and/or anxiety symptoms.
* Have either a minimum of CES-D 20-item scale score of 16 OR a minimum of 8 on the Hospital Anxiety Scale (HADS-A) 7-item sub-scale.
* Have sufficient hearing to be able to follow verbal instructions
* Ability to sit independently without physical discomfort for 30 minutes.
* Willing and able to attend, via Microsoft TEAMS software, the four initial training sessions of MEDITATION or HEP and at least 6 follow-up sessions.
* Willing to dedicate 33 minutes per day to their assigned home practice.
Exclusion Criteria:
* Inability to provide informed consent.
* Dementia as defined by MoCA \< 21.
* Have significant suicidal ideation as per self-report (CES-D = 3 on item question 14 and/or 15).
* Have severe depression CES-D ≥ 24.
* Participating in other similar studies.
* Have a lifetime diagnosis of self-reported other mental disorders, including bipolar I or II disorder, primary psychotic disorder (schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder).
* Self-reported substance abuse or dependence within the past 3 months.
* Have an acutely unstable medical illnesses, including delirium or acute cerebrovascular or cardiovascular events within the last 6 months.
* Have a terminal medical diagnosis with prognosis of less than 12 months.
* Having any planned changes to mood-altering medications at the time of enrollment for the next 12 weeks.
Primary outcome measure(s)
Participants screened — Through study completion, an average of 1 year Number of participants screened
Participants enrolled — Through study completion, an average of 1 year Proportion of patients and caregivers who enrol in the study after screening
Retention rate — Up to 12 weeks. Rate of participation retention in the study
Adherence rate — Up to 12 weeks Rate of adherence to study protocol
Assessment rating and duration — Up to 12 weeks Proportion of planned ratings that are completed and duration of assessment visits
Intervention cost — Up to 12 weeks Intervention cost per case
Data quality — Up to 12 weeks Completeness and quality of final data for analysis
Trial sites (1)
Facility
City
Region
Status
St. Joseph's Hospital, Ivey Eye Institute
London
Ontario
More London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's trials in Canada
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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