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Health Education vs Meditation in Irreversible Age-Related Vision Loss Patients and Their Caregivers | Clinical Trials | Clareo Health

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Health Education vs Meditation in Irreversible Age-Related Vision Loss Patients and Their Caregivers

NCT03166072•London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

View on ClinicalTrials.gov

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.

Detailed Description

Using a mixed-method design, a pilot randomized controlled trial (RCT) study, investigators aim to assess the feasibility of delivering two augmentation interventions, Meditation to Remove Stress and Create Proper System in Mind (MEDITATION) and a Health Enhancement Program (HEP) for potentially enhancing the quality of life and mental health of Irreversible Age-Related Vision Loss (IARVL) patients and/or their caregivers. MEDITATION is a standardized, manualized therapy where participants will be guided by an instructor on meditation techniques, followed by weekly reinforcement sessions. HEP is a similarly structured intervention that controls for several factors experienced in the MEDITATION group, such as group support and morale, behavioral activation, reduction of stigma, facilitator attention, treatment duration, and time spent on at-home practice. 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.

Eligibility

Age

18 - 85 years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

St. Joseph's Hospital, Ivey Eye Institute

London, Ontario, Canada

Key Dates

Start Date

April 20, 2026

Primary Completion Date

June 15, 2027

Completion Date

December 20, 2027

Last Updated

February 3, 2026

Enrollment

150

ESTIMATED participants

Conditions

Low Vision, One Eye, Unspecified EyeLow Vision Blindness

Interventions

Meditation

OTHER

Health Enhancement Program

OTHER

Contacts

Monali Malvankar, PhD

CONTACT

5196858500 monali.malvankar@sjhc.london.on.ca