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

Overview

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.

Interventions

• Other 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 medita
• Other 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

Primary outcome measures

• Participants screened [Time frame: Through study completion, an average of 1 year]
• Participants enrolled [Time frame: Through study completion, an average of 1 year]
• Retention rate [Time frame: Up to 12 weeks.]
• Adherence rate [Time frame: Up to 12 weeks]
• Assessment rating and duration [Time frame: Up to 12 weeks]
• Intervention cost [Time frame: Up to 12 weeks]
• Data quality [Time frame: Up to 12 weeks]

Secondary outcome measures (8)

• Change in health-related quality of life (HRQOL) [Time frame: Up to 12 weeks]
• Number of participants approached [Time frame: Through study completion, an average of 1 year]
• Change in vision-related quality of life (VRQOL) [Time frame: Up to 12 weeks]
• Change in depression score [Time frame: Up to 12 weeks]
• Change in anxiety score [Time frame: Up to 12 weeks]
• Change in sleep quality [Time frame: Up to 12 weeks]
• Change in community integration [Time frame: Up to 12 weeks]
• Change in caregiver burden [Time frame: Up to 12 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Supportive care

Study locations

Canada · 1 center

• St. Joseph's Hospital, Ivey Eye Institute — London

Identifiers

NCT: NCT03166072 · 111334

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗