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

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

Status: Begins enrollment in 2 months

Conditions: Low Vision Blindness; Low Vision, One Eye, Unspecified Eye

Treatments: Other: Health Enhancement Program; Other: Meditation

Study type: Interventional

Funder types: Other

Identifiers

NCT03166072

111334

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 3 patient groups

Meditation

Active Comparator group

Description:

Participants randomized to this arm will undergo the MEDITATION intervention, with weekly training and reinforcement sessions.

Treatment:

Other: Meditation

Treatment as Usual

No Intervention group

Description:

Participants randomized to this arm will continue to undergo the usual standard of care. The usual standard of care for IARVL patients includes no active treatment since eye surgeons have done all that could possibly be done to restore vision.

Health Enhancement Program (HEP)

Other group

Description:

Participants randomized to this arm will undergo the Health Enhancement Program (HEP) intervention, with weekly sessions identical in structure to those of the MEDITATION arm.

Treatment:

Other: Health Enhancement Program