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

NCT03166072 | Not Yet Recruiting DMC

• 1 other identifier: 111334
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Irreversible age-related vision loss; Randomized controlled trial; Meditation; Pilot study; Quality of life

Outcome Measures

Primary Outcomes (7)

• Participants screened

  Number of participants screened

  Through study completion, an average of 1 year

• Participants enrolled

  Proportion of patients and caregivers who enrol in the study after screening

  Through study completion, an average of 1 year

• Retention rate

  Rate of participation retention in the study

  Up to 12 weeks.

• Adherence rate

  Rate of adherence to study protocol

  Up to 12 weeks

• Assessment rating and duration

  Proportion of planned ratings that are completed and duration of assessment visits

  Up to 12 weeks

• Intervention cost

  Intervention cost per case

  Up to 12 weeks

• Data quality

  Completeness and quality of final data for analysis

  Up to 12 weeks

Secondary Outcomes (8)

• Change in health-related quality of life (HRQOL)

  Up to 12 weeks

• Number of participants approached

  Through study completion, an average of 1 year

• Change in vision-related quality of life (VRQOL)

  Up to 12 weeks

• Change in depression score

  Up to 12 weeks

• Change in anxiety score

  Up to 12 weeks

Study Arms (3)

Meditation

ACTIVE COMPARATOR

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

Other: Meditation

Treatment as Usual

NO INTERVENTION

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

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.

Other: Health Enhancement Program

Interventions

Meditation OTHER

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.

Meditation

Health Enhancement Program OTHER

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.

Health Enhancement Program (HEP)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

St. Joseph's Hospital, Ivey Eye Institute

London, Ontario, N6G0H8, Canada

Location

MeSH Terms

Conditions

Vision, Low

Interventions

Meditation

Condition Hierarchy (Ancestors)

Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Relaxation Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Monali Malvankar

  Western University, Canada

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Monali Malvankar, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 23, 2017
• First Posted: May 24, 2017
• Study Start: April 20, 2026
• Primary Completion (Estimated): June 15, 2027
• Study Completion (Estimated): December 20, 2027
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)