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NCT Number: NCT03166072

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

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Joseph's Hospital, Ivey Eye Institute

London, Ontario, N6G0H8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Participants screened

    Time frame: Through study completion, an average of 1 year

    Number of participants screened

  2. Participants enrolled

    Time frame: Through study completion, an average of 1 year

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

  3. Retention rate

    Time frame: Up to 12 weeks.

    Rate of participation retention in the study

  4. Adherence rate

    Time frame: Up to 12 weeks

    Rate of adherence to study protocol

  5. Assessment rating and duration

    Time frame: Up to 12 weeks

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

  6. Intervention cost

    Time frame: Up to 12 weeks

    Intervention cost per case

  7. Data quality

    Time frame: Up to 12 weeks

    Completeness and quality of final data for analysis

Secondary outcomes

  1. Change in health-related quality of life (HRQOL)

    Time frame: Up to 12 weeks

    Improvement in HRQOL score as measured by the Short Form 12 Health Survey (SF-12) up to 12 weeks.

  2. Number of participants approached

    Time frame: Through study completion, an average of 1 year

    Number of potential participants (IARVL patients and their caregivers) approached per month

  3. Change in vision-related quality of life (VRQOL)

    Time frame: Up to 12 weeks

    Improvement in VRQOL score as measured by the Visual Function 14-item questionnaire (VF-14) up to 12 weeks.

  4. Change in depression score

    Time frame: Up to 12 weeks

    Reduction in depressive symptoms as measured by the Center for Epidemiological Studies Depression questionnaire (CES-D) scores up to 12 weeks.

  5. Change in anxiety score

    Time frame: Up to 12 weeks

    Reduction in anxiety symptoms as measured by the Hospital Anxiety Scale questionnaire (HADS-A) scores up to 12 weeks.

  6. Change in sleep quality

    Time frame: Up to 12 weeks

    Enhanced sleep quality as measured by reduction in Pittsburg Sleep Quality Index questionnaire (PSQI) scores (≤ 5) up to 12 weeks.

  7. Change in community integration

    Time frame: Up to 12 weeks

    Enhanced community integration as measured by an increase in Community Integration Questionnaire (CIQ) scores up to 12 weeks.

  8. Change in caregiver burden

    Time frame: Up to 12 weeks

    Reduced caregiver burden as measured by reduction in Zarit Burden Interview (ZBI) scores up to 12 weeks.

Study contacts

Contact information is provided by the study sponsor or research team.

Monali Malvankar, PhD

CONTACT

[email protected]

5196858500 ext. 61288

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 24, 2017
Registry last updated
Feb 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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