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Not yet recruitingNCT03166072Updated Feb 3, 2026

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

An interventional study of Meditation and Health Enhancement Program in Low Vision, One Eye, Unspecified Eye and Low Vision Blindness, sponsored by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's. Not yet recruiting at 1 site in Canada. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-02-03.

Sponsored by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Low Vision, One Eye, Unspecified Eye
  • Low Vision Blindness

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Keywords

  • Irreversible age-related vision loss
  • Randomized controlled trial
  • Meditation
  • Pilot study
  • Quality of life
03

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
150 participants (estimated)

Study arms

  • Active comparator
    Meditation

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

    Other: Meditation

  • No intervention
    Treatment as Usual

    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.

  • Other
    Health Enhancement Program (HEP)

    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

  • OtherMeditation

    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.

  • OtherHealth 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 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.

05

What researchers measure

Primary outcomes

  1. Participants screened

    Number of participants screened

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

  2. Participants enrolled

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

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

  3. Retention rate

    Rate of participation retention in the study

    Time frame: Up to 12 weeks.

  4. Adherence rate

    Rate of adherence to study protocol

    Time frame: Up to 12 weeks

  5. Assessment rating and duration

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

    Time frame: Up to 12 weeks

  6. Intervention cost

    Intervention cost per case

    Time frame: Up to 12 weeks

  7. Data quality

    Completeness and quality of final data for analysis

    Time frame: Up to 12 weeks

Secondary outcomes

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

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

    Time frame: Up to 12 weeks

  2. Number of participants approached

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

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

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

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

    Time frame: Up to 12 weeks

  4. Change in depression score

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

    Time frame: Up to 12 weeks

  5. Change in anxiety score

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

    Time frame: Up to 12 weeks

  6. Change in sleep quality

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

    Time frame: Up to 12 weeks

  7. Change in community integration

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

    Time frame: Up to 12 weeks

  8. Change in caregiver burden

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

    Time frame: Up to 12 weeks

06

Study locations

1 site
  • St. Joseph's Hospital, Ivey Eye Institute
    London, Ontario N6G0H8, Canada
07

References and documents

Individual participant data

Plan to share: No — IPD will not be available to other researchers since the current research team has the necessary expertise to conduct data analysis.

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03166072
Lead sponsor
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Responsible party
Monali Malvankar (Assistant Professor, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's) — Principal investigator
First posted
May 24, 2017
Start date
Apr 20, 2026 (estimated)
Primary completion
Jun 15, 2027 (estimated)
Completion
Dec 20, 2027 (estimated)
Last update
Feb 3, 2026

Study contacts

Monali Malvankar, PhD
Contact
monali.malvankar@sjhc.london.on.ca
5196858500 ext. 61288
Monali Malvankar
principal investigator · Western University, Canada

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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