GlaucomaNCT05697094
Impact of Meditation on Improving Quality of Life Among Glaucoma Patients: An Electronic Pilot Feasibility Study
A study testing Meditation to Remove Stress and Create A Proper System in Mind in people with Glaucoma and Depression, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
Glaucoma is a chronic disease that causes loss of vision and potentially blindness as a result of optic nerve damage due to increased intraocular pressure. Currently, it is the leading cause of irreversible blindness worldwide1. Read more about this study
- Who is it for?
- Ages 65 to 75 years
- Conditions the study is for
- Glaucoma, Depression, Anxiety
- What is being tested?
- Meditation to Remove Stress and Create A Proper System in Mind
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 1 Nov 2023to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 75 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients diagnosed with mild glaucoma.
- Patients aged 65-75.
- Being able to provide valid informed consent to participate in the research study.
- Being able to read and understand English.
- Having no significant self-reported or physician-diagnosed mental health disorder.
- Able to independently access a computer to participate in virtual meditation sessions.
- Must be able to sit comfortably for 30-35 minutes without any major pain or discomfort, can hear well enough to follow verbal instructions when the eyes are closed, and be in good general physical health.
Who cannot join
- Inability to provide valid informed consent.
- Significant communication barriers or lack of English proficiency that prevents participants from completing the questionnaires.
- Severe depression as confirmed by a CES-D ≥ 24.
- Having a lifetime diagnosis of self-reported other serious 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.
- Having acutely unstable medical illnesses, including delirium or acute cerebrovascular or cardiovascular events within the last 6 months.
- Having irreversible vision loss that prevents one from completing the questionnaires.
- Participation in a study involving similar techniques.
Trial locations and contacts
1 site in 1 country.
About this study
Glaucoma is a chronic disease that causes loss of vision and potentially blindness as a result of optic nerve damage due to increased intraocular pressure. Currently, it is the leading cause of irreversible blindness worldwide1. In 2020, 4.1 million and 3.6 million adults over the age of 50 suffered from mild to severe visual impairment and blindness respectively induced by glaucoma1. However, these predictions are likely underestimated since glaucoma can remain asymptomatic until later stages in disease progression2.
There is a convincing body of evidence suggesting that there is a linear relationship between visual impairment and decreased quality of life (QOL) among glaucoma patients3. Furthermore, evidence from The National Health and Aging Trends Study suggests that this relationship may be bidirectional where older adults with visual impairment are more likely to suffer from mental illness and older adults with mental illness are more likely to suffer from visual impairment4. Mindfulness-based meditation is a promising non-pharmacological treatment that has been shown to reduce intraocular pressure and improve QOL in patients with glaucoma5.
A feasibility study will be conducted using a mixed-method design to assess the feasibility of delivering a meditation intervention online to enhance the QOL and mental health of glaucoma patients. Participants will be recruited and randomized in blocks of 10 and will undergo 1:1 randomization to the intervention arm or usual care arm. The purpose of this block randomization technique is to minimize the wait time between patient recruitment and study initiation. Participants in each arm will complete online questionnaires at patient recruitment, weeks 1, 3, 6, and 12 to measure self-reported health, depression symptoms, anxiety, and sleep quality using REDCap, an electronic data capturing system provided by Lawson Health Research Institute (LHRI).
- Conditions
- Glaucoma, Depression, Anxiety, Sleep Disorder, Quality of Life
- Being tested
- Meditation to Remove Stress and Create A Proper System in Mind
- Keywords
- Health-related quality of life, Glaucoma, Meditation
- Medical subject headings
- Glaucoma, Depression, Anxiety Disorders, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meditation to Remove Stress and Create A Proper System in MindBehavioural
Also called Beyond Mindfulness Meditation
Meditation to Remove Stress and Create A Proper System in Mind is a guided meditation.
| Study group | Role | What they receive |
|---|---|---|
| Meditation to Remove Stress and Create A Proper System in Mind | Experimental | The study intervention will be administered to participants randomized to the intervention arm. The meditation intervention will be delivered virtually via the hospital-approved Microsoft Teams platform. Participants will be taught an evidence-based meditation technique which includes two online sessions (60 minutes/day) with a trained, experienced, and certified teacher of Prasanna Wellness, a non-profit service organization. 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. The participants in the intervention arm will complete 60-minute follow-up sessions with the Prasanna Wellness staff which will include 33 minutes of guided meditation practice, and then a discussion of participants' experiences with meditation during the week, additional observations, and a review of relevant knowledge to support their home practice. Receives: Behavioral: Meditation to Remove Stress and Create A Proper System in Mind |
| Usual Care | No intervention | Participants will continue with their usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The 12-item short form survey
The 12-Item Short Form Survey (SF-12) is a questionnaire that measures self-reported health. Scores are calculated by converting the sum of responses to a scale from 0 to 100 where a higher score indicates superior health. In addition, results can be summarised using the physical component summary (PCS) score and the mental component summary (MCS) score.
Measured: Week 1, week 3, week 6, week 12
Secondary outcomes (3)
Depression
Depression is a feeling of severe despondency and dejection. Depression will be measured using the Center for Epidemiological Studies - Depression (CES-D) score.
The CES-D provides scores from 0 to 60. Higher scores indicate worse outcome.
Measured: Week 1, week 3, week 6, week 12
Anxiety
Anxiety will be measured using Hospital Anxiety and Depression Scale - Anxiety (HADS-A) subscale.
The HADS-A provides scores from 0-21. Higher scores indicate worse outcome.
Measured: Week 1, week 3, week 6, week 12
Sleep quality
Sleep quality as measured using the Pittsburgh Sleep Quality Index (PSQI) scores. The PSQI provides scores from 0-21. Higher scores indicate worse outcome.
Measured: Week 1, week 3, week 6, week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2023
- Study start1 Nov 2023 (estimated)
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Monali Malvankar, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05697094
- Sponsor's protocol ID
- 119431
- Status last verified
- Nov 2023
- First submitted
- 25 Jun 2021
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified individual participant data (IPD) collected in this study will not be available to other researchers (e.g., outside the primary research group). Since the primary research group has the necessary expertise to analyze the data and do not need any outside help.
Publications
Atreya CE, Kubo A, Borno HT, Rosenthal B, Campanella M, Rettger JP, Joseph G, Allen IE, Venook AP, Altschuler A, Dhruva A. Being Present: A single-arm feasibility study of audio-based mindfulness meditation for colorectal cancer patients and caregivers. PLoS One. 2018 Jul 23;13(7):e0199423. doi: 10.1371/journal.pone.0199423. eCollection 2018.
PubMed 30036361Yunesian M, Aslani A, Vash JH, Yazdi AB. Effects of Transcendental Meditation on mental health: a before-after study. Clin Pract Epidemiol Ment Health. 2008 Nov 1;4:25. doi: 10.1186/1745-0179-4-25.
PubMed 18976496
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Meditation on Improving Quality of Life Among Glaucoma Patients: An Electronic Pilot Feasibility Study
- ClinicalTrials.gov ID
- NCT05697094
- Acronym / sponsor ID
- 119431
- Conditions
- Glaucoma, Depression, Anxiety, Sleep Disorder, Quality of Life
- Keywords
- Health-related quality of life, Glaucoma, Meditation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 1 Nov 2023 (estimated)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 25 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Glaucoma is a chronic disease that causes loss of vision and potentially blindness as a result of optic nerve damage due to increased intraocular pressure. Currently, it is the leading cause of irreversible blindness worldwide1. In 2020, 4.1 million and 3.6 million adults over the age of 50 suffered from mild to severe visual impairment and blindness respectively induced by glaucoma1. However, these predictions are likely underestimated since glaucoma can remain asymptomatic until later stages in disease progression2.
There is a convincing body of evidence suggesting that there is a linear relationship between visual impairment and decreased quality of life (QOL) among glaucoma patients3. Furthermore, evidence from The National Health and Aging Trends Study suggests that this relationship may be bidirectional where older adults with visual impairment are more likely to suffer from mental illness and older adults with mental illness are more likely to suffer from visual impairment4. Mindfulness-based meditation is a promising non-pharmacological treatment that has been shown to reduce intraocular pressure and improve QOL in patients with glaucoma5.
A feasibility study will be conducted using a mixed-method design to assess the feasibility of delivering a meditation intervention online to enhance the QOL and mental health of glaucoma patients. Participants will be recruited and randomized in blocks of 10 and will undergo 1:1 randomization to the intervention arm or usual care arm. The purpose of this block randomization technique is to minimize the wait time between patient recruitment and study initiation. Participants in each arm will complete online questionnaires at patient recruitment, weeks 1, 3, 6, and 12 to measure self-reported health, depression symptoms, anxiety, and sleep quality using REDCap, an electronic data capturing system provided by Lawson Health Research Institute (LHRI).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Meditation to Remove Stress and Create A Proper System in Mind | Experimental | Behavioral: Meditation to Remove Stress and Create A Proper System in MindThe study intervention will be administered to participants randomized to the intervention arm. The meditation intervention will be delivered virtually via the hospital-approved Microsoft Teams platform. Participants will be taught an evidence-based meditation technique which includes two online sessions (60 minutes/day) with a trained, experienced, and certified teacher of Prasanna Wellness, a non-profit service organization. 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. The participants in the intervention arm will complete 60-minute follow-up sessions with the Prasanna Wellness staff which will include 33 minutes of guided meditation practice, and then a discussion of participants' experiences with meditation during the week, additional observations, and a review of relevant knowledge to support their home practice. |
| Usual Care | No intervention | –Participants will continue with their usual care. |
Who may qualify
- Ages
- 65 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- Patients diagnosed with mild glaucoma.
- Patients aged 65-75.
- Being able to provide valid informed consent to participate in the research study.
- Being able to read and understand English.
- Having no significant self-reported or physician-diagnosed mental health disorder.
Key exclusion criteria (8 listed)
- Inability to provide valid informed consent.
- Significant communication barriers or lack of English proficiency that prevents participants from completing the questionnaires.
- Severe depression as confirmed by a CES-D ≥ 24.
- Having a lifetime diagnosis of self-reported other serious 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Meditation to Remove Stress and Create A Proper System in MindAlso: Beyond Mindfulness MeditationMeditation to Remove Stress and Create A Proper System in Mind is a guided meditation. | Behavioural | Meditation to Remove Stress and Create A Proper System in Mind |
Primary outcome
The 12-item short form survey
Time frame: Week 1, week 3, week 6, week 12
The 12-Item Short Form Survey (SF-12) is a questionnaire that measures self-reported health. Scores are calculated by converting the sum of responses to a scale from 0 to 100 where a higher score indicates superior health. In addition, results can be summarised using the physical component summary (PCS) score and the mental component summary (MCS) score.
3 secondary outcomes
Depression
Time frame: Week 1, week 3, week 6, week 12
Anxiety
Time frame: Week 1, week 3, week 6, week 12
Sleep quality
Time frame: Week 1, week 3, week 6, week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Background: PubMed 30036361Atreya CE, Kubo A, Borno HT, Rosenthal B, Campanella M, Rettger JP, Joseph G, Allen IE, Venook AP, Altschuler A, Dhruva A. Being Present: A single-arm feasibility study of audio-based mindfulness meditation for colorectal cancer patients and caregivers. PLoS One. 2018 Jul 23;13(7):e0199423. doi: 10.1371/journal.pone.0199423. eCollection 2018.
- Background: PubMed 18976496Yunesian M, Aslani A, Vash JH, Yazdi AB. Effects of Transcendental Meditation on mental health: a before-after study. Clin Pract Epidemiol Ment Health. 2008 Nov 1;4:25. doi: 10.1186/1745-0179-4-25.
- Individual participant dataSharing planned: No. De-identified individual participant data (IPD) collected in this study will not be available to other researchers (e.g., outside the primary research group). Since the primary research group has the necessary expertise to analyze the data and do not need any outside help.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meditation to Remove Stress and Create A Proper System in Mind in people with Glaucoma and Depression, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Monali Malvankar, PhD (5196858500 ext. 61288, monali.malvankar@schulich.uwo.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The 12-item short form survey (time frame: Week 1, week 3, week 6, week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05697094, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2023.