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Impact of Meditation on Improving Quality of Life Among Glaucoma Patients: An Electronic Pilot Feasibility Study

Primary Purpose

Glaucoma, Depression, Anxiety

Status
Not yet recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Meditation to Remove Stress and Create A Proper System in Mind
Health Education Program
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Glaucoma focused on measuring Health-related quality of life, Glaucoma, Meditation

Eligibility Criteria

65 Years - 75 Years (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria 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. Exclusion Criteria 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.

Sites / Locations

  • St. Joseph's Hospital, Ivey Eye Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Meditation to Remove Stress and Create A Proper System in Mind

Health Education Program

Arm Description

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.

A Health Enhancement Program (HEP) has been administered as an active control in previous meditation-based trials (manual can be found at https://minds.wisconsin.edu/bitstream/handle/1793/28198/HEP%20Guidelines%20%282011%29.pdf?sequence=6&isAllowed=y). An HEP controls for several non-specific factors in an online meditation intervention such as socialization, destigmatization, behavioral activation, attention from the facilitator, and at-home practice. Considering this, an HEP that is structurally equivalent to the online meditation program will be administered to participants randomized to the control arm.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
June 25, 2021
Last Updated
July 14, 2023
Sponsor
Lawson Health Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05697094
Brief Title
Impact of Meditation on Improving Quality of Life Among Glaucoma Patients: An Electronic Pilot Feasibility Study
Official Title
Impact of Meditation on Improving Quality of Life Among Glaucoma Patients: An Electronic Pilot Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2023 (Anticipated)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lawson Health Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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 Health Enhancement Program (HEP) 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, week 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Depression, Anxiety, Sleep Disorder, Quality of Life
Keywords
Health-related quality of life, Glaucoma, Meditation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Meditation to Remove Stress and Create A Proper System in Mind
Arm Type
Experimental
Arm Description
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.
Arm Title
Health Education Program
Arm Type
Active Comparator
Arm Description
A Health Enhancement Program (HEP) has been administered as an active control in previous meditation-based trials (manual can be found at https://minds.wisconsin.edu/bitstream/handle/1793/28198/HEP%20Guidelines%20%282011%29.pdf?sequence=6&isAllowed=y). An HEP controls for several non-specific factors in an online meditation intervention such as socialization, destigmatization, behavioral activation, attention from the facilitator, and at-home practice. Considering this, an HEP that is structurally equivalent to the online meditation program will be administered to participants randomized to the control arm.
Intervention Type
Behavioral
Intervention Name(s)
Meditation to Remove Stress and Create A Proper System in Mind
Other Intervention Name(s)
Beyond Mindfulness Meditation
Intervention Description
Meditation to Remove Stress and Create A Proper System in Mind is a guided meditation.
Intervention Type
Dietary Supplement
Intervention Name(s)
Health Education Program
Intervention Description
HEP facilitators will promote discussions regarding healthy lifestyle habits and how participants can integrate them into their daily lives.
Primary Outcome Measure Information:
Title
The 12-item short form survey
Description
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.
Time Frame
Week 1, week 3, week 6, week 12
Secondary Outcome Measure Information:
Title
Depression
Description
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.
Time Frame
Week 1, week 3, week 6, week 12
Title
Anxiety
Description
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.
Time Frame
Week 1, week 3, week 6, week 12
Title
Sleep quality
Description
Sleep quality as measured using the Pittsburgh Sleep Quality Index (PSQI) scores. The PSQI provides scores from 0-21. Higher scores indicate worse outcome.
Time Frame
Week 1, week 3, week 6, week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria 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. Exclusion Criteria 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Monali Malvankar, PhD
Phone
5196858500
Ext
61288
Email
monali.malvankar@schulich.uwo.ca
Facility Information:
Facility Name
St. Joseph's Hospital, Ivey Eye Institute
City
London
State/Province
Ontario
ZIP/Postal Code
N6G0H8
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
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.
Citations:
PubMed Identifier
30036361
Citation
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.
Results Reference
background
PubMed Identifier
18976496
Citation
Yunesian 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.
Results Reference
background

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Impact of Meditation on Improving Quality of Life Among Glaucoma Patients: An Electronic Pilot Feasibility Study

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