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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05697094
• Other study ID #: 119431
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: December 30, 2024

Study information

• Verified date: November 2023
• Source: Lawson Health Research Institute
• Contact: Monali Malvankar, PhD
• Phone: 5196858500
• Email: monali.malvankar[@]schulich.uwo.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 75 Years

Eligibility

Inclusion Criteria

1. Patients diagnosed with mild glaucoma.

2. Patients aged 65-75.

3. Being able to provide valid informed consent to participate in the research study.

4. Being able to read and understand English.

5. Having no significant self-reported or physician-diagnosed mental health disorder.

6. Able to independently access a computer to participate in virtual meditation sessions.

7. 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

1. Inability to provide valid informed consent.

2. Significant communication barriers or lack of English proficiency that prevents participants from completing the questionnaires.

3. Severe depression as confirmed by a CES-D = 24.

4. 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).

5. Self-reported substance abuse or dependence within the past 3 months.

6. Having acutely unstable medical illnesses, including delirium or acute cerebrovascular or cardiovascular events within the last 6 months.

7. Having irreversible vision loss that prevents one from completing the questionnaires.

8. Participation in a study involving similar techniques.

Related Conditions & MeSH terms

• Anxiety
• Depression
• Glaucoma
• Quality of Life
• Sleep Disorder
• Sleep Wake Disorders

Intervention

Behavioral:
• Meditation to Remove Stress and Create A Proper System in Mind
Meditation to Remove Stress and Create A Proper System in Mind is a guided meditation.

Locations

Country	Name	City	State
Canada	St. Joseph's Hospital, Ivey Eye Institute	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Week 1, week 3, week 6, week 12
Secondary	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.	Week 1, week 3, week 6, week 12
Secondary	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.	Week 1, week 3, week 6, week 12
Secondary	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.	Week 1, week 3, week 6, week 12