Back to resultsVirtual Health Education vs Meditation in Irreversible Age-Related Vision Loss Patients and Their Caregivers
Primary Purpose
Vision; Disorder, Loss, Caregiver Burnout, Quality of Life
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Sahaj Samadhi Meditation
Health Enhancement Program
Sponsored by
About this trial
This is an interventional treatment trial for Vision; Disorder, Loss focused on measuring Irreversible Age-Related Vision Loss, Caregivers, Quality of Life, Mental Health, Depression, Anxiety, Sleep Quality, Community Integration, Resilience, Caregiver Burden, Sahaj Samadhi Meditation, Health Enhancement Program, Virtual
Eligibility Criteria
Inclusion Criteria:
- Patients diagnosed with irreversible age-related vision loss (IARVL) by an experienced ophthalmologist and/or their caregivers.
- IARVL patients between the age range of 60 to 85 years, while caregivers between the age range of 18 to 85 years.
- Be able to provide valid informed consent to participate in the research study.
- Being able to speak as well as understand English without the requirement for interpretation or other communication assistance.
- Having no significant self-reported or a physician-diagnosed mental health disorder other than depressive and/or anxiety symptoms.
- Should reach a minimal threshold of depressive and/or anxiety symptoms as confirmed by either a minimum of Centre for Epidemiologic Studies - Depression (CES-D) 20-item scale score of 16 OR a minimum of 8 on the Hospital Anxiety and Depression Scale - Anxiety subscale (HADS-A).
- Have sufficient hearing to be able to follow verbal instructions
- Have the ability to sit independently without physical discomfort for 30 minutes.
- Willing and able to attend virtual intervention via Cisco WebEx software, the four initial training sessions of SSM or HEP and at least 6 out of 11 weekly follow-up sessions.
- Willing to dedicate 20 minutes twice per day six days per week to their assigned home practice.
Exclusion Criteria:
- Inability to provide a valid informed consent.
- Having an underlying major neurocognitive disorder as suggested by a Montreal Cognitive Assessment (MoCA) score < 21.
- Having significant suicidal ideation as per self-report (CES-D = 3 on item question 14 and/or 15).
- Having severe depression as confirmed by a CES-D ≥ 24.
- Participating in other similar studies.
- 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 an acutely unstable medical illnesses, including delirium or acute cerebrovascular or cardiovascular events within the last 6 months.
- Having 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
No Intervention
Arm Label
Sahaj Samadhi Meditation
Health Enhancement Program
Treatment as Usual
Arm Description
Participants randomized to the Sahaj Samadhi Meditation (SSM) arm will undergo SSM training in groups of 10. SSM will be delivered virtually using the Cisco WebEx platform by trained, certified non-clinician teachers. Participants will be trained for 4 consecutive days (2 hours/day) in the first week, followed by 1-hour weekly reinforcement sessions for 11 weeks. Participants will also be encouraged to practice twice daily at home for 20 minutes per session. They will be given a daily practice log on which they check off a box indicating if they have done their home practice.
Participants randomized to the Health Enhancement Program (HEP) arm will undergo HEP training in groups of 10. HEP will be delivered virtually using the Cisco WebEx platform by trained non-clinician teachers. Participants will be trained for 4 consecutive days (2 hours/day) in the first week, followed by 1-hour weekly reinforcement sessions for 11 weeks. Participants will also be encouraged to practice twice daily at home for 20 minutes per session. They will be given a daily practice log on which they check off a box indicating if they have done their home practice.
Participants randomized to the Treatment as Usual (TAU) arm will continue to receive their treatment as usual. The usual standard of care for irreversible age-related vision patients includes no active treatment since eye surgeons have done all that could possibly be done to restore vision.
Outcomes
Primary Outcome Measures
Number of Potential Participants Approached Per Month
The number of potential participants approached per month will be calculated as a feasibility measure.
Number of Participants who are Successfully Screened
The number of participants who are successfully screened will be calculated as a feasibility measure.
Proportion of Successfully Screened in Participants who Enroll
The proportion of successfully screened in participants who enroll in the study will be calculated as a feasibility measure.
Rate of Retention
The rate of retention of participants in the study will be calculated as a feasibility measure.
Rate of Adherence to Study Protocol
At the end of the study any deviations from the protocol will be examined to determine the rate of adherence to the study protocol. This information will be calculated as a feasibility measure.
Proportion of Planned Ratings that are Completed
The proportion of completed planned ratings will be calculated as a feasibility measure.
Intervention Cost Per Case
The cost per participant of attending the SSM program will be calculated as a feasibility measure.
Percentage of Time Trade-Off (TTO) Questionnaires Completed
The percentage of TTO questionnaires completed by each participant will be examined at the end of the study to assess the completeness of the data as a feasibility measure.
Percentage of Visual Function Index (VF-14) Questionnaires Completed
The percentage of VF-14 questionnaires completed by each participant will be examined at the end of the study to assess the completeness of the data as a feasibility measure.
Percentage of Center for Epidemiologic Studies - Depression (CES-D) Questionnaires Completed
The percentage of CES-D questionnaires completed by each participant will be examined at the end of the study to assess the completeness of the data as a feasibility measure.
Percentage of Hospital Anxiety and Depression Scale - Anxiety (HADS-A) Questionnaires Completed
The percentage of HADS-A questionnaires completed by each participant will be examined at the end of the study to assess the completeness of the data as a feasibility measure.
Percentage of Pittsburgh Sleep Quality Index (PSQI) Questionnaires Completed
The percentage of PSQI questionnaires completed by each participant will be examined at the end of the study to assess the completeness of the data as a feasibility measure.
Percentage of Community Integration Questionnaire (CIQ) Questionnaires Completed
The percentage of CIQ questionnaires completed by each participant will be examined at the end of the study to assess the completeness of the data as a feasibility measure.
Percentage of Connor-Davidson Resilience Scale (CD-RISC) Questionnaires Completed
The percentage of CD-RISC questionnaires completed by each participant will be examined at the end of the study to assess the completeness of the data as a feasibility measure.
Percentage of Zarit Burden Interview (ZBI) Questionnaires Completed
The percentage of ZBI questionnaires completed by each participant will be examined at the end of the study to assess the completeness of the data as a feasibility measure.
Secondary Outcome Measures
Change in Health-Related Quality of Life Score
Change in Health-Related Quality of Life (HRQOL) score as measured by the Time Trade-Off questionnaire (TTO) over a 12-week follow-up. TTO scores range between 0 and 1, with higher scores indicating a higher quality of life.
Change in Vision-Related Quality of Life Score
Change in Vision-Related Quality of Life (VRQOL) score as measured by the Visual Function Index questionnaire (VF-14) over a 12-week follow-up. VF-14 scores range from 0 to 100, with higher scores representing a greater VRQOL.
Change in Depressive Symptoms
Change in depressive symptoms as measured by change in Center for Epidemiologic Studies - Depression (CES-D) scores over a 12-week follow-up. The possible range of CES-D scores is 0 to 60, with the higher scores indicating the presence of more depressive symptomatology.
Change in Anxiety Symptoms
Change in anxiety symptoms as measured by change in Hospital Anxiety and Depression Scale - Anxiety (HADS-A) scores over a 12-week follow-up. Total scores on the HADS-A range from 0 to 21. Higher scores represent higher levels of psychological distress.
Change in Sleep Quality: Pittsburgh Sleep Quality Index (PSQI)
Change in sleep quality as measured by change in Pittsburgh Sleep Quality Index (PSQI) scores over a 12-week follow-up. PSQI scores range from 0 to 21. Higher PSQI scores indicate worse sleep quality.
Change in Community Integration
Change in community integration as measured by change in Community Integration Questionnaire (CIQ) scores over a 12-week follow-up. The overall score for the CIQ ranges from 0 to 29. Higher CIQ score represents greater integration.
Change in Resilience
Change in resilience as measured by change in Connor-Davidson Resilience Scale (CD-RISC) scores over a 12-week follow-up. Total scores for the CD-RISC range from 0 to 40, with higher scores representing greater resilience.
Change in Caregiver Burden
Change in caregiver burden as measured by change in Zarit Burden Interview (ZBI) scores over a 12-week follow-up. Total scores for the ZBI range from 0 to 88. Higher scores represent a more severe self-perceived burden of caregiving.
Full Information
NCT ID
NCT04583748
First Posted
September 21, 2020
Last Updated
April 10, 2022
Sponsor
Lawson Health Research Institute
Collaborators
The Art of Living Foundation
1. Study Identification
Unique Protocol Identification Number
NCT04583748
Brief Title
Virtual Health Education vs Meditation in Irreversible Age-Related Vision Loss Patients and Their Caregivers
Official Title
Virtual Health Education vs Meditation in Irreversible Age-Related Vision Loss Patients and Their Caregivers: A Pilot Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Withdrawn
Why Stopped
COVID 19
Study Start Date
April 2022 (Anticipated)
Primary Completion Date
April 9, 2022 (Actual)
Study Completion Date
April 9, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lawson Health Research Institute
Collaborators
The Art of Living Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Vision loss is common among older adults and leads to an increased risk for depression and difficulties in daily tasks, thus requiring dependence on caregivers. This study will assess the feasibility of providing two virtual interventions, Sahaj Samadhi Meditation (SSM) and Health Enhancement Program (HEP), to supplement care of patients with irreversible age-related vision loss (IARVL) and their caregivers, with the goal of enhancing mental health and quality of life.
Detailed Description
Through a high-quality, single-blind, three-arm mixed-method pilot feasibility study using randomized treatment assignment, the study team will assess two new innovative interventions, Sahaj Samadhi Meditation (SSM) and Health Enhancement Program (HEP), both delivered virtually, to augment clinical care of patients with irreversible age-related vision loss (IARVL), with the goal of enhancing mental health and quality of life (QOL) for patients and/or their caregivers. Participants will be blinded to the treatment hypothesis, while investigators and treating clinicians will be additionally blinded to the intervention. Both SSM and HEP will be taught over 4 consecutive days in similar sized groups (10 patients and/or their 10 caregivers) followed by weekly reinforcement sessions for subsequent 11 weeks. Self-rated questionnaires will be used to collect data on quality of life and mental health symptoms at 0-week and 12-week follow-up
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vision; Disorder, Loss, Caregiver Burnout, Quality of Life, Depression, Anxiety, Sleep
Keywords
Irreversible Age-Related Vision Loss, Caregivers, Quality of Life, Mental Health, Depression, Anxiety, Sleep Quality, Community Integration, Resilience, Caregiver Burden, Sahaj Samadhi Meditation, Health Enhancement Program, Virtual
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients will undergo 1:1:1 randomization to Sahaj Samadhi Meditation or Health Enhancement Program or Treatment as Usual, stratified by gender. Twenty-five irreversible age-related vision loss patients and their 25 caregivers will be assigned, on a rolling basis, in the three groups.
Masking
InvestigatorOutcomes Assessor
Masking Description
Participants will be blinded to the treatment hypothesis, while investigators and treating clinicians will be additionally blinded to the intervention.
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sahaj Samadhi Meditation
Arm Type
Experimental
Arm Description
Participants randomized to the Sahaj Samadhi Meditation (SSM) arm will undergo SSM training in groups of 10. SSM will be delivered virtually using the Cisco WebEx platform by trained, certified non-clinician teachers. Participants will be trained for 4 consecutive days (2 hours/day) in the first week, followed by 1-hour weekly reinforcement sessions for 11 weeks. Participants will also be encouraged to practice twice daily at home for 20 minutes per session. They will be given a daily practice log on which they check off a box indicating if they have done their home practice.
Arm Title
Health Enhancement Program
Arm Type
Active Comparator
Arm Description
Participants randomized to the Health Enhancement Program (HEP) arm will undergo HEP training in groups of 10. HEP will be delivered virtually using the Cisco WebEx platform by trained non-clinician teachers. Participants will be trained for 4 consecutive days (2 hours/day) in the first week, followed by 1-hour weekly reinforcement sessions for 11 weeks. Participants will also be encouraged to practice twice daily at home for 20 minutes per session. They will be given a daily practice log on which they check off a box indicating if they have done their home practice.
Arm Title
Treatment as Usual
Arm Type
No Intervention
Arm Description
Participants randomized to the Treatment as Usual (TAU) arm will continue to receive their treatment as usual. The usual standard of care for irreversible age-related vision patients includes no active treatment since eye surgeons have done all that could possibly be done to restore vision.
Intervention Type
Behavioral
Intervention Name(s)
Sahaj Samadhi Meditation
Other Intervention Name(s)
SSM
Intervention Description
Sahaj Samadhi Meditation (SSM) is a form of automatic self-transcending meditation that involves relaxed attention to a precise sound (mantra), to allow stress reduction and deep relaxation. This technique is easy to learn and offers the support of a group and facilitator.
Intervention Type
Behavioral
Intervention Name(s)
Health Enhancement Program
Other Intervention Name(s)
HEP
Intervention Description
The Health Enhancement Program (HEP) is a standardized program used to teach participants about health promotion, including the benefits of a lifestyle of healthy diet, music, recreation, and exercise. In HEP, participants get the support of a group and facilitator, and talk through and try to implement positive health-enhancing life changes.
Primary Outcome Measure Information:
Title
Number of Potential Participants Approached Per Month
Description
The number of potential participants approached per month will be calculated as a feasibility measure.
Time Frame
1 year
Title
Number of Participants who are Successfully Screened
Description
The number of participants who are successfully screened will be calculated as a feasibility measure.
Time Frame
1 year
Title
Proportion of Successfully Screened in Participants who Enroll
Description
The proportion of successfully screened in participants who enroll in the study will be calculated as a feasibility measure.
Time Frame
1 year
Title
Rate of Retention
Description
The rate of retention of participants in the study will be calculated as a feasibility measure.
Time Frame
1 year
Title
Rate of Adherence to Study Protocol
Description
At the end of the study any deviations from the protocol will be examined to determine the rate of adherence to the study protocol. This information will be calculated as a feasibility measure.
Time Frame
1 year
Title
Proportion of Planned Ratings that are Completed
Description
The proportion of completed planned ratings will be calculated as a feasibility measure.
Time Frame
1 year
Title
Intervention Cost Per Case
Description
The cost per participant of attending the SSM program will be calculated as a feasibility measure.
Time Frame
1 year
Title
Percentage of Time Trade-Off (TTO) Questionnaires Completed
Description
The percentage of TTO questionnaires completed by each participant will be examined at the end of the study to assess the completeness of the data as a feasibility measure.
Time Frame
1 year
Title
Percentage of Visual Function Index (VF-14) Questionnaires Completed
Description
The percentage of VF-14 questionnaires completed by each participant will be examined at the end of the study to assess the completeness of the data as a feasibility measure.
Time Frame
1 year
Title
Percentage of Center for Epidemiologic Studies - Depression (CES-D) Questionnaires Completed
Description
The percentage of CES-D questionnaires completed by each participant will be examined at the end of the study to assess the completeness of the data as a feasibility measure.
Time Frame
1 year
Title
Percentage of Hospital Anxiety and Depression Scale - Anxiety (HADS-A) Questionnaires Completed
Description
The percentage of HADS-A questionnaires completed by each participant will be examined at the end of the study to assess the completeness of the data as a feasibility measure.
Time Frame
1 year
Title
Percentage of Pittsburgh Sleep Quality Index (PSQI) Questionnaires Completed
Description
The percentage of PSQI questionnaires completed by each participant will be examined at the end of the study to assess the completeness of the data as a feasibility measure.
Time Frame
1 year
Title
Percentage of Community Integration Questionnaire (CIQ) Questionnaires Completed
Description
The percentage of CIQ questionnaires completed by each participant will be examined at the end of the study to assess the completeness of the data as a feasibility measure.
Time Frame
1 year
Title
Percentage of Connor-Davidson Resilience Scale (CD-RISC) Questionnaires Completed
Description
The percentage of CD-RISC questionnaires completed by each participant will be examined at the end of the study to assess the completeness of the data as a feasibility measure.
Time Frame
1 year
Title
Percentage of Zarit Burden Interview (ZBI) Questionnaires Completed
Description
The percentage of ZBI questionnaires completed by each participant will be examined at the end of the study to assess the completeness of the data as a feasibility measure.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Change in Health-Related Quality of Life Score
Description
Change in Health-Related Quality of Life (HRQOL) score as measured by the Time Trade-Off questionnaire (TTO) over a 12-week follow-up. TTO scores range between 0 and 1, with higher scores indicating a higher quality of life.
Time Frame
Weeks 0 and 12
Title
Change in Vision-Related Quality of Life Score
Description
Change in Vision-Related Quality of Life (VRQOL) score as measured by the Visual Function Index questionnaire (VF-14) over a 12-week follow-up. VF-14 scores range from 0 to 100, with higher scores representing a greater VRQOL.
Time Frame
Weeks 0 and 12
Title
Change in Depressive Symptoms
Description
Change in depressive symptoms as measured by change in Center for Epidemiologic Studies - Depression (CES-D) scores over a 12-week follow-up. The possible range of CES-D scores is 0 to 60, with the higher scores indicating the presence of more depressive symptomatology.
Time Frame
Weeks 0 and 12
Title
Change in Anxiety Symptoms
Description
Change in anxiety symptoms as measured by change in Hospital Anxiety and Depression Scale - Anxiety (HADS-A) scores over a 12-week follow-up. Total scores on the HADS-A range from 0 to 21. Higher scores represent higher levels of psychological distress.
Time Frame
Weeks 0 and 12
Title
Change in Sleep Quality: Pittsburgh Sleep Quality Index (PSQI)
Description
Change in sleep quality as measured by change in Pittsburgh Sleep Quality Index (PSQI) scores over a 12-week follow-up. PSQI scores range from 0 to 21. Higher PSQI scores indicate worse sleep quality.
Time Frame
Weeks 0 and 12
Title
Change in Community Integration
Description
Change in community integration as measured by change in Community Integration Questionnaire (CIQ) scores over a 12-week follow-up. The overall score for the CIQ ranges from 0 to 29. Higher CIQ score represents greater integration.
Time Frame
Weeks 0 and 12
Title
Change in Resilience
Description
Change in resilience as measured by change in Connor-Davidson Resilience Scale (CD-RISC) scores over a 12-week follow-up. Total scores for the CD-RISC range from 0 to 40, with higher scores representing greater resilience.
Time Frame
Weeks 0 and 12
Title
Change in Caregiver Burden
Description
Change in caregiver burden as measured by change in Zarit Burden Interview (ZBI) scores over a 12-week follow-up. Total scores for the ZBI range from 0 to 88. Higher scores represent a more severe self-perceived burden of caregiving.
Time Frame
Weeks 0 and 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients diagnosed with irreversible age-related vision loss (IARVL) by an experienced ophthalmologist and/or their caregivers.
IARVL patients between the age range of 60 to 85 years, while caregivers between the age range of 18 to 85 years.
Be able to provide valid informed consent to participate in the research study.
Being able to speak as well as understand English without the requirement for interpretation or other communication assistance.
Having no significant self-reported or a physician-diagnosed mental health disorder other than depressive and/or anxiety symptoms.
Should reach a minimal threshold of depressive and/or anxiety symptoms as confirmed by either a minimum of Centre for Epidemiologic Studies - Depression (CES-D) 20-item scale score of 16 OR a minimum of 8 on the Hospital Anxiety and Depression Scale - Anxiety subscale (HADS-A).
Have sufficient hearing to be able to follow verbal instructions
Have the ability to sit independently without physical discomfort for 30 minutes.
Willing and able to attend virtual intervention via Cisco WebEx software, the four initial training sessions of SSM or HEP and at least 6 out of 11 weekly follow-up sessions.
Willing to dedicate 20 minutes twice per day six days per week to their assigned home practice.
Exclusion Criteria:
Inability to provide a valid informed consent.
Having an underlying major neurocognitive disorder as suggested by a Montreal Cognitive Assessment (MoCA) score < 21.
Having significant suicidal ideation as per self-report (CES-D = 3 on item question 14 and/or 15).
Having severe depression as confirmed by a CES-D ≥ 24.
Participating in other similar studies.
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 an acutely unstable medical illnesses, including delirium or acute cerebrovascular or cardiovascular events within the last 6 months.
Having 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Akshya Vasudev, MD
Organizational Affiliation
London Health Sciences Centre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Cindy Hutnik, MD, PhD
Organizational Affiliation
St. Joseph's Healthcare London
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Virtual Health Education vs Meditation in Irreversible Age-Related Vision Loss Patients and Their Caregivers
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