- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04583748
Virtual Health Education vs Meditation in Irreversible Age-Related Vision Loss Patients and Their Caregivers
April 10, 2022 updated by: Akshya Vasudev, Lawson Health Research Institute
Virtual Health Education vs Meditation in Irreversible Age-Related Vision Loss Patients and Their Caregivers: A Pilot Randomized Controlled Trial
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.
Study Overview
Status
Withdrawn
Intervention / Treatment
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
Study Type
Interventional
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 83 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Sahaj Samadhi Meditation
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.
|
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.
Other Names:
|
Active Comparator: Health Enhancement Program
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.
|
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.
Other Names:
|
No Intervention: Treatment as Usual
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Potential Participants Approached Per Month
Time Frame: 1 year
|
The number of potential participants approached per month will be calculated as a feasibility measure.
|
1 year
|
Number of Participants who are Successfully Screened
Time Frame: 1 year
|
The number of participants who are successfully screened will be calculated as a feasibility measure.
|
1 year
|
Proportion of Successfully Screened in Participants who Enroll
Time Frame: 1 year
|
The proportion of successfully screened in participants who enroll in the study will be calculated as a feasibility measure.
|
1 year
|
Rate of Retention
Time Frame: 1 year
|
The rate of retention of participants in the study will be calculated as a feasibility measure.
|
1 year
|
Rate of Adherence to Study Protocol
Time Frame: 1 year
|
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.
|
1 year
|
Proportion of Planned Ratings that are Completed
Time Frame: 1 year
|
The proportion of completed planned ratings will be calculated as a feasibility measure.
|
1 year
|
Intervention Cost Per Case
Time Frame: 1 year
|
The cost per participant of attending the SSM program will be calculated as a feasibility measure.
|
1 year
|
Percentage of Time Trade-Off (TTO) Questionnaires Completed
Time Frame: 1 year
|
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.
|
1 year
|
Percentage of Visual Function Index (VF-14) Questionnaires Completed
Time Frame: 1 year
|
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.
|
1 year
|
Percentage of Center for Epidemiologic Studies - Depression (CES-D) Questionnaires Completed
Time Frame: 1 year
|
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.
|
1 year
|
Percentage of Hospital Anxiety and Depression Scale - Anxiety (HADS-A) Questionnaires Completed
Time Frame: 1 year
|
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.
|
1 year
|
Percentage of Pittsburgh Sleep Quality Index (PSQI) Questionnaires Completed
Time Frame: 1 year
|
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.
|
1 year
|
Percentage of Community Integration Questionnaire (CIQ) Questionnaires Completed
Time Frame: 1 year
|
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.
|
1 year
|
Percentage of Connor-Davidson Resilience Scale (CD-RISC) Questionnaires Completed
Time Frame: 1 year
|
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.
|
1 year
|
Percentage of Zarit Burden Interview (ZBI) Questionnaires Completed
Time Frame: 1 year
|
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.
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Health-Related Quality of Life Score
Time Frame: Weeks 0 and 12
|
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.
|
Weeks 0 and 12
|
Change in Vision-Related Quality of Life Score
Time Frame: Weeks 0 and 12
|
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.
|
Weeks 0 and 12
|
Change in Depressive Symptoms
Time Frame: Weeks 0 and 12
|
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.
|
Weeks 0 and 12
|
Change in Anxiety Symptoms
Time Frame: Weeks 0 and 12
|
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.
|
Weeks 0 and 12
|
Change in Sleep Quality: Pittsburgh Sleep Quality Index (PSQI)
Time Frame: Weeks 0 and 12
|
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.
|
Weeks 0 and 12
|
Change in Community Integration
Time Frame: Weeks 0 and 12
|
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.
|
Weeks 0 and 12
|
Change in Resilience
Time Frame: Weeks 0 and 12
|
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.
|
Weeks 0 and 12
|
Change in Caregiver Burden
Time Frame: Weeks 0 and 12
|
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.
|
Weeks 0 and 12
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Akshya Vasudev, MD, London Health Sciences Centre
- Principal Investigator: Cindy Hutnik, MD, PhD, St. Joseph's Healthcare London
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
April 1, 2022
Primary Completion (Actual)
April 9, 2022
Study Completion (Actual)
April 9, 2022
Study Registration Dates
First Submitted
September 21, 2020
First Submitted That Met QC Criteria
October 6, 2020
First Posted (Actual)
October 12, 2020
Study Record Updates
Last Update Posted (Actual)
April 18, 2022
Last Update Submitted That Met QC Criteria
April 10, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4860
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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