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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
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.
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.
Number of Potential Participants Approached Per Month
The number of potential participants approached per month will be calculated as a feasibility measure.
Time frame: 1 year
Number of Participants who are Successfully Screened
The number of participants who are successfully screened will be calculated as a feasibility measure.
Time frame: 1 year
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.
Time frame: 1 year
Rate of Retention
The rate of retention of participants in the study will be calculated as a feasibility measure.
Time frame: 1 year
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.
Time frame: 1 year
Proportion of Planned Ratings that are Completed
The proportion of completed planned ratings will be calculated as a feasibility measure.
Time frame: 1 year
Intervention Cost Per Case
The cost per participant of attending the SSM program will be calculated as a feasibility measure.
Time frame: 1 year
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.
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Time frame: 1 year
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.
Time frame: 1 year
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.
Time frame: 1 year
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.
Time frame: 1 year
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.
Time frame: 1 year
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.
Time frame: 1 year
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.
Time frame: 1 year
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.
Time frame: 1 year
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.
Time frame: Weeks 0 and 12
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.
Time frame: Weeks 0 and 12
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.
Time frame: Weeks 0 and 12
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.
Time frame: Weeks 0 and 12
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.
Time frame: Weeks 0 and 12
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.
Time frame: Weeks 0 and 12
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.
Time frame: Weeks 0 and 12
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.
Time frame: Weeks 0 and 12