Virtual Health Education vs Meditation in Irreversible Age-Related Vision Loss Patients and Their Caregivers

Lawson Health Research Institute

Status: Withdrawn

Conditions: Quality of Life; Caregiver Burnout; Depression; Anxiety; Vision; Disorder, Loss; Sleep

Treatments: Behavioral: Health Enhancement Program; Behavioral: Sahaj Samadhi Meditation

Study type: Interventional

Funder types: Other

Identifiers

NCT04583748

4860

Details and patient eligibility

About

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.

Full 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

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Patients diagnosed with irreversible age-related vision loss (IARVL) by an experienced ophthalmologist and/or their caregivers.
2. IARVL patients between the age range of 60 to 85 years, while caregivers between the age range of 18 to 85 years.
3. Be able to provide valid informed consent to participate in the research study.
4. Being able to speak as well as understand English without the requirement for interpretation or other communication assistance.
5. Having no significant self-reported or a physician-diagnosed mental health disorder other than depressive and/or anxiety symptoms.
6. 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).
7. Have sufficient hearing to be able to follow verbal instructions
8. Have the ability to sit independently without physical discomfort for 30 minutes.
9. 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.
10. Willing to dedicate 20 minutes twice per day six days per week to their assigned home practice.

Exclusion criteria

1. Inability to provide a valid informed consent.
2. Having an underlying major neurocognitive disorder as suggested by a Montreal Cognitive Assessment (MoCA) score < 21.
3. Having significant suicidal ideation as per self-report (CES-D = 3 on item question 14 and/or 15).
4. Having severe depression as confirmed by a CES-D ≥ 24.
5. Participating in other similar studies.
6. 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).
7. Self-reported substance abuse or dependence within the past 3 months.
8. Having an acutely unstable medical illnesses, including delirium or acute cerebrovascular or cardiovascular events within the last 6 months.
9. Having a terminal medical diagnosis with prognosis of less than 12 months.
10. Having any planned changes to mood-altering medications at the time of enrollment for the next 12 weeks.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 3 patient groups

Sahaj Samadhi Meditation

Experimental group

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.

Treatment:

Behavioral: Sahaj Samadhi Meditation

Health Enhancement Program

Active Comparator group

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.

Treatment:

Behavioral: Health Enhancement Program

Treatment as Usual

No Intervention group

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.