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

NCT ID: NCT04583748

Last Updated: 2022-04-18

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-30
• Study Completion Date: 2022-04-09

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

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Sahaj Samadhi Meditation

Intervention Type: BEHAVIORAL

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.

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.

Group Type: ACTIVE_COMPARATOR

Health Enhancement Program

Intervention Type: BEHAVIORAL

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Sahaj Samadhi Meditation

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

Health Enhancement Program

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

SSM; HEP

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Art of Living Foundation

OTHER

Sponsor Role: collaborator

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

Sponsor Role: lead

Responsible Party

Akshya Vasudev

Consultant Geriatric Psychiatrist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Akshya Vasudev, MD

Role: PRINCIPAL_INVESTIGATOR

London Health Sciences Centre

Cindy Hutnik, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

St. Joseph's Healthcare London

Other Identifiers

4860

Identifier Type: -

Identifier Source: org_study_id