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

NCT04583748 | Withdrawn

• 1 other identifier: 4860
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (15)

• Number of Potential Participants Approached Per Month

  The number of potential participants approached per month will be calculated as a feasibility measure.

  1 year

• Number of Participants who are Successfully Screened

  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

  The proportion of successfully screened in participants who enroll in the study will be calculated as a feasibility measure.

  1 year

• Rate of Retention

  The rate of retention of participants in the study will be calculated as a feasibility measure.

  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.

  1 year

• Proportion of Planned Ratings that are Completed

  The proportion of completed planned ratings will be calculated as a feasibility measure.

  1 year

• Intervention Cost Per Case

  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

  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

  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

  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

  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

  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

  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

  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

  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 Outcomes (8)

• Change in Health-Related Quality of Life Score

  Weeks 0 and 12

• Change in Vision-Related Quality of Life Score

  Weeks 0 and 12

• Change in Depressive Symptoms

  Weeks 0 and 12

• Change in Anxiety Symptoms

  Weeks 0 and 12

• Change in Sleep Quality: Pittsburgh Sleep Quality Index (PSQI)

  Weeks 0 and 12

Study Arms (3)

Sahaj Samadhi Meditation

EXPERIMENTAL

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.

Behavioral: Sahaj Samadhi Meditation

Health Enhancement Program

ACTIVE COMPARATOR

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.

Behavioral: Health Enhancement Program

Treatment as Usual

NO INTERVENTION

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.

Interventions

Sahaj Samadhi Meditation 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.

Also known as: SSM

Sahaj Samadhi Meditation

Health Enhancement Program 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.

Also known as: HEP

Health Enhancement Program

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• The Art of Living Foundation: collaborator

MeSH Terms

Conditions

Caregiver Burden; Depression; Anxiety Disorders; Psychological Well-Being; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior; Mental Disorders; Personal Satisfaction; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Akshya Vasudev, MD

  London Health Sciences Centre

  PRINCIPAL INVESTIGATOR

• Cindy Hutnik, MD, PhD

  St. Joseph's Healthcare London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants will be blinded to the treatment hypothesis, while investigators and treating clinicians will be additionally blinded to the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Geriatric Psychiatrist

Model Details: 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.

Study Record Dates

• First Submitted: September 21, 2020
• First Posted: October 12, 2020
• Study Start: April 1, 2022
• Primary Completion: April 9, 2022
• Study Completion: April 9, 2022
• Last Updated: April 18, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share