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

Обзор

Investigators aim to assess the feasibility of delivering two augmentation interventions, Meditation and a Health Enhancement Program, for potentially enhancing the quality of life and mental health of Irreversible Age-Related Vision Loss (IARVL) patients and/or their caregivers.

Подробное описание

Using a mixed-method design, a pilot randomized controlled trial (RCT) study, investigators aim to assess the feasibility of delivering two augmentation interventions, Meditation to Remove Stress and Create Proper System in Mind (MEDITATION) and a Health Enhancement Program (HEP) for potentially enhancing the quality of life and mental health of Irreversible Age-Related Vision Loss (IARVL) patients and/or their caregivers. MEDITATION is a standardized, manualized therapy where participants will be guided by an instructor on meditation techniques, followed by weekly reinforcement sessions. HEP is a similarly structured intervention that controls for several factors experienced in the MEDITATION group, such as group support and morale, behavioral activation, reduction of stigma, facilitator attention, treatment duration, and time spent on at-home practice. Participants will learn about health promotion, including the benefits of a lifestyle of healthy diet, music, recreation, and exercise, but will not learn breathing techniques, or meditation.

Вмешательства

• Другое Meditation
  This therapy will be delivered using the hospital approved Microsoft TEAMS platform by trained, certified non-clinician teachers. 25 irreversible age-related vision loss patients and their 25 caregivers in the MEDITATION arm will be trained for 2 consecutive days (2 hours/day) in the first week, followed by 1-hour weekly reinforcement sessions for 11 weeks. Participants will learn how to respond to experiences that arise in meditation, will discuss what enhances or detracts from effective medita
• Другое Health Enhancement Program
  HEP was designed and used as a manualized active control in meditation-based intervention trials. We have tailored HEP to be structurally equivalent to MEDITATION intervention, with similar-sized groups, meeting for 2 days for 2 hours, and then one 60-75-minute follow up session weekly for the subsequent 11 follow ups. Participants allocated to HEP will be completing the same amount of home practice as MEDITATION, and will be asked to complete weekly practice logs. Participants will learn about

Первичные конечные точки

• Participants screened [Срок оценки: Through study completion, an average of 1 year]
• Participants enrolled [Срок оценки: Through study completion, an average of 1 year]
• Retention rate [Срок оценки: Up to 12 weeks.]
• Adherence rate [Срок оценки: Up to 12 weeks]
• Assessment rating and duration [Срок оценки: Up to 12 weeks]
• Intervention cost [Срок оценки: Up to 12 weeks]
• Data quality [Срок оценки: Up to 12 weeks]

Вторичные конечные точки (8)

• Change in health-related quality of life (HRQOL) [Срок оценки: Up to 12 weeks]
• Number of participants approached [Срок оценки: Through study completion, an average of 1 year]
• Change in vision-related quality of life (VRQOL) [Срок оценки: Up to 12 weeks]
• Change in depression score [Срок оценки: Up to 12 weeks]
• Change in anxiety score [Срок оценки: Up to 12 weeks]
• Change in sleep quality [Срок оценки: Up to 12 weeks]
• Change in community integration [Срок оценки: Up to 12 weeks]
• Change in caregiver burden [Срок оценки: Up to 12 weeks]

Критерии участия

Критерии включения

• Patients with irreversible age-related vision loss (IARVL) and have ongoing significant disability and/or their caregivers who agree to consent.
• IARVL patients between age 60 to 85 years or caregivers between 18 to 85 years.
• Deemed competent to provide individual consent to participate.
• Speak and understand English without requirement for interpretation or assistance.
• Have no significant self-reported or physician diagnosed mental health disorder other than depressive and/or anxiety symptoms.
• Have either a minimum of CES-D 20-item scale score of 16 OR a minimum of 8 on the Hospital Anxiety Scale (HADS-A) 7-item sub-scale.
• Have sufficient hearing to be able to follow verbal instructions
• Ability to sit independently without physical discomfort for 30 minutes.
• Willing and able to attend, via Microsoft TEAMS software, the four initial training sessions of MEDITATION or HEP and at least 6 follow-up sessions.
• Willing to dedicate 33 minutes per day to their assigned home practice.

Критерии исключения

• Inability to provide informed consent.
• Dementia as defined by MoCA < 21.
• Have significant suicidal ideation as per self-report (CES-D = 3 on item question 14 and/or 15).
• Have severe depression CES-D ≥ 24.
• Participating in other similar studies.
• Have a lifetime diagnosis of self-reported other 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.
• Have an acutely unstable medical illnesses, including delirium or acute cerebrovascular or cardiovascular events within the last 6 months.
• Have 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Канада · 1 центр

• St. Joseph's Hospital, Ivey Eye Institute — London

Идентификаторы

NCT: NCT03166072 · 111334

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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