Self-Care Training for Family Caregivers of Persons With Neurodegeneration

Официальное название

Caring for the Family Caregiver: Testing the Effect of Two Wellness Programs That Support the Well-being of Family Caregivers of Persons With Neurodegenerative Disorders

Обзор

The purpose of this study is to assess whether an 8-week mindfulness program enhances psychological well-being (e.g., stress, depressive symptoms), biological indicators of stress (e.g., inflammation), and cognitive function (e.g., attentional ability) in primary family caregivers of persons with dementia or a related neurodegenerative disease. A total of 232 primary family caregivers aged 50+ years of age will be recruited for this study and randomized to one of three groups: mindfulness meditation (MM), psychoeducation (PSY) or caregiver respite (CR). All participants will complete three testing sessions: baseline (pre-intervention \[T1\]), post 8-week follow-up (post-intervention, \[T2\]), and 12-month follow-up (T3).

Подробное описание

The purpose of this study is to assess the benefits of 2 virtual self-care programs - mindfulness meditation or a psychoeducation support group - for family caregivers of persons with a neurodegenerative disorder. Both programs are 8-weeks in length. A third arm will include a respite-ony group, which may be considered "treatment as usual". Outcomes of interest include psychological well-being (e.g., stress, depressive symptoms), biological indicators of stress (e.g., inflammation), and cognitive function (e.g., attentional ability). All participants will complete three testing sessions: baseline (pre-intervention \[T1\]), post 8-week follow-up (post-intervention, \[T2\]), and 12-month follow-up (T3). The target sample is 232 family/informal caregivers, aged 50+ years old. All sessions will be conducted using the Zoom platform. Participants will be required to go to LifeLabs for blood collection. Blood results will be shared with participants.

Вмешательства

• Другое Mindfulness Meditation
  8-week mindfulness meditation program, based on Kabat-Zinn's MBSR program and modified for caregivers. The intervention will be led by MBSR-trained facilitators.
• Другое Psychoeducation
  A lecture-style program based on the "10 Keys"TM to Healthy Aging Course, an evidence-based program for older adults. The program will be delivered by a facilitator experienced in delivering similar content.
• Другое Wait list control
  Participants will receive two hours of respite from their caregiving responsibilities per week, for eight weeks. They will be given the opportunity to participate in either the MM or the PSY condition following completion of testing.

Первичные конечные точки

• Perceived Stress Scale [Срок оценки: Baseline, post-intervention (within 1 week following intervention completion), 12-month follow-up.]
• Center for Epidemiological Studies - Depression [Срок оценки: Baseline, post-intervention (within 1 week following intervention completion), 12-month follow-up.]

Вторичные конечные точки (3)

• Zarit Burden Interview [Срок оценки: Baseline, post-intervention (within 1 week following intervention completion), 12-month follow-up.]
• Flanker Task [Срок оценки: Baseline, post-intervention (within 1 week following intervention completion), 12-month follow-up.]
• Allostatic Load Index [Срок оценки: Baseline, post-intervention (within 1 week following intervention completion), 12-month follow-up]

Критерии участия

Критерии включения

• 50+ years of age
• Currently a primary family caregiver
• Fluent in English

Критерии исключения

• Existing mindfulness practice
• Diagnosed/Presenting with Post-traumatic Stress Disorder; Substance Disorder; Psychosis
• Unable to attend 8 sessions
• No access to a computer or high-speed internet
• Not willing to be randomized

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Канада · 1 центр

• Toronto Metropolitan University — Toronto

Публикации

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• Bohlmeijer E, ten Klooster PM, Fledderus M, Veehof M, Baer R. Psychometric properties of the five facet mindfulness questionnaire in depressed adults and development of a short form. Assessment. 2011 Sep;18(3):308-20. doi: 10.1177/1073191111408231. Epub 2011 May 17. PMID 21586480
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Идентификаторы

NCT: NCT06200909 · REB 2022-003

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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