Self-Care Training for Family Caregivers of Persons With Neurodegeneration

Official title

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

Overview

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).

Detailed description

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.

Interventions

• Other 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.
• Other 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.
• Other 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.

Primary outcome measures

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

Secondary outcome measures (3)

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

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Prevention

Study locations

Canada · 1 center

• Toronto Metropolitan University — Toronto

Publications

• Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available. PMID 6668417
• Kaufman EA, Xia M, Fosco G, Yaptangco M, Skidmore CR, Crowell SE. The Difficulties in Emotion Regulation Scale Short Form (DERS-SF): Validation and Replication in Adolescent and Adult Samples. J Psychopathol Behav Assess. 2016 Sep;38(3):443-455. doi: 10.1007/s10862-015-9529-3. Epub 2015 Nov 23. PMID 41522882
• Radloff LS. The CES-D Scale: A Self-Report Depression Scale for Research in the General Population. Applied Psychological Measurement. 1977;1(3):385-401. doi:10.1177/014662167700100306
• Zarit SH, Reever KE, Bach-Peterson J. Relatives of the impaired elderly: correlates of feelings of burden. Gerontologist. 1980 Dec;20(6):649-55. doi: 10.1093/geront/20.6.649. No abstract available. PMID 7203086
• Juster RP, Bizik G, Picard M, Arsenault-Lapierre G, Sindi S, Trepanier L, Marin MF, Wan N, Sekerovic Z, Lord C, Fiocco AJ, Plusquellec P, McEwen BS, Lupien SJ. A transdisciplinary perspective of chronic stress in relation to psychopathology throughout life span development. Dev Psychopathol. 2011 Aug;23(3):725-76. doi: 10.1017/S0954579411000289. PMID 21756430
• 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
• Pearlin LI, Lieberman MA, Menaghan EG, Mullan JT. The stress process. J Health Soc Behav. 1981 Dec;22(4):337-56. No abstract available. PMID 7320473
• Neff KD. The Development and Validation of a Scale to Measure Self-Compassion. Self and Identity. 2003;2(3):223-250. doi:10.1080/15298860309027

Identifiers

NCT: NCT06200909 · REB 2022-003

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗