Self-Care Training for Family Caregivers of Persons With Neurodegeneration (MCP)

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

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).

Study Overview

• Status: Recruiting
• Conditions: Caregiver Burden; Caregiver Stress
• Intervention / Treatment: Other: Mindfulness Meditation; Other: Psychoeducation; Other: Wait list control

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.

• Study Type: Interventional
• Enrollment (Estimated): 232
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alexandra Fiocco, PhD; Phone Number: 553233 416-979-5000; Email: afiocco@torontomu.ca
• Study Contact Backup: Name: Rhiannon Ueberholz, BA; Phone Number: 553233 416-979-5000; Email: star.lab@torontomu.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5B 2K3
      • Recruiting
      • Toronto Metropolitan University
      • Contact: Alexandra Fiocco, PhD; Phone Number: 553233 416-979-5000; Email: afiocco@torontomu.ca
      • Contact: Rhiannon Ueberholz, BA; Phone Number: 553233 416-979-5000; Email: star.lab@torontomu.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mindfulness Meditation (MM); 8-week mindfulness meditation program is based on Kabat-Zinn's MBSR program and will be led by MBSR-trained facilitators. The program has been modified to make it more accessible to caregivers. Weekly sessions will be 120-minutes long (instead of original 150-180-minute sessions). Formal meditation practices described in the original MBSR program (i.e., body scan, sitting meditation, mindful movement, mindful eating and walking) will be taught, in addition to loving kindness meditation (LKM). Participants will be given guided meditation recordings and compliance with home practice will be monitored with a practice log. The prescribed home practice has been modified to accommodate the needs of the caregiver: each practice is offered in 5- to 10-minute intervals (5 min, 10 min, and 20 min practice) to accommodate the caregiver's schedule.	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.
Active Comparator: Psychoeducation; Psychoeducation (PSY) condition will be similar to MM with respect to number and duration of weekly sessions and daily homework. PSY is a lecture-based program based on the "10 Keys"TM to Healthy Aging Course, an evidence-based program for older adults. Each session focuses on a specific topic related to wellness (e.g., nutrition, physical activity, medical screening) and caregiver-specific topics (e.g., understanding dementia and neurodegenerative disease, legal and financial issues).	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.
Active Comparator: Respite control; Participant allocated to RC will not be exposed to a program, but will be offered 120-minutes of weekly respite care. Caregivers will be asked to record how they spend respite hours each week.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived Stress Scale	10-item Likert-type scale that measured level of distress in the past month. The questionnaire will be modified to cover the past 2 weeks. Higher scores (range 0-40) indicate greater perceived stress.	Baseline, post-intervention (within 1 week following intervention completion), 12-month follow-up.
Center for Epidemiological Studies - Depression	A 20-item Likert-type questionnaire that measures presence of depressive symptoms in the past week. Higher scores (range 0-60) indicate greater depressive symptoms.	Baseline, post-intervention (within 1 week following intervention completion), 12-month follow-up.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Zarit Burden Interview	A 22-item Likert-type scale that measures distress surrounding the caregiver role. Greater scores (range 0-88) indicate greater caregiver burden.	Baseline, post-intervention (within 1 week following intervention completion), 12-month follow-up.
Flanker Task	The flanker task is a classic test of inhibitory control, in which participants are asked to indicate the direction in which a central arrow points while ignoring an array of "flanking" arrows. Flanker interference (difference in reaction times between congruent and incongruent trials for the correct responses, incongruent-congruent) will be calculated with greater scores indicating greater interference.	Baseline, post-intervention (within 1 week following intervention completion), 12-month follow-up.
Allostatic Load Index	Blood samples will be collected to measure biomarkers of biological stress to create an allostatic load (AL) index. Using the count-based calculation method, biomarker values that fall above the 75th percentile of the sample distribution are categorized as 1 and those below the 75th percentile are categorized as 0; except for DHEA-S, HDL cholesterol, which are categorized as 1 for values that fall below the 25th percentile and 0 for values that fall above the 25th percentile (Seeman et al., 1997). Subsystem scores (metabolic, immune, cardiovascular, neuroendocrine) are created by summing the relative biomarker scores and a total AL index score is calculated by summing all biomarker scores. Greater AL index score indicates greater cumulative biological stress.	Baseline, post-intervention (within 1 week following intervention completion), 12-month follow-up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difficulties in Emotion Regulation - Short Form	A 16-item Likert-type scale that measure subjective, trait emotion-regulation ability. Participant respond to questions on a 5-point Likert scale with higher scores (range 16-80) indicating greater emotion dysregulation.	Baseline, post-intervention (within 1 week following intervention completion), 12-month follow-up.
Five Factor Mindfulness Questionnaire - Short Form	A 24-item Likert-type questionnaire that measures the 5 facets of trait mindfulness. Subscale scores range from 8 to 40 for the observing, describing, acting with awareness, and non-judging facets, or 7 to 35 for the non-reacting facet, resulting in an overall FFMQ score range of 39 to 195. Higher scores indicate greater trait mindfulness.	Baseline, post-intervention (within 1 week following intervention completion), 12-month follow-up.
Self-Compassion Scale	26-item Likert type scale the measures self-compassion, with higher scores (range 1-5) indicating greater self-compassion.	Baseline, post-intervention (within 1 week following intervention completion), 12-month follow-up.
WHO Quality of Life Scale - Brief	26-item questionnaire that measures satisfaction with quality of life, health and other areas of the respondent's life.Higher scores (range 0-100) indicate greater quality of life.	Baseline, post-intervention (within 1 week following intervention completion), 12-month follow-up.
Pearlin Mastery Scale	This 7-item scale measures the extent to which an individual regards their life chances as being under their personal control. Responses are given on a four-point Likert scale ranging from "Strongly Disagree" to "Strongly Agree"	Baseline, post-intervention (within 1 week following intervention completion), 12-month follow-up.
UMASS Stress Reduction Program Follow-up Questionnaire	Questionnaire to assess perceived change driven by participation in a stress reduction program. Will be administered to those in the psychoeducation and mindfulness condition only.	Baseline, post-intervention (within 1 week following intervention completion), 12-month follow-up.
Fear and Resistance to Mindfulness Scale	A 29-item scale designed to measure fears and resistances to engaging in mindfulness practice. Items are rated on a five-point Likert scale ranging from 1: Not at all like me to 5 (extremely like me). Will be completed by mindfulness condition only.	Up to 1 week prior to participation in mindfulness condition; post-intervention (within 1 week following intervention completion)

Collaborators and Investigators

• Sponsor: Toronto Metropolitan University
• Investigators: Principal Investigator: Alexandra Fiocco, PhD, Toronto Metropolitan University

Publications and helpful links

General 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.
• 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.
• Pearlin LI, Lieberman MA, Menaghan EG, Mullan JT. The stress process. J Health Soc Behav. 1981 Dec;22(4):337-56. No abstract available.
• 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.
• 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;38(3):443-455. doi:10.1007/s10862-015-9529-3
• 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
• 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.
• 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
• Power MJ. Quality of life. In: Lopez SJ, Snyder CR, eds. Positive Psychological Assessment: A Handbook of Models and Measures. American Psychological Association; 2003:427-441. doi:10.1037/10612-027
• Gilbert P, Basran J, Plowright P, Matos M, Kirby J, Petrocchi N. Fears and Resistances to Mindfulness: Development of a Self-Report Scale. Mindfulness. 2023;14(11):2602-2616. doi:10.1007/s12671-023-02171-y

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): September 1, 2028

Study Registration Dates

• First Submitted: December 8, 2023
• First Submitted That Met QC Criteria: December 28, 2023
• First Posted (Actual): January 11, 2024

Study Record Updates

• Last Update Posted (Actual): April 10, 2024
• Last Update Submitted That Met QC Criteria: April 8, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological; Caregiver Burden
• Other Study ID Numbers: REB 2022-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: De-identified quantitative data will be posted on an open science framework when published in an open access journal. Data will also be made available upon request under ethical guidance.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No