Self-Care Training for Family Caregivers of Persons With Neurodegeneration

Caregiver Burden Clinical Trial

— MCP  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06200909
• Other study ID #: REB 2022-003
• Status: Recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: September 2028

Study information

• Verified date: April 2024
• Source: Toronto Metropolitan University
• Contact: Rhiannon Ueberholz, BA
• Phone: 416-979-5000
• Email: star.lab[@]torontomu.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 232
• Est. completion date: September 2028
• Est. primary completion date: November 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Caregiver Burden
• Caregiver Stress

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Canada	Toronto Metropolitan University	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Toronto Metropolitan University

Country where clinical trial is conducted

Canada, 

References & Publications (10)

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. — View Citation

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. — View Citation

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

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. — View Citation

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

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

Pearlin LI, Lieberman MA, Menaghan EG, Mullan JT. The stress process. J Health Soc Behav. 1981 Dec;22(4):337-56. No abstract available. — View Citation

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

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.
Other	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.
Other	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.
Other	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.
Other	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.
Other	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.
Other	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)
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	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