Self-Care Training for Family Caregivers of Persons With Neurodegeneration

Not Applicable

Recruiting

• Conditions: Caregiver Burden; Caregiver Stress

• Registration Number: NCT06200909
• Lead Sponsor: Toronto Metropolitan University

Brief 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).

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 Timeline

• Study First Submitted: 2023-12-08
• Study First Submitted QC: 2023-12-28
• Study First Posted: 2024-01-11
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-08
• Last Update Posted: 2024-04-10
• Study Start: 2024-06
• Primary Completion: 2027-11
• Study Completion: 2028-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 232

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Center for Epidemiological Studies - Depression	Baseline, post-intervention (within 1 week following intervention completion), 12-month follow-up.	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.
Perceived Stress Scale	Baseline, post-intervention (within 1 week following intervention completion), 12-month follow-up.	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.

Secondary Outcome Measures

Name	Time	Method
Zarit Burden Interview	Baseline, post-intervention (within 1 week following intervention completion), 12-month follow-up.	A 22-item Likert-type scale that measures distress surrounding the caregiver role. Greater scores (range 0-88) indicate greater caregiver burden.
Allostatic Load Index	Baseline, post-intervention (within 1 week following intervention completion), 12-month follow-up	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.
Flanker Task	Baseline, post-intervention (within 1 week following intervention completion), 12-month follow-up.	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.

Trial Locations

Locations (1)

Toronto Metropolitan University; 🇨🇦 Toronto, Ontario, Canada