Caregiver Burden, Caregiver Stress
Conditions
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.
Interventions
OTHERMindfulness 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.
OTHERPsychoeducation
A lecture-style program based on the 10 KeysTM to Healthy Aging Course, an evidence-based program for older adults. The program will be delivered by a facilitator experienced in delivering similar content.
OTHERWait 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.
Sponsors
Toronto Metropolitan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
Researchers who engage in pre-post testing assessment will be blinded to participant allocation.
Intervention model description
A prospective single-blinded mixed methods randomized controlled superiority trial, with participants randomized in blocks of 8-12 to either MM, PSY, or RC.
Eligibility
Sex/Gender
ALL
Age
50 Years to 100 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| UMASS Stress Reduction Program Follow-up Questionnaire | Baseline, post-intervention (within 1 week following intervention completion), 12-month follow-up. | 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. |
| Difficulties in Emotion Regulation - Short Form | Baseline, post-intervention (within 1 week following intervention completion), 12-month follow-up. | 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. |
| Fear and Resistance to Mindfulness Scale | Up to 1 week prior to participation in mindfulness condition; post-intervention (within 1 week following intervention completion) | 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. |
| Five Factor Mindfulness Questionnaire - Short Form | Baseline, post-intervention (within 1 week following intervention completion), 12-month follow-up. | 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. |
| Pearlin Mastery Scale | Baseline, post-intervention (within 1 week following intervention completion), 12-month follow-up. | 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 |
| Self-Compassion Scale | Baseline, post-intervention (within 1 week following intervention completion), 12-month follow-up. | 26-item Likert type scale the measures self-compassion, with higher scores (range 1-5) indicating greater self-compassion. |
| WHO Quality of Life Scale - Brief | Baseline, post-intervention (within 1 week following intervention completion), 12-month follow-up. | 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. |
Countries
Canada
Contacts
Primary ContactRhiannon Ueberholz, BA
Backup ContactAlexandra Fiocco, PhD
Outcome results
None listed