Self-Care Training for Family Caregivers of Persons With Neurodegeneration
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-100
SponsorToronto Metropolitan University
About this trial
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).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
50+ years of age
Currently a primary family caregiver
Fluent in English
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Mindfulness Meditation
Other intervention8-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
Other interventionA 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
Other interventionParticipants 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.
Treatment groups
232 Participants
are divided into 3 treatment groupsGroup A: Mindfulness Meditation (MM)Experimental treatment 1 intervention
Group B: PsychoeducationActive comparator 1 intervention
Group C: Respite controlActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline, post-intervention (within 1 week following intervention completion), 12-month follow-up.2
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.
Time frame
Baseline, post-intervention (within 1 week following intervention completion), 12-month follow-up.Secondary outcomes
1
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.
Time frame
Baseline, post-intervention (within 1 week following intervention completion), 12-month follow-up.2
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.
Time frame
Baseline, post-intervention (within 1 week following intervention completion), 12-month follow-up.3
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.
Time frame
Baseline, post-intervention (within 1 week following intervention completion), 12-month follow-upOther outcomes
1
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.
Time frame
Baseline, post-intervention (within 1 week following intervention completion), 12-month follow-up.2
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.
Time frame
Baseline, post-intervention (within 1 week following intervention completion), 12-month follow-up.3
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"
Time frame
Baseline, post-intervention (within 1 week following intervention completion), 12-month follow-up.4
Self-Compassion Scale
26-item Likert type scale the measures self-compassion, with higher scores (range 1-5) indicating greater self-compassion.
Time frame
Baseline, post-intervention (within 1 week following intervention completion), 12-month follow-up.Sponsors and contacts
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Source ClinicalTrials.gov