Clinical trial NCT06200909: Self-Care Training for Family Caregivers of Persons With Neurodegeneration
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Caregiver Burden
Caregiver Stress
Lead sponsor: Toronto Metropolitan University
Sponsor class: OTHER
First posted: 2024-01-11
Enrollment: 232
Sex: ALL
Minimum age (years): 50
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Perceived Stress Scale
timeFrame: Baseline, post-intervention (within 1 week following intervention completion), 12-month follow-up.
measure: Center for Epidemiological Studies - Depression
timeFrame: Baseline, post-intervention (within 1 week following intervention completion), 12-month follow-up.
Secondary outcomes:
measure: Zarit Burden Interview
timeFrame: Baseline, post-intervention (within 1 week following intervention completion), 12-month follow-up.
measure: Flanker Task
timeFrame: Baseline, post-intervention (within 1 week following intervention completion), 12-month follow-up.
measure: Allostatic Load Index
timeFrame: Baseline, post-intervention (within 1 week following intervention completion), 12-month follow-up
Other outcomes:
measure: Difficulties in Emotion Regulation - Short Form
timeFrame: Baseline, post-intervention (within 1 week following intervention completion), 12-month follow-up.
measure: Five Factor Mindfulness Questionnaire - Short Form
timeFrame: Baseline, post-intervention (within 1 week following intervention completion), 12-month follow-up.
measure: Pearlin Mastery Scale
timeFrame: Baseline, post-intervention (within 1 week following intervention completion), 12-month follow-up.
measure: Self-Compassion Scale
timeFrame: Baseline, post-intervention (within 1 week following intervention completion), 12-month follow-up.
measure: WHO Quality of Life Scale - Brief
timeFrame: Baseline, post-intervention (within 1 week following intervention completion), 12-month follow-up.
measure: UMASS Stress Reduction Program Follow-up Questionnaire
timeFrame: Baseline, post-intervention (within 1 week following intervention completion), 12-month follow-up.
measure: Fear and Resistance to Mindfulness Scale
timeFrame: Up to 1 week prior to participation in mindfulness condition; post-intervention (within 1 week following intervention completion)
Locations:
city: Toronto
country: Canada
facility: Toronto Metropolitan University
state: Ontario
Study officials:
affiliation: Toronto Metropolitan University
name: Alexandra Fiocco, PhD
role: PRINCIPAL_INVESTIGATOR
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