Mindfulness-Based Intervention for Caregivers of Frail Older Chinese Adults: Testing an Intergenerational Caregiving Model
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 240
- Locations
- 1
- Primary Endpoint
- Depression
Study Overview
Brief Summary
This is study to investigate the effects of a brief mindfulness-based program for frail older adults caregivers.
Detailed Description
The proposed study is a multi-site, three-arm randomized controlled trial of a mindfulness-based intervention for Chinese family caregivers in Hong Kong. Effects of the intervention will be compared with those of an evidence-based psychoeducation program, and treatment-as-usual. 240 caregivers of frail elderly with moderate to severe levels of frailty, will be recruited and randomly assigned to mindfulness-based intervention, psychoeducation, and treatment-as-usual experimental conditions. Overall program effectiveness will be analyzed on measures of caregiver burden, depression, anxiety, positive caregiving experience, spirituality, family conflict, and the biomarker of heart rate variability. Measures on coping styles, experiential avoidance, and self-efficacy will be explored to see if they mediate the changes to participant improvements in outcomes. 6-month follow-up will be included to investigate the maintenance effects.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Caregivers of frail elderly based on a professional's assessment of Clinical Frailty Scale with a score of 6, indicating a moderate level of frailty or above (Rockwood et al., 2005)
- •Caregivers being adult children or children in-law of the elder care receiver
- •Caregivers who are experiencing caregiver burden at the time of study, with scores of 8 or above in Zarit Burden Interview-4
Exclusion Criteria
- •impairment, which may present difficulties in comprehending the content of the program
- •Spouses, siblings, or friends will be excluded
- •Caregivers of elders with moderate to severe dementia will be excluded and the Clinical Dementia Rating Scale will be administered
- •Caregivers who had participated in an eight week Mindfulness-Based Stress Reduction or equivalent
Arms & Interventions
Psychoeducation
A four session program, each last for 2.5 hours. It promotes the coping and problem solving of caregivers. Brief home application included.
Intervention: Psychoeducation (Behavioral)
Treatment-as-usual
Brief mindfulness based program
A four session program, each last for 2.5 hours. Brief mindfulness exercises promote stress reduction, with an introduction of mindfulness to caregivers and home practice is encouraged with guidance.
Intervention: Brief mindfulness based program (Behavioral)
Outcomes
Primary Outcomes
Depression
Time Frame: Change from pre-intervention, to 1-month follow-up, and to 6-month follow-up
assessed by a self-reported measure The Center for Epidemiologic Studies Depression Scale, 10 items, sum of scores from 0 to 30, the higher the score, the more severe in the depression symptoms
Secondary Outcomes
- Anxiety(Change from pre-intervention, to 1-month follow-up, and to 6-month follow-up)
- family conflicts(Change from pre-intervention, to 1-month follow-up, and to 6-month follow-up)
- Heart rate variability(Change from pre-intervention, to 1-month follow-up, and to 6-month follow-up.)
- Coping styles(Change from pre-intervention, to 1-month follow-up, and to 6-month follow-up)
- Caregiver burden(Change from pre-intervention, to 1-month follow-up, and to 6-month follow-up.)
- Spiritual well-being(Change from pre-intervention, to 1-month follow-up, and to 6-month follow-up.)