Mindfulness-Based Intervention for Caregivers of Frail Older Chinese Adults
- Conditions
- FrailtyCaregiver Burnout
- Interventions
- Behavioral: Brief mindfulness based programBehavioral: Psychoeducation
- Registration Number
- NCT04861610
- Lead Sponsor
- The Hong Kong Polytechnic University
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 240
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Brief mindfulness based program 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. Psychoeducation Psychoeducation A four session program, each last for 2.5 hours. It promotes the coping and problem solving of caregivers. Brief home application included.
- Primary Outcome Measures
Name Time Method Depression 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 Outcome Measures
Name Time Method Caregiver burden Change from pre-intervention, to 1-month follow-up, and to 6-month follow-up. assessed by a self-reported measure Zarit Burden Interview, 22 items, sum of scores from 0 to 88, the higher the score, the more severe in the caregiver burden
Spiritual well-being Change from pre-intervention, to 1-month follow-up, and to 6-month follow-up. assessed by a self-reported measure Functional Assessment of Chronic Illness, 12 items, sum of scores from 0 to 48, the higher the score, the better the level in well-being Therapy-Spiritual Well-Being Scale
Anxiety Change from pre-intervention, to 1-month follow-up, and to 6-month follow-up assessed by a self-reported measure Hospital Anxiety and Depression Scale -Anxiety subscale, 7 items, sum of scores from 0 to 21, the higher the score, the more severe in the anxiety symptoms
family conflicts Change from pre-intervention, to 1-month follow-up, and to 6-month follow-up assessed by a self-reported measure Revised Conflict Tactics Scale, 10 items, sum of scores from 0 to 40, the higher the score, the more severe in the level of family conflicts
Heart rate variability Change from pre-intervention, to 1-month follow-up, and to 6-month follow-up. measured by the CorSense Heart Rate Variability monitor, the higher the heart rate variability, the better the ability to self-regulate in response to stressful situations
Coping styles Change from pre-intervention, to 1-month follow-up, and to 6-month follow-up measured by a self-reported scale brief COPE, 28 items, sum of scores from 28 to 112, the higher the score, the better the level of positive coping
Trial Locations
- Locations (1)
The Hong Kong Polytechnic University
ðŸ‡ðŸ‡°Hong Kong, Hong Kong