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Clinical Trials/NCT04861610
NCT04861610
Recruiting
Not Applicable

Mindfulness-Based Intervention for Caregivers of Frail Older Chinese Adults: Testing an Intergenerational Caregiving Model

The Hong Kong Polytechnic University1 site in 1 country240 target enrollmentMay 3, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Frailty
Sponsor
The Hong Kong Polytechnic University
Enrollment
240
Locations
1
Primary Endpoint
Depression
Status
Recruiting
Last Updated
2 years ago

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.

Registry
clinicaltrials.gov
Start Date
May 3, 2021
End Date
March 30, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

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

  • 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.)
  • 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)

Study Sites (1)

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