Mindfulness-Based Intervention for Caregivers of Frail Older Chinese Adults

The Hong Kong Polytechnic University

Status: Enrolling

Conditions: Caregiver Burnout; Frailty

Treatments: Behavioral: Psychoeducation; Behavioral: Brief mindfulness based program

Study type: Interventional

Funder types: Other

Identifiers

NCT04861610

15604220

Details and patient eligibility

About

This is study to investigate the effects of a brief mindfulness-based program for frail older adults caregivers.

Full 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.

Enrollment: 240 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 3 patient groups

Brief mindfulness based program

Experimental group

Description:

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.

Treatment:

Behavioral: Brief mindfulness based program

Psychoeducation

Active Comparator group

Description:

A four session program, each last for 2.5 hours. It promotes the coping and problem solving of caregivers. Brief home application included.

Treatment:

Behavioral: Psychoeducation

Treatment-as-usual

No Intervention group