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Mindfulness-Based Intervention for Caregivers of Frail Older Chinese Adults

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04861610
Enrollment
240
Registered
2021-04-27
Start date
2021-05-03
Completion date
2024-03-30
Last updated
2024-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Caregiver Burnout, Frailty

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.

Interventions

BEHAVIORALBrief mindfulness based program

An intervention promotes the acceptance and emotion regulation in caregiving for frail older adults

BEHAVIORALPsychoeducation

An intervention promotes the coping and problem solving in caregiving for the frail older adults

Sponsors

The Hong Kong Polytechnic University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
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

Design outcomes

Primary

MeasureTime frameDescription
DepressionChange from pre-intervention, to 1-month follow-up, and to 6-month follow-upassessed 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

MeasureTime frameDescription
AnxietyChange from pre-intervention, to 1-month follow-up, and to 6-month follow-upassessed 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
Spiritual well-beingChange 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
Caregiver burdenChange 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
Heart rate variabilityChange 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 stylesChange from pre-intervention, to 1-month follow-up, and to 6-month follow-upmeasured 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
family conflictsChange from pre-intervention, to 1-month follow-up, and to 6-month follow-upassessed 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

Countries

Hong Kong

Contacts

Primary ContactHerman, Hay-ming LO, PhD
herman.lo@polyu.edu.hk+85296279830

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026