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

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

Study Overview

• Status: Recruiting
• Conditions: Frailty; Caregiver Burnout
• Intervention / Treatment: Behavioral: Brief mindfulness based program; Behavioral: Psychoeducation

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 Type: Interventional
• Enrollment (Estimated): 240
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Herman, Hay-ming LO, PhD; Phone Number: +85296279830; Email: herman.lo@polyu.edu.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong, 852
    • Recruiting
    • The Hong Kong Polytechnic University
    • Contact: Hay-ming Herman Lo, PhD; Phone Number: 852-2766-5769; Email: herman.lo@polyu.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Brief mindfulness based program; An intervention promotes the acceptance and emotion regulation in caregiving for frail older adults
Active Comparator: Psychoeducation; A four session program, each last for 2.5 hours. It promotes the coping and problem solving of caregivers. Brief home application included.	Behavioral: Psychoeducation; An intervention promotes the coping and problem solving in caregiving for the frail older adults
No Intervention: Treatment-as-usual

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression	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	Change from pre-intervention, to 1-month follow-up, and to 6-month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Caregiver burden	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	Change from pre-intervention, to 1-month follow-up, and to 6-month follow-up.
Anxiety	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	Change from pre-intervention, to 1-month follow-up, and to 6-month follow-up
Spiritual well-being	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	Change from pre-intervention, to 1-month follow-up, and to 6-month follow-up.
family conflicts	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	Change from pre-intervention, to 1-month follow-up, and to 6-month follow-up
Heart rate variability	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	Change from pre-intervention, to 1-month follow-up, and to 6-month follow-up.
Coping styles	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	Change from pre-intervention, to 1-month follow-up, and to 6-month follow-up

Collaborators and Investigators

• Sponsor: The Hong Kong Polytechnic University
• Investigators: Principal Investigator: Herman, Hay-ming LO, PhD, Hong Kong Polytechnic University

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2021
• Primary Completion (Estimated): March 30, 2024
• Study Completion (Estimated): March 30, 2024

Study Registration Dates

• First Submitted: April 12, 2021
• First Submitted That Met QC Criteria: April 23, 2021
• First Posted (Actual): April 27, 2021

Study Record Updates

• Last Update Posted (Estimated): March 5, 2024
• Last Update Submitted That Met QC Criteria: March 4, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Pathologic Processes; Stress, Psychological; Frailty; Caregiver Burden
• Other Study ID Numbers: 15604220

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No