Mindfulness-Based Intervention for Caregivers of Frail Older Chinese Adults

Study 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.

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

Conditions
-----------------
Frailty, Caregiver Burnout

Intervention / Treatment
-----------------
* Behavioral: Brief mindfulness based program
* Behavioral: Psychoeducation


Participation Criteria
=================
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
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Brief mindfulness based program<br>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<br>* An intervention promotes the acceptance and emotion regulation in caregiving for frail older adults<br>|
| Active Comparator: Psychoeducation<br>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<br>* An intervention promotes the coping and problem solving in caregiving for the frail older adults<br>|
| No Intervention: Treatment-as-usual<br> | |

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 |