Mindfulness-Based Intervention for Caregivers of Frail Older Chinese Adults: Testing an Intergenerational Caregiving Model
Phase: NA
Conditions: Frailty, Caregiver Burnout
Sponsor: The Hong Kong Polytechnic University

 
 
Official title: Mindfulness-Based Intervention for Caregivers of Frail older adults: 
Towards a model of intergenerational caregiving for Chinese families 
 
NCT number: to be assigned 
 
Document date: April 22, 2021 
 
 

The research questions of the proposed study are:  
1) investigate the effects of a brief mindfulness-based intervention for caregivers of 
frail elders in reducing caregiver burden and depression;  
2) compare the effects of mindfulness-based intervention with an evidence-based 
caregiver programme; and  
3) explore the factors that contribute to the positive improvements of both caregiver 
programmes, and develop a preliminary model for understanding and reducing 
caregiver burden and depression. 
 
RESEARCH PLAN AND METHODOLOGY 
Study design 
In view of the research objectives about efficacy of the MBI and in the interest of 
developing a model of mediators in the MBI and intergenerational caregiving, a 
multi-site, three-arm, randomized controlled trial will be implemented (Baron et al., 
2013). The effects of the MBI for caregivers for frail elderly will be tested by 
comparing the MBI (Arm 1), with psychoeducation (Arm 2), and treatment-as-usual 
(Arm 3). Assessments will be scheduled pre-intervention (T0), post-intervention (T1), 
and at 6-month follow-up (T2). The program effects will be tested using both pairwise 
between-subject comparisons (Arm 1 vs Arm 2, Arm 2 vs Arm 3, and Arm 1 vs Arm 
3) and within-subject comparisons (measures at T0, T1, and T2). The between-group 
analyses will be adjusted for baseline scores and for factors related to outcomes, 
including the age and sex of the caregivers, the severity of depression, 
anxiety, caregiver burden, and the level of frailty of elderly. Refinement of design 
from a pilot study. A pilot study has been conducted in August to 
September 2019.  
 
Sample size estimation. We calculated the sample size needed for the first two 
hypotheses and choose the larger one for the estimation of overall sample size. For the 
first hypothesis, the calculation is based on a previous study of an MBI for caregivers 
(Hou et al., 2014), in which an effect size of 0.64 in depression, with an estimation of 
an effect size of 0.14 for Arm 3. For a two-tailed α error of 5%, an 80% power, and a 
test of three independent groups, the required sample size will be 64 per arm (Cohen, 
1988). For the second hypothesis, the calculation is based on a non-inferiority 
comparison was conducted. A non-inferiority margin of 50%, as common practice in 
non-inferiority trials (Althunian et al., 2017), is selected and the required sample size 
will be 51 per arm. We further adjust the sample size based on an estimation of drop-
out rate and intra-class correlation. An estimation of a drop-out rate of 15% is based 
on two local studies of mindfulness-based intervention (Hou et al., 2014; Lo et al., 

2015). Besides, an estimation of intra-class correlations of 0.07 is based on PI’s two 
recent mindfulness multi-site studies ranged from 0 to 0.07 (Lo et al., 2017; Lo et al., 
in press), and 240 caregivers will be recruited for this study. Based on such 
estimation, it should also be necessary to conduct mediational studies with .8 
statistical power (Fritz & MacKinnon, 2007). 
Recruitment of participants. The inclusion criteria for participation in this study are: 
1) 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). 2) Caregivers being adult children or children in-law of the elder care 
receiver. 3) Caregivers who are experiencing caregiver burden at the time of study, 
with scores of 8 or above in ZBI-4 (Bedard et al., 2001). The exclusion criteria 
include: 1) Caregivers who have diagnoses of psychosis, developmental disabilities, 
or cognitive impairment, which may present difficulties in comprehending the content 
of the program. 2) Spouses, siblings, or friends will be excluded as their burden or 
depressive symptoms may be attributed to different reasons. 3) Caregivers of elders 
with moderate to severe dementia will be excluded and the Clinical Dementia Rating 
Scale will be administered (Huges et al., 1982), and 4) Caregivers who had 
participated in a MBSR or equivalent. 
The research project will be announced and promoted among collaborating NGOs and 
through advertisement in social media, promotional emails, and project leaflets. Four 
NGOs have indicated their intentions to contribute to this study by assisting in 
promotion, recruitment, program implementation and data collection. Support letters 
of these NGO collaborators have been provided in the appendix. 
We will organize briefing sessions for explaining the rationale and procedures of the 
study half yearly. All interested caregivers will be screened using Clinical Frailty 
Scale, Clinical Dementia Rating Scale, and caregiver stress. Written consent will be 
collected for eligible participants. All NGO collaborators will provide standard care to 
the participants, including participants in Arm 3 who will not receive MBI nor 
psychoeducation before T2. The Research Assistant who is blinded to the personal 
data of the participants, will administer the random assignment using computer 
generated programming. Participants will be randomly assigned to MBI (Arm 1), 
psychoeducation (Arm 2), or treatment-as-usual (Arm 3). During the recruitment and 
implementation, both arm 1 and 2 are called “Family Psychoeducation Program”, and 
the term “mindfulness” will not be used for Arm 1 to minimize the potential placebo 
effect. Cash remuneration coupons will be provided to caregivers who can complete 
the study at T1 and T2. A recruitment flowchart is attached in Appendix 1. 
 
Procedures 

Program planning and training. The themes and content of arms 1 and 2 are 
summarized in Appendix 2. 
MBI (Arm 1). Based on the protocols of PI’s previous clinical trials, brief mindfulness 
exercises will be integrated with psychoeducation of caregiving for frail elderly. The 
protocol for Arm 1 has been developed on mid-Sept, 2019 for the first pilot study. 
Psychoeducation. 
(Arm 2). The research team will modify START (STrAtegies for RelaTives) program 
for 
caregivers of dementia (Livingstone et al., 2014) into a 10-hour group program. Major 
changes include the content originally related to the caregiving needs of dementia will 
changed to frail elderly. Two hours will be added to allow for more discussion of 
individual caregiver’s concerns. The protocol for Arm 2 will be developed and a pilot 
study will be conducted shortly in early 2020. Arm 1 and 2 are parallel in program 
design. Both will be 4-session programs to be organized bi-weekly, and last for 10 
hours in total. Both programs include 15-minute daily home practice assignments, 
with Arm 1 being guided with mindfulness exercises, and Arm 2 with coping and 
problem-solving skills. Both arms will be delivered in group format, with 10 to 15 
caregivers in each group. Programs will be conducted in the service units of four 
NGO collaborators and PI’s university. All instructors for Arm 1 require basic 
professional training in MBI, plus at least two-year experience in conducting MBI. 
Instructors for Arm 2 will be recruited from NGO with experience in working with 
caregivers of frail elderly for more than two years. Implementation and assessment. 
After the pre-intervention assessment (T0), caregivers who meet inclusion criteria will 
be randomized into a MBI (Arm 1), psychoeducation (PSY, Arm 2), or treatment-as-
usual (TAU, Arm 3). After the intervention programs, participants in three arms will 
complete the post-intervention assessment (T1). A 6-month follow up (T2) is 
offered as a booster and final assessment for arms 1 and 2. This study will be single-
blinded and outcome assessors will be blinded to randomization status. 
To ensure intervention fidelity, all program sessions will be audio-recorded and an 
independent rater will listen to 20% of the selected clips on random basis, and assess 
whether each element in the intervention protocol has been implemented with 
consistency. Higher concordance rates will signify greater fidelity to the intervention 
protocol, which will be carefully monitored throughout the study. The treatment 
fidelity of Arm 1 will be further assessed by Mindfulness-based Interventions-
Teaching Assessment Criteria Scale (Crane et al., 2013). Those of Arm 2 will be 
assessed by a checklist for implementing START program. 
 
 
 

Table 1. Outcome variables and measures 
Study variables and measures  
Validation 
in 
HK 
samples 
Primary outcome variables  
 
Caregiver burden 
- Measured by 22-item Zarit Burden Interview (ZBI) (Zarit et al., 1980) 
 
α = .88 (Tang et al., 
2017) 
Secondary outcome variables  
 
Depressive symptoms 
- measured by 10-item The Center for Epidemiologic Studies Depression 
Scale (CES-D) (Radloff, 1977) 
 
α = 0.78 (Boey, 1999) 
Anxiety symptoms 
- measured by 7-item Hospital  Anxiety and Depression Scale – Anxiety 
subscale (HAD-A) (Zigmond & Snaith, 1983) 
 
α = 0.77 to 0.82 (Leung 
et al., 1999) 
Positive caregiving experiences 
- Measured by 9-item Positive Aspects of Caregiving Scale (PAC) (Tarlow 
et al., 2004) 
 
α = 0.89 (Lou et al., 
2015) 
Spiritual well-being 
- measured by 12-item Functional Assessment of Chronic Illness Therapy–
Spiritual Well-Being Scale (FACIT-Sp-12) (Peterman et al., 2002), with 
two subscales in meaning/peace and faith  
 
α = 0.80 (Wang, 2016) 
Family conflicts  
- measured by 10-item Revised Conflict Tactics Scale (CTS2) (Beach et al., 
2005), with subscales in psychological mistreatment (5 items) and physical 
abuse (5-items)  
 
α = .81 to .82 (Yan & 
Tang, 2001) 
Biomarker: Heart rate variability 
- measured by the CorSense Heart Rate Variability monitor 
 
N.A. 
Mediators of outcome 
 
Cognitive factor: Coping styles 
- measured by 28-item brief COPE (Carver, 1997), with 11 subscales 
(problem-solving, 
accommodation, 
support-seeking, 
behavioral 
disengagement, denial, self-distraction, self-blame, humour, venting, 
substance use, and religion) 
 
α = 0.76 for whole 
scale, and α = .49 to .87 
for subscales (Tang et 
al., 2016) 
Cognitive factor (psychoeducation-specific): Self efficacy 
- Measured by 5-item subscale of controlling upsetting thoughts (5 items) 
in the Revised Scale for Caregiving Self-Efficacy (RSCSE) (Steffen et al., 
2002) 
 
α = .86 (Au et al., 2009) 
Cognitive factor (mindfulness-specific): Experiential avoidance 
- measured by 15-item The Brief Experiential Avoidance (BEAQ) 
Questionnaire (Gamez et al., 2011) 
 
α = 0.81 (Lo et al., in 
review) 
 
3. Data Analyses  
All analyses will be carried out according to the intention-to-treat approach and all 
participants who receive randomization and allocation to one of three treatment arms 
will be included for analyses (Moher et al., 2010). Repeated measure ANOVA will be 
used to evaluate the effects of the MBI (Arm 1), relative to PSY (Arm 2) and TAU 
(Arm 3), and the analyses of the primary and secondary outcome measures will be 
analyzed. In addition to the immediate programme effects, outcomes measured at T1 
and T2 will be compared, to assess whether maintenance effects will be sustained at 
6-months.   
  The mediation effects on the relationships between group (MBI or PSY vs. TAU) 

variables and caregiver outcome variables (ZBI, CES-D, HAD-A), controlling the 
baseline variables (sex and age of caregivers, frailty score), will be evaluated using 
the PROCESS macro in SPSS (Hayes, 2012), in order to compute the effect of the 
independent variable on the mediator (a), the effect of the mediator on the dependent 
variable (b),_total effect (c), direct effect (c’), and bootstrapped (i.e., 10,000 random 
samples) bias-corrected 95% confidence intervals of the indirect effect (ab). 
According to Hayes (2009), with significant paths a and b, even without a significant 
path c, confidence intervals that do not include zero indicate a significant indirect 
(i.e., mediation) effect.