Mindfulness-based intervention (MBI) has been shown promising effects in enhancing the well-being of caregivers of patients with dementia (PWD). However, the time schedule and the mode of delivering the conventional MBI was demanding to family caregivers of PWD, and therefore impeding the feasibility of use among caregivers. Our research team had developed a hybrid MBI program which includes face to face and online mode of mindfulness sessions w. The study aims to evaluate the effectiveness of this 6-week hybrid MBI program on caregivers of PWD over a 6-month follow up. This study is a two-arm parallel randomized controlled trial. Participants are family caregivers of PWD and we aimed to recruit 290 subjects. Eligible participants will be recruited from three local nongovernmental organizations (NGOs) in Hong Kong. They will be randomly allocated into MBI group and a control group (with 145 participants in each group) . The participants in the MBI group will receive 6 weekly 90-minute group-based sessions delivered through a face-to-face and online approach. The participants in control group will receive brief education on dementia care with the same group size, duration, and frequency as the sessions in the intervention group. Assessment (using questionnaire) about caregiving stress and other outcomes (positive aspect of caregiving, depression, dyadic relationship, anxiety, neuropsychiatric symptoms of patients) will be assessed at baseline, immediately after the intervention and at the 6-month follow up. Focus group interview will also be conducted to explore family caregivers' experience in participating in the program. We aimed to recruit 20 caregivers for the interviews via purposive sampling. It is hypothesized that compared to the control group, the MBI group will have a reduction on caregiving stress and improve other outcomes after the intervention.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
290
The hybrid MBDCP includes 6 weekly 90-minute group-based sessions delivered through a face-to-face (1st, 2nd, and 6th sessions) and online approach (3rd, 4th, and 5th sessions). The online session is designed for self-directed learning. The MBDCP includes different mindfulness practices (e.g., mindful eating, body scanning, and mindful walking), psychoeducation on caregiving, and group sharing, aimed at helping caregivers to develop mindfulness skills through the formal and informal practice of mindfulness, and to integrate these skills into their everyday life. The duration of each session is 90 minutes. Th MBDCP will be delivered by a qualified mindfulness therapist. In the MBDCP's online sessions, the caregivers will watch a teaching video (e.g., a video demonstrating mindfulness practices) through a website.
This program serves as a control for the social effects of the MBDCP. The brief education program consists of 6 weekly 90-minutes group sessions in which the sessions (1st, 2nd, and 6th) and (3rd 4th 5th) will be delivered through the face-to-face and online approach respectively, with the similar group size of the MBDCP. The education contents include caregiving skills, education on mood, and group sharing. The program will be led by a nurse.
Change in perceived Stress scale of caregivers
The change in stress will be measured by the Chinese version of perceived stress scale (Cohen et al., 1983) . The PSS contains 10 items. It is a 5 point Likert scale (1= never, 5=Very often). The total score is ranged from 10 to 50. A higher score indicating higher level of perceived stress
Time frame: baseline, immediately after the intervention, 6 month- after the intervention
Change in depressive symptoms of caregivers
The change in depressive symptoms will be measured by the Centre for Epidemiologic Studies Depression scale (CESD) (Robert \& Vernon, 1983) . It is a self-reported measurement containing 20 items. Rating were based on a 4 point likert scale ranging from 0 (Rarely or none of the time) to 3 (most or all of the time). The total score is ranged from 0-60. A higher score indicates a higher level of depression
Time frame: baseline, immediately after the intervention, 6 month- after the intervention
Change in positive caregiving experience of caregivers
This will be measured by thePositive aspect of caregiving scale (PAC) (Kate et al., 2012) . The PAC contains 11 items with 5 point likert scale for all item responses. The total score ranged from 11 to 55. , with higher score indicating a more positive perception of caregiving.
Time frame: baseline, immediately after the intervention, 6 month- after the intervention
Change in caregiving burden of caregivers
This will be measured by the Zarit Burden Interview (ZBI) (Zarit et al,1980) . The scale comprises of 22 items. Items are presented in the format of 5 point Likert scale (0= None, 4=Extremely distressing). The total score is ranged from 0-88, with a higher score representing a higher level of caregiving burden.
Time frame: baseline, immediately after the intervention, 6 month- after the intervention
Change in dyadic relationship
This will be measured using the dyadic relationship scale(Sebern \& Whitlatch, 2007). This scale is completed by the family caregivers and it assesses a variety of relationship stressor. Items are presented in a format of 4 point Likert scale (1= strongly disagree, 4 =strongly agree). The scale contains two subscale scores: dyadic strain (range of score: 5-20) and positive dyadic relationship (range of score: 6 to 24) . Higher score on each of these scales indicate higher level of strain and positive interactions respectively.
Time frame: baseline, immediately after the intervention, 6 month- after the intervention
Change in heart rate variability of caregivers
This will be measured by using validated Polar heart rate monitors. Heart rate variability will be interpreted following the guidelines for the Standard measurement and interpretation of HRV (European Society of Cardiology and the North American Society of Pacing and Electrophysiology) using the frequency domain method ( Vanderlei et al 2008; Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology, 1996).
Time frame: baseline, immediately after the intervention, 6 month- after the intervention
Change in neuropsychiatric symptoms of the care recipients
This will be measured by the Neuropsychiatric inventory Questionnaire (NPI-Q) (Cummings et al., 1994) through caregivers. NPI-Q is an informant based instrument that measures the presence and severity of 12 symptoms in patients with dementia and caregivers distress. The caregivers will be asked to identify whether the symptoms of the care recipients had been present in the past week, and rate the severity of the symptoms (from a likert scale ranged from 1 to 3) and the corresponding distress to them( from likert scale ranged from 1 to 5). The NPI-Q provides two scores, namely, total severity of symptoms (range of score: 12 to 36) and total distress scores (range of score: 12 to 60). The higher scores of these two subscales represent a higher level of symptoms severity of care recipients and distress of caregivers.
Time frame: baseline, immediately after the intervention, 6 month- after the intervention
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