The Effects of a Hybrid Face-To-Face and Online Mode of Delivering a Mindfulness-Based Dementia Caregiving Programme for Family Caregivers of Persons With Dementia: A Randomized Controlled Trial

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 Overview

• Status: Not yet recruiting
• Conditions: Caregiver Burden
• Intervention / Treatment: Behavioral: The Hybrid Mindfulness-based Dementia caregiving program (MBDCP); Behavioral: Psychoeducation educational program

• Study Type: Interventional
• Enrollment (Anticipated): 290
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pui Kin Patrick Kor; Phone Number: 2766 5622; Email: patrick.kor@polyu.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Caregivers who are aged 18 or above
• Caregivers who are taking care for a family member medically diagnosed with dementia who has been residing in the community;
• Caregivers who are providing care to the dementia care recipients for at least 6 months prior to the subject recruitment.

Exclusion Criteria:

• Caregivers who have participated in any structured psychosocial intervention or mindfulness-based intervention/training in the 6 months prior to recruitment,
• Caregivers who have acute psychiatric and medical comorbidities that are potentially life-threatening (e.g., suicidal ideation) or leave them with a limited ability to participate or adhere to the intervention (e.g., acute psychosis),
• caregivers who do not have Internet access.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A hybrid Mindfulness-based Dementia Caregiving Program (MBDCP); Participants from the experimental group will receive a hybrid Mindfulness-based Dementia Caregiving Program (MBDCP). It is a 6-week program. In the 1st, 2nd and 6th session, it is delivered through face to face, while in the 3rd, 4th and 5th sessions, it will be delivered via online approach.	Behavioral: The Hybrid Mindfulness-based Dementia caregiving program (MBDCP); 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.
Active Comparator: Control group; The family caregivers in the control group will receive 6 week education programme on dementia. It is a control for the social effects of the MBDCP. In the 1st, 2nd and 6th session, it is delivered through face to face, while in the 3rd, 4th and 5th sessions, it will be delivered via online approach.	Behavioral: Psychoeducation educational program; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	baseline, immediately after the intervention, 6 month- after the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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.	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.	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).	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.	baseline, immediately after the intervention, 6 month- after the intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of mindfulness	Caregivers' level of mindfulness will be measured as the process indicator by using the Five Facets Mindfulness Questionnaire Short Form (Baer et al., 2006) . It is a 20 item self-report questionnaire measuring the five facets of mindfulness which includes observing, describing, acting with awareness, non-judging of inner and non-reactivity to inner experience. The total score ranges from 20 to 100 and the higher the score, the higher level of mindfulness.	baseline, immediately after the intervention, 6 month- after the intervention

Collaborators and Investigators

• Sponsor: The Hong Kong Polytechnic University

Publications and helpful links

General Publications

• Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
• Cummings JL, Mega M, Gray K, Rosenberg-Thompson S, Carusi DA, Gornbein J. The Neuropsychiatric Inventory: comprehensive assessment of psychopathology in dementia. Neurology. 1994 Dec;44(12):2308-14. doi: 10.1212/wnl.44.12.2308.
• Zarit SH, Reever KE, Bach-Peterson J. Relatives of the impaired elderly: correlates of feelings of burden. Gerontologist. 1980 Dec;20(6):649-55. doi: 10.1093/geront/20.6.649. No abstract available.
• Heart rate variability: standards of measurement, physiological interpretation and clinical use. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Circulation. 1996 Mar 1;93(5):1043-65. No abstract available.
• Sebern MD, Whitlatch CJ. Dyadic relationship scale: a measure of the impact of the provision and receipt of family care. Gerontologist. 2007 Dec;47(6):741-51. doi: 10.1093/geront/47.6.741.
• Baer RA, Smith GT, Hopkins J, Krietemeyer J, Toney L. Using self-report assessment methods to explore facets of mindfulness. Assessment. 2006 Mar;13(1):27-45. doi: 10.1177/1073191105283504.
• Vanderlei LC, Silva RA, Pastre CM, Azevedo FM, Godoy MF. Comparison of the Polar S810i monitor and the ECG for the analysis of heart rate variability in the time and frequency domains. Braz J Med Biol Res. 2008 Oct;41(10):854-9. doi: 10.1590/s0100-879x2008005000039. Epub 2008 Sep 30.
• Roberts RE, Vernon SW. The Center for Epidemiologic Studies Depression Scale: its use in a community sample. Am J Psychiatry. 1983 Jan;140(1):41-6. doi: 10.1176/ajp.140.1.41.
• Kate N, Grover S, Kulhara P, Nehra R. Scale for positive aspects of caregiving experience: development, reliability, and factor structure. East Asian Arch Psychiatry. 2012 Jun;22(2):62-9.
• Kor PPK, Li ML, Kwok DKS, Leung AYM, Lai DLL, Liu JYW. Evaluating the effectiveness of a 6-week hybrid mindfulness-based intervention in reducing the stress among caregivers of patients with dementia during COVID-19 pandemic: protocol of a randomized controlled trial. BMC Psychol. 2022 Jul 19;10(1):178. doi: 10.1186/s40359-022-00876-8.

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2022
• Primary Completion (Anticipated): October 1, 2023
• Study Completion (Anticipated): June 30, 2024

Study Registration Dates

• First Submitted: February 8, 2022
• First Submitted That Met QC Criteria: February 8, 2022
• First Posted (Actual): February 16, 2022

Study Record Updates

• Last Update Posted (Actual): February 16, 2022
• Last Update Submitted That Met QC Criteria: February 8, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Stress, Psychological; Dementia; Caregiver Burden
• Other Study ID Numbers: HSEARS20210709005

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