The Use of Modified Mindfulness-Based Stress Reduction and Mindfulness-Based Cognitive Therapy Program for Family Caregivers of People Living with Dementia: A Feasibility Study

Purpose The aim of this study was to investigate the feasibility and preliminary efficacy of a modified mindfulness-based stress reduction (MBSR) program and mindfulness-based cognitive therapy (MBCT) program for reducing the stress, depressive symptoms, and subjective burden of family caregivers of people with dementia (PWD). Methods A prospective, parallel-group, randomized controlled trial design was adopted. Fifty-seven participants were recruited from the community and randomized into either the modified MBSR group (n = 27) or modified MBCT group (n = 26), receiving seven face-to-face intervention sessions for more than 16 weeks. Various psychological outcomes were measured at baseline (T0), immediately after intervention (T1), and at the 3-month follow-up (T2). Results Both interventions were found to be feasible in view of the high attendance (more than 70.0%) and low attrition (3.8%) rates. The mixed analysis of variance (ANOVA) results showed positive within-group effects on perceived stress (p = .030, Cohen's d = 0.54), depressive symptoms (p = .002, Cohen's d = 0.77), and subjective caregiver burden (p < .001, Cohen's d = 1.12) in both interventions across the time points, whereas the modified MBCT had a larger effect on stress reduction, compared with the modified MBSR (p = .019). Conclusion Both the modified MBSR and MBCT are acceptable to family caregivers of PWD. Their preliminary effects were improvements in stress, depressive symptoms, and subjective burden. The modified MBCT may be more suitable for caregivers of PWD than the MBSR. A future clinical trial is needed to confirm their effectiveness in improving the psychological well-being of caregivers of PWD

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

Abstract Background Mindfulness-based intervention (MBI), an emotion-focused approach, has been shown promising and sustainable effects on enhancing the well-being of caregivers of patients with dementia (PWD). However, the conventional MBI was quite demanding, had high rates of attrition and inconsistent long-term effect. The social distancing measures introduced during the COVID-19 pandemic also restricted face-to-face psychosocial intervention. The study aims to evaluate the effectiveness of a 6-week hybrid MBI in caregivers of PWD over a 6-month follow up. Methods This is a single-blinded, parallel-group randomized controlled trial (RCT). Eligible participants from three local nongovernmental organizations (NGOs) will be randomly divided into intervention groups and control groups in a ratio of 1:1. The participants in the intervention group will receive 6 weekly 90-min group-based sessions delivered through a face-to-face and online approach. The participants in the control group will receive brief education on dementia care with the same group size, duration, and frequency as the sessions in the intervention group. Immediately after the intervention and at the 6-month follow-up, caring stress and other outcomes will be assessed. Besides, a focus group interview will be conducted to identify the strengths, limitations, and therapeutic components of the intervention from their perspectives. For quantitative data, intention-to-treat analysis and Generalized Estimating Equations (GEE) will be used. For qualitative data, content analysis will be used. Discussion This proposed hybrid model of MBI has several advantages, such as lower duration, longer follow-up period and easier access by family caregivers. Also, physiological indicators (e.g., heart rate viability and neuropsychiatric symptoms) will be measured in this study to show the body change after MBI. The quantitative and qualitative data of this research can also benefit the development of online or hybrid MBI for caregivers of PWD during the COVID-19 pandemic. Despite these strengths, it does have practical challenges and limitations. However, this proposed intervention has the potential to benefit not only the participants, but also the researcher as well as public health providers. Trial registration: NCT05242614. Registered on 2022-02-16, https://clinicaltrials.gov/ct2/show/NCT0524261

Sequential multiple assignment randomised controlled trial protocol for developing an adaptive intervention to improve depressive symptoms among family caregivers of people with dementia.

Peer reviewed: TrueOBJECTIVES: Family caregivers of people with dementia (FC-of-PWD) suffer from a high level of stress and depressive symptoms, which usually require different interventions at different stages. Although some standalone interventions such as behavioural activation (BA) and mindfulness practice (MP) have been shown to be potentially effective at reducing depressive symptoms, the best sequence and combination of these interventions for caregivers are unknown. This study aims to develop and identify a two-stage adaptive intervention with prespecified rules guiding whether, how or when to offer different interventions initially/over time to reduce depressive symptoms in FG-of-PWD. METHODS: A sequential multiple assignment randomised trial design will be adopted. 272 FG-of-PWD with mild to moderate depressive symptoms will be recruited from the community. Four two-stage, embedded adaptive interventions involving BA and MP of different sequences and dosages (eg, 8 weeks of BA followed by booster sessions for responders and 8 weeks of MP for non-responders) will be assigned to the participants following a set of decision rules. The primary outcomes will be depressive symptoms (measured using the Patient Health Questionnaire-9), assessed after the second stage of the intervention. Other outcomes, such as positive aspects of caregiving (measured using the Positive Aspects of Caregiving Scale), sleep quality (measured using the Pittsburgh Sleep Quality Index) and time points will also be assessed. The analyses will follow the intention-to-treat principle. Several process indicators (eg, engagement in meaningful activities and level of mindfulness) will also be assessed. The findings will have strong implications for the further development of psychosocial adaptive interventions to reduce depressive symptoms among FC-of-PWD. ETHICS AND DISSEMINATION: This study has received ethical approval from the Human Research Ethics Committee at The Hong Kong Polytechnic University (HSEARS20211223001). The findings will be presented at academic conferences and submitted to peer-reviewed journals for publication. TRIAL REGISTRATION NUMBER: NCT05634317

Sequential multiple assignment randomised controlled trial protocol for developing an adaptive intervention to improve depressive symptoms among family caregivers of people with dementia

Objectives Family caregivers of people with dementia (FC-of-PWD) suffer from a high level of stress and depressive symptoms, which usually require different interventions at different stages. Although some standalone interventions such as behavioural activation (BA) and mindfulness practice (MP) have been shown to be potentially effective at reducing depressive symptoms, the best sequence and combination of these interventions for caregivers are unknown. This study aims to develop and identify a two-stage adaptive intervention with prespecified rules guiding whether, how or when to offer different interventions initially/over time to reduce depressive symptoms in FG-of-PWD.Methods A sequential multiple assignment randomised trial design will be adopted. 272 FG-of-PWD with mild to moderate depressive symptoms will be recruited from the community. Four two-stage, embedded adaptive interventions involving BA and MP of different sequences and dosages (eg, 8 weeks of BA followed by booster sessions for responders and 8 weeks of MP for non-responders) will be assigned to the participants following a set of decision rules. The primary outcomes will be depressive symptoms (measured using the Patient Health Questionnaire-9), assessed after the second stage of the intervention. Other outcomes, such as positive aspects of caregiving (measured using the Positive Aspects of Caregiving Scale), sleep quality (measured using the Pittsburgh Sleep Quality Index) and time points will also be assessed. The analyses will follow the intention-to-treat principle. Several process indicators (eg, engagement in meaningful activities and level of mindfulness) will also be assessed. The findings will have strong implications for the further development of psychosocial adaptive interventions to reduce depressive symptoms among FC-of-PWD.Ethics and dissemination This study has received ethical approval from the Human Research Ethics Committee at The Hong Kong Polytechnic University (HSEARS20211223001). The findings will be presented at academic conferences and submitted to peer-reviewed journals for publication.Trial registration number NCT05634317

Sequential multiple assignment randomised controlled trial protocol for developing an adaptive intervention to improve depressive symptoms among family caregivers of people with dementia.

ObjectivesFamily caregivers of people with dementia (FC-of-PWD) suffer from a high level of stress and depressive symptoms, which usually require different interventions at different stages. Although some standalone interventions such as behavioural activation (BA) and mindfulness practice (MP) have been shown to be potentially effective at reducing depressive symptoms, the best sequence and combination of these interventions for caregivers are unknown. This study aims to develop and identify a two-stage adaptive intervention with prespecified rules guiding whether, how or when to offer different interventions initially/over time to reduce depressive symptoms in FG-of-PWD.MethodsA sequential multiple assignment randomised trial design will be adopted. 272 FG-of-PWD with mild to moderate depressive symptoms will be recruited from the community. Four two-stage, embedded adaptive interventions involving BA and MP of different sequences and dosages (eg, 8 weeks of BA followed by booster sessions for responders and 8 weeks of MP for non-responders) will be assigned to the participants following a set of decision rules. The primary outcomes will be depressive symptoms (measured using the Patient Health Questionnaire-9), assessed after the second stage of the intervention. Other outcomes, such as positive aspects of caregiving (measured using the Positive Aspects of Caregiving Scale), sleep quality (measured using the Pittsburgh Sleep Quality Index) and time points will also be assessed. The analyses will follow the intention-to-treat principle. Several process indicators (eg, engagement in meaningful activities and level of mindfulness) will also be assessed. The findings will have strong implications for the further development of psychosocial adaptive interventions to reduce depressive symptoms among FC-of-PWD.Ethics and disseminationThis study has received ethical approval from the Human Research Ethics Committee at The Hong Kong Polytechnic University (HSEARS20211223001). The findings will be presented at academic conferences and submitted to peer-reviewed journals for publication.Trial registration numberNCT05634317

Fitbit Inspire 2^® (San Francisco, IL).

IntroductionThere is a considerably large group of community-dwelling spinal cord injury (SCI) survivors living with low quality of life. Physical inactivity, depression, and chronic pain are major problems faced by SCI survivors discharged from the acute phase of treatment or inpatient rehabilitation. This study aims to evaluate the feasibility, acceptability, and preliminary effects of a Physical-Psychological Integrative (PPI) online group intervention on community-dwelling SCI survivors’ physical activity, depression, and chronic pain.MethodsThis is a two-arm pilot randomized controlled trial with repeated measures (pre-, post-intervention, and 3-month follow-up) design. Seventy-two participants will be randomly assigned to two study groups. The PPI intervention group will receive a video program for physical activity training and eight-week online group psychological interventions using skills of group-based motivational interviewing and mindfulness-based stress reduction. The control group will receive an eight-week online didactic education programed. Focus-group interviews will be conducted post-intervention to explore their views about acceptance and suggested improvements to the intervention. The feasibility of study procedures and the acceptability of interventions will be evaluated. The effectiveness of the PPI intervention will be evaluated by leisure-time physical activity, depression, chronic pain, exercise efficacy, mindfulness, and quality of life. We will use the generalized estimating equation to assess intervention effects and content analysis for interview data. This study has received ethical approval from the Hong Kong Polytechnic University (HSEARS20210705004) and was registered in ClinicalTrials.gov (NCT05535400).DiscussionThis study will be the first to provide empirical data on the evaluation of an online-group intervention integrating both physical activity promotion and psychological approaches, aimed at reducing physical inactivity, depression, and chronic pain for community-dwelling SCI survivors in Hong Kong. The findings could provide evidence supporting the use of PPI intervention as a novel online group support, in addressing both the physical and psychological needs of community-dwelling SCI survivors.</div

SPIRIT schedule of enrollment, interventions, and assessments.

SPIRIT schedule of enrollment, interventions, and assessments.</p

Flow chart of the study.

IntroductionThere is a considerably large group of community-dwelling spinal cord injury (SCI) survivors living with low quality of life. Physical inactivity, depression, and chronic pain are major problems faced by SCI survivors discharged from the acute phase of treatment or inpatient rehabilitation. This study aims to evaluate the feasibility, acceptability, and preliminary effects of a Physical-Psychological Integrative (PPI) online group intervention on community-dwelling SCI survivors’ physical activity, depression, and chronic pain.MethodsThis is a two-arm pilot randomized controlled trial with repeated measures (pre-, post-intervention, and 3-month follow-up) design. Seventy-two participants will be randomly assigned to two study groups. The PPI intervention group will receive a video program for physical activity training and eight-week online group psychological interventions using skills of group-based motivational interviewing and mindfulness-based stress reduction. The control group will receive an eight-week online didactic education programed. Focus-group interviews will be conducted post-intervention to explore their views about acceptance and suggested improvements to the intervention. The feasibility of study procedures and the acceptability of interventions will be evaluated. The effectiveness of the PPI intervention will be evaluated by leisure-time physical activity, depression, chronic pain, exercise efficacy, mindfulness, and quality of life. We will use the generalized estimating equation to assess intervention effects and content analysis for interview data. This study has received ethical approval from the Hong Kong Polytechnic University (HSEARS20210705004) and was registered in ClinicalTrials.gov (NCT05535400).DiscussionThis study will be the first to provide empirical data on the evaluation of an online-group intervention integrating both physical activity promotion and psychological approaches, aimed at reducing physical inactivity, depression, and chronic pain for community-dwelling SCI survivors in Hong Kong. The findings could provide evidence supporting the use of PPI intervention as a novel online group support, in addressing both the physical and psychological needs of community-dwelling SCI survivors.</div

Project submitted to the ethics committee.

IntroductionThere is a considerably large group of community-dwelling spinal cord injury (SCI) survivors living with low quality of life. Physical inactivity, depression, and chronic pain are major problems faced by SCI survivors discharged from the acute phase of treatment or inpatient rehabilitation. This study aims to evaluate the feasibility, acceptability, and preliminary effects of a Physical-Psychological Integrative (PPI) online group intervention on community-dwelling SCI survivors’ physical activity, depression, and chronic pain.MethodsThis is a two-arm pilot randomized controlled trial with repeated measures (pre-, post-intervention, and 3-month follow-up) design. Seventy-two participants will be randomly assigned to two study groups. The PPI intervention group will receive a video program for physical activity training and eight-week online group psychological interventions using skills of group-based motivational interviewing and mindfulness-based stress reduction. The control group will receive an eight-week online didactic education programed. Focus-group interviews will be conducted post-intervention to explore their views about acceptance and suggested improvements to the intervention. The feasibility of study procedures and the acceptability of interventions will be evaluated. The effectiveness of the PPI intervention will be evaluated by leisure-time physical activity, depression, chronic pain, exercise efficacy, mindfulness, and quality of life. We will use the generalized estimating equation to assess intervention effects and content analysis for interview data. This study has received ethical approval from the Hong Kong Polytechnic University (HSEARS20210705004) and was registered in ClinicalTrials.gov (NCT05535400).DiscussionThis study will be the first to provide empirical data on the evaluation of an online-group intervention integrating both physical activity promotion and psychological approaches, aimed at reducing physical inactivity, depression, and chronic pain for community-dwelling SCI survivors in Hong Kong. The findings could provide evidence supporting the use of PPI intervention as a novel online group support, in addressing both the physical and psychological needs of community-dwelling SCI survivors.</div