Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06346223
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-04
First Post:
2024-03-28
Brief Title:
Mindfulness-Based Intervention for Family Caregivers
Sponsor:
The Hong Kong Polytechnic University
Organization:
The Hong Kong Polytechnic University
Study Overview
Official Title:
Effect of a Single-Session Mindfulness-Based Intervention for Reducing Stress in Family Caregivers of People With Dementia A Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study is to investigate the efficiency of a single-session mindfulness-based intervention for reducing stress and promoting psychological health in family caregivers of people with dementia The single-session mindfulness intervention includes one 90-minute group-based session containing different mindfulness practices psychoeducation and group sharing activities in the single-session mindfulness intervention A self-practice tool kit with the teaching materials eg recording of guided mindfulness activities will be provided to the participants for home practice 20 minutes daily through an online platform and the participants will be told to develop the practice as a daily habit
Participants will be randomly assigned to receive either the mindfulness intervention combined with psychoeducation or psychoeducation alone Evaluations will be conducted at baseline 0 weeks immediately post-intervention 8 weeks and during a follow-up assessment 6 months Both groups will complete the same assessments at the same time-points
Participants will be randomly assigned to receive either the mindfulness intervention combined with psychoeducation or psychoeducation alone Evaluations will be conducted at baseline 0 weeks immediately post-intervention 8 weeks and during a follow-up assessment 6 months Both groups will complete the same assessments at the same time-points
Detailed Description:
The majority of people with dementia receive care from their family members who assist them with daily activities and managing behavioral problems associated with the illness such as wandering and agitation The demanding nature of caregiving tasks coupled with unpredictable symptoms related to the illness and limited time for other social activities often leads to high levels of stress among caregivers By increasing the caregivers self-awareness in the present moment through the practice of mindfulness the caregivers tend to step outside their negative experiences and thoughts through a process of decentering leading to stress reduction However considering the growing number of caregivers for people with dementia there may be insufficient resources to implement intensive mindfulness-based interventions with lengthy durations because most family caregivers are heavily engaged in various caregiving tasks making a single-session mindfulness-based intervention more suitable for this population compared to a traditional mindfulness program Although a few pilot studies have demonstrated some preliminary effects of single-session mindfulness-based interventions on promoting mental health none of these studies focused on family caregivers of individuals with dementia but rather adolescents or adults in general Further research is necessary to explore the effects of single-session mindfulness-based interventions on reducing stress among family caregivers of individuals with dementia who experience chronic caregiving stress Therefore this study aims to investigate the effectiveness of a single-session mindfulness-based intervention in reducing stress among family caregivers of people with dementia Additionally the study will examine other secondary outcomes such as the impact on the dyadic relationship between caregivers and care-recipients as well as behavioral and psychological symptoms of dementia
The target population for this study will be community-dwelling family caregivers of people with dementia They will be recruited from five elderly centers through the collaboration of two local non-governmental organizations Interested participants will be assessed for eligibility After interested and eligible participants provide their consent they will be randomly assigned to receive either the mindfulness intervention combined with psychoeducation or psychoeducation alone
The single-session mindfulness intervention includes one 90-minute group-based session containing different mindfulness practices psychoeducation and group sharing activities in the single-session mindfulness intervention A self-practice tool kit with the teaching materials eg recording of guided mindfulness activities will be provided to the participants for home practice 20 minutes daily through an online platform and the participants will be told to develop the practice as a daily habit
The control group will receive brief education on dementia with the same group size and of the same duration 90-minutes as the sessions in the intervention arm The nurse will deliver brief education 15 minutes on dementia in the session followed by group sharing and discussion on their daily caregiving experience The caregivers in the control group will be provided with a toolkit with education materials about the common health problems of older adults and also be given access to a social media platform in which they can communicate and share their caregiving experiences with classmates
The outcome measures assessed include perceived caregiving stress primary depressive symptoms positive aspect of caregiving dyadic relationship trait mindfulness neuropsychiatric symptoms Feasibility measures include eligibility and enrollment attendance rate adherence to self-practice and retention rate Evaluations will be conducted at baseline 0 weeks immediately post-intervention 8 weeks and during a follow-up assessment 6 months Both groups will complete the same assessments at the same time-points
The target population for this study will be community-dwelling family caregivers of people with dementia They will be recruited from five elderly centers through the collaboration of two local non-governmental organizations Interested participants will be assessed for eligibility After interested and eligible participants provide their consent they will be randomly assigned to receive either the mindfulness intervention combined with psychoeducation or psychoeducation alone
The single-session mindfulness intervention includes one 90-minute group-based session containing different mindfulness practices psychoeducation and group sharing activities in the single-session mindfulness intervention A self-practice tool kit with the teaching materials eg recording of guided mindfulness activities will be provided to the participants for home practice 20 minutes daily through an online platform and the participants will be told to develop the practice as a daily habit
The control group will receive brief education on dementia with the same group size and of the same duration 90-minutes as the sessions in the intervention arm The nurse will deliver brief education 15 minutes on dementia in the session followed by group sharing and discussion on their daily caregiving experience The caregivers in the control group will be provided with a toolkit with education materials about the common health problems of older adults and also be given access to a social media platform in which they can communicate and share their caregiving experiences with classmates
The outcome measures assessed include perceived caregiving stress primary depressive symptoms positive aspect of caregiving dyadic relationship trait mindfulness neuropsychiatric symptoms Feasibility measures include eligibility and enrollment attendance rate adherence to self-practice and retention rate Evaluations will be conducted at baseline 0 weeks immediately post-intervention 8 weeks and during a follow-up assessment 6 months Both groups will complete the same assessments at the same time-points
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None