Clinical trial NCT06346223: Mindfulness-Based Intervention for Family Caregivers
Official title: Effect of a Single-Session Mindfulness-Based Intervention for Reducing Stress in Family Caregivers of People With Dementia: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Caregiving Stress
Keywords: Family Caregivers
People With Dementia
Mindfulness-Based Intervention
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
Collaborators: name: Health and Medical Research Fund
First posted: 2024-04-03
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A single-blinded, parallel-group, randomized-controlled trial (RCT) design.
Primary purpose: SUPPORTIVE_CARE

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 (e.g., 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.

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 (e.g., 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.

Eligibility criteria: Inclusion Criteria:

* aged 18 or above;
* family caregivers of an individual who has been residing in the community with a confirmed medical diagnosis of any type of dementia (from NGO record or the care-recipients' medical record);
* have been providing care for at least 3 months prior to recruitment with the daily contact of at least 4 hours or more;
* screened positive for caregivers' stress (a summed score of ≥ 25 as measured by the Caregiver Burden Inventory).

Exclusion Criteria:

* have participated in any structured mind-body intervention, or structured psychosocial intervention 6 months prior to recruitment;
* have acute psychiatric condition that are potentially life-threatening or would limit the caregivers' participation in the study (an answer of "yes" to any of the six questions of Columbia Suicide Severity Rating Scale).

Primary outcomes:
measure: Perceived Caregiving Stress in the Family Caregiver
timeFrame: 6 months
Secondary outcomes:
measure: Depressive Symptoms in the Family Caregiver
timeFrame: 6 months
measure: Positive Aspect of Caregiving in the Family Caregiver
timeFrame: 6 months
measure: Dyadic Relationship Between the Family Caregiver and the Care Recipient
timeFrame: 6 months
measure: Trait Mindfulness in the Family Caregiver
timeFrame: 6 months
measure: Neuropsychiatric Syndromes in the Care Recipient
timeFrame: 6 months
measure: Feasibility of Eligibility and Enrollment
timeFrame: 8 weeks
measure: Feasibility of Attendance Rate
timeFrame: 8 weeks
measure: Feasibility of Adherence to Self-Practice
timeFrame: 6 months
measure: Feasibility of Retention Rate
timeFrame: 6 months
Other outcomes:
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