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Caregiving StressNCT06346223

Mindfulness-Based Intervention for Family Caregivers

A study testing Mindfulness and psychoeducation and Psychoeducation in people with Caregiving Stress, run by The Hong Kong Polytechnic University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Caregiving Stress
What is being tested?
Mindfulness and psychoeducation and Psychoeducation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
No sites listed yet
Study dates
Aug 2024to Aug 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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).

About this study

Official title: Effect of a Single-Session Mindfulness-Based Intervention for Reducing Stress in Family Caregivers of People With Dementia: A Randomized Controlled Trial

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.

Read the 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.

Being tested
Mindfulness and psychoeducation, Psychoeducation
Keywords
Family Caregivers, People With Dementia, Mindfulness-Based Intervention
Medical subject headings
Caregiver Burden

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mindfulness and psychoeducationBehavioural

    The single-session mindfulness intervention includes a 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 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. All of the teaching contents will be closely related to dementia caregiving and delivered by a mindfulness teacher who has received 40 hours training in dementia caregiving. A weekly mindfulness practice reminder will be sent to the participants through SMS for 8 weeks. The caregivers will also be provided with access to a social media online platform for sharing their practice experience with their classmates online. The interventionist will address their difficulties and challenges via the platform to reinforce skill mastery.

  • PsychoeducationBehavioural

    The caregivers in 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.

Study groups in NCT06346223
Study groupRoleWhat they receive
Mindfulness and psychoeducationExperimentalNot described
Receives: Behavioral: Mindfulness and psychoeducation
PsychoeducationActive comparatorNot described
Receives: Behavioral: Psychoeducation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Perceived Caregiving Stress in the Family Caregiver

    The Perceived Stress Scale (PSS) comprises 10 items rated on a 5-point Likert Scale (0 = never to 4 = very often) to assess perceived stress levels. The total score varies from 0 to 40, with a higher score reflecting more perceived stress. Scores within the ranges of 0-13, 14-26, and 27-40 correspond to low, moderate, and high levels of perceived stress, respectively.

    Measured: 6 months

Secondary outcomes (9)
  1. Depressive Symptoms in the Family Caregiver

    The Center for Epidemiologic Studies Depression Scale (CESD) comprises 20 items rated on a 4-point Likert scale (0 = rarely or none of the time to 3 = most or almost all the time) to assess the severity of depressive symptoms experienced in the past week. The total score ranges from 0 to 60, with a higher score indicating more severe depressive symptoms. Scores within the ranges of 0-14, 15-21, and 22-60 correspond to low, mild to moderate, and a potential indication of major depression, respectively.

    Measured: 6 months

  2. Positive Aspect of Caregiving in the Family Caregiver

    The Positive Aspects of Caregiving Scale (PAC) evaluates the perception of positive aspects of caregiving. It consists of 9 items and is rated on a 5-point Likert scale (1 = strongly disagree to 5 = strongly agree). A higher score of the PAC suggests a more positive caregiving experience.

    Measured: 6 months

  3. Dyadic Relationship Between the Family Caregiver and the Care Recipient

    The Dyadic Relationship Scale (DRS) measures the quality of the dyadic relationship between the family caregiver and the care recipient. This scale consists of two versions: the patient version (10 items) and the caregiver version (11 items). Both versions include two subscales: dyadic strain and positive dyadic interaction. They are rated on a 4-point Likert scale (1 = strongly disagree, 4 = strongly agree). Higher scores on each of these scales indicate higher levels of strain and positive interaction, respectively.

    Measured: 6 months

  4. Trait Mindfulness in the Family Caregiver

    The Five-Facet Mindfulness Questionnaire-Short Form measures trait mindfulness. It consists of 20 items that assess five domains of mindfulness: observing, describing, acting with awareness, nonjudging, and nonreacting. Each domain comprises 4 items and is rated on a 5-point Likert scale (1 = never, 5 = very often). The facet score for each domain is the average of the four items, with higher scores (range = 1-5) indicating higher levels of mindfulness.

    Measured: 6 months

  5. Neuropsychiatric Syndromes in the Care Recipient

    The Neuropsychiatric Inventory (NPI) measures neuropsychiatric syndromes that occur in Alzheimer's disease and other neurodegenerative disorders. The NPI is administered by the family caregiver and consists of the following domains: Delusions, Hallucinations, Agitation/Aggression, Depression/Dysphoria, Anxiety, Elation/Euphoria, Apathy/Indifference, Disinhibition, Irritability/Lability, and Aberrant Motor Behavior. Each domain is rated based on its frequency (1 = rarely, less than once per week; 4 = very often, once or more per day) and severity (1 = mild, producing little distress in the patient; 3 = severe, very disturbing to the patient and difficult to redirect). A total score can be obtained for each domain by multiplying the frequency and severity ratings. The total score of the NPI is obtained by summing the scores across all domains, with a higher score indicating more severe neuropsychiatric syndromes.

    Measured: 6 months

  6. Feasibility of Eligibility and Enrollment

    Number of eligible participants, and the proportion of those eligible that enrolled will be assessed.

    Measured: 8 weeks

  7. Feasibility of Attendance Rate

    Number and proportion of attended participants.

    Measured: 8 weeks

  8. Feasibility of Adherence to Self-Practice

    The frequency of duration of practicing of mindfulness will be assessed by the number of views and downloads of self-learning materials in an online platform and duration of practice per week in a logbook given to the participants.

    Measured: 6 months

  9. Feasibility of Retention Rate

    Number and proportion of participants completing all assessments.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Apr 2024
  2. Study startAug 2024 (estimated)
  3. Primary completionAug 2025 (estimated)
  4. Study completionAug 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
A single-blinded, parallel-group, randomized-controlled trial (RCT) design.
Masking
Single blind
Who is masked
Participant
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06346223
Sponsor's protocol ID
HSEARS20230928006
Status last verified
Apr 2024
First submitted
28 Mar 2024
Last updated
4 Apr 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Kor PPK, Chou KL, Zarit SH, Galante J, Chan WC, Tsang APL, Lai DLL, Cheung DSK, Ho KHM, Liu JYW. Effect of a single-session mindfulness-based intervention for reducing stress in family caregivers of people with dementia: study protocol for a randomized controlled trial. BMC Psychol. 2024 Oct 21;12(1):582. doi: 10.1186/s40359-024-02027-7.

    PubMed 39434193

Questions about this trial

What is this clinical trial studying?

A study testing Mindfulness and psychoeducation and Psychoeducation in people with Caregiving Stress, run by The Hong Kong Polytechnic University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 4 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Perceived Caregiving Stress in the Family Caregiver (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06346223, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2024.

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