Mindfulness-Based Intervention for Family Caregivers

NCT06346223 | Not Yet Recruiting

• 1 other identifier: HSEARS20230928006
• Study Type: interventional
• Target: 160
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Caregiving Stress

Keywords

Family Caregivers; People With Dementia; Mindfulness-Based Intervention

Outcome Measures

Primary Outcomes (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.

  6 months

Secondary Outcomes (9)

• Depressive Symptoms in the Family Caregiver

  6 months

• Positive Aspect of Caregiving in the Family Caregiver

  6 months

• Dyadic Relationship Between the Family Caregiver and the Care Recipient

  6 months

• Trait Mindfulness in the Family Caregiver

  6 months

• Neuropsychiatric Syndromes in the Care Recipient

  6 months

Study Arms (2)

Mindfulness and psychoeducation

EXPERIMENTAL

Behavioral: Mindfulness and psychoeducation

Psychoeducation

ACTIVE COMPARATOR

Behavioral: Psychoeducation

Interventions

Mindfulness and psychoeducation BEHAVIORAL

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.

Mindfulness and psychoeducation

Psychoeducation BEHAVIORAL

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.

Psychoeducation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead
• Health and Medical Research Fund: collaborator

Related Publications (1)

• 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.

  PMID: 39434193 DERIVED

MeSH Terms

Conditions

Caregiver Burden

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: A single-blinded, parallel-group, randomized-controlled trial (RCT) design.

Study Record Dates

• First Submitted: March 28, 2024
• First Posted: April 3, 2024
• Study Start: August 1, 2024
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: April 4, 2024

Record last verified: 2024-04