NCT05123261

Brief Summary

This study aims to verify the effectiveness of the mindfulness-based elder care (MBEC) therapy developed by McBee (2008) in improving the psychological and spiritual well-being of seniors with disabilities living in residential long-term care institutions in Taiwan.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
77

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2018

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

April 7, 2021

Completed
7 months until next milestone

First Posted

Study publicly available on registry

November 17, 2021

Completed
Last Updated

May 1, 2025

Status Verified

April 1, 2025

Enrollment Period

1.5 years

First QC Date

April 7, 2021

Last Update Submit

April 28, 2025

Conditions

Mental Health Issue

Keywords

long term care institutionsseniors with disabilitymindfulness-based elder carespiritual well-being

Outcome Measures

Primary Outcomes (3)

  • Change in depression summary scores before intervention to 4-week post intervention.

    Depression was measured using the Chinese version of the Geriatric Depression Scale-Short-Short Form (GDS-SF). The Geriatric Depression Scale-Short-Short Form scores range from 0 to 15. Higher scores represent an increased level of depressive symptoms and a cut-off value of 5 is commonly indicative of depression.

    The data were collected before the intervention to week 12: baseline, in the middle of the intervention (the fourth week), at the end of the intervention (the eighth week), and the follow-up four weeks after the intervention (the twelfth week).

  • Change in Anxiety summary scores before intervention to 4-week post intervention.

    Anxiety was measured using the Chinese version of the State Trait Anxiety Inventory (STAI). The State Trait Anxiety Inventory measures two types of anxiety - state anxiety, or anxiety about an event. The total scores range from 40-160 and higher scores are positively correlated with higher levels of anxiety.

    The data were collected before the intervention to week 12: baseline, in the middle of the intervention (the fourth week), at the end of the intervention (the eighth week), and the follow-up four weeks after the intervention (the twelfth week).

  • Change in Spiritual well-being summary scores before intervention to 4-week post intervention.

    Spiritual well-being was measured using the Chinese version of the Spiritual Well-Being Scale (SWBS). The Spiritual Well-Being Scale scores range from 20 to 120. Higher scores represent an increased level of spiritual well-being.

    The data were collected before the intervention to week 12: baseline, in the middle of the intervention (the fourth week), at the end of the intervention (the eighth week), and the follow-up four weeks after the intervention (the twelfth week).

Secondary Outcomes (1)

  • Change in Meaning in life summary scores before intervention to 4-week post intervention.

    The data were collected before the intervention to week 12: baseline, in the middle of the intervention (the fourth week), at the end of the intervention (the eighth week), and the follow-up four weeks after the intervention (the twelfth week).

Study Arms (2)

the mindfulness-based elder care (MBEC) therapy

EXPERIMENTAL

The experimental group was offered eight 50-minute courses once a week.

Behavioral: the mindfulness-based elder care (MBEC) therapy

the routine activities

NO INTERVENTION

The control group maintained routine activities. And each CG participant had a weekly visit from the research team.

Interventions

the mindfulness-based elder care (MBEC) therapyBEHAVIORAL

According to the mindfulness-based elder care (MBEC) therapy developed by McBee (2008), the experimental group was offered eight 50-minute courses once a week.

the mindfulness-based elder care (MBEC) therapy

Eligibility Criteria

Age65 Years - 110 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • The exclusive criteria were residents have the diagnosis of psychotic disorders, infectious diseases, or been hospitalized.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Nursing

New Taipei City, Taiwan

Location

Related Publications (1)

  • Hsiung Y, Chen YH, Lin LC, Wang YH. Effects of Mindfulness-Based Elder Care (MBEC) on symptoms of depression and anxiety and spiritual well-being of institutionalized seniors with disabilities: a randomized controlled trial. BMC Geriatr. 2023 Aug 18;23(1):497. doi: 10.1186/s12877-023-04220-6.

    PMID: 37596549DERIVED

MeSH Terms

Interventions

Therapeutics

Study Officials

  • Yi-Heng Chen, PhD

    Department of Nursing, Mackay Medical College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
The Office of Research and Development

Study Record Dates

First Submitted

April 7, 2021

First Posted

November 17, 2021

Study Start

July 1, 2016

Primary Completion

January 15, 2018

Study Completion

January 15, 2018

Last Updated

May 1, 2025

Record last verified: 2025-04

Locations

TW(1)