Clinical trial NCT05123261: Effects of Mindfulness Based Elder Care (MBEC) on Psychological and Spiritual Well Being
Official title: Effects of Mindfulness Based Elder Care (MBEC) on Psychological and Spiritual Well Being of Institutional Seniors With Disability
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health Issue
Keywords: long term care institutions
seniors with disability
mindfulness-based elder care
spiritual well-being
Lead sponsor: Mackay Medical College
Sponsor class: OTHER
First posted: 2021-11-17
Enrollment: 77
Sex: ALL
Minimum age (years): 65
Maximum age (years): 110
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: Background: Existing literature indicates that seniors with disabilities living in long-term care institutions are confronted with such issues as changes in their living environment, institutionalized living schedules, and reduced social interaction, which may affect their mental health and cause spiritual disturbances. In recent years, mindfulness therapy has been increasingly proven to effectively improve individuals' mental health and spiritual well-being. However, the effectiveness of the therapy for seniors with disabilities admitted to residential institutions needs to be further verified by empirical studies.

Purpose: 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.

Methods: A Randomized control trial was used. The subjects enrolled in this study were the seniors with disability in the residential long-term care institutions in the northern and central part of Taiwan. The inclusion criteria were the seniors with disabilities who (1) lived in a care institution for over 3 months; (2) were aged 65 years or above; (3) failed to obtain a full score for Barthel Index; (4) were able to communicate in Mandarin or Taiwanese; and (5) had no history of mental illness. According to the intervention scheme, the experimental group was offered eight 50-minute courses once a week, while the control group maintained routine activities. In terms of the evaluation of intervention effectiveness, basic data collection tables, and the Barthel Index were used to collect the information of the included seniors with disabilities on basic demography, and ability to perform daily activities. The Geriatric Depression Scale-Short-Short Form (GDS-SF), State Trait Anxiety Inventory (STAI), and Spiritual Well-Being Scale (SWBS) were also adopted to understand the included seniors with disabilities depression, anxiety, and spiritual well-being. The data were collected four times: before the intervention, 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). The collected data was analyzed by SPSS 22.0. Descriptive statistics and the independent samples t-test were used to identify the homogeneity of the two groups, and the linear mixed model was used to compare the improvement results of the experimental group alone and the two groups at different time points.

Eligibility criteria: * The inclusion criteria were the seniors with disabilities who (1) lived in a care institution for over 3 months; (2) were aged 65 years or above; (3) failed to obtain a full score for Barthel Index; (4) were able to communicate in Mandarin or Taiwanese; and (5) had no history of mental illness.
* The exclusive criteria were residents have the diagnosis of psychotic disorders, infectious diseases, or been hospitalized.

Primary outcomes:
measure: Change in depression summary scores before intervention to 4-week post intervention.
timeFrame: 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).
measure: Change in Anxiety summary scores before intervention to 4-week post intervention.
timeFrame: 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).
measure: Change in Spiritual well-being summary scores before intervention to 4-week post intervention.
timeFrame: 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:
measure: Change in Meaning in life summary scores before intervention to 4-week post intervention.
timeFrame: 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).
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Department of Nursing
Study officials:
affiliation: Department of Nursing, Mackay Medical College
name: Yi-Heng Chen, PhD
role: PRINCIPAL_INVESTIGATOR
References: