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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05123261
Other study ID # MOST-103-2314-B-715-002-MY3
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 1, 2016
Est. completion date January 15, 2018

Study information

Verified date November 2021
Source Mackay Medical College
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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: Cluster randomized control trials were 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, mini-mental status examination (MMSE), and the Barthel Index were used to collect the information of the included seniors with disabilities on basic demography, cognitive function, and ability to perform daily activities. The Geriatric Depression Scale-Short-Short Form (GDS-SF), State Trait Anxiety Inventory (STAI), Meaning in Life Scale Test (PIL), and Spiritual Well-Being Scale (SWBS) were also adopted to understand the included seniors with disabilities depression, anxiety, purpose of life, 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.


Recruitment information / eligibility

Status Completed
Enrollment 77
Est. completion date January 15, 2018
Est. primary completion date January 15, 2018
Accepts healthy volunteers No
Gender All
Age group 65 Years to 110 Years
Eligibility - 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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Taiwan Department of Nursing New Taipei City

Sponsors (1)

Lead Sponsor Collaborator
Mackay Medical College

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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).
Primary 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).
Primary 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 Change in Meaning in life summary scores before intervention to 4-week post intervention. Meaning in life was measured using the Purpose in Life Test (PIL). The Purpose in Life Test scores range from 20-140 and higher scores are represent an higher level of meaning and purpose in respondents' lives. 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).
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