Mental Health IssueNCT05123261
Effects of Mindfulness Based Elder Care (MBEC) on Psychological and Spiritual Well Being
A study testing the mindfulness-based elder care (MBEC) therapy in people with Mental Health Issue, run by Mackay Medical College at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 65 to 110 years
- Conditions the study is for
- Mental Health Issue
- What is being tested?
- the mindfulness-based elder care (MBEC) therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jul 2016to 15 Jan 2018
- 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 65 to 110 years
- All sexes
- No healthy volunteers
- Older adult
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Mindfulness Based Elder Care (MBEC) on Psychological and Spiritual Well Being of Institutional Seniors With Disability
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.
Read the 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.
- Conditions
- Mental Health Issue
- Being tested
- the mindfulness-based elder care (MBEC) therapy
- Keywords
- long term care institutions, seniors with disability, mindfulness-based elder care, spiritual well-being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the mindfulness-based elder care (MBEC) therapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| the mindfulness-based elder care (MBEC) therapy | Experimental | The experimental group was offered eight 50-minute courses once a week. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
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.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2021
- Study start1 Jul 2016
- Primary completion15 Jan 2018
- Study completion15 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental Health IssueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mackay Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chin-Tsung Shen, Mackay Medical College
- Investigators
- Yi-Heng Chen, PhD, Principal investigator, Department of Nursing, Mackay Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05123261
- Sponsor's protocol ID
- MOST-103-2314-B-715-002-MY3
- Status last verified
- Apr 2025
- First submitted
- 7 Apr 2021
- Last updated
- 1 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37596549
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Mindfulness Based Elder Care (MBEC) on Psychological and Spiritual Well Being of Institutional Seniors With Disability
- ClinicalTrials.gov ID
- NCT05123261
- Acronym / sponsor ID
- MOST-103-2314-B-715-002-MY3
- Conditions
- Mental Health Issue
- Keywords
- long term care institutions, seniors with disability, mindfulness-based elder care, spiritual well-being
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Mackay Medical CollegeUniversity, hospital or other
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 15 Jan 2018 (actual)
- Study completion
- 15 Jan 2018 (actual)
- First posted
- 17 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the mindfulness-based elder care (MBEC) therapy | Experimental | Behavioral: the mindfulness-based elder care (MBEC) therapyThe experimental group was offered eight 50-minute courses once a week. |
| the routine activities | No intervention | –The control group maintained routine activities. And each CG participant had a weekly visit from the research team. |
Who may qualify
- Ages
- 65 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| the mindfulness-based elder care (MBEC) therapyAccording to the mindfulness-based elder care (MBEC) therapy developed by McBee (2008), the experimental group was offered eight 50-minute courses once a week. | Behavioural | the mindfulness-based elder care (MBEC) therapy |
Primary outcome
Change in depression summary scores before intervention to 4-week post intervention.
Time frame: 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).
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.
Change in Anxiety summary scores before intervention to 4-week post intervention.
Time frame: 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).
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.
Change in Spiritual well-being summary scores before intervention to 4-week post intervention.
Time frame: 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).
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.
1 secondary outcome
Change in Meaning in life summary scores before intervention to 4-week post intervention.
Time frame: 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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2025.
- Derived from this study: PubMed 37596549Hsiung 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yi-Heng Chen, PhD principal investigator
Department of Nursing, Mackay Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the mindfulness-based elder care (MBEC) therapy in people with Mental Health Issue, run by Mackay Medical College at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 1 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in depression summary scores before intervention to 4-week post intervention. (time frame: 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).). The study lists 3 primary outcomes in all. 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 NCT05123261, 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 1 May 2025.