Mental Health Wellness 1NCT03950713
Mindfulness Program for Older-Diabetes
A study testing Mindfulness-based Stress Reduction Program - Taiwan (MBSR-T) in people with Mental Health Wellness 1, run by Fooyin University at 1 site in Taiwan.
Trial summary
This study aimed to evaluate the effectiveness of the newly developed Mindfulness-Based Stress Reduction-Taiwan program (MBSR-T) for old people with type 2 diabetes living in long-term care facilities. Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Mental Health Wellness 1
- What is being tested?
- Mindfulness-based Stress Reduction Program - Taiwan (MBSR-T)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2017to 31 Jul 2017
- 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 85 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age 65-85 years old
- Diagnosed with type 2 diabetes
- Moving into the facility within a year
- No obvious delirium, confusion or current psychiatric illness
- Being able to communicate in Chinese.
Who cannot join
- Terminally ill
- Unable to communicate in Chinese.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Taiwanese Mindfulness Program for Long Term Residents With Type 2 Diabetes
This study aimed to evaluate the effectiveness of the newly developed Mindfulness-Based Stress Reduction-Taiwan program (MBSR-T) for old people with type 2 diabetes living in long-term care facilities.
Read the detailed description
This study reported the first randomized controlled trial of Mindfulness-based reduction stress for residents with type 2 diabetes newly moved into long-term care facilities on depression, relocation stress and HbA1c levels. The results highlighted the benefits of using strategies in the MBSR-T to promote good quality of diabetes care for residents in long-term care.
The contents of the 9-week MBSR-T program were adapted from an initial MBSR program by the Taiwan Mindfulness Association for older people with diabetes (Chinese version). The program consisted of a 1.5-hour session each week for 9-weeks for a group of 8 to 10 participants. Each session included 30 minutes of mindful deep breathing relaxation and 60 minutes of practicing mindfulness activities.
A total sample of 140 was determined. All eligible individuals in each long-term care facility were randomized by computerized random numbers, sequence generated by an independent statistician with one-to-one ratio for allocating to either control or intervention group. All participants were blinded to group allocation. Participants in the control group received usual care, while participants in the intervention group received the MBSR-T in addition to the usual care. All sessions in the MBSR-T were delivered by a trained mindfulness registered nurse who had received additional trainer qualification of mindfulness. A research assistant was blinded to the study protocol, who was employed to undertake data collection at baseline, at 3, 6, and 9 weeks (T0, T1, T2, T3).
- Conditions
- Mental Health Wellness 1
- Being tested
- Mindfulness-based Stress Reduction Program - Taiwan (MBSR-T)
- Keywords
- Mindfulness-based Program, Relocation stress, Depression, Glycemic control
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-based Stress Reduction Program - Taiwan (MBSR-T)Behavioural
The MBSR-T is focused on strategies to manage diabetes distress for new residents by three new techniques. Firstly, it involves practicing body and meditation exercises for openness to the awareness and acceptance of transferred life experiences, such as mindful attention exercise, which is assumed to allow the residents to behave in a less reactive and more reflective manner when confronted with transferred life stressors. Second, mindfulness meditation techniques were provided for difficult thoughts and feelings related to diabetes, such as paying full attention to the present moment of life and choosing to respond skillfully rather than reacting automatically to external events, thoughts or emotions as they arise. Third, a specific topic, for example on how to be mindful when life style is changed, or how to pay attention to the present moment within Chinese culture of peacefulness was discussed in each session.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-based Stress Reduction Program - Taiwan (MBSR-T) | Experimental | Participants in the intervention group received the MBSR-T in addition to routine care. Receives: Behavioral: Mindfulness-based Stress Reduction Program - Taiwan (MBSR-T) |
| Routine care | No intervention | The control group received the routine care provided in facilities, including routine check-ups at diabetes clinics as necessary. |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c values
Glycemic control was measured by HbA1c values, and data were collected from participants' medical records.
Measured: Change from baseline HbA1c values at 12 weeks
Secondary outcomes (2)
Relocation Stress Scale
Relocation Stress Scale (Chinese version), This scale is a 29-item functional assessment of health status with a 5-point Likert scale (5 is the highest relocation stress, 1 is the lowest). The internal consistency .72 has been reported.
Measured: Change from baseline relocation stress mean scores at 9 weeks
Depression and Anxiety Stress Scale (DASS-21)
The Depression and Anxiety Stress Scale (DASS-21) was used to measure depression. The DASS-21 in Chinese version consists of 21 items with a 4-point Likert scale. The good internal consistency for the DASS-21 subscales .92 for depression, .94 for anxiety, and .91 for stress have been reported.
Measured: Change from baseline depression and anxiety stress mean scores at 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2019
- Study start1 Jan 2017
- Primary completion31 Jul 2017
- Study completion31 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health Wellness 1Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A cluster randomized controlled trial was used to examine the effectiveness of the MBSR-T. The outcomes included HbA1c levels progression as the primary endpoint, and relocation stress, depression as secondary end points. Participants in the intervention group received the MBSR-T in addition to routine care. The control group received the routine care provided in facilities, including routine check-ups at diabetes clinics as necessary.
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fooyin University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shu-Ming Chen, Study chair, Fooyin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03950713
- Sponsor's protocol ID
- FYH-IRB-1040602
- Status last verified
- Aug 2016
- First submitted
- 9 May 2019
- Last updated
- 15 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: In the study consent form, the participants only singe their agreements for this study authors, not for other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Taiwanese Mindfulness Program for Long Term Residents With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT03950713
- Acronym / sponsor ID
- FYH-IRB-1040602
- Conditions
- Mental Health Wellness 1
- Keywords
- Mindfulness-based Program, Relocation stress, Depression, Glycemic control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Fooyin UniversityUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Jul 2017 (actual)
- Study completion
- 31 Jul 2017 (actual)
- First posted
- 15 May 2019 (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 aimed to evaluate the effectiveness of the newly developed Mindfulness-Based Stress Reduction-Taiwan program (MBSR-T) for old people with type 2 diabetes living in long-term care facilities.
Detailed description
This study reported the first randomized controlled trial of Mindfulness-based reduction stress for residents with type 2 diabetes newly moved into long-term care facilities on depression, relocation stress and HbA1c levels. The results highlighted the benefits of using strategies in the MBSR-T to promote good quality of diabetes care for residents in long-term care.
The contents of the 9-week MBSR-T program were adapted from an initial MBSR program by the Taiwan Mindfulness Association for older people with diabetes (Chinese version). The program consisted of a 1.5-hour session each week for 9-weeks for a group of 8 to 10 participants. Each session included 30 minutes of mindful deep breathing relaxation and 60 minutes of practicing mindfulness activities.
A total sample of 140 was determined. All eligible individuals in each long-term care facility were randomized by computerized random numbers, sequence generated by an independent statistician with one-to-one ratio for allocating to either control or intervention group. All participants were blinded to group allocation. Participants in the control group received usual care, while participants in the intervention group received the MBSR-T in addition to the usual care. All sessions in the MBSR-T were delivered by a trained mindfulness registered nurse who had received additional trainer qualification of mindfulness. A research assistant was blinded to the study protocol, who was employed to undertake data collection at baseline, at 3, 6, and 9 weeks (T0, T1, T2, T3).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A cluster randomized controlled trial was used to examine the effectiveness of the MBSR-T. The outcomes included HbA1c levels progression as the primary endpoint, and relocation stress, depression as secondary end points. Participants in the intervention group received the MBSR-T in addition to routine care. The control group received the routine care provided in facilities, including routine check-ups at diabetes clinics as necessary.
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-based Stress Reduction Program - Taiwan (MBSR-T) | Experimental | Behavioral: Mindfulness-based Stress Reduction Program - Taiwan (MBSR-T)Participants in the intervention group received the MBSR-T in addition to routine care. |
| Routine care | No intervention | –The control group received the routine care provided in facilities, including routine check-ups at diabetes clinics as necessary. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Age 65-85 years old
- Diagnosed with type 2 diabetes
- Moving into the facility within a year
- No obvious delirium, confusion or current psychiatric illness
- Being able to communicate in Chinese.
Key exclusion criteria (2 listed)
- Terminally ill
- Unable to communicate in Chinese.
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 |
|---|---|---|
| Mindfulness-based Stress Reduction Program - Taiwan (MBSR-T)The MBSR-T is focused on strategies to manage diabetes distress for new residents by three new techniques. Firstly, it involves practicing body and meditation exercises for openness to the awareness and acceptance of transferred life experiences, such as mindful attention exercise, which is assumed to allow the residents to behave in a less reactive and more reflective manner when confronted with transferred life stressors. Second, mindfulness meditation techniques were provided for difficult thoughts and feelings related to diabetes, such as paying full attention to the present moment of life and choosing to respond skillfully rather than reacting automatically to external events, thoughts or emotions as they arise. Third, a specific topic, for example on how to be mindful when life style is changed, or how to pay attention to the present moment within Chinese culture of peacefulness was discussed in each session. | Behavioural | Mindfulness-based Stress Reduction Program - Taiwan (MBSR-T) |
Primary outcome
HbA1c values
Time frame: Change from baseline HbA1c values at 12 weeks
Glycemic control was measured by HbA1c values, and data were collected from participants' medical records.
2 secondary outcomes
Relocation Stress Scale
Time frame: Change from baseline relocation stress mean scores at 9 weeks
Depression and Anxiety Stress Scale (DASS-21)
Time frame: Change from baseline depression and anxiety stress mean scores at 9 weeks
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 15 May 2019.
- Individual participant dataSharing planned: No. In the study consent form, the participants only singe their agreements for this study authors, not for other researchers.
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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.
Shu-Ming Chen study chair
Fooyin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-based Stress Reduction Program - Taiwan (MBSR-T) in people with Mental Health Wellness 1, run by Fooyin University 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?
The sponsor lists 5 inclusion and 2 exclusion criteria. 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 15 May 2019. 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?
HbA1c values (time frame: Change from baseline HbA1c values at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 May 2019.