Mindfulness Program for Older-Diabetes
- Conditions
- Mental Health Wellness 1
- Interventions
- Behavioral: Mindfulness-based Stress Reduction Program - Taiwan (MBSR-T)
- Registration Number
- NCT03950713
- Lead Sponsor
- Fooyin University
- Brief 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.
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 140
- 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.
- Terminally ill
- Unable to communicate in Chinese.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Mindfulness-based Stress Reduction Program - Taiwan (MBSR-T) Mindfulness-based Stress Reduction Program - Taiwan (MBSR-T) Participants in the intervention group received the MBSR-T in addition to routine care.
- Primary Outcome Measures
Name Time Method HbA1c values Change from baseline HbA1c values at 12 weeks Glycemic control was measured by HbA1c values, and data were collected from participants' medical records.
- Secondary Outcome Measures
Name Time Method Relocation Stress Scale Change from baseline relocation stress mean scores at 9 weeks 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.
Depression and Anxiety Stress Scale (DASS-21) Change from baseline depression and anxiety stress mean scores at 9 weeks 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.
Trial Locations
- Locations (1)
Fooyin University
🇨🇳Kaohsiung City, Taiwan