Mindfulness Program for Older-Diabetes

Mental Health Wellness 1 Clinical Trial

Official title:

Taiwanese Mindfulness Program for Long Term Residents With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03950713
• Other study ID #: FYH-IRB-1040602
• Status: Completed
• Phase: N/A
• Start date: January 1, 2017
• Est. completion date: July 31, 2017

Study information

• Verified date: August 2016
• Source: Fooyin University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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 information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: July 31, 2017
• Est. primary completion date: July 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 85 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Terminally ill

• Unable to communicate in Chinese.

Related Conditions & MeSH terms

• Mental Health Wellness 1

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Taiwan	Fooyin University	Kaohsiung City

Sponsors (1)

Lead Sponsor	Collaborator
Fooyin University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c values	Glycemic control was measured by HbA1c values, and data were collected from participants' medical records.	Change from baseline HbA1c values at 12 weeks
Secondary	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.	Change from baseline relocation stress mean scores at 9 weeks
Secondary	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.	Change from baseline depression and anxiety stress mean scores at 9 weeks