Mindfulness Program for Older-Diabetes

NCT ID: NCT03950713

Last Updated: 2019-05-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-01
• Study Completion Date: 2017-07-31

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).

Conditions

Mental Health Wellness 1

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mindfulness-based Stress Reduction Program - Taiwan (MBSR-T)

Participants in the intervention group received the MBSR-T in addition to routine care.

Group Type: EXPERIMENTAL

Mindfulness-based Stress Reduction Program - Taiwan (MBSR-T)

Intervention Type: BEHAVIORAL

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.

Routine care

The control group received the routine care provided in facilities, including routine check-ups at diabetes clinics as necessary.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fooyin University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shu-Ming Chen

Role: STUDY_CHAIR

Fooyin University

Locations

Fooyin University

Kaohsiung City, , Taiwan

Countries

Taiwan

Other Identifiers

FYH-IRB-1040602

Identifier Type: -

Identifier Source: org_study_id