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Completed

NCT Number: NCT03950713

Mindfulness Program for Older-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.

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Key information

Conditions

Mental Health Wellness 1 Behavior Behavioral Symptoms Depression

Age range

65 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fooyin University

Kaohsiung City, 83102, Taiwan

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Relocation Stress Scale

    Time frame: 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.

  2. Depression and Anxiety Stress Scale (DASS-21)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Fooyin University

Other

Registry information

Official study title

Taiwanese Mindfulness Program for Long Term Residents With Type 2 Diabetes

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
May 15, 2019
Registry last updated
May 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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