Mindfulness Program for Older-Diabetes

NCT03950713 | Completed DMC

• 1 other identifier: FYH-IRB-1040602
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Mental Health Wellness 1

Keywords

Mindfulness-based Program; Relocation stress; Depression; Glycemic control

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Relocation Stress Scale

  Change from baseline relocation stress mean scores at 9 weeks

• Depression and Anxiety Stress Scale (DASS-21)

  Change from baseline depression and anxiety stress mean scores at 9 weeks

Study Arms (2)

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

EXPERIMENTAL

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

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.

Interventions

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.

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

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Terminally ill
• Unable to communicate in Chinese.

Sponsors & Collaborators

• Fooyin University: lead

Study Sites (1)

Fooyin University

Kaohsiung City, 83102, Taiwan

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Shu-Ming Chen

  Fooyin University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 9, 2019
• First Posted: May 15, 2019
• Study Start: January 1, 2017
• Primary Completion: July 31, 2017
• Study Completion: July 31, 2017
• Last Updated: May 15, 2019

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)