Effectiveness of a Mindfulness and Digital Technology Program for Healthy Aging (MMP-DTLA)

NCT07025655 | Not Yet Recruiting DMC

• 2 other identifiers: 202400087B0C6001NSTC 113-2410-H-255 -001 -MY2
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to evaluate the effectiveness of a mindfulness program integrated with digital technology-assisted learning on healthy aging among community-dwelling older adults. In a randomized controlled trial, 100 participants will be randomly assigned to either an experimental or a control group. The experimental group will receive a ten-week mindfulness program supported by digital tools such as educational videos and LINE Bot messaging. Primary outcomes include mindfulness awareness, physical activity, heart rate variability, cognitive function, sleep quality, perception of aging, and healthy aging perspectives. Additionally, qualitative interviews will be conducted with 10 experimental group participants to explore their intervention experiences.

Conditions

Mindfulness; Healthy Aging

Outcome Measures

Primary Outcomes (9)

• mindfulness awareness

  The Five Facet Mindfulness Questionnaire (FFMQ) will be used. Items are rated on a 5-point Likert scale ranging from 5 (almost always) to 1 (never), with higher scores indicating greater frequency. Certain items are reverse-coded, and total scores are computed after adjusting for these items. A higher total score reflects a greater level of mindfulness.

  We will collect four times of data: 1. Baseline 2. The fourth week 3. Up to 10 weeks 4. After completing the study for one month

• Physical activity: PASE-C

  The PASE-C encompasses domains including total physical activity, leisure activities, household activities, and occupational activities. Higher scores indicate greater levels of physical activity.

  We will collect four times of data: 1. Baseline 2. The fourth week 3. Up to 10 weeks 4. After completing the study for one month

• Physical activity: SPPB

  The SPPB comprises three components: balance tests, gait speed tests, and chair stand tests. A total score ranging from 0 to 9 indicates mobility impairment, whereas a score between 10 and 12 reflects normal mobility function.

  We will collect four times of data: 1. Baseline 2. The fourth week 3. Up to 10 weeks 4. After completing the study for one month

• Cognitive function

  The Montreal Cognitive Assessment (MoCA) will be used to assess cognitive function among community-dwelling older adults. The total score ranges from 0 to 30, with higher scores indicating better overall cognitive functioning. A score of 26 or above is generally considered within the normal range.

  We will collect four times of data: 1. Baseline 2. The fourth week 3. Up to 10 weeks 4. After completing the study for one month

• Heart rate variability: SDNN

  Heart rate variability (HRV) was assessed using a monitoring device to evaluate autonomic nervous system activity. The standard deviation of normal-to-normal intervals (SDNN) reflects the variability in RR intervals from electrocardiogram recordings, with higher SDNN values indicating greater heart rate variability.

  We will collect four times of data: 1. Baseline 2. The fourth week 3. Up to 10 weeks 4. After completing the study for one month

• Heart rate variability: LF/HF ratio

  Heart rate variability (HRV) was assessed using a monitoring device to evaluate autonomic nervous system activity. Sympathetic and parasympathetic activity were assessed through frequency-domain measures, including low-frequency (LF) and high-frequency (HF) components. The LF/HF ratio was calculated to evaluate the balance of autonomic nervous system activity.

  We will collect four times of data: 1. Baseline 2. The fourth week 3. Up to 10 weeks 4. After completing the study for one month

• Sleep quality

  The study utilized the Pittsburgh Sleep Quality Index (PSQI) to measure sleep quality. The Pittsburgh Sleep Quality Index (PSQI) yields a global score ranging from 0 to 21, with higher scores indicating poorer sleep quality. A global PSQI score greater than 5 is indicative of clinically significant sleep disturbance.

  We will collect four times of data: 1. Baseline 2. The fourth week 3. Up to 10 weeks 4. After completing the study for one month

• Perception of ageing

  The perception of ageing was measured using the Brief Aging Perceptions Questionnaire (B-APQ). A 5-point Likert scale was used for scoring, with 1 indicating 'strongly disagree,' 2 'disagree,' 3 'neutral,' 4 'agree,' and 5 'strongly agree.' Higher scores reflect more positive perceptions of aging.

  We will collect four times of data: 1. Baseline 2. The fourth week 3. Up to 10 weeks 4. After completing the study for one month

• Healthy ageing perspectives

  The Healthy Aging Perspectives Questionnaire (HAPQ) will be used. This questionnaire adopts a 5-point Likert scale, where 1 indicates 'strongly disagree,' 2 'disagree,' 3 'neutral,' 4 'agree,' and 5 'strongly agree.' Higher scores indicate more positive perspective of healthy aging.

  We will collect four times of data: 1. Baseline 2. The fourth week 3. Up to 10 weeks 4. After completing the study for one month

Study Arms (2)

Mindfulness

EXPERIMENTAL

Ten-week mindfulness programs supported by digital technology-assisted teaching materials

Behavioral: Multifaceted Mindfulness Program

Control

PLACEBO COMPARATOR

No intervention

Behavioral: Placebo

Interventions

Multifaceted Mindfulness Program BEHAVIORAL

Ten-week mindfulness classes

Also known as: Mindfulness

Mindfulness

Placebo BEHAVIORAL

Regular daily activity

Control

Eligibility Criteria

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

You may qualify if:

• ability to communicate in Mandarin or Taiwanese
• aged 65 years or older in the community
• Currently using a mobile phone and the LINE application as a means of communication.

You may not qualify if:

• Individuals with cognitive impairments
• Unable to communicate verbally

Sponsors & Collaborators

• Chang Gung University of Science and Technology: lead
• National Science and Technology Council, Taiwan: collaborator

Related Publications (1)

• Wang YR, Lee HF, Hsieh PL, Chang CH, Chen CM. Relationship between physical activity and perceptions of ageing from the perspective of healthy ageing among older people with frailty with chronic disease: a cross-sectional study. BMC Nurs. 2023 Sep 16;22(1):319. doi: 10.1186/s12912-023-01481-9.

  PMID: 37716946 BACKGROUND

Related Links

• Using the mindfullness practice for the development of the program

MeSH Terms

Interventions

Mindfulness

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Yu-Rung Wang, PhD

  Chang Gung University of Science and Technology, Chiayi Campus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yu-Rung Wang, PhD

CONTACT

88653628800; daisy025@gmail.com

Yu-Rung Wang, PhD

CONTACT

886-53628800; daisy025@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 30, 2025
• First Posted: June 17, 2025
• Study Start: June 11, 2025
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: June 17, 2025

Record last verified: 2025-04