NCT07711860

Brief Summary

This study is to examine the feasibility of a proposed mindfulness-based intervention (MBI) and study methodology for future main study.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
18mo left

Started Oct 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 6, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 17, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2026

Expected
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2028

Last Updated

July 17, 2026

Status Verified

July 1, 2026

Enrollment Period

1.2 years

First QC Date

July 6, 2026

Last Update Submit

July 14, 2026

Conditions

Keywords

Mindfulness-based interventionlonelinessolder adults with emigrant children

Outcome Measures

Primary Outcomes (2)

  • Feasibility of Mindfulness-based Intervention (MBI)

    The feasibility of the MBI will be evaluated using the following criteria: recruitment and retention rates. The recruitment rate is ≥80% of subject recruitment of the study, time required to recruit to target sample size (≤4 months for recruiting 45 subjects; ≤9 months for recruiting 90 subjects), Adverse Effects reported by the subjects is ≤5% for the whole study, attendance rate is ≥75% of subjects attend each session of health education, reasons for drop out or withdrawal from the study record in number and percentage, program completion rate of the subject ≥70%.

    After the 12-week MBI training

  • Acceptability of the Mindfulness-based Intervention (MBI)

    Acceptability will be assessed via a self-developed evaluation form completed after the 12-week MBI training. The form has three-part: Part 1 includes 4 questions on perceived benefits of MBI; Part 2 includes 8 questions on satisfaction with MBI class arrangement; Part 3 includes 3 questions for suggestions and feedbacks. Questions 1 to 12 (part 1 and 2) use a five-point Likert Scale (5 = "Strongly agree", 1 = "strongly not agree"). Question 10 assesses subjects' willingness to continue MBI practice. Questions 13 and 15 (part 3) are open-ended, collecting "other comments" and suggestions for improving the MBI class, respectively.

    After the 12-week MBI training

Secondary Outcomes (7)

  • Loneliness

    Baseline, week 12 and week 24

  • Sleep quality

    Baseline, week 12 and week 24

  • Stress level

    Baseline, week 12 and week 24

  • Participants' Quality of Life

    Baseline, week 12 and week 24

  • Mindfulness

    Baseline, week 12 and week 24

  • +2 more secondary outcomes

Study Arms (3)

Lonely adults with emigrant children (ME)

EXPERIMENTAL

Attend eight MBI lessons, and receive seven instant messages individually and four phone calls in 12-week to enhance and guide home self-practice

Behavioral: Intervention

Lonely adults without emigrant children (MW)

EXPERIMENTAL

Attend eight MBI lessons, and receive seven instant messages individually and four phone calls in 12-week to enhance and guide home self-practice

Behavioral: Intervention

Lonely adults with emigrant children (C)

ACTIVE COMPARATOR

Receive eight health education and craft sessions, seven instant messages individually, four phone calls, and maintain usual activities without participating in mind-body exercise/ activities or stress reduction programme in 12-week

Other: Active Control

Interventions

Eight health education and craft sessions, seven instant messages individually, four phone calls, and maintain usual activities without participating in mind-body exercise/ activities or stress reduction programme in 12-week

Lonely adults with emigrant children (C)
InterventionBEHAVIORAL

Eight MBI lessons, and receive seven instant messages individually and four phone calls in 12-week to enhance and guide home self-practice

Lonely adults with emigrant children (ME)Lonely adults without emigrant children (MW)

Eligibility Criteria

Age65 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Chinese adults aged 65 to 75 years,
  • able to communicate and understand Cantonese (class will be held in Cantonese),
  • OAs with or without emigrant children,
  • feeling of loneliness (3-item UCLA ≥6) \[25\], and
  • living in public housing, reliant on pension, savings, or living in subvented housing.

You may not qualify if:

  • Acute or severe physical symptoms such as impaired mobility, COPD or respiratory failure, uncontrolled epilepsy, and severe chronic pain syndrome,
  • Abbreviated Mental Test (AMT)\< 6 \[26\],
  • met DSM-V TR criteria for treated or untreated major depressive disorder, bipolar disorder, cyclothymic disorder and/or on regular medication treatment,
  • have significant suicidal risk, and
  • previous experience in instructor-led mindfulness training within the half year prior to the commencement of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hong Kong Metropolitan University

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Methods

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Yuen Ling Leung

    Hong Kong Metropolitan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuen Ling LEUNG, Doctor of Nursing

CONTACT

Wing Yee HO, PhD

CONTACT

Study Design

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

Study Record Dates

First Submitted

July 6, 2026

First Posted

July 17, 2026

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

March 31, 2028

Last Updated

July 17, 2026

Record last verified: 2026-07

Locations