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Not yet recruiting NCT07711860

Mindfulness for Lonely Older Adults With Emigrant Children

No phase Interventional Loneliness Sleep Quality Quality of Life Stress

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Intervention, Active Control.
Who it may be relevant to
Registry conditions: Loneliness, Sleep Quality, Quality of Life, Stress. Basic parameters: 65 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hong Kong
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Feasibility and Acceptability of Implementation of Mindfulness-Based Intervention for Community-Dwelling Older Adults With Emigrant Children Suffering From Loneliness: A Pilot Randomized Controlled Trial

Overview

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

Detailed description

The goal of this 3-arm randomized controlled trial is to examine the feasibility of a proposed mindfulness-based intervention (MBI) and study methodology for future main study. It will identify the acceptability, feasibility, and potential effectiveness of the MBI for lonely older adults (OAs) with emigrant children. The main questions it aims to answer are:

1. To what extent is the MBI study process feasible and acceptable for lonely OAs whose children have emigrated? 2. Do subjects in the intervention group show significant improvements in loneliness levels, sleep quality, stress levels, and quality of life (QoL) during follow-up assessments at weeks 12 and 24 compared to baseline? 3. How practical and effective is the recruitment process for enrolling the target study subjects?

Researchers will compare lonely adults with or without out emigrant children to see if MBI to reduce the loneliness level.

Participants will attend a 12-week programme with 8-section face-to-face MBI training, guided by 7 mindfulness video clips plus 4 individual support phone calls, and follow-up at week 12 and 24. In addition, an individual semi-structured interview will be carried out to explore the experience and perceived programme effects of the intervention.

Interventions

  • Behavioral Intervention
    Eight MBI lessons, and receive seven instant messages individually and four phone calls in 12-week to enhance and guide home self-practice
  • Other Active Control
    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

Primary outcome measures

  • Feasibility of Mindfulness-based Intervention (MBI) [Time frame: After the 12-week MBI training]
  • Acceptability of the Mindfulness-based Intervention (MBI) [Time frame: After the 12-week MBI training]
Secondary outcome measures (7)
  • Loneliness [Time frame: Baseline, week 12 and week 24]
  • Sleep quality [Time frame: Baseline, week 12 and week 24]
  • Stress level [Time frame: Baseline, week 12 and week 24]
  • Participants' Quality of Life [Time frame: Baseline, week 12 and week 24]
  • Mindfulness [Time frame: Baseline, week 12 and week 24]
  • Cardiometabolic outcomes [Time frame: Baseline, week 12 and week 24]
  • Others [Time frame: Baseline, week 12 and week 24]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Other

Study locations

Hong Kong · 1 center
  • Hong Kong Metropolitan University — Hong Kong

Identifiers

NCT: NCT07711860 · HE-HMRF2025/10 · 23240241

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗