Mindfulness for Lonely Older Adults With Emigrant Children
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65-75
SponsorHong Kong Metropolitan University
About this trial
This study is to examine the feasibility of a proposed mindfulness-based intervention (MBI) and study methodology for future main study.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Intervention
BehavioralEight MBI lessons, and receive seven instant messages individually and four phone calls in 12-week to enhance and guide home self-practice
Active Control
Other interventionEight 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
Treatment groups
90 Participants
are divided into 3 treatment groupsGroup A: Lonely adults with emigrant children (ME)Experimental treatment 1 intervention
Group B: Lonely adults without emigrant children (MW)Experimental treatment 1 intervention
Group C: Lonely adults with emigrant children (C)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
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%.
Time frame
After the 12-week MBI training2
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.
Time frame
After the 12-week MBI trainingSecondary outcomes
1
Loneliness
The Chinese version of the Revised University of California Los Angeles (R-UCLA) 3-item Loneliness Short Scale used to measure subjective feelings of loneliness. This 3-item, 4-point Likert scale (0 = "never", 3 = "always") yields scores from 0 to 9, with higher scores indicating greater perceived loneliness. Cronbach's for the Chinese R-UCLA is 0.87.
Time frame
Baseline, week 12 and week 242
Sleep quality
The Chinese Pittsburgh Sleep Quality Index (PSQI) assesses sleep quality over past month across seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, sleep medication, and daytime dysfunctions. This 19-item, 4-point Likert scale (0 = "no difficulty, 3 = "severe difficulty") generates scores from 0 to 21, with ≥8 indicates sleep disturbance. Cronbach's α for the Chinese PSQI is 0.79.
Time frame
Baseline, week 12 and week 243
Stress level
The Chinese 10-item Perceived Stress Scale (PSS-10) measures stress using a 5-point Likert scale (0 = "never", 4 = "very often") generate score from 0 to 40. It includes four positive items assessing stress adaptation and six negative items evaluating negative affective reactions and lack of control. Higher scores indicate greater stress. Cronbach's α for PSS-10 is 0.83.
Time frame
Baseline, week 12 and week 244
Participants' Quality of Life
The EuroQol 5-Dimension 5-Level (EQ-5D-5L) HK evaluates QoL across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five levels (no problem to extreme problems). A utility score (-1 to 1; \<1 = "worse than death", 0 = "death", 1 = "full health") is derived for clinical and economic appraisal.
Time frame
Baseline, week 12 and week 24Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Hong Kong Metropolitan University
Lead sponsor
Health and Medical Research Fund
Collaborator
Source ClinicalTrials.gov
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