- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07283549
Reducing Loneliness Among Older Adults in Hong Kong by Volunteer-delivered Mindfulness and Behavioral Activation Intervention
December 15, 2025 updated by: Chou Kee Lee, Education University of Hong Kong
This study aims to recruit and train retirees and young people to be volunteers who will deliver the layperson-delivered, telephone-based behavioral activation and mindfulness intervention to older adults.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Retirees and young people will be recruited, trained, and delivered telephone-based psychosocial interventions to older adults.
Study Type
Interventional
Enrollment (Actual)
251
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Hong Kong, Hong Kong
- The Education University of Hong Kong
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 65 years older and above
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Tele-BA
Behavioral Activation
|
Behavioral Activation
|
|
Experimental: Tele-MF
Mindfulness
|
Mindfulness
|
|
Active Comparator: Tele-BF
Befriending
|
Befriending
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Loneliness
Time Frame: Baseline, 4 weeks, 3 months
|
UCLA Loneliness Scale; Each item will be rated from 1=Never to 4=Always.
Total scores range from 20 to 80.
|
Baseline, 4 weeks, 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Loneliness
Time Frame: Baseline, 4 weeks, 3 months
|
De Jong Gierveld Loneliness Scale; Each item will be rated from 1=Yes to 3=No.
Total scores range from 0 to 6, with subscale score ranging from 0 to 3.
|
Baseline, 4 weeks, 3 months
|
|
Anxiety
Time Frame: Baseline, 4 weeks, 3 months
|
Hospital Anxiety and Depression Scale; Each item will be rated from 0=Not at all to 3=Most of the time.
Total score range from 0 to 42.
|
Baseline, 4 weeks, 3 months
|
|
Sleep Quality
Time Frame: Baseline, 4 weeks, 3 months
|
Sleep Condition Indicator; Each item will be rated from 0 to 4. Total score range from 0 to 32.
|
Baseline, 4 weeks, 3 months
|
|
Stress
Time Frame: Baseline, 4 weeks, 3 months
|
Perceived Stress Scale; Each item will be rated from 0=Never to 4=Very often.
Total scores range from 0 to 56.
|
Baseline, 4 weeks, 3 months
|
|
Well-Being
Time Frame: Baseline, 4 weeks, 3 months
|
Psychological Well-Being Scale; Each item will be rated from 1=strongly agree to 7=strongly disagree.
|
Baseline, 4 weeks, 3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2024
Primary Completion (Actual)
July 23, 2025
Study Completion (Actual)
July 23, 2025
Study Registration Dates
First Submitted
December 4, 2025
First Submitted That Met QC Criteria
December 4, 2025
First Posted (Estimated)
December 16, 2025
Study Record Updates
Last Update Posted (Actual)
December 19, 2025
Last Update Submitted That Met QC Criteria
December 15, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023-2024-0570
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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