Developing and Testing a Machine Learning Enabled Mindfulness Intervention for Reducing Loneliness Among Hong Kong Chinese Older Adults

Developing and Testing a Machine Learning Enabled Mindfulness Intervention for Reducing Loneliness Among Hong Kong Chinese Older Adults: A Hybrid Experimental Design Study

Develop and test an effective machine learning enabled application-based (app-based) mindfulness intervention for reducing loneliness of Hong Kong Chinese older adults.

Study Overview

• Status: Not yet recruiting
• Conditions: Loneliness
• Intervention / Treatment: Behavioral: Mindfulness - Continue; Behavioral: Active Control; Behavioral: Mindfulness - Enhance human coaching; Behavioral: Mindfulness - Booster

Detailed Description

This study will utilize a hybrid Sequential Multiple Assignment Randomized Trial-Micro Randomized Trial (Hybrid SMART-MRT) to: 1) evaluate the effectiveness of a single-session intervention (SSI) of mindfulness on reducing loneliness; 2) identify the optimal first-line coaching approach after the SSI of mindfulness; 3) examine whether increasing the intensity of human coaching or adding a telephone-based human-delivered booster session will benefit participants who do not respond to the first-line coaching; 4) determine whether sending push notifications increases the engagement of our app-based coaching, by comparing its results with those of no push notification; 5) determine whether sending a recommended activity increases the engagement of our app-based coaching, by comparing its results with those of no recommended activity; and 6) determine whether sending a personalized motivational message increases the engagement of our app-based coaching, by comparing its results with those of a standard motivational message.

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kee Lee Chou, PhD; Phone Number: +85229487473; Email: klchou@eduhk.hk
• Study Contact Backup: Name: Vivien Tang, MSc; Email: s1135125@s.eduhk.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • The Education University of Hong Kong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Aged 65 or older
• Possess a smartphone with an Android or iOS operating system
• Communicable in Cantonese
• Lonely (cut-off >/=6 on the three-item UCLA Loneliness Scale)

Exclusion Criteria:

• Cognitive impairment, psychiatric disorder, learning disability
• Active suicide ideation
• Engaged in psychotherapy and psychosocial interventions in the past year

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

13

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: App & Human Coaching + Continue Intervention; First-line of coaching (4 weeks): Single-Session Intervention of Mindfulness (App + Human Coaching) Responder	Behavioral: Mindfulness - Continue; Second-line of coaching (4 weeks): Continue with existing intervention plan
Active Comparator: Active Control	Behavioral: Active Control; No rerandomization, no mindfulness, No MRT
Experimental: App & Human Coaching + Increase intensity in human coaching; First-line of coaching (4 weeks): Single-Session Intervention of Mindfulness (App + Human Coaching) Non-Responder	Behavioral: Mindfulness - Enhance human coaching; Second-line of coaching (4 weeks): Increase intensity of human coaching
Experimental: App & Human Coaching + Booster; First-line of coaching (4 weeks): Single-Session Intervention of Mindfulness (App + Human Coaching) Non-Responder	Behavioral: Mindfulness - Booster; Second-line of coaching (4 weeks): Add a booster session
Experimental: App Coaching + Continue Intervention; First-line of coaching (4 weeks): Single-Session Intervention of Mindfulness (App Coaching) Responder	Behavioral: Mindfulness - Continue; Second-line of coaching (4 weeks): Continue with existing intervention plan
Experimental: App Coaching + Increase intensity in human coaching; First-line of coaching (4 weeks): Single-Session Intervention of Mindfulness (App Coaching) Non-Responder	Behavioral: Mindfulness - Enhance human coaching; Second-line of coaching (4 weeks): Increase intensity of human coaching
Experimental: App Coaching + Booster; First-line of coaching (4 weeks): Single-Session Intervention of Mindfulness (App Coaching) Non-Responder	Behavioral: Mindfulness - Booster; Second-line of coaching (4 weeks): Add a booster session
Experimental: Human Coaching + Continue Intervention; First-line of coaching (4 weeks): Single-Session Intervention of Mindfulness (Human Coaching) Responder	Behavioral: Mindfulness - Continue; Second-line of coaching (4 weeks): Continue with existing intervention plan
Experimental: Human Coaching + Increase intensity in human coaching; First-line of coaching (4 weeks): Single-Session Intervention of Mindfulness (Human Coaching) Non-Responder	Behavioral: Mindfulness - Enhance human coaching; Second-line of coaching (4 weeks): Increase intensity of human coaching
Experimental: Human Coaching + Booster; First-line of coaching (4 weeks): Single-Session Intervention of Mindfulness (Human Coaching) Non-Responder	Behavioral: Mindfulness - Booster; Second-line of coaching (4 weeks): Add a booster session
Experimental: No Coaching + Continue Intervention; First-line of coaching (4 weeks): No Single-Session Intervention of Mindfulness Responder	Behavioral: Mindfulness - Continue; Second-line of coaching (4 weeks): Continue with existing intervention plan
Experimental: No Coaching + Increase intensity in human coaching; First-line of coaching (4 weeks): No Single-Session Intervention of Mindfulness Non-Responder	Behavioral: Mindfulness - Enhance human coaching; Second-line of coaching (4 weeks): Increase intensity of human coaching
Experimental: No Coaching + Booster; First-line of coaching (4 weeks): No Single-Session Intervention of Mindfulness Non-Responder	Behavioral: Mindfulness - Booster; Second-line of coaching (4 weeks): Add a booster session

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Loneliness	UCLA Loneliness Scale; each item will be rated from 1=Never to 4=Always. Total scores range from 20 to 80	Baseline (T0), within 1 week after 1st-line of coaching (T1), within 1 week after 2nd-line of coaching (T2), 3 months after 2nd-line of coaching (T3), 6 months after 2nd-line of coaching (T4)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Loneliness	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 (T0), within 1 week after 1st-line of coaching (T1), within 1 week after 2nd-line of coaching (T2), 3 months after 2nd-line of coaching (T3), 6 months after 2nd-line of coaching (T4)
Stress	Perceived Stress Scale; each item will be rated from 0=Never to 4=Very often. Total scores range from 0 to 56.	Baseline (T0), within 1 week after 1st-line of coaching (T1), within 1 week after 2nd-line of coaching (T2), 3 months after 2nd-line of coaching (T3), 6 months after 2nd-line of coaching (T4)
Sleep Quality	Pittsburgh Sleep Quality Index; each item will be rated from 0=No difficulty to 3=Severe difficulty. Total scores range from 0 to 21.	Baseline (T0), within 1 week after 1st-line of coaching (T1), within 1 week after 2nd-line of coaching (T2), 3 months after 2nd-line of coaching (T3), 6 months after 2nd-line of coaching (T4)
Depression	Patient Health Questionnaire-9; Each item will be rated from 0=Not at all to 3=nearly everyday. Total scores range from 0 to 27	Baseline (T0), within 1 week after 1st-line of coaching (T1), within 1 week after 2nd-line of coaching (T2), 3 months after 2nd-line of coaching (T3), 6 months after 2nd-line of coaching (T4)
Physical Health	Lawton Instrumental Activities of Daily Living; each item will be rated 0=dependent to 1=independent. Total scores range from 0 to 8.	Baseline (T0), 6 months after 2nd-line of coaching (T4)
Physical Health	Activities of Daily Living; each item will be rate from 0=dependent to 5/10=independent. Total scores range from 0 to 100.	Baseline (T0), 6 months after 2nd-line of coaching (T4)
Physical Symptoms	Wahler Physical Symptoms Inventory; each item will be rated from 0=almost never agree to 5=agree almost every day. Total score range from 0 to 210.	Baseline (T0), 6 months after 2nd-line of coaching (T4)
Chronic Illness	Participants will indicate any presence of chronic illness (e.g., diabetes, asthma, high blood pressure).	Baseline (T0), 6 months after 2nd-line of coaching (T4)
Multidimensional Scale of Perceived Social Support	MSPSS evaluates the social support derived from three key sources: family, friends, and significant others. Each item will be rated from 1=Strongly disagree to 7=Strongly agree. Total scores range from 12 to 84.	Baseline (T0), within 1 week after 1st-line of coaching (T1), within 1 week after 2nd-line of coaching (T2), 3 months after 2nd-line of coaching (T3), 6 months after 2nd-line of coaching (T4)
Lubben Social Network Scale	LSNS is used to assess the social networks of participants. Each item will be rated 0=None to 5=9 or more. Total scores range from 0 to 30.	Baseline (T0), within 1 week after 1st-line of coaching (T1), within 1 week after 2nd-line of coaching (T2), 3 months after 2nd-line of coaching (T3), 6 months after 2nd-line of coaching (T4)
Anxiety	Generalised Anxiety Disorder; each item will be rated from 0=not at all to 3=nearly every day. Total score range from 0 to 21.	Baseline (T0), within 1 week after 1st-line of coaching (T1), within 1 week after 2nd-line of coaching (T2), 3 months after 2nd-line of coaching (T3), 6 months after 2nd-line of coaching (T4)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mindfulness	Mindfulness Attention Awareness Scale; each item will be rated from 1=Almost always to 6=Almost never. Average score will be calculated.	Baseline (T0), within 1 week after 1st-line of coaching (T1), within 1 week after 2nd-line of coaching (T2), 3 months after 2nd-line of coaching (T3), 6 months after 2nd-line of coaching (T4)
Perceived Social Support	Each item is rated on a 7-point Likert scale ranging from 1=Strongly disagree to 7=Strongly agree. Total scores range from 12 to 84, with subscale score ranging from 4 to 28. A higher score indicates higher levels of perceived support.	Baseline (T0), within 1 week after 1st-line of coaching (T1), within 1 week after 2nd-line of coaching (T2), 3 months after 2nd-line of coaching (T3), 6 months after 2nd-line of coaching (T4)
Social Isolation	Lubben Social Network Scale; Each item is rated on a 6-point Likert scale ranging from 0=None to 5=9 or more. Total scores range from 0 to 30, with a higher score indicating greater social engagement and lower risk of social isolation.	Baseline (T0), within 1 week after 1st-line of coaching (T1), within 1 week after 2nd-line of coaching (T2), 3 months after 2nd-line of coaching (T3), 6 months after 2nd-line of coaching (T4)

Collaborators and Investigators

• Sponsor: Education University of Hong Kong
• Collaborators: University of Texas at Austin
• Investigators: Principal Investigator: Kee Lee Chou, PhD, The Education University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: December 8, 2025
• First Submitted That Met QC Criteria: December 20, 2025
• First Posted (Actual): December 29, 2025

Study Record Updates

• Last Update Posted (Actual): March 19, 2026
• Last Update Submitted That Met QC Criteria: March 18, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Mindfulness; Older Adults; Loneliness; hybrid SMART-MRT
• Other Study ID Numbers: 2023-2024-0147

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data sharing will be available upon reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No