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

NCT07308613 | Not Yet Recruiting

• 1 other identifier: 2023-2024-0147
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Loneliness

Keywords

Loneliness; Older Adults; Mindfulness; hybrid SMART-MRT

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Loneliness

  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

  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

  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

  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

  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 Outcomes (3)

• Mindfulness

  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

  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

  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)

Study Arms (13)

App & Human Coaching + Continue Intervention

EXPERIMENTAL

First-line of coaching (4 weeks): Single-Session Intervention of Mindfulness (App + Human Coaching) Responder

Behavioral: Mindfulness - Continue

Active Control

ACTIVE COMPARATOR

Active Control

Behavioral: Active Control

App & Human Coaching + Increase intensity in human coaching

EXPERIMENTAL

First-line of coaching (4 weeks): Single-Session Intervention of Mindfulness (App + Human Coaching) Non-Responder

Behavioral: Mindfulness - Enhance human coaching

App & Human Coaching + Booster

EXPERIMENTAL

First-line of coaching (4 weeks): Single-Session Intervention of Mindfulness (App + Human Coaching) Non-Responder

Behavioral: Mindfulness - Booster

App Coaching + Continue Intervention

EXPERIMENTAL

First-line of coaching (4 weeks): Single-Session Intervention of Mindfulness (App Coaching) Responder

Behavioral: Mindfulness - Continue

App Coaching + Increase intensity in human coaching

EXPERIMENTAL

First-line of coaching (4 weeks): Single-Session Intervention of Mindfulness (App Coaching) Non-Responder

Behavioral: Mindfulness - Enhance human coaching

App Coaching + Booster

EXPERIMENTAL

First-line of coaching (4 weeks): Single-Session Intervention of Mindfulness (App Coaching) Non-Responder

Behavioral: Mindfulness - Booster

Human Coaching + Continue Intervention

EXPERIMENTAL

First-line of coaching (4 weeks): Single-Session Intervention of Mindfulness (Human Coaching) Responder

Behavioral: Mindfulness - Continue

Human Coaching + Increase intensity in human coaching

EXPERIMENTAL

First-line of coaching (4 weeks): Single-Session Intervention of Mindfulness (Human Coaching) Non-Responder

Behavioral: Mindfulness - Enhance human coaching

Human Coaching + Booster

EXPERIMENTAL

First-line of coaching (4 weeks): Single-Session Intervention of Mindfulness (Human Coaching) Non-Responder

Behavioral: Mindfulness - Booster

No Coaching + Continue Intervention

EXPERIMENTAL

First-line of coaching (4 weeks): No Single-Session Intervention of Mindfulness Responder

Behavioral: Mindfulness - Continue

No Coaching + Increase intensity in human coaching

EXPERIMENTAL

First-line of coaching (4 weeks): No Single-Session Intervention of Mindfulness Non-Responder

Behavioral: Mindfulness - Enhance human coaching

No Coaching + Booster

EXPERIMENTAL

First-line of coaching (4 weeks): No Single-Session Intervention of Mindfulness Non-Responder

Behavioral: Mindfulness - Booster

Interventions

Mindfulness - Continue BEHAVIORAL

Second-line of coaching (4 weeks): Continue with existing intervention plan

App & Human Coaching + Continue Intervention; App Coaching + Continue Intervention; Human Coaching + Continue Intervention; No Coaching + Continue Intervention

Mindfulness - Enhance human coaching BEHAVIORAL

Second-line of coaching (4 weeks): Increase intensity of human coaching

App & Human Coaching + Increase intensity in human coaching; App Coaching + Increase intensity in human coaching; Human Coaching + Increase intensity in human coaching; No Coaching + Increase intensity in human coaching

Mindfulness - Booster BEHAVIORAL

Second-line of coaching (4 weeks): Add a booster session

App & Human Coaching + Booster; App Coaching + Booster; Human Coaching + Booster; No Coaching + Booster

Active Control BEHAVIORAL

No rerandomization, no mindfulness, No MRT

Active Control

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Education University of Hong Kong: lead
• University of Texas at Austin: collaborator

Study Sites (1)

The Education University of Hong Kong

Hong Kong, Hong Kong

Location

Study Officials

• Kee Lee Chou, PhD

  The Education University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kee Lee Chou, PhD

CONTACT

+85229487473; klchou@eduhk.hk

Vivien Tang, MSc

CONTACT

s1135125@s.eduhk.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair Professor

Model Details: A hybrid factorial-SMART-MRT experimental design with a 2x2+1 factorial design (with five arms) randomized clinical trial, a two-stage SMART, and three MRTs will be utilized.

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: December 29, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

HK (1)