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

NCT ID: NCT07308613

Last Updated: 2025-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-04-01

Study Completion Date

2027-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Loneliness

Keywords

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Loneliness Older Adults Mindfulness hybrid SMART-MRT

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

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.
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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App & Human Coaching + Continue Intervention

First-line of coaching (4 weeks):

Single-Session Intervention of Mindfulness (App + Human Coaching) Responder

Group Type EXPERIMENTAL

Mindfulness - Continue

Intervention Type BEHAVIORAL

Second-line of coaching (4 weeks):

Continue with existing intervention plan

Active Control

Active Control

Group Type ACTIVE_COMPARATOR

Active Control

Intervention Type BEHAVIORAL

No rerandomization, no mindfulness, No MRT

App & Human Coaching + Increase intensity in human coaching

First-line of coaching (4 weeks):

Single-Session Intervention of Mindfulness (App + Human Coaching) Non-Responder

Group Type EXPERIMENTAL

Mindfulness - Enhance human coaching

Intervention Type BEHAVIORAL

Second-line of coaching (4 weeks):

Increase intensity of human coaching

App & Human Coaching + Booster

First-line of coaching (4 weeks):

Single-Session Intervention of Mindfulness (App + Human Coaching) Non-Responder

Group Type EXPERIMENTAL

Mindfulness - Booster

Intervention Type BEHAVIORAL

Second-line of coaching (4 weeks):

Add a booster session

App Coaching + Continue Intervention

First-line of coaching (4 weeks):

Single-Session Intervention of Mindfulness (App Coaching) Responder

Group Type EXPERIMENTAL

Mindfulness - Continue

Intervention Type BEHAVIORAL

Second-line of coaching (4 weeks):

Continue with existing intervention plan

App Coaching + Increase intensity in human coaching

First-line of coaching (4 weeks):

Single-Session Intervention of Mindfulness (App Coaching) Non-Responder

Group Type EXPERIMENTAL

Mindfulness - Enhance human coaching

Intervention Type BEHAVIORAL

Second-line of coaching (4 weeks):

Increase intensity of human coaching

App Coaching + Booster

First-line of coaching (4 weeks):

Single-Session Intervention of Mindfulness (App Coaching) Non-Responder

Group Type EXPERIMENTAL

Mindfulness - Booster

Intervention Type BEHAVIORAL

Second-line of coaching (4 weeks):

Add a booster session

Human Coaching + Continue Intervention

First-line of coaching (4 weeks):

Single-Session Intervention of Mindfulness (Human Coaching) Responder

Group Type EXPERIMENTAL

Mindfulness - Continue

Intervention Type BEHAVIORAL

Second-line of coaching (4 weeks):

Continue with existing intervention plan

Human Coaching + Increase intensity in human coaching

First-line of coaching (4 weeks):

Single-Session Intervention of Mindfulness (Human Coaching) Non-Responder

Group Type EXPERIMENTAL

Mindfulness - Enhance human coaching

Intervention Type BEHAVIORAL

Second-line of coaching (4 weeks):

Increase intensity of human coaching

Human Coaching + Booster

First-line of coaching (4 weeks):

Single-Session Intervention of Mindfulness (Human Coaching) Non-Responder

Group Type EXPERIMENTAL

Mindfulness - Booster

Intervention Type BEHAVIORAL

Second-line of coaching (4 weeks):

Add a booster session

No Coaching + Continue Intervention

First-line of coaching (4 weeks):

No Single-Session Intervention of Mindfulness Responder

Group Type EXPERIMENTAL

Mindfulness - Continue

Intervention Type BEHAVIORAL

Second-line of coaching (4 weeks):

Continue with existing intervention plan

No Coaching + Increase intensity in human coaching

First-line of coaching (4 weeks):

No Single-Session Intervention of Mindfulness Non-Responder

Group Type EXPERIMENTAL

Mindfulness - Enhance human coaching

Intervention Type BEHAVIORAL

Second-line of coaching (4 weeks):

Increase intensity of human coaching

No Coaching + Booster

First-line of coaching (4 weeks):

No Single-Session Intervention of Mindfulness Non-Responder

Group Type EXPERIMENTAL

Mindfulness - Booster

Intervention Type BEHAVIORAL

Second-line of coaching (4 weeks):

Add a booster session

Interventions

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Mindfulness - Continue

Second-line of coaching (4 weeks):

Continue with existing intervention plan

Intervention Type BEHAVIORAL

Mindfulness - Enhance human coaching

Second-line of coaching (4 weeks):

Increase intensity of human coaching

Intervention Type BEHAVIORAL

Mindfulness - Booster

Second-line of coaching (4 weeks):

Add a booster session

Intervention Type BEHAVIORAL

Active Control

No rerandomization, no mindfulness, No MRT

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Texas at Austin

OTHER

Sponsor Role collaborator

Education University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Chou Kee Lee

Chair Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kee Lee Chou, PhD

Role: PRINCIPAL_INVESTIGATOR

The Education University of Hong Kong

Locations

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The Education University of Hong Kong

Hong Kong, , Hong Kong

Site Status

Countries

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Hong Kong

Central Contacts

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Kee Lee Chou, PhD

Role: CONTACT

Phone: +85229487473

Email: [email protected]

Vivien Tang, MSc

Role: CONTACT

Email: [email protected]

Other Identifiers

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2023-2024-0147

Identifier Type: -

Identifier Source: org_study_id