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NCT Number: NCT07308613

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

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

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Key information

Conditions

Loneliness

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Education University of Hong Kong

Hong Kong

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mindfulness - Continue

Behavioral

Second-line of coaching (4 weeks):

Continue with existing intervention plan

Mindfulness - Enhance human coaching

Behavioral

Second-line of coaching (4 weeks):

Increase intensity of human coaching

Mindfulness - Booster

Behavioral

Second-line of coaching (4 weeks):

Add a booster session

Active Control

Behavioral

No rerandomization, no mindfulness, No MRT

Primary outcomes

  1. Loneliness

    Time frame: 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)

    UCLA Loneliness Scale; each item will be rated from 1=Never to 4=Always. Total scores range from 20 to 80

Secondary outcomes

  1. Loneliness

    Time frame: 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)

    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.

  2. Stress

    Time frame: 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 Stress Scale; each item will be rated from 0=Never to 4=Very often. Total scores range from 0 to 56.

  3. Sleep Quality

    Time frame: 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)

    Pittsburgh Sleep Quality Index; each item will be rated from 0=No difficulty to 3=Severe difficulty. Total scores range from 0 to 21.

  4. Depression

    Time frame: 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)

    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

  5. Anxiety

    Time frame: 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)

    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.

  6. Physical Health

    Time frame: Baseline (T0), 6 months after 2nd-line of coaching (T4)

    Lawton Instrumental Activities of Daily Living; each item will be rated 0=dependent to 1=independent. Total scores range from 0 to 8.

  7. Physical Health

    Time frame: Baseline (T0), 6 months after 2nd-line of coaching (T4)

    Activities of Daily Living; each item will be rate from 0=dependent to 5/10=independent. Total scores range from 0 to 100.

  8. Physical Symptoms

    Time frame: Baseline (T0), 6 months after 2nd-line of coaching (T4)

    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.

  9. Chronic Illness

    Time frame: Baseline (T0), 6 months after 2nd-line of coaching (T4)

    Participants will indicate any presence of chronic illness (e.g., diabetes, asthma, high blood pressure).

  10. Multidimensional Scale of Perceived Social Support

    Time frame: 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)

    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.

  11. Lubben Social Network Scale

    Time frame: 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)

    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.

Other outcomes

  1. Mindfulness

    Time frame: 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)

    Mindfulness Attention Awareness Scale; each item will be rated from 1=Almost always to 6=Almost never. Average score will be calculated.

  2. Perceived Social Support

    Time frame: 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)

    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.

  3. Social Isolation

    Time frame: 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; 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kee Lee Chou, PhD

CONTACT

[email protected]

+85229487473

Vivien Tang, MSc

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Education University of Hong Kong

Other

Collaborators

  • University of Texas at Austin

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Dec 29, 2025
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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