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

No phase Interventional Loneliness

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Mindfulness - Continue, Mindfulness - Enhance human coaching, Mindfulness - Booster, Active Control.
Who it may be relevant to
Registry conditions: Loneliness. Basic parameters: from 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hong Kong
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

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.

Interventions

  • Behavioral Mindfulness - Continue
    Second-line of coaching (4 weeks): Continue with existing intervention plan
  • Behavioral Mindfulness - Enhance human coaching
    Second-line of coaching (4 weeks): Increase intensity of human coaching
  • Behavioral Mindfulness - Booster
    Second-line of coaching (4 weeks): Add a booster session
  • Behavioral Active Control
    No rerandomization, no mindfulness, No MRT

Primary outcome measures

  • 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)]
Secondary outcome measures (11)
  • 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)]
  • 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)]
  • 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)]
  • 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)]
  • 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)]
  • Physical Health [Time frame: Baseline (T0), 6 months after 2nd-line of coaching (T4)]
  • Physical Health [Time frame: Baseline (T0), 6 months after 2nd-line of coaching (T4)]
  • Physical Symptoms [Time frame: Baseline (T0), 6 months after 2nd-line of coaching (T4)]
  • Chronic Illness [Time frame: Baseline (T0), 6 months after 2nd-line of coaching (T4)]
  • 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)]
  • 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)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Factorial
Masking
Double blind
Primary purpose
Prevention

Study locations

Hong Kong · 1 center
  • The Education University of Hong Kong — Hong Kong

Identifiers

NCT: NCT07308613 · 2023-2024-0147

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗