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| Name | Class |
|---|---|
| University of Texas at Austin | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| App & Human Coaching + Continue Intervention | Experimental | First-line of coaching (4 weeks): Single-Session Intervention of Mindfulness (App + Human Coaching) Responder |
|
| Active Control | Active Comparator | Active Control |
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| 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 |
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| App & Human Coaching + Booster | Experimental | First-line of coaching (4 weeks): Single-Session Intervention of Mindfulness (App + Human Coaching) Non-Responder |
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| App Coaching + Continue Intervention | Experimental | First-line of coaching (4 weeks): Single-Session Intervention of Mindfulness (App Coaching) Responder |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness - Continue | Behavioral | Second-line of coaching (4 weeks): Continue with existing intervention plan |
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| 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) |
| 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) |
| 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) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kee Lee Chou, PhD | Contact | +85229487473 | klchou@eduhk.hk | |
| Vivien Tang, MSc | Contact | s1135125@s.eduhk.hk |
| Name | Affiliation | Role |
|---|---|---|
| Kee Lee Chou, PhD | The Education University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Education University of Hong Kong | Hong Kong | Hong Kong |
Data sharing will be available upon reasonable request.
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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.
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| App Coaching + Increase intensity in human coaching |
| Experimental |
First-line of coaching (4 weeks): Single-Session Intervention of Mindfulness (App Coaching) Non-Responder |
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| App Coaching + Booster | Experimental | First-line of coaching (4 weeks): Single-Session Intervention of Mindfulness (App Coaching) Non-Responder |
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| Human Coaching + Continue Intervention | Experimental | First-line of coaching (4 weeks): Single-Session Intervention of Mindfulness (Human Coaching) Responder |
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| Human Coaching + Increase intensity in human coaching | Experimental | First-line of coaching (4 weeks): Single-Session Intervention of Mindfulness (Human Coaching) Non-Responder |
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| Human Coaching + Booster | Experimental | First-line of coaching (4 weeks): Single-Session Intervention of Mindfulness (Human Coaching) Non-Responder |
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| No Coaching + Continue Intervention | Experimental | First-line of coaching (4 weeks): No Single-Session Intervention of Mindfulness Responder |
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| No Coaching + Increase intensity in human coaching | Experimental | First-line of coaching (4 weeks): No Single-Session Intervention of Mindfulness Non-Responder |
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| No Coaching + Booster | Experimental | First-line of coaching (4 weeks): No Single-Session Intervention of Mindfulness Non-Responder |
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| Mindfulness - Enhance human coaching | Behavioral | Second-line of coaching (4 weeks): Increase intensity of human coaching |
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| Mindfulness - Booster | Behavioral | Second-line of coaching (4 weeks): Add a booster session |
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| Active Control | Behavioral | No rerandomization, no mindfulness, No MRT |
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| 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) |
| 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) |
| 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) |
| 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) |