Loneliness
Conditions
Keywords
Loneliness, Older Adults, Mindfulness, hybrid SMART-MRT
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.
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
BEHAVIORALMindfulness - Continue
Second-line of coaching (4 weeks): Continue with existing intervention plan
BEHAVIORALMindfulness - Enhance human coaching
Second-line of coaching (4 weeks): Increase intensity of human coaching
BEHAVIORALMindfulness - Booster
Second-line of coaching (4 weeks): Add a booster session
BEHAVIORALActive Control
No rerandomization, no mindfulness, No MRT
Sponsors
Education University of Hong Kong
University of Texas at Austin
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | UCLA Loneliness Scale; each item will be rated from 1=Never to 4=Always. Total scores range from 20 to 80 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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. |
| 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) | Perceived Stress Scale; each item will be rated from 0=Never to 4=Very often. Total scores range from 0 to 56. |
| 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) | Pittsburgh Sleep Quality Index; each item will be rated from 0=No difficulty to 3=Severe difficulty. Total scores range from 0 to 21. |
| 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) | 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 |
| 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) | 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. |
| Physical Health | 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. |
| Physical Symptoms | 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. |
| Chronic Illness | 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). |
| Multidimensional Scale of 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) | 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. |
| Lubben Social Network Scale | 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. |
Countries
Hong Kong
Contacts
PRINCIPAL_INVESTIGATORKee Lee Chou, PhD
The Education University of Hong Kong
Outcome results
None listed