ChiCTR2300077472Not yet recruitingUnknown
Identification of an Effective Two-stage Adaptive Intervention for Reducing Loneliness among Hong Kong Chinese Older Adults
General Research Funding1 site in 1 countryStarted: January 1, 2024Last updated:
Trial Snapshot
- Phase
- Unknown
- Status
- Not yet recruiting
- Sponsor
- Locations
- 1
- Primary Endpoint
- Loneliness
Study Overview
Brief Summary
To develop and identify an effective two-stage adaptive intervention for optimizing the reduction of loneliness and four secondary outcomes (stress, sleeping problem, symptoms of depression and anxiety) among Hong Kong Chinese older adults using the sequential multiple assignment randomized trial (SMART) approach. The specific objectives of this proposed study are as follows:
- To evaluate whether a telephone-delivered behavioral activation (Tele-BA) intervention or a telephone-delivered mindfulness (Tele-MF) intervention is a more effective first-stage intervention in terms of reducing loneliness and four secondary outcomes.
- To evaluate whether extending the original first-stage intervention with an additional motivation component or switching to an alternative intervention is more effective in reducing loneliness and four secondary outcomes when participants are not responding to the first-stage intervention.
- To evaluate whether the Tele-BA-Tele-MF sequence (8 weeks) or the Tele-MF-Tele-BA sequence (8 weeks) is more effective in reducing loneliness and four secondary outcomes.
- To identify which of our four embedded 2-stage adaptive interventions is most effective for reducing loneliness and the four secondary outcomes: (1) 4-week Tele-BA: if no response, deliver another 4 weeks of Tele-BA with an additional motivation component (Tele-BA-and-Tele-BA); otherwise, two monthly booster sessions; (2) 4-week Tele-BA: if no response, deliver a further 4 weeks of Tele-MF (Tele-BA-and-Tele-MF); otherwise, two monthly booster sessions; (3) 4-week Tele-MF: if no response, deliver another 4 weeks of Tele-MF with an additional motivation component (Tele-MF-and-Tele-MF); otherwise, two monthly booster sessions; (4) 4-week Tele-MF: if no response, deliver a further 4 weeks of Tele-BA (Tele-MF-and-Tele-BA); otherwise two monthly booster sessions.
Study Design
- Study Type
- Interventional
- Primary Purpose
- 随机平行对照
- Masking
- The outcome assessor will be blinded to the intervention allocation.
Eligibility Criteria
- Ages
- 65 to 100 (—)
- Sex
- All
Inclusion Criteria
- •Hong Kong Chinese older adults, aged 65 and older;
- •Able to communicate through Cantonese over the phone;
- •Have no cognitive impairment;
- •Have no psychiatric disorder, learning disability, or active suicidal ideation;
- •Not engaged in any psychotherapy, psychosocial intervention, regular systematic mindfulness meditation, or related mind-body practice in the past six months;
- •Feeling lonely (cut-off <6 of 3-item UCLA Loneliness Scale).
Exclusion Criteria
- •Those for do not meet the inclusion criteria.
Arms & Interventions
Tele-BA (Responders)
Tele-MF (Responders)
Tele-BA (Non-responders)
Tele-MF (Non-responders)
Outcomes
Primary Outcomes
Loneliness
Time Frame: T1, T2, T3, T4, T5
Secondary Outcomes
- Stress(T1, T2, T3, T4, T5)
- Sleep Quality(T1, T2, T3, T4, T5)
- Depression(T1, T2, T3, T4, T5)
- Anxiety(T1, T2, T3, T4, T5)
- Mindfulness(T1, T2, T3, T4, T5)
- Health(T1, T2, T3, T4, T5)
- Positive and meaning activities(T1, T2, T3, T4, T5)
- Engagement of activities(T1, T2, T3, T4, T5)
- Loneliness(T1, T2, T3, T4, T5)
- Age(T1)
- Gender(T1)
- Marital Status(T1)
- Living arrangements(T1)
- Education attainment(T1)
- Employment status(T1, T2, T3, T4, T5)
- Household income(T1, T2, T3, T4, T5)
- Financial Status(T1, T2, T3, T4, T5)
- Use of social and healthcare services(T1, T2, T3, T4, T5)
Investigators
Study Sites (1)
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