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临床试验/ChiCTR2300077472
ChiCTR2300077472尚未招募Unknown

Identification of an Effective Two-stage Adaptive Intervention for Reducing Loneliness among Hong Kong Chinese Older Adults

General Research Funding1 个研究点 分布在 1 个国家开始时间: 2024年1月1日最近更新:

试验速览

阶段
Unknown
状态
尚未招募
发起方
试验地点
1
主要终点
Loneliness

研究概览

简要总结

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:

  1. 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.
  2. 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.
  3. 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.
  4. 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.

研究设计

研究类型
Interventional
主要目的
随机平行对照
盲法
The outcome assessor will be blinded to the intervention allocation.

入排标准

年龄范围
65 至 100(—)
性别
All

入选标准

  • 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).

排除标准

  • Those for do not meet the inclusion criteria.

研究组 & 干预措施

Tele-BA (Responders)

Tele-MF (Responders)

Tele-BA (Non-responders)

Tele-MF (Non-responders)

结局指标

主要结局

Loneliness

时间窗: T1, T2, T3, T4, T5

次要结局

  • 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)

研究者

发起方
General Research Funding

研究点 (1)

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