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Clinical Trials/ChiCTR2300077472
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:

  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.

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

Sponsor
General Research Funding

Study Sites (1)

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