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NCT Number: NCT07123064

Alleviating Loneliness in Older Adults Living in Poverty: A Multi-level Intervention

The study aims to reduce loneliness among Hong Kong Chinese older adults living in poverty with a multi-level intervention involving components at the individual, interpersonal, and community levels.

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Key information

Conditions

Loneliness Poverty

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Loneliness is widespread, with negative impacts on both individuals and society and associated direct and indirect healthcare and long-term care costs. Thus, it is imperative to alleviate loneliness in old age by implementing effective, accessible, affordable, and scalable interventions. Loneliness is often erroneously considered an individual problem due to personal failure. Still, growing evidence indicates that loneliness is caused by factors at multiple levels, including the individual, interpersonal, and community levels. Hence, a multi-level approach is recommended to alleviate loneliness.

However, multi-level interventions for reducing loneliness are in their infancy, and there is yet to be evidence to suggest that they are more effective than single-level interventions. The investigators will conduct an innovative and impactful study to fill this important research gap. This study is a single-blinded cluster, four-arm randomized controlled trial (RCT) designed to test the effect and cost-effectiveness of a multi-level intervention to alleviate loneliness among Hong Kong Chinese older adults living in poverty. The investigators will also adopt the modified biopsychosocial (BPS) model, called the BPS-Pathways model, as the theoretical framework to guide our selection of interventions, mediators, secondary outcomes, long-term outcomes, and impact.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • aged 65 years or older
  • living in poverty (defined: inability to afford at least 5 items on the material deprivation index)
  • proficiency in spoken Cantonese
  • experiencing loneliness (defined: score of ≥ 6 on the 3-item UCLA Loneliness Scale)

Exclusion criteria

  • cognitive impairments, psychiatric disorders, learning disabilities, or active suicidal ideation
  • actively participating in other psychotherapy or psychosocial interventions in the past 1 year

Exclusion criteria

-

Treatment and study plan

Individual level

Behavioral

A 8-weekly, 1hour telephone-delivered sessions using mindfulness and SOLUS-D program. Key contents include: introduction to mindfulness - Body awareness and present moment experiences, emotional awareness and mind-body labeling, relaxation techniques and sensory discrimination, deepening awareness and accepting feelings, personal values, interconnection between thought patterns and emotions, identifying and analyzing of thought traps, and challenging thoughts and future planning. Maintenance sessions which focus on embedding mindfulness practices and SOLUS-D program among older adults as a persistent habit will be conducted.

Interpersonal Level

Behavioral

A 8 weekly, 1hr sessions through telephone or Zoom using the Group 4 Health. Key contents include: understanding the benefits of social connections, exploring self and community, community and action, support and breakthrough, summary and moving forward. Maintenance sessions which focus on continuous practice of support and community will be conducted.

Community Level

Behavioral

A 4 weekly, 2hour in-person sessions through (1) strengthening collective efficacy via neighbor identification with the community. Key contents include: building neighbourhood connections, getting to know each other, health aging, neighbourhood care, vibrant exploration, thriving community, connecting the dots.

Education Control

Other

Monthly monthly messages via text, graphics or voice recordings will be sent over a period of 6 months. Key content includes: healthy diet tips, recognizing warning signs of health, understanding dementia, fall prevention tips, health message, and anti-fraud tips.

Primary outcomes

  1. UCLA Loneliness Scale

    Time frame: Baseline, 2-month, 4-month, 6-month, 12-month, 24-month

    The 20-item UCLA Loneliness Scale is a reliable self-assessment tool designed to evaluate feelings of loneliness. Each item will be rated from 1=Never to 4=Always. Total scores range from 20 to 80.

Secondary outcomes

  1. Pittsburgh Sleep Quality Index

    Time frame: Baseline, 2-month, 4-month, 6-month, 12-month, 24-month

    PSQI evaluates seven components of sleep: sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbance, use of sleep medication, and daytime dysfunction. Each item will be rated from 0=No difficulty to 3=Severe difficulty. Total scores range from 0 to 21,

  2. Satisfaction with Life Scale

    Time frame: Baseline, 2-month, 4-month, 6-month, 12-month, 24-month

    SWLS measures the subjective well-being and life satisfaction. Each item will be rated from 1=Strongly disagree to 7=Strongly agree. Total scores range from 5 to 35.

  3. De Jong Gierveld Loneliness Scale

    Time frame: Baseline, 2-month, 4-month, 6-month, 12-month, 24-month

    The De Jong Gierveld Loneliness Scale is known for assessing loneliness with social and emotional loneliness subscale. 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.

  4. Lawton Instrumental Activities of Daily Living

    Time frame: Baseline, 12-month, 24-month

    IADL is used to measure participant's ability in performing instrumental activities. Each item will be rated 0=dependent to 1=independent. Total scores range from 0 to 8.

  5. Activities of Daily Living

    Time frame: Baseline, 12-month, 24-month

    ADL is used to measure participant's independence in completing activities of daily living. Each item will be rate from 0=dependent to 5/10=independent. Total scores range from 0 to 100.

  6. Physical Symptoms Inventory

    Time frame: Baseline, 2-month, 4-month, 6-month, 12-month, 24-month

    Participants will rate the presence of each physical symptom in the past 30 days from 0=Never to 4=Often. Total scores range from 0 to 72.

  7. Charlson Comorbidity Index

    Time frame: Baseline, 12-month, 24-month

    Participants will rate the presence a list of 16 comorbid condition. Total scores range from 0 to 37.

  8. Perceived Stress Scale

    Time frame: Baseline, 2-month, 4-month, 6-month, 12-month, 24-month

    PSS is use to measure perceived stress levels. Each item will be rated from 0=Never to 4=Very often. Total scores range from 0 to 56.

  9. 6-Minutes Walking Test

    Time frame: Baseline, 12-month, 24-month

    Participants will be asked to walk the furthest distance possible in 6 minutes, rate their level of breathlessness using the Borg scale from 0=No breathlessness to 10=Maximal breathlessness.

  10. Hospital Anxiety and Depression Scale

    Time frame: Baseline, 2-month, 4-month, 6-month, 12-month, 24-month

    HADS measure the severity of anxiety and depression. Each item will be rated from 0=Not at all to 3=Most of the time. Total score range from 0 to 42.

  11. Montreal Cognitive Assessment - Hong Kong

    Time frame: Baseline, 12-month, 24-month

    MoCA-HK is a tool to evaluate cognitive functioning in older adults, which compromises of seven cognitive domains. Total score range from 0 to 30.

Other outcomes

  1. Mindfulness Attention Awareness Scale

    Time frame: Baseline, 2-month, 4-month, 6-month, 12-month, 24-month

    Each item will be rated from 1=Almost always to 6=Almost never. Average score will be calculated.

  2. Self-Compassion Scale

    Time frame: Baseline, 2-month, 4-month, 6-month, 12-month, 24-month

    SCS-SF measures self-compassion and have 6 subscales. Each item will be rated from 1=Almost never to 5=Almost always. Mean score will be calculated for each subscale and overall scale.

  3. Emotion Regulation Questionnaire

    Time frame: Baseline, 2-month, 4-month, 6-month, 12-month, 24-month

    ERQ-CR is used for assessing emotional regulation strategies; cognitive reappraisal (6 items). Each item will be rated from 1=Strongly disagree to 7=Strongly agree. Mean score will be calculated.

  4. Multidimensional Scale of Perceived Social Support

    Time frame: Baseline, 2-month, 4-month, 6-month, 12-month, 24-month

    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.

  5. Lubben Social Network Scale

    Time frame: Baseline, 2-month, 4-month, 6-month, 12-month, 24-month

    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.

  6. Neighbourhood Collective Efficacy Scale

    Time frame: Baseline, 2-month, 4-month, 6-month, 12-month, 24-month

    NEC assesses the neighborhood collective efficacy and identity of the community. Each item will be rated from from 1=Strongly agree to 5=Strongly disagree. Mean score will be calculated.

  7. EuroQol 5-dimension 5-level instrument

    Time frame: Baseline, 2-month, 4-month, 6-month, 12-month, 24-month

    EQ-5D-5L assesses descriptive system and visual analogue scale. Participants will rate their health status from 0=No problem to 5=Unable to perform, and their overall health status on the day of assessment from 0=Worst health to 100=Best health.

  8. Healthcare Service Usage

    Time frame: Baseline, 2-month, 4-month, 6-month, 12-month, 24-month

    Participants will rate their frequency of use of outpatient medical treatment, accident and emergency treatment, and inpatient medical treatment over the past three months at both public and private facilities from 0=None to 3=three times or more.

Sponsors and collaborators

Lead sponsor

Education University of Hong Kong

Other

Collaborators

  • Australian National University
  • Chinese University of Hong Kong
  • Linkoeping University
  • Medical School Berlin
  • The Hong Kong Polytechnic University
  • The University of Hong Kong
  • University College, London
  • University of Bern
  • University of Texas at Austin

Registry information

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Aug 14, 2025
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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