NCT06932731

Brief Summary

Loneliness is a global health issue, particularly affecting the physical and mental health of older adults residing in long term care. The COVID-19 pandemic has further exacerbated isolation in these settings, calling for an urgent attention for finding an effective intervention to alleviate loneliness among long term care residents. Mind-body interventions (MBIs) present as a potentially promising approach aimed at reducing loneliness and mental wellbeing. This study aims to examine the effect of a nurse-led MBI compared to a befriending intervention on loneliness, quality of life, depression and level of mindfulness among older adults in long term care. The primary outcome is loneliness while secondary outcome is quality of life, depression and level of mindfulness.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
13mo left

Started Apr 2025

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress50%
Apr 2025Jun 2027

First Submitted

Initial submission to the registry

April 10, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 17, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

April 17, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

April 14, 2026

Status Verified

August 1, 2025

Enrollment Period

2 years

First QC Date

April 10, 2025

Last Update Submit

April 12, 2026

Conditions

Keywords

lonelinessmindfulness

Outcome Measures

Primary Outcomes (1)

  • Loneliness

    For Mind-Body Intervention group and Befriending Intervention group, measured by UCLA 8-item Loneliness Scale is the shortened version of UCLA Loneliness Scale. The shortened scale consists of 8 questions with 4-point Likert scale ranged from 'never' to 'often'. The higher the score, the higher the level of perceived loneliness. Item 3 and Item 5 are reversely scored. Higher the score, the higher loneliness level.

    Baselines , 5 weeks, and 12 weeks after baseline

Secondary Outcomes (3)

  • Level of mindfulness

    Baselines , 5 weeks, and 12 weeks after baseline

  • Depression

    Baseline, 5 weeks, and 12 weeks after baseline

  • Health-related quality of life

    Baseline , 5 weeks, and 12 weeks after baseline

Study Arms (2)

Mind-Body Intervention Group

EXPERIMENTAL

The entire intervention will be conducted in a group setting for 5 sessions. Each session 45 to 60 minutes weekly. Intervention is led by a registered nurse. Participants will be instructed to perform mind-body intervention during session and encouraged to have home practice between the next session.

Behavioral: Mind-body Intervention

Befriending Intervention Group

ACTIVE COMPARATOR

This group will receive befriending intervention provided by volunteers with health care background. Volunteers are either studying or graduated from a health science related programme. Participants will meet volunteers each week in a group setting for 5 sessions. Each session 45 to 60 minutes.

Behavioral: Befriending Intervention

Interventions

The Mind-Body Intervention group designed to included several elements with mind and body involvement such as mindful breathing, body scan, stretching, mindful movement as well as adapting mindful practice in their routine. Mind-Body Intervention group will join the activities in a group setting for 5 sessions. Each session 45 to 60 minutes. Intervention is led by a registered nurse. Each session (except for the first session) will start by sharing of practice from the past week. Followed by mind-body practices. Before the end of session, a group discussion on the practice of that day and reflection will be done.

Mind-Body Intervention Group

In this group, volunteer will spend time with the participants, engaging in conversation and join their routine activities by the time of visit or other scheduled activities in the institution (such as arts and crafts, playing board games or reminiscing activities).

Befriending Intervention Group

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Long-term care residents aged 60 or above
  • Communicable in Cantonese/Chinese
  • Mentally competent (Abbreviated Mental Test score \>6)
  • Could read, write and understand Chinese language
  • Able to provide written consent

You may not qualify if:

  • Have regular practice of mindfulness once a week or more during the past 6 months
  • Have any other contraindication or severe comorbidity that may limit their full participation (e.g. acute psychiatric conditions, severe hearing, vision impairment, or severe medical condition etc).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

School of Nursing, LKS Faculty of Medicine, The University of Hong Kong

Hong Kong, Hong Kong

NOT YET RECRUITING

School of Nursing, LKS Faculty of Medicine, The University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

Study Officials

  • Jojo Yan Yan Kwok, PhD

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Cheuk Yan Szeto, MScN

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 10, 2025

First Posted

April 17, 2025

Study Start

April 17, 2025

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

April 14, 2026

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

The data supporting the findings of this study are available upon request from the principal investigator, Ms Szeto. These data are not publicly available, as they contain information that could compromise the privacy of research participants.

Locations