Clinical trial NCT06932731: Mind-Body Intervention for Older Adults in Long-term Care
Official title: The Effects of Mind-Body Intervention Versus Befriending Intervention on Loneliness for Older Adults in Long-term Care: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Long Term Care Facility
Keywords: loneliness
mindfulness
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2025-04-17
Enrollment: 120
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: Loneliness is becoming a global health threat particularly in older population due to natural life events such as illness, death of a spouse and a lack of friends In Hong Kong, it has been reported the 58.1% of the older people experienced a high level of loneliness. Loneliness can have a devastating impact on mental and physical health by increasing the risk of dementia, depression, anxiety, stroke, myocardial infarction and poor quality of sleep.The associated mortality rate can be as high as 26% which is comparable to the harm of prime health dangers like alcohol and cigarette. The problem is particularly pressing for the older adults residing in long term care facilities during the COVID-19 pandemic. Outbreaks occurred in more than 90% of long-term care facility in Hong Kong. Resulting in further isolation in their own facilities or community isolation facilities. Preventing institutionalized older adults from being trapped in loneliness is of key importance. A promotion of intervention that is driven by theoretical framework and suitable for long-term care setting is required.

Mind-body practice has been extensively studied in different population such as chronic pain, heart disease, respiratory disease and community dwelling older adults. However, there is little evidence of wellbeing and loneliness reduction in mind-body practice among long term care older adults. This study will adopt befriending intervention as the control group. As befriending intervention is common in Hong Kong by volunteer visiting.

This study describes a randomised controlled trial designed to compare the effectiveness of a nurse-led MBI versus befriending intervention for LTC residents to reduce loneliness and enhance wellbeing.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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).

Primary outcomes:
measure: Loneliness
timeFrame: Baselines , 5 weeks, and 12 weeks after baseline
Secondary outcomes:
measure: Level of mindfulness
timeFrame: Baselines , 5 weeks, and 12 weeks after baseline
measure: Depression
timeFrame: Baseline, 5 weeks, and 12 weeks after baseline
measure: Health-related quality of life
timeFrame: Baseline , 5 weeks, and 12 weeks after baseline
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: School of Nursing, LKS Faculty of Medicine, The University of Hong Kong
Study officials:
affiliation: The University of Hong Kong
name: Jojo Yan Yan Kwok, PhD
role: PRINCIPAL_INVESTIGATOR
References: