- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06932731
Mind-Body Intervention for Older Adults in Long-term Care
The Effects of Mind-Body Intervention Versus Befriending Intervention on Loneliness for Older Adults in Long-term Care: A Randomised Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Cheuk Yan Szeto, MScN
- Phone Number: +85236536780
- Email: jodies@connect.hku.hk
Study Locations
-
-
-
Hong Kong, Hong Kong
- Not yet recruiting
- School of Nursing, LKS Faculty of Medicine, The University of Hong Kong
-
Contact:
- Cheuk Yan Szeto, MScN
- Phone Number: +85236536780
- Email: jodies@connect.hku.hk
-
Principal Investigator:
- Cheuk Yan Szeto, MSc
-
Hong Kong, Hong Kong
- Recruiting
- School of Nursing, LKS Faculty of Medicine, The University of Hong Kong
-
Contact:
- Cheuk Yan Szeto, MScN
- Phone Number: +85236536780
- Email: jodies@connect.hku.hk
-
Principal Investigator:
- Cheuk Yan Szeto, MScN
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Mind-Body Intervention Group
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.
|
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.
|
|
Active Comparator: Befriending Intervention Group
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.
|
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).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Loneliness
Time Frame: Baselines , 5 weeks, and 12 weeks after baseline
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Level of mindfulness
Time Frame: Baselines , 5 weeks, and 12 weeks after baseline
|
For Mind-Body Intervention group and Befriending Intervention group, measured by Multidimentional Assessment of Interoceptive Awareness (MAIA).
It is a 32 items state-trait self reported questionnaires and is categorized into eight scales in 6 point Likert scale from 0 (never ) to 5 (always).
A higher score indicates a more appraised interoceptive awareness and higher level of mindfulness.
|
Baselines , 5 weeks, and 12 weeks after baseline
|
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Depression
Time Frame: Baseline, 5 weeks, and 12 weeks after baseline
|
For Mind-Body Intervention group and Befriending Intervention group, measured by Geriatric Depression Scale 4 items (GDS-4) is a brief version of Geriatric Depression Scale 30 items (GDS-30).
GDS-4 consists of 4 items from the original items of GDS-30.
Total scores more than 2 is considered at risk of depression.
|
Baseline, 5 weeks, and 12 weeks after baseline
|
|
Health-related quality of life
Time Frame: Baseline , 5 weeks, and 12 weeks after baseline
|
For Mind-Body Intervention group and Befriending Intervention group, measured by World Health Organization Well-Being Index (WHO-5 scale).
It is a five items 6-point Likert-type scale from 0 (at no time) to 5 (all of the time).
It focuses on positive emotions that included 5 items: "I have felt cheerful and in good spirits", "I have felt calm and relaxed", "I have felt cheerful and in good spirits", "I woke up feeling fresh and rested" and "I have felt active and vigorous".
The participants are asked how well each of the items applied to them in the past two weeks.
The higher the score, the better the mental wellbeing.
|
Baseline , 5 weeks, and 12 weeks after baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jojo Yan Yan Kwok, PhD, The University of Hong Kong
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- UW 25-016
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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