Aging WellNCT06204562
Feasibility and Effects of Laughter-imitation Therapy (LIT)
A study testing imitated laughter practice in people with Aging Well, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
Background: The mental wellbeing of the institutional population has to be promoted, particularly after the serious hit by the pandemic. Objectives: 1. To develop a LIT intervention to promote mental wellbeing of institutional older adults 2. To explore the feasibility and acceptability of such intervention; 3. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging Well
- What is being tested?
- imitated laughter practice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteHong Kong
- Study dates
- 6 Sep 2023to 31 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- aged ≥65 years, ii. living in institutions for ≥6 months and will continue to live there for ≥6 months, iii. no communication problems, iv. cognitively capable (screened by 5-min Montreal Cognitive Assessment (MoCA) > age-and-education specific cutoff at 7th-percentile).
Who cannot join
- facial paralysis or paralysed Zygomaticus major muscle or orbicularis oculi muscle, ii. hearing problem that prevent them from following audio recording, iii. undergoing oxygen therapy that may hinder their practice, iv. those with undiagnosed depression but is detected by screening with Geriatric Depression Scale ≥ 8 (they will be referred to professional service).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility and Effects of Laughter-imitation Therapy (LIT) in Promoting Mental Wellbeing Among Institutional Older Adults
Background: The mental wellbeing of the institutional population has to be promoted, particularly after the serious hit by the pandemic.
Objectives:
Read more
- To develop a LIT intervention to promote mental wellbeing of institutional older adults
- To explore the feasibility and acceptability of such intervention;
- To explore the potential effect of the intervention
Design and subject:
A pilot cluster randomized control trial will be conducted. The target population is institutional older adults. About 30 participants will be recruited from 2 nursing homes. The intervention is one-month imitated laughter practice. Each practice session lasts for 3 minutes once a day, giving a total of 21 minutes per week and the waitlist control group will be under usual care for the first 8 weeks. Then, they will start intervention after the 8 week, and receive two additional outcome assessments. A brief one-to-one training will be offered and a trained research assistant (RA1). Further in-person demonstration and return demonstration will be conducted until participant is able to demonstrate the Duchenne smile on their own. RA1 will be on-site for two days in the first week and one day in the second week to support the participants. At the end of the intervention, qualitative feedback will be collected from purposive sample until data saturation.
Instruments: Chinese version including the World Health Organization Five Well-Being Index (WHO-5), 4-item Subjective Happiness Scale (SHS), Geriatric Depression Scale (GDS), Pittsburgh Sleep Quality Index (PSQI), 5-min Montreal Cognitive Assessment, FRAIL scale, Geriatric Adverse Life Events Scale (GALES).
Main outcome measures: Feasibility and acceptability of laughter-imitation therapy (LIT)
Data analysis: Descriptive statistics will be calculated for participants' characteristics, practice frequency, satisfaction, and health outcomes. Linear mixed-effects models will be used to evaluate health outcomes. Content analysis will be conducted for qualitative feedback.
Expected results: The intervention is expected to be feasible and acceptable to institutional older adults as a means for promoting mental wellbeing, and potential beneficial effects will be demonstrated.
- Conditions
- Aging Well
- Being tested
- imitated laughter practice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
imitated laughter practiceBehavioural
To imitate laughter, participants will practice "Duchenne smile", which is reported to associate with positive emotion in people producing it If participants cannot imitate a Duchenne smile, they can hold a chopstick horizontally in their mouth tightly. To help timing the 3-minute and to enhance adherence, an audio recording with joyous music and vocal instruction will be played alongside the practice. Versions with or without laugh voice will be prepared for their preferences. A logbook will be given to each participant to record their practice. To remind participants to practise, a reminder will be made each day through the public announcement system of the respective nursing home, and the audio guide will be played.
| Study group | Role | What they receive |
|---|---|---|
| one-month imitated laughter practice | Experimental | The intervention is one-month imitated laughter practice. Each practice session lasts for 3 minutes once a day, giving a total of 21 minutes per week. A brief one-to-one training will be offered and a trained research assistant (RA1). Further in-person demonstration and return demonstration will be conducted until participant is able to demonstrate the Duchenne smile on their own. RA1 will be on-site for two days in the first week and one day in the second week to support the participants. Receives: Behavioral: imitated laughter practice |
| waitlist control | Experimental | The waitlist control group will be under usual care for the first 8 weeks. Then, they will start intervention after the 8 week, and receive two additional outcome assessments. Receives: Behavioral: imitated laughter practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participation rate of laughter-imitation therapy (LIT)
To reflect feasibility, the participation rate, calculated by dividing the number of participants joining the study by the number of participants invited, will be calculated.
Measured: 16 weeks after baseline
Compliance rate of laughter-imitation therapy (LIT)
To calculate the compliance rate, the number of practiced session divided by the number of scheduled session will be estimated. The participants will use a log book (Appendix V) to record their daily practice of self-induced laughter.
Measured: 16 weeks after baseline
Acceptance of laughter-imitation therapy (LIT)
To measure acceptance, level of satisfaction with the intervention will be collected by a single question with five point likert scale.
Measured: 16 weeks after baseline
Secondary outcomes (20)
Change from baseline mental wellbeing at 4 weeks
Measured by the Chinese version of the World Health Organization Five Well-Being Index (WHO-5). WHO-5 consists of five statements on their mental wellbeing in the past two weeks, using a score from 0 (no time) to 5 (all of the time). The total raw score is multiplied by 4 to give the final score which ranges from 0 to 100, higher score indicates better well-being.
Measured: 4 weeks after baseline
Change from baseline mental wellbeing at 8 weeks
Measured by the Chinese version of the World Health Organization Five Well-Being Index (WHO-5). WHO-5 consists of five statements on their mental wellbeing in the past two weeks, using a score from 0 (no time) to 5 (all of the time). The total raw score is multiplied by 4 to give the final score which ranges from 0 to 100, higher score indicates better well-being.
Measured: 8 weeks after baseline
Change from baseline mental wellbeing at 12 weeks
Measured by the Chinese version of the World Health Organization Five Well-Being Index (WHO-5). WHO-5 consists of five statements on their mental wellbeing in the past two weeks, using a score from 0 (no time) to 5 (all of the time). The total raw score is multiplied by 4 to give the final score which ranges from 0 to 100, higher score indicates better well-being.
Measured: 12 weeks after baseline
Change from baseline mental wellbeing at 16 weeks
Measured by the Chinese version of the World Health Organization Five Well-Being Index (WHO-5). WHO-5 consists of five statements on their mental wellbeing in the past two weeks, using a score from 0 (no time) to 5 (all of the time). The total raw score is multiplied by 4 to give the final score which ranges from 0 to 100, higher score indicates better well-being.
Measured: 16 weeks after baseline
Change from baseline subjective happiness at 4 weeks
Measured by the Chinese version of the 4-item Subjective Happiness Scale (SHS). Participants will respond on a 7-point Likert scale. The score is the average of the four items, and ranges from 1 to 7; a higher score indicates a higher happiness level.
Measured: 4 weeks after baseline
Change from baseline subjective happiness at 8 weeks
Measured by the Chinese version of the 4-item Subjective Happiness Scale (SHS). Participants will respond on a 7-point Likert scale. The score is the average of the four items, and ranges from 1 to 7; a higher score indicates a higher happiness level.
Measured: 8 weeks after baseline
Change from baseline subjective happiness at 12 weeks
Measured by the Chinese version of the 4-item Subjective Happiness Scale (SHS). Participants will respond on a 7-point Likert scale. The score is the average of the four items, and ranges from 1 to 7; a higher score indicates a higher happiness level.
Measured: 12 weeks after baseline
Change from baseline subjective happiness at 16 weeks
Measured by the Chinese version of the 4-item Subjective Happiness Scale (SHS). Participants will respond on a 7-point Likert scale. The score is the average of the four items, and ranges from 1 to 7; a higher score indicates a higher happiness level.
Measured: 16 weeks after baseline
Change from baseline depressive symptoms at 4 weeks
Measured by the Chinese version of the Geriatric Depression Scale (GDS). Chinese version of GDS has been validated as a promising screening instrument for depression in Chinese older adult and comprises 15 questions scored in a dichotomous format. Using a cut-off score of 8 is suggested to be the indicator of being depressed.
Measured: 4 weeks after baseline
Change from baseline depressive symptoms at 8 weeks
Measured by the Chinese version of the Geriatric Depression Scale (GDS). Chinese version of GDS has been validated as a promising screening instrument for depression in Chinese older adult and comprises 15 questions scored in a dichotomous format. Using a cut-off score of 8 is suggested to be the indicator of being depressed.
Measured: 8 weeks after baseline
Change from baseline depressive symptoms at 12 weeks
Measured by the Chinese version of the Geriatric Depression Scale (GDS). Chinese version of GDS has been validated as a promising screening instrument for depression in Chinese older adult and comprises 15 questions scored in a dichotomous format. Using a cut-off score of 8 is suggested to be the indicator of being depressed.
Measured: 12 weeks after baseline
Change from baseline depressive symptoms at 16 weeks
Measured by the Chinese version of the Geriatric Depression Scale (GDS). Chinese version of GDS has been validated as a promising screening instrument for depression in Chinese older adult and comprises 15 questions scored in a dichotomous format. Using a cut-off score of 8 is suggested to be the indicator of being depressed.
Measured: 16 weeks after baseline
Change from baseline sleep quality at 4 weeks
Measured by the Chinese version of the Pittsburgh Sleep Quality Index (PSQI). PSQI has been validated as a reliable tool for older adults in Chinese. The 19-item scale covers 7 components and the global PSQI score ranges from 0 to 21 with higher score indicating poorer quality.
Measured: 4 weeks after baseline
Change from baseline sleep quality at 8 weeks
Measured by the Chinese version of the Pittsburgh Sleep Quality Index (PSQI). PSQI has been validated as a reliable tool for older adults in Chinese. The 19-item scale covers 7 components and the global PSQI score ranges from 0 to 21 with higher score indicating poorer quality.
Measured: 8 weeks after baseline
Change from baseline sleep quality at 12 weeks
Measured by the Chinese version of the Pittsburgh Sleep Quality Index (PSQI). PSQI has been validated as a reliable tool for older adults in Chinese. The 19-item scale covers 7 components and the global PSQI score ranges from 0 to 21 with higher score indicating poorer quality.
Measured: 12 weeks after baseline
Change from baseline sleep quality at 16 weeks
Measured by the Chinese version of the Pittsburgh Sleep Quality Index (PSQI). PSQI has been validated as a reliable tool for older adults in Chinese. The 19-item scale covers 7 components and the global PSQI score ranges from 0 to 21 with higher score indicating poorer quality.
Measured: 16 weeks after baseline
Change from baseline pain experience at 4 weeks
Measured by the recall period of one week for pain severity ratings from 0 to 10 with higher score indicating greater severity and methods of pain relief will be evaluated.
Measured: 4 weeks after baseline
Change from baseline pain experience at 8 weeks
Measured by the recall period of one week for pain severity ratings from 0 to 10 with higher score indicating greater severity and methods of pain relief will be evaluated.
Measured: 8 weeks after baseline
Change from baseline pain experience at 12 weeks
Measured by the recall period of one week for pain severity ratings from 0 to 10 with higher score indicating greater severity and methods of pain relief will be evaluated.
Measured: 12 weeks after baseline
Change from baseline pain experience at 16 weeks
Measured by the recall period of one week for pain severity ratings from 0 to 10 with higher score indicating greater severity and methods of pain relief will be evaluated.
Measured: 16 weeks after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study start6 Sep 2023
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aging WellStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Pui-Hing Chau, The University of Hong Kong
- Investigators
- Pui Hing Chau, PhD, Principal investigator, School of Nursing, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06204562
- Sponsor's protocol ID
- UW 23-424
- Status last verified
- Mar 2025
- First submitted
- 2 Jan 2024
- Last updated
- 28 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Effects of Laughter-imitation Therapy (LIT) in Promoting Mental Wellbeing Among Institutional Older Adults
- ClinicalTrials.gov ID
- NCT06204562
- Acronym / sponsor ID
- UW 23-424
- Conditions
- Aging Well
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 6 Sep 2023 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 12 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: The mental wellbeing of the institutional population has to be promoted, particularly after the serious hit by the pandemic.
Objectives:
- To develop a LIT intervention to promote mental wellbeing of institutional older adults
- To explore the feasibility and acceptability of such intervention;
- To explore the potential effect of the intervention
Design and subject:
A pilot cluster randomized control trial will be conducted. The target population is institutional older adults. About 30 participants will be recruited from 2 nursing homes. The intervention is one-month imitated laughter practice. Each practice session lasts for 3 minutes once a day, giving a total of 21 minutes per week and the waitlist control group will be under usual care for the first 8 weeks. Then, they will start intervention after the 8 week, and receive two additional outcome assessments. A brief one-to-one training will be offered and a trained research assistant (RA1). Further in-person demonstration and return demonstration will be conducted until participant is able to demonstrate the Duchenne smile on their own. RA1 will be on-site for two days in the first week and one day in the second week to support the participants. At the end of the intervention, qualitative feedback will be collected from purposive sample until data saturation.
Instruments: Chinese version including the World Health Organization Five Well-Being Index (WHO-5), 4-item Subjective Happiness Scale (SHS), Geriatric Depression Scale (GDS), Pittsburgh Sleep Quality Index (PSQI), 5-min Montreal Cognitive Assessment, FRAIL scale, Geriatric Adverse Life Events Scale (GALES).
Main outcome measures: Feasibility and acceptability of laughter-imitation therapy (LIT)
Data analysis: Descriptive statistics will be calculated for participants' characteristics, practice frequency, satisfaction, and health outcomes. Linear mixed-effects models will be used to evaluate health outcomes. Content analysis will be conducted for qualitative feedback.
Expected results: The intervention is expected to be feasible and acceptable to institutional older adults as a means for promoting mental wellbeing, and potential beneficial effects will be demonstrated.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| one-month imitated laughter practice | Experimental | Behavioral: imitated laughter practiceThe intervention is one-month imitated laughter practice. Each practice session lasts for 3 minutes once a day, giving a total of 21 minutes per week. A brief one-to-one training will be offered and a trained research assistant (RA1). Further in-person demonstration and return demonstration will be conducted until participant is able to demonstrate the Duchenne smile on their own. RA1 will be on-site for two days in the first week and one day in the second week to support the participants. |
| waitlist control | Experimental | Behavioral: imitated laughter practiceThe waitlist control group will be under usual care for the first 8 weeks. Then, they will start intervention after the 8 week, and receive two additional outcome assessments. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- aged ≥65 years, ii. living in institutions for ≥6 months and will continue to live there for ≥6 months, iii. no communication problems, iv. cognitively capable (screened by 5-min Montreal Cognitive Assessment (MoCA) > age-and-education specific cutoff at 7th-percentile).
Key exclusion criteria (1 listed)
- facial paralysis or paralysed Zygomaticus major muscle or orbicularis oculi muscle, ii. hearing problem that prevent them from following audio recording, iii. undergoing oxygen therapy that may hinder their practice, iv. those with undiagnosed depression but is detected by screening with Geriatric Depression Scale ≥ 8 (they will be referred to professional service).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| imitated laughter practiceTo imitate laughter, participants will practice "Duchenne smile", which is reported to associate with positive emotion in people producing it If participants cannot imitate a Duchenne smile, they can hold a chopstick horizontally in their mouth tightly. To help timing the 3-minute and to enhance adherence, an audio recording with joyous music and vocal instruction will be played alongside the practice. Versions with or without laugh voice will be prepared for their preferences. A logbook will be given to each participant to record their practice. To remind participants to practise, a reminder will be made each day through the public announcement system of the respective nursing home, and the audio guide will be played. | Behavioural | one-month imitated laughter practice, waitlist control |
Primary outcome
Participation rate of laughter-imitation therapy (LIT)
Time frame: 16 weeks after baseline
To reflect feasibility, the participation rate, calculated by dividing the number of participants joining the study by the number of participants invited, will be calculated.
Compliance rate of laughter-imitation therapy (LIT)
Time frame: 16 weeks after baseline
To calculate the compliance rate, the number of practiced session divided by the number of scheduled session will be estimated. The participants will use a log book (Appendix V) to record their daily practice of self-induced laughter.
Acceptance of laughter-imitation therapy (LIT)
Time frame: 16 weeks after baseline
To measure acceptance, level of satisfaction with the intervention will be collected by a single question with five point likert scale.
20 secondary outcomes
Change from baseline mental wellbeing at 4 weeks
Time frame: 4 weeks after baseline
Change from baseline mental wellbeing at 8 weeks
Time frame: 8 weeks after baseline
Change from baseline mental wellbeing at 12 weeks
Time frame: 12 weeks after baseline
Change from baseline mental wellbeing at 16 weeks
Time frame: 16 weeks after baseline
Change from baseline subjective happiness at 4 weeks
Time frame: 4 weeks after baseline
Change from baseline subjective happiness at 8 weeks
Time frame: 8 weeks after baseline
Change from baseline subjective happiness at 12 weeks
Time frame: 12 weeks after baseline
Change from baseline subjective happiness at 16 weeks
Time frame: 16 weeks after baseline
Change from baseline depressive symptoms at 4 weeks
Time frame: 4 weeks after baseline
Change from baseline depressive symptoms at 8 weeks
Time frame: 8 weeks after baseline
Change from baseline depressive symptoms at 12 weeks
Time frame: 12 weeks after baseline
Change from baseline depressive symptoms at 16 weeks
Time frame: 16 weeks after baseline
Change from baseline sleep quality at 4 weeks
Time frame: 4 weeks after baseline
Change from baseline sleep quality at 8 weeks
Time frame: 8 weeks after baseline
Change from baseline sleep quality at 12 weeks
Time frame: 12 weeks after baseline
Change from baseline sleep quality at 16 weeks
Time frame: 16 weeks after baseline
Change from baseline pain experience at 4 weeks
Time frame: 4 weeks after baseline
Change from baseline pain experience at 8 weeks
Time frame: 8 weeks after baseline
Change from baseline pain experience at 12 weeks
Time frame: 12 weeks after baseline
Change from baseline pain experience at 16 weeks
Time frame: 16 weeks after baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pui Hing Chau, PhD principal investigator
School of Nursing, The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing imitated laughter practice in people with Aging Well, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participation rate of laughter-imitation therapy (LIT) (time frame: 16 weeks after baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2025.