Mental Health IssueNCT04394013
A Web-Based Gentle Body Stretching to Alleviate Loneliness and Improve Mental Fitness During COVID-19 Isolation Period
A study testing Mindfulness intervention and Non-Mindfulness intervention in people with Mental Health Issue, run by Monash University Malaysia at 1 site in Malaysia.
Trial summary
During the COVID-19 pandemic, individuals are having to stay at home in quarantine to reduce the risk of transmission of the virus. Depending on the number of occupants and the dwelling space available, this can lead to household crowding, which can have an effect on mental health. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Health Issue
- What is being tested?
- Mindfulness intervention and Non-Mindfulness intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteMalaysia
- Study dates
- 26 Aug 2020to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult participants
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
During the COVID-19 pandemic, individuals are having to stay at home in quarantine to reduce the risk of transmission of the virus. Depending on the number of occupants and the dwelling space available, this can lead to household crowding, which can have an effect on mental health. In addition, the closing of leisure facilities, including restaurants, cafes and, with the need to self-isolate and socially distance, has led to loneliness. The focus on "loneliness" has recently been on a rise, and being described as an epidemic, especially when it has been shown to be associated with various diseases as well as increased risk of mortality. Studies conducted on participants in isolation has shown increased mental health issues including anxiety, stress and depression.
Mindfulness intervention has been shown to alleviate mental health issues including loneliness. However, to date, there is limited studies examining the effectiveness of a remote mindfulness intervention. This proposal aims to deliver a remote mindfulness program that can be accessible by participants easily and even during the isolation period. This intervention will investigate the effectiveness and safety in elevating mental health issues faced by the general population.
Read the detailed description
Loneliness, mindfulness and quality of life will be assessed as the primary outcome of the study. A mindfulness video will be used as the intervention for participants, and is compared with a group with similar video content without mindfulness component. The effect of changes in primary outcome will be assessed between groups after 2-4weeks.
- Conditions
- Mental Health Issue
- Being tested
- Mindfulness intervention, Non-Mindfulness intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness interventionBehavioural
Gentle body stretching with the incorporation of breathing technique
Non-Mindfulness interventionBehavioural
Gentle body stretching without the incorporation of breathing technique
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Arm | Experimental | The content of the approximately 20 minutes video is recorded in advance of the intervention by a certified teacher with teaching experience. The 20 minutes session consists of a series of body stretching exercises (around 17 different gentle and simple stretches from head to toe) with the incorporation of breathing technique (i.e. when to breathe in and breathe out). The whole body stretching exercise is performed with a sitting position, ideally on an exercise mat. As mentioned above, the participants are required to conduct the stretching exercise by following the guidance video for at least 5 days weekly for at least 2 weeks duration. The video will be uploaded onto a webpage which requires participants to log in and view the video. The webpage and video will be accessible through computers and mobile phones. Receives: Behavioral: Mindfulness intervention |
| Non-mindfulness Arm | Active comparator | In this study, for control group, the participants are instructed with a similar video content as the intervention group, minus the incorporation of breathing technique, as breathing technique is hypothesised to be a key component of mindfulness. Receives: Behavioral: Non-Mindfulness intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Loneliness (UCLA-8 Loneliness Scale)
Measured using University of California, Los Angeles (UCLA)-8 Loneliness Scale; Higher score indicates higher loneliness level
Measured: 2-4weeks
Mindfulness (FFMQ)
Five-Facet Mindfulness Questionnaire (FFMQ); Higher score indicates higher mindfulness level
Measured: 2-4weeks
Quality of life (EQ-5D-5L Questionnaire)
EQ-5D-5L Questionnaire; Higher score indicates higher quality of life
Measured: 2-4weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2020
- Study start26 Aug 2020
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental Health IssueStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Monash University Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Teoh Siew Li, Monash University Malaysia
- Investigators
- Siew Li Teoh, PhD, Principal investigator, Monash University Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04394013
- Sponsor's protocol ID
- 180320201
- Status last verified
- Feb 2021
- First submitted
- 18 May 2020
- Last updated
- 24 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Upon request via direct contact to researcher
Publications
Jong FJX, Lee CCW, Ting RS, Lin MH, Ong LK, Quek XF, Lee SWH, Ng ALO, Teoh SL. Effects of online mindful stretching exercises for loneliness, mindfulness, and hair cortisol: A mixed method study. Explore (NY). 2025 Jul-Aug;21(4):103204. doi: 10.1016/j.explore.2025.103204. Epub 2025 Jun 26.
PubMed 40614537
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Web-Based Gentle Body Stretching to Alleviate Loneliness and Improve Mental Fitness During COVID-19 Isolation Period
- ClinicalTrials.gov ID
- NCT04394013
- Acronym / sponsor ID
- 180320201
- Conditions
- Mental Health Issue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Monash University MalaysiaUniversity, hospital or other
- Study start
- 26 Aug 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 19 May 2020 (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.
During the COVID-19 pandemic, individuals are having to stay at home in quarantine to reduce the risk of transmission of the virus. Depending on the number of occupants and the dwelling space available, this can lead to household crowding, which can have an effect on mental health. In addition, the closing of leisure facilities, including restaurants, cafes and, with the need to self-isolate and socially distance, has led to loneliness. The focus on "loneliness" has recently been on a rise, and being described as an epidemic, especially when it has been shown to be associated with various diseases as well as increased risk of mortality. Studies conducted on participants in isolation has shown increased mental health issues including anxiety, stress and depression.
Mindfulness intervention has been shown to alleviate mental health issues including loneliness. However, to date, there is limited studies examining the effectiveness of a remote mindfulness intervention. This proposal aims to deliver a remote mindfulness program that can be accessible by participants easily and even during the isolation period. This intervention will investigate the effectiveness and safety in elevating mental health issues faced by the general population.
Detailed description
Loneliness, mindfulness and quality of life will be assessed as the primary outcome of the study. A mindfulness video will be used as the intervention for participants, and is compared with a group with similar video content without mindfulness component. The effect of changes in primary outcome will be assessed between groups after 2-4weeks.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Arm | Experimental | Behavioral: Mindfulness interventionThe content of the approximately 20 minutes video is recorded in advance of the intervention by a certified teacher with teaching experience. The 20 minutes session consists of a series of body stretching exercises (around 17 different gentle and simple stretches from head to toe) with the incorporation of breathing technique (i.e. when to breathe in and breathe out). The whole body stretching exercise is performed with a sitting position, ideally on an exercise mat. As mentioned above, the participants are required to conduct the stretching exercise by following the guidance video for at least 5 days weekly for at least 2 weeks duration. The video will be uploaded onto a webpage which requires participants to log in and view the video. The webpage and video will be accessible through computers and mobile phones. |
| Non-mindfulness Arm | Active comparator | Behavioral: Non-Mindfulness interventionIn this study, for control group, the participants are instructed with a similar video content as the intervention group, minus the incorporation of breathing technique, as breathing technique is hypothesised to be a key component of mindfulness. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult participants
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Mindfulness interventionGentle body stretching with the incorporation of breathing technique | Behavioural | Mindfulness Arm |
| Non-Mindfulness interventionGentle body stretching without the incorporation of breathing technique | Behavioural | Non-mindfulness Arm |
Primary outcome
Loneliness (UCLA-8 Loneliness Scale)
Time frame: 2-4weeks
Measured using University of California, Los Angeles (UCLA)-8 Loneliness Scale; Higher score indicates higher loneliness level
Mindfulness (FFMQ)
Time frame: 2-4weeks
Five-Facet Mindfulness Questionnaire (FFMQ); Higher score indicates higher mindfulness level
Quality of life (EQ-5D-5L Questionnaire)
Time frame: 2-4weeks
EQ-5D-5L Questionnaire; Higher score indicates higher quality of life
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2021.
- Derived from this study: PubMed 40614537Jong FJX, Lee CCW, Ting RS, Lin MH, Ong LK, Quek XF, Lee SWH, Ng ALO, Teoh SL. Effects of online mindful stretching exercises for loneliness, mindfulness, and hair cortisol: A mixed method study. Explore (NY). 2025 Jul-Aug;21(4):103204. doi: 10.1016/j.explore.2025.103204. Epub 2025 Jun 26.
- Individual participant dataSharing planned: No. Upon request via direct contact to researcher
Related trials for Mental Health Issue
Active, not recruiting
Improving Maternal Mental Health & SUD Screening and Treatment
Mental Health Issue, Substance Use Disorders
Recruiting
Family Spirit Strengths
Depressive Symptoms, Anxiety Disorders and Symptoms
RecruitingObservational study
Proximal Risk for Suicide in Adolescents
Suicide, Mental Health Issue
Recruiting
Striving Towards EmPowerment and Medication Adherence R01
Hiv, Mental Health Issue
Active, not recruiting
Determining the Effectiveness of Working Out Dads to Reduce Mental Health Difficulties in Fathers of Young Children
Mental Health Issue
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.
Siew Li Teoh, PhD principal investigator
Monash University Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness intervention and Non-Mindfulness intervention in people with Mental Health Issue, run by Monash University Malaysia at 1 site in Malaysia.
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: finished, as of the sponsor's last update on 24 Feb 2021. 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 Malaysia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Loneliness (UCLA-8 Loneliness Scale) (time frame: 2-4weeks). 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?
On the ClinicalTrials.gov record for NCT04394013, which also lists 1 linked publication.
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 24 Feb 2021; AzTrials last refreshed its copy on 6 Nov 2026.