NCT04394013

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

May 18, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 19, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

August 26, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

February 24, 2021

Status Verified

February 1, 2021

Enrollment Period

4 months

First QC Date

May 18, 2020

Last Update Submit

February 22, 2021

Conditions

Outcome Measures

Primary Outcomes (3)

  • Loneliness (UCLA-8 Loneliness Scale)

    Measured using University of California, Los Angeles (UCLA)-8 Loneliness Scale; Higher score indicates higher loneliness level

    2-4weeks

  • Mindfulness (FFMQ)

    Five-Facet Mindfulness Questionnaire (FFMQ); Higher score indicates higher mindfulness level

    2-4weeks

  • Quality of life (EQ-5D-5L Questionnaire)

    EQ-5D-5L Questionnaire; Higher score indicates higher quality of life

    2-4weeks

Study Arms (2)

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.

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.

Behavioral: Non-Mindfulness intervention

Interventions

Gentle body stretching with the incorporation of breathing technique

Mindfulness Arm

Gentle body stretching without the incorporation of breathing technique

Non-mindfulness Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult participants

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Monash University Malaysia

Subang Jaya, Selangor, 47500, Malaysia

Location

Related Publications (1)

  • 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.

Study Officials

  • Siew Li Teoh, PhD

    Monash University Malaysia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

May 18, 2020

First Posted

May 19, 2020

Study Start

August 26, 2020

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

February 24, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Upon request via direct contact to researcher

Locations