A Web-Based Gentle Body Stretching to Alleviate Loneliness and Improve Mental Fitness During COVID-19 Isolation Period

Mental Health Issue Clinical Trial

Official title:

A Web-Based Gentle Body Stretching to Alleviate Loneliness and Improve Mental Fitness During COVID-19 Isolation Period

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04394013
• Other study ID #: 180320201
• Status: Completed
• Phase: N/A
• Start date: August 26, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: February 2021
• Source: Monash University Malaysia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult participants

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Mental Health Issue

Intervention

Behavioral:
• Mindfulness intervention
Gentle body stretching with the incorporation of breathing technique
• Non-Mindfulness intervention
Gentle body stretching without the incorporation of breathing technique

Locations

Country	Name	City	State
Malaysia	Monash University Malaysia	Subang Jaya	Selangor

Sponsors (1)

Lead Sponsor	Collaborator
Monash University Malaysia

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Loneliness (UCLA-8 Loneliness Scale)	Measured using University of California, Los Angeles (UCLA)-8 Loneliness Scale; Higher score indicates higher loneliness level	2-4weeks
Primary	Mindfulness (FFMQ)	Five-Facet Mindfulness Questionnaire (FFMQ); Higher score indicates higher mindfulness level	2-4weeks
Primary	Quality of life (EQ-5D-5L Questionnaire)	EQ-5D-5L Questionnaire; Higher score indicates higher quality of life	2-4weeks