Ultra-brief Online Mindfulness-based Intervention During COVID-19 Movement Control Order

Psychological Distress Clinical Trial

Official title:

Effects of an Ultra-brief Online Mindfulness-based Intervention on Mental Health During the Coronavirus Disease (COVID-19) Outbreak in Malaysia: A Randomised Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04536441
• Other study ID #: U/SERC/62/2020
• Status: Completed
• Phase: N/A
• Start date: April 1, 2020
• Est. completion date: June 30, 2020

Study information

• Verified date: September 2020
• Source: Universiti Tunku Abdul Rahman
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The federal government of Malaysia implemented a nationwide Movement Control Order (MCO) to control the COVID-19 outbreak. The MCO, however, has been found to have a negative impact on people's mental wellbeing. Interventions that can improve mental health under restricted movement condition is urgently. The present study investigated the impact of a brief, online mindfulness-based intervention on mental health using two-arm randomized controlled trial design. A total of 161 participants self-reported their feeling, anxiety, psychological insecurity, and well-being at baseline (T1) and post-test (T2), while 61 of them answered the same set of measures and the fear of COVID-19 scale in a follow-up study two weeks later (T3).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 161
• Est. completion date: June 30, 2020
• Est. primary completion date: May 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• People residing in Malaysia during the Movement Control Order.

Exclusion Criteria:

• People who are unable to read or write in either Malay, English or Mandarin languages.

Related Conditions & MeSH terms

• Mental Health Wellness
• Psychological Distress
• Psychological Security

Intervention

Behavioral:
• Ultra Brief Online Mindfulness-based Intervention
We adapted and contextualized the original RAIN protocol to local pandemic-induced lockdown situation, with short journaling prompts that engage participants in self-reflection. Journaling is known to be a creative way to engage people in a therapeutic activity which promotes self-awareness (Utley & Garza, 2011). Creating a visual narration of thoughts, feelings and experiences help individuals make internal experiences more tangible and manageable, especially during these uncertain times.
• Control
The control group participants were asked to report preventive measures that they have taken to prevent COVID-19, ways that they obtained Movement Control Order news, and things that they wished to do once the Movement Control Order is lifted.

Locations

Country	Name	City	State
Malaysia	Universiti Tunku Abdul Rahman	Kampar	Perak

Sponsors (2)

Lead Sponsor	Collaborator
Universiti Tunku Abdul Rahman	Sunway University

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of Subjective Unit of Distress	This is being measured with the Subject Unit of Distress Scale.	It was measured at pre-intervention, post-intervention (through intervention completion, on average 10 minutes), and 2-week follow up.
Primary	Changes of Anxiety Scores	This is being measured with the GAD-7 questionnaire.	It was being It was measured at pre-intervention, post-intervention (through intervention completion, on average 10 minutes), and 2-week follow up.
Primary	Changes of Psychological Insecurity	This is being measured with the Psychological Insecurity Scale.	It was being It was measured at pre-intervention, post-intervention (through intervention completion, on average 10 minutes), and 2-week follow up.
Secondary	Changes of General Well-being	This is being measured with the WHO-5 Well-being Index questionnaire.	It was being It was measured at pre-intervention, post-intervention (through intervention completion, on average 10 minutes), and 2-week follow up.
Secondary	Fear of COVID-19	This is being measured with the Fear of COVID-19 Scale.	It was being measured at 2-week follow up.