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

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Mental Health Wellness, Psychological Security, Psychological Distress

Intervention / Treatment
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* Behavioral: Ultra Brief Online Mindfulness-based Intervention
* Behavioral: Control


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Ultra Brief Online Mindfulness-based Intervention | Behavioral: Ultra Brief Online Mindfulness-based Intervention<br>* 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.<br>|
| Placebo Comparator: Control<br>This arm requires participants to answer questions about themselves. | Behavioral: Control<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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. | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| Fear of COVID-19 | This is being measured with the Fear of COVID-19 Scale. | It was being measured at 2-week follow up. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mindfulness, Online Intervention, COVID-19, Movement Control Order