Skip to main content
OpenTrials
Completed

NCT Number: NCT04536441

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Mental Health Wellness COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral Psychological Distress Psychological Security RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universiti Tunku Abdul Rahman

Kampar, Perak, 31900, Malaysia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ultra Brief Online Mindfulness-based Intervention

Behavioral

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

Behavioral

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.

Primary outcomes

  1. Changes of Subjective Unit of Distress

    Time frame: It was measured at pre-intervention, post-intervention (through intervention completion, on average 10 minutes), and 2-week follow up.

    This is being measured with the Subject Unit of Distress Scale.

  2. Changes of Anxiety Scores

    Time frame: It was being It was measured at pre-intervention, post-intervention (through intervention completion, on average 10 minutes), and 2-week follow up.

    This is being measured with the GAD-7 questionnaire.

  3. Changes of Psychological Insecurity

    Time frame: It was being It was measured at pre-intervention, post-intervention (through intervention completion, on average 10 minutes), and 2-week follow up.

    This is being measured with the Psychological Insecurity Scale.

Secondary outcomes

  1. Changes of General Well-being

    Time frame: It was being It was measured at pre-intervention, post-intervention (through intervention completion, on average 10 minutes), and 2-week follow up.

    This is being measured with the WHO-5 Well-being Index questionnaire.

  2. Fear of COVID-19

    Time frame: It was being measured at 2-week follow up.

    This is being measured with the Fear of COVID-19 Scale.

Sponsors and collaborators

Lead sponsor

Universiti Tunku Abdul Rahman

Other

Collaborators

  • Sunway University

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Sep 2, 2020
Registry last updated
Sep 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.