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Clinical Trials/NCT04536441
NCT04536441CompletedNot Applicable

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

Universiti Tunku Abdul Rahman2 sites in 1 country161 target enrollmentStarted: April 1, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
161
Locations
2
Primary Endpoint
Changes of Subjective Unit of Distress

Study Overview

Brief 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).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to 99 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Outcomes

Primary Outcomes

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.

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.

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

  • Changes of General Well-being(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(It was being measured at 2-week follow up.)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Pheh Kai Shuen

Lecturer

Universiti Tunku Abdul Rahman

Study Sites (2)

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