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

September 1, 2020 updated by: Pheh Kai Shuen, Universiti Tunku Abdul Rahman

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

161

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malaysia
    • Perak
      • Kampar, Perak, Malaysia, 31900
        • Universiti Tunku Abdul Rahman

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Treatment
Ultra Brief Online Mindfulness-based 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.
PLACEBO_COMPARATOR: Control
This arm requires participants to answer questions about themselves.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
It was measured at pre-intervention, post-intervention (through intervention completion, on average 10 minutes), and 2-week follow up.
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.
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
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.
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
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.
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
Time Frame: It was being measured at 2-week follow up.
This is being measured with the Fear of COVID-19 Scale.
It was being measured at 2-week follow up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universiti Tunku Abdul Rahman

Collaborators

Sunway University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 1, 2020

Primary Completion (ACTUAL)

May 30, 2020

Study Completion (ACTUAL)

June 30, 2020

Study Registration Dates

First Submitted

August 26, 2020

First Submitted That Met QC Criteria

September 1, 2020

First Posted (ACTUAL)

September 2, 2020

Study Record Updates

Last Update Posted (ACTUAL)

September 2, 2020

Last Update Submitted That Met QC Criteria

September 1, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U/SERC/62/2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

The data will be become available once the study is being published, for 5 years.

IPD Sharing Access Criteria

The data will be made available upon request to the corresponding author.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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