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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
161

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universiti Tunku Abdul Rahman

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2020

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 30, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 26, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 1, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 2, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 2, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 1, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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