Ultra-brief Online Mindfulness-based Intervention During COVID-19 Movement Control Order
Primary Purpose
Mental Health Wellness, Psychological Security, Psychological Distress
Status
Completed
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Ultra Brief Online Mindfulness-based Intervention
Control
Sponsored by
About this trial
This is an interventional prevention trial for Mental Health Wellness focused on measuring Mindfulness, Online Intervention, COVID-19, Movement Control Order
Eligibility Criteria
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.
Sites / Locations
- Universiti Tunku Abdul Rahman
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Treatment
Control
Arm Description
Ultra Brief Online Mindfulness-based Intervention
This arm requires participants to answer questions about themselves.
Outcomes
Primary Outcome Measures
Changes of Subjective Unit of Distress
This is being measured with the Subject Unit of Distress Scale.
Changes of Anxiety Scores
This is being measured with the GAD-7 questionnaire.
Changes of Psychological Insecurity
This is being measured with the Psychological Insecurity Scale.
Secondary Outcome Measures
Changes of General Well-being
This is being measured with the WHO-5 Well-being Index questionnaire.
Fear of COVID-19
This is being measured with the Fear of COVID-19 Scale.
Full Information
NCT ID
NCT04536441
First Posted
August 26, 2020
Last Updated
September 1, 2020
Sponsor
Universiti Tunku Abdul Rahman
Collaborators
Sunway University
1. Study Identification
Unique Protocol Identification Number
NCT04536441
Brief Title
Ultra-brief Online Mindfulness-based Intervention During COVID-19 Movement Control Order
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
April 1, 2020 (Actual)
Primary Completion Date
May 30, 2020 (Actual)
Study Completion Date
June 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universiti Tunku Abdul Rahman
Collaborators
Sunway University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Health Wellness, Psychological Security, Psychological Distress
Keywords
Mindfulness, Online Intervention, COVID-19, Movement Control Order
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
161 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Ultra Brief Online Mindfulness-based Intervention
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
This arm requires participants to answer questions about themselves.
Intervention Type
Behavioral
Intervention Name(s)
Ultra Brief Online Mindfulness-based Intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Control
Intervention Description
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 Outcome Measure Information:
Title
Changes of Subjective Unit of Distress
Description
This is being measured with the Subject Unit of Distress Scale.
Time Frame
It was measured at pre-intervention, post-intervention (through intervention completion, on average 10 minutes), and 2-week follow up.
Title
Changes of Anxiety Scores
Description
This is being measured with the GAD-7 questionnaire.
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.
Title
Changes of Psychological Insecurity
Description
This is being measured with the Psychological Insecurity Scale.
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.
Secondary Outcome Measure Information:
Title
Changes of General Well-being
Description
This is being measured with the WHO-5 Well-being Index questionnaire.
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.
Title
Fear of COVID-19
Description
This is being measured with the Fear of COVID-19 Scale.
Time Frame
It was being measured at 2-week follow up.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kai-Shuen Pheh, MClinPsych
Organizational Affiliation
Universiti Tunku Abdul Rahman
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universiti Tunku Abdul Rahman
City
Kampar
State/Province
Perak
ZIP/Postal Code
31900
Country
Malaysia
12. IPD Sharing Statement
Plan to Share 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.
Learn more about this trial
Ultra-brief Online Mindfulness-based Intervention During COVID-19 Movement Control Order
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