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

NCT04536441 | Completed

• 1 other identifier: U/SERC/62/2020
• Study Type: interventional
• Target: 161
• Locations: 1 country
• Sites: 1

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).

Conditions

Mental Health Wellness; Psychological Security; Psychological Distress

Keywords

Mindfulness; Online Intervention; COVID-19; Movement Control Order

Outcome Measures

Primary Outcomes (3)

• Changes of Subjective Unit of Distress

  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

  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

  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 Outcomes (2)

• 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.

Study Arms (2)

Treatment

EXPERIMENTAL

Ultra Brief Online Mindfulness-based Intervention

Behavioral: Ultra Brief Online Mindfulness-based Intervention

Control

PLACEBO COMPARATOR

This arm requires participants to answer questions about themselves.

Behavioral: Control

Interventions

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.

Treatment

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.

Control

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• People residing in Malaysia during the Movement Control Order.

You may not qualify if:

• People who are unable to read or write in either Malay, English or Mandarin languages.

Sponsors & Collaborators

• Universiti Tunku Abdul Rahman: lead
• Sunway University: collaborator

Study Sites (1)

Universiti Tunku Abdul Rahman

Kampar, Perak, 31900, Malaysia

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Kai-Shuen Pheh, MClinPsych

  Universiti Tunku Abdul Rahman

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: August 26, 2020
• First Posted: September 2, 2020
• Study Start: April 1, 2020
• Primary Completion: May 30, 2020
• Study Completion: June 30, 2020
• Last Updated: September 2, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: The data will be become available once the study is being published, for 5 years.
• Access Criteria: The data will be made available upon request to the corresponding author.

Locations

MY (1)