How Does Mindfulness Meditation Buffer the Negative Effects of Pain and Suffering in the COVID-19 World? (Healthy Sample)

Online RCT Comparing the Effects of Mindfulness, Sham Mindfulness and Book Listening Control on Coronavirus-related Catastrophizing in Adults

Both mindfulness meditation and expectancy effects are known to reduce anxiety, stress and catastrophizing, but it is unknown whether and how expectancy effects contribute to the overall effect of mindfulness meditation on these outcomes, especially during significant global events such as the coronavirus pandemic. This study includes four interrelated aims that will probe these effects and interactions.

Study Overview

• Status: Completed
• Conditions: Catastrophizing Coronavirus (COVID-19)
• Intervention / Treatment: Other: Meditation (1 x 20-minute guided audio training)

• Study Type: Interventional
• Enrollment (Actual): 744
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Queensland
    • Brisbane, Queensland, Australia, 4072
      • Health and Behavioural Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• At least 18 years of age
• Able to read and understand English

Exclusion Criteria:

• Recurrent pain (two or more days in the last month)
• Chronic pain (pain most days in the last three months)
• Incomplete or invalid data (response time < 32 minutes, failing attention checks)
• Completing the 20-minute training module in < 18 minutes or > 90 minutes

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Book listening control; this group completes no meditation training. They listen to a spoken excerpt from the audiobook "The Natural History and Antiquities of Selborne"
Experimental: Mindfulness meditation; "focussed attention" mindfulness meditation technique taught as means to reduce coronavirus-related catastrophizing.	Other: Meditation (1 x 20-minute guided audio training); Participants will complete a single session of 20-minutes online guided audio-delivered training session of one of the four conditions.
Sham Comparator: Specific sham mindfulness meditation; a training session designed to specifically match the real mindfulness training while lacking the proposed active elements of mindfulness training. Delivered as a means to elicit expectancy-mediated (but not mindfulness-mediated) reductions in coronavirus-related catastrophizing.	Other: Meditation (1 x 20-minute guided audio training); Participants will complete a single session of 20-minutes online guided audio-delivered training session of one of the four conditions.
Sham Comparator: General sham mindfulness meditation; a training session designed to generally match focussed-attention mindfulness meditation while maintaining greater distance from proposed mindfulness mechanisms. Delivered as a means to elicit expectancy-mediated (but not mindfulness-mediated) reductions in coronavirus-related catastrophizing.	Other: Meditation (1 x 20-minute guided audio training); Participants will complete a single session of 20-minutes online guided audio-delivered training session of one of the four conditions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Coronavirus-related catastrophizing	assessed via a covid-19-related catastrophizing scale (CCS; 0=no catastrophizing, 52=highest catastrophizing, 30+=clinically significant catastrophizing)	40 minutes

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Expectancy	assessed via self-report questions (0=lowest expectancy, 10=highest expectancy)	40 minutes
State Mindfulness	assessed via the State Mindfulness Survey (SMS; 1=lowest mindfulness, 21=highest mindfulness)	40 minutes
State Decentering	assessed via the Metacognitive Processes of Decentering - State (MpoD-s; 0=lowest decentering, 3=highest decentering)	40 minutes
Reappraisal	assessed via the Cognitive Emotion Regulation Questionnaire (CERQ-R; 4=lowest reappraisal, 20=highest reappraisal)	40 minutes
Mindful observing	assessed via the Five Facet Mindfulness Questionnaire Observing subscale (FFMQ-O; 1=lowest observing, 5=highest observing)	40 minutes
Mindful non-reactivity	assessed via the Five Facet Mindfulness Questionnaire Non-reacting subscale (FFMQ-NR; 1=lowest non-reactivity, 5=highest non-reactivity)	40 minutes

Collaborators and Investigators

• Sponsor: The University of Queensland
• Collaborators: University of California, San Diego; University of Sydney
• Investigators: Principal Investigator: Melissa Day, PhD, The University of Queensland

Publications and helpful links

Helpful Links

• INFORMATION ABOUT THE STUDY
• TAKE THE SURVEY NOW - LINK FOR PARTICIPANTS WISHING TO PARTICIPATE

Study record dates

Study Major Dates

• Study Start (Actual): October 28, 2020
• Primary Completion (Actual): September 26, 2021
• Study Completion (Actual): September 26, 2021

Study Registration Dates

• First Submitted: October 19, 2020
• First Submitted That Met QC Criteria: October 22, 2020
• First Posted (Actual): October 26, 2020

Study Record Updates

• Last Update Posted (Actual): January 11, 2022
• Last Update Submitted That Met QC Criteria: January 10, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Coronavirus-related Catastrophizing
• Additional Relevant MeSH Terms: Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Coronavirus Infections
• Other Study ID Numbers: 2019000347-S4C

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All of the individual trial-related participant data collected during the trial, after de-identification.
• IPD Sharing Time Frame: Immediately following publication up and for a further 10 years .

IPD Sharing Access Criteria

Investigators whose proposed use of the data has been approved by an independent review committee. Initial contact should be directed to the contact person for scientific enquiries (Mr Jonathan Davies, jonathan.davies@uq.edu.au).

Note: Requestors will need to sign a data access agreement.

• IPD Sharing Supporting Information Type: SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No