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
1 other identifier
interventional
744
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 19, 2020
CompletedFirst Posted
Study publicly available on registry
October 26, 2020
CompletedStudy Start
First participant enrolled
October 28, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 26, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 26, 2021
CompletedJanuary 11, 2022
January 1, 2022
11 months
October 19, 2020
January 10, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
Expectancy
40 minutes
Reappraisal
40 minutes
Mindful observing
40 minutes
- +3 more other outcomes
Study Arms (4)
Mindfulness meditation
EXPERIMENTAL"focussed attention" mindfulness meditation technique taught as means to reduce coronavirus-related catastrophizing.
Specific sham mindfulness meditation
SHAM COMPARATORa 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.
General sham mindfulness meditation
SHAM COMPARATORa 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.
Book listening control
NO INTERVENTIONthis group completes no meditation training. They listen to a spoken excerpt from the audiobook "The Natural History and Antiquities of Selborne"
Interventions
Participants will complete a single session of 20-minutes online guided audio-delivered training session of one of the four conditions.
Eligibility Criteria
You may qualify if:
- At least 18 years of age
- Able to read and understand English
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The University of Queenslandlead
- University of Sydneycollaborator
- University of California, San Diegocollaborator
Study Sites (1)
Health and Behavioural Sciences
Brisbane, Queensland, 4072, Australia
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Melissa Day, PhD
The University of Queensland
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 19, 2020
First Posted
October 26, 2020
Study Start
October 28, 2020
Primary Completion
September 26, 2021
Study Completion
September 26, 2021
Last Updated
January 11, 2022
Record last verified: 2022-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- SAP, ICF
- Time Frame
- Immediately following publication up and for a further 10 years .
- 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.
All of the individual trial-related participant data collected during the trial, after de-identification.