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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04602312
Registration number
NCT04602312
Ethics application status
Date submitted
19/10/2020
Date registered
26/10/2020
Date last updated
11/01/2022
Titles & IDs
Public title
How Does Mindfulness Meditation Buffer the Negative Effects of Pain and Suffering in the COVID-19 World? (Healthy Sample)
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Scientific title
Online RCT Comparing the Effects of Mindfulness, Sham Mindfulness and Book Listening Control on Coronavirus-related Catastrophizing in Adults
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Secondary ID [1]
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2019000347-S4C
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Catastrophizing Coronavirus (COVID-19)
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Condition category
Condition code
Infection
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Other infectious diseases
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Respiratory
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Meditation (1 x 20-minute guided audio training)
Experimental: Mindfulness meditation - "focussed attention" mindfulness meditation technique taught as means to reduce coronavirus-related catastrophizing.
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.
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.
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"
Other interventions: 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.
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Coronavirus-related catastrophizing
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Assessment method [1]
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assessed via a covid-19-related catastrophizing scale (CCS; 0=no catastrophizing, 52=highest catastrophizing, 30+=clinically significant catastrophizing)
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Timepoint [1]
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40 minutes
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Eligibility
Key inclusion criteria
- At least 18 years of age
- Able to read and understand English
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
28/10/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
26/09/2021
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Sample size
Target
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Accrual to date
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Final
744
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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Health and Behavioural Sciences - Brisbane
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Recruitment postcode(s) [1]
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4072 - Brisbane
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Funding & Sponsors
Primary sponsor type
Other
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Name
The University of Queensland
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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University of Sydney
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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University of California, San Diego
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Address [2]
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Country [2]
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04602312
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Melissa Day, PhD
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Address
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The University of Queensland
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04602312
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