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

Primary Purpose

Catastrophizing Coronavirus (COVID-19)

Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Meditation (1 x 20-minute guided audio training)
Sponsored by
The University of Queensland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Catastrophizing Coronavirus (COVID-19) focused on measuring Coronavirus-related Catastrophizing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Health and Behavioural Sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Sham Comparator

Sham Comparator

No Intervention

Arm Label

Mindfulness meditation

Specific sham mindfulness meditation

General sham mindfulness meditation

Book listening control

Arm Description

"focussed attention" mindfulness meditation technique taught as means to reduce coronavirus-related catastrophizing.

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.

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.

this group completes no meditation training. They listen to a spoken excerpt from the audiobook "The Natural History and Antiquities of Selborne"

Outcomes

Primary Outcome Measures

Coronavirus-related catastrophizing
assessed via a covid-19-related catastrophizing scale (CCS; 0=no catastrophizing, 52=highest catastrophizing, 30+=clinically significant catastrophizing)

Secondary Outcome Measures

Full Information

First Posted
October 19, 2020
Last Updated
January 10, 2022
Sponsor
The University of Queensland
Collaborators
University of Sydney, University of California, San Diego
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1. Study Identification

Unique Protocol Identification Number
NCT04602312
Brief Title
How Does Mindfulness Meditation Buffer the Negative Effects of Pain and Suffering in the COVID-19 World? (Healthy Sample)
Official Title
Online RCT Comparing the Effects of Mindfulness, Sham Mindfulness and Book Listening Control on Coronavirus-related Catastrophizing in Adults
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
October 28, 2020 (Actual)
Primary Completion Date
September 26, 2021 (Actual)
Study Completion Date
September 26, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Queensland
Collaborators
University of Sydney, University of California, San Diego

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Catastrophizing Coronavirus (COVID-19)
Keywords
Coronavirus-related Catastrophizing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
4 x (2) mixed design, with training (mindfulness vs specific sham mindfulness vs general sham mindfulness vs book listening control, between subjects) and time (pre-treatment vs post-treatment, within-subjects) as factors.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
744 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness meditation
Arm Type
Experimental
Arm Description
"focussed attention" mindfulness meditation technique taught as means to reduce coronavirus-related catastrophizing.
Arm Title
Specific sham mindfulness meditation
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
General sham mindfulness meditation
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
Book listening control
Arm Type
No Intervention
Arm Description
this group completes no meditation training. They listen to a spoken excerpt from the audiobook "The Natural History and Antiquities of Selborne"
Intervention Type
Other
Intervention Name(s)
Meditation (1 x 20-minute guided audio training)
Intervention Description
Participants will complete a single session of 20-minutes online guided audio-delivered training session of one of the four conditions.
Primary Outcome Measure Information:
Title
Coronavirus-related catastrophizing
Description
assessed via a covid-19-related catastrophizing scale (CCS; 0=no catastrophizing, 52=highest catastrophizing, 30+=clinically significant catastrophizing)
Time Frame
40 minutes
Other Pre-specified Outcome Measures:
Title
Expectancy
Description
assessed via self-report questions (0=lowest expectancy, 10=highest expectancy)
Time Frame
40 minutes
Title
Reappraisal
Description
assessed via the Cognitive Emotion Regulation Questionnaire (CERQ-R; 4=lowest reappraisal, 20=highest reappraisal)
Time Frame
40 minutes
Title
Mindful observing
Description
assessed via the Five Facet Mindfulness Questionnaire Observing subscale (FFMQ-O; 1=lowest observing, 5=highest observing)
Time Frame
40 minutes
Title
Mindful non-reactivity
Description
assessed via the Five Facet Mindfulness Questionnaire Non-reacting subscale (FFMQ-NR; 1=lowest non-reactivity, 5=highest non-reactivity)
Time Frame
40 minutes
Title
State Mindfulness
Description
assessed via the State Mindfulness Survey (SMS; 1=lowest mindfulness, 21=highest mindfulness)
Time Frame
40 minutes
Title
State Decentering
Description
assessed via the Metacognitive Processes of Decentering - State (MpoD-s; 0=lowest decentering, 3=highest decentering)
Time Frame
40 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melissa Day, PhD
Organizational Affiliation
The University of Queensland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Health and Behavioural Sciences
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4072
Country
Australia

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
https://sites.google.com/view/uqcovidmeditation
Links:
URL
https://sydneypsy.qualtrics.com/jfe/form/SV_6P8sOROQ5eq8SpL?src=CTGC
Description
TAKE THE SURVEY NOW - LINK FOR PARTICIPANTS WISHING TO PARTICIPATE
URL
https://sites.google.com/view/uqcovidmeditation
Description
INFORMATION ABOUT THE STUDY

Learn more about this trial

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

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