NCT04602312

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
744

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 19, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 26, 2020

Completed
2 days until next milestone

Study Start

First participant enrolled

October 28, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 26, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 26, 2021

Completed
Last Updated

January 11, 2022

Status Verified

January 1, 2022

Enrollment Period

11 months

First QC Date

October 19, 2020

Last Update Submit

January 10, 2022

Conditions

Keywords

Coronavirus-related Catastrophizing

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.

Other: Meditation (1 x 20-minute guided audio training)

Specific sham mindfulness meditation

SHAM COMPARATOR

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)

General sham mindfulness meditation

SHAM COMPARATOR

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)

Book listening control

NO INTERVENTION

this 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.

General sham mindfulness meditationMindfulness meditationSpecific sham mindfulness meditation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Study Sites (1)

Health and Behavioural Sciences

Brisbane, Queensland, 4072, Australia

Location

Related Links

MeSH Terms

Conditions

COVID-19

Interventions

Meditation

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesRelaxation TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Melissa Day, PhD

    The University of Queensland

    PRINCIPAL INVESTIGATOR

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
Model Details: 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.
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

All of the individual trial-related participant data collected during the trial, after de-identification.

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.
More information

Locations