Clinical trial NCT04602286: How Does Mindfulness Meditation Buffer the Negative Effects of Pain and Suffering in the COVID-19 World? (Pain Sample)
Official title: An Online Randomized Controlled Trial Comparing the Effects of Mindfulness, Sham Mindfulness and Book Listening Control on Pain Experience in Adults With Recurrent and Chronic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Intractable
Pain, Chronic
Lead sponsor: The University of Queensland
Sponsor class: OTHER
Collaborators: name: University of Sydney
name: University of California, San Diego
First posted: 2020-10-26
Enrollment: 373
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief summary: Both mindfulness meditation and expectancy effects are known to reduce pain intensity, pain unpleasantness and pain 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.

Detailed description: As many as 1 in 4 Australians experience chronic pain. Further, it is yet unknown the effects of the Coronavirus (COVID-19) pandemic on Australians with or at risk of chronic pain. There is a critical need for the development and evaluation of fast-acting non-pharmaceutical treatments that have the capacity to target the multidimensional nature of chronic pain. This study will investigate how mindfulness meditation and common expectancy effects interact and will further characterise the mechanisms underlying these effects. Results will ultimately lead to targeted interventions that more effectively engage cognitive mechanisms associated with pain attenuation.

Eligibility criteria: Inclusion Criteria:

* At least 18 years of age
* Recurrent pain (two or more days in the last month)
* Chronic pain (pain most days in the last three months)
* Able to read and understand English

Exclusion Criteria:

* Not experiencing recurrent or chronic pain
* Incomplete or invalid data (response time \< 32 minutes, failing attention checks)
* Completing the 20-minute training module in \< 18 minutes or \> 90 minutes

Primary outcomes:
measure: Pain intensity
timeFrame: 40 minutes
measure: Pain Unpleasantness
timeFrame: 40 minutes
Secondary outcomes:
measure: Pain Catastrophizing
timeFrame: 40 minutes
Other outcomes:
measure: Expectancy
timeFrame: 40 minutes
measure: Pain Reappraisal
timeFrame: 40 minutes
measure: Mindful observing
timeFrame: 40 minutes
measure: Mindful non-reactivity
timeFrame: 40 minutes
measure: State Mindfulness
timeFrame: 40 minutes
measure: State Decentering
timeFrame: 40 minutes
Locations:
city: Brisbane
country: Australia
facility: Health and Behavioural Sciences
state: Queensland
Study officials:
affiliation: The University of Queensland
name: Melissa Day, PhD
role: PRINCIPAL_INVESTIGATOR
References: