Pain, Chronic, Pain, Intractable
Conditions
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.
Interventions
Participants will complete a single session of 20-minutes online guided audio-delivered training session of one of the four conditions.
Sponsors
University of Sydney
University of California, San Diego
The University of Queensland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity | 40 minutes | Assessed via a numerical rating scale (0=no pain, 10=most intense pain imaginable) |
| Pain Unpleasantness | 40 minutes | assessed via a numerical rating scale (0=no pain, 10=most unpleasant pain imaginable) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Catastrophizing | 40 minutes | assessed via the Pain Catastrophizing Scale (PCS; 0=no catastrophizing, 52=highest catastrophizing, 30+=clinically significant catastrophizing) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Mindful non-reactivity | 40 minutes | assessed via the Five Facet Mindfulness Questionnaire Non-reacting Subscale (FFMQ-NR; 1=lowest non-reactivity, 5=highest non-reactivity) |
| Expectancy | 40 minutes | assessed via self-report questions (0=lowest expectancy, 10=highest expectancy) |
| State Decentering | 40 minutes | assessed via the Metacognitive Processes of Decentering - State (MpoD-s; 0=lowest decentering, 3=highest decentering) |
| State Mindfulness | 40 minutes | assessed via the State Mindfulness Survey (SMS; 1=lowest mindfulness, 21=highest mindfulness) |
| Pain Reappraisal | 40 minutes | assessed via the Pain-related Cognitive Processes Questionnaire (PCPQ-R; 0=lowest reappraisal, 4=highest reappraisal) |
| Mindful observing | 40 minutes | assessed via the Five Facet Mindfulness Questionnaire Observing Subscale (FFMQ-O; 1=lowest observing, 5=highest observing) |
Countries
Australia
Outcome results
None listed