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| Name | Class |
|---|---|
| University of Sydney | OTHER |
| University of California, San Diego | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindfulness meditation | Experimental | "focussed attention" mindfulness meditation technique taught as means to reduce pain intensity and unpleasantness. |
|
| 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 placebo-mediated (but not mindfulness-mediated) reductions in pain intensity and unpleasantness |
|
| 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 placebo-mediated (but not mindfulness-mediated) reductions in pain intensity and unpleasantness |
|
| 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" |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meditation (1 x 20-minute guided audio training) | Other | Participants will complete a single session of 20-minutes online guided audio-delivered training session of one of the four conditions. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity | Assessed via a numerical rating scale (0=no pain, 10=most intense pain imaginable) | 40 minutes |
| Pain Unpleasantness | assessed via a numerical rating scale (0=no pain, 10=most unpleasant pain imaginable) | 40 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Catastrophizing | assessed via the Pain Catastrophizing Scale (PCS; 0=no catastrophizing, 52=highest catastrophizing, 30+=clinically significant catastrophizing) | 40 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Expectancy | assessed via self-report questions (0=lowest expectancy, 10=highest expectancy) | 40 minutes |
| Pain Reappraisal | assessed via the Pain-related Cognitive Processes Questionnaire (PCPQ-R; 0=lowest reappraisal, 4=highest reappraisal) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Melissa Day, PhD | The University of Queensland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Health and Behavioural Sciences | Brisbane | Queensland | 4072 | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37310492 | Derived | Davies JN, Colagiuri B, Sharpe L, Day MA. Placebo effects contribute to brief online mindfulness interventions for chronic pain: results from an online randomized sham-controlled trial. Pain. 2023 Oct 1;164(10):2273-2284. doi: 10.1097/j.pain.0000000000002928. Epub 2023 Jun 9. |
| Label | URL |
|---|---|
| TAKE THE SURVEY NOW - LINK FOR PARTICIPANTS WISHING TO PARTICIPATE | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 10.17605/OSF.IO | Statistical Analysis Plan | View IPD |
All of the individual trial-related participant data collected during the trial, after de-identification.
Immediately following publication up and for a further 10 years .
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.
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| ID | Term |
|---|---|
| D010148 | Pain, Intractable |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D019122 | Meditation |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026443 | Spiritual Therapies |
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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.
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| 40 minutes |
| Mindful observing | assessed via the Five Facet Mindfulness Questionnaire Observing Subscale (FFMQ-O; 1=lowest observing, 5=highest observing) | 40 minutes |
| Mindful non-reactivity | assessed via the Five Facet Mindfulness Questionnaire Non-reacting Subscale (FFMQ-NR; 1=lowest non-reactivity, 5=highest non-reactivity) | 40 minutes |
| State Mindfulness | assessed via the State Mindfulness Survey (SMS; 1=lowest mindfulness, 21=highest mindfulness) | 40 minutes |
| State Decentering | assessed via the Metacognitive Processes of Decentering - State (MpoD-s; 0=lowest decentering, 3=highest decentering) | 40 minutes |
| INFORMATION ABOUT THE STUDY | View source |
The Statistical Analysis Plan for this trial was prospectively registered on the Open Science Framework on October 8, 2020 |
| D012064 |
| Relaxation Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |