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| Name | Class |
|---|---|
| University of Washington | OTHER |
| University of Alabama at Birmingham | OTHER |
| Rush University Medical Center | OTHER |
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Up to 80% of Australians experience back pain and 10% have significant disability as a result. There is a critical need for the development and evaluation of innovative treatments that have the capacity to target the multidimensional nature of chronic low back pain. This study will compare the effects and mechanisms of Mindfulness Meditation, Cognitive Therapy, and Mindfulness-Based Cognitive Therapy for chronic low back pain. Results will ultimately lead to streamlined interventions designed to efficiently maximise benefit.
Up to 80% of Australians experience back pain and 10% have significant disability as a result. This translates into substantial economic cost with far reaching psychological, emotional and social implications. Unfortunately, the treatment options for chronic low back pain (CLBP) are limited and typical medical/pharmacological approaches entail potentially serious side-effects (e.g., opioid addiction). There is a critical need for the development and evaluation of innovative interventions that have the capacity to target the multidimensional nature of CLBP.
Research indicates that psychosocial interventions for CLBP are viable treatment approaches that entail few (if any) deleterious side effects and can have benefit beyond pain reduction. Cognitive Therapy (CT) and Mindfulness Meditation (MM) have both been found to be feasible and effective for CLBP. A promising recently developed treatment that combines aspects of CT and MM is Mindfulness-Based Cognitive Therapy (MBCT). MBCT has been successfully applied to problems such as depression and headache; however, this approach has not been investigated for CLBP.
Thus, the current study is a randomised controlled trial (RCT) designed to examine the effects and mechanisms (i.e., how and for whom do these treatments work) of CT, MM, and MBCT for CLBP. Brain state data (electroencephalogram (EEG)) as well as self-report data will be examined to investigate the potential unique and shared mechanisms underlying treatment effects. Furthering the field's understanding of these treatments and their mechanisms will lead to the development of streamlined interventions designed to efficiently maximise benefit for individuals with CLBP, and that optimise relief from suffering.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive Therapy | Active Comparator | Eight, 2-hours sessions of group delivered cognitive therapy. |
|
| Mindfulness Meditation | Active Comparator | Eight, 2-hours sessions of group delivered mindfulness meditation. |
|
| Mindfulness-Based Cognitive Therapy | Active Comparator | Eight, 2-hours sessions of group delivered mindfulness-based cognitive therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Therapy | Other |
| ||
| Mindfulness Meditation |
| Measure | Description | Time Frame |
|---|---|---|
| Pain interference PROMIS scale | Participants are assessed pre-treatment and then following the 8-week treatment (post-treatment); change in pain interference is assessed via the PROMIS scale | pre to post-treatment (at least 8 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity assessed via the numerical rating scale (NRS) | Participants are assessed pre-treatment and then following the 8-week treatment (post-treatment); change in pain intensity is assessed via the numerical rating scale (NRS) | pre to post-treatment (at least 8 weeks) |
| Pain catastrophizing assessed via the Pain Catastrophizing Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Melissa Day, MA(Clin), PhD | The University of Queensland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Queensland | Brisbane | Queensland | 4072 | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30920244 | Derived | Day MA, Matthews N, Newman A, Mattingley JB, Jensen MP. An evaluation of the behavioral inhibition and behavioral activation system (BIS-BAS) model of pain. Rehabil Psychol. 2019 Aug;64(3):279-287. doi: 10.1037/rep0000274. Epub 2019 Mar 28. |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D064866 | Mindfulness |
| D000099025 | Mindfulness-Based Cognitive Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| Mindfulness-Based Cognitive Therapy | Other |
|
Participants are assessed pre-treatment and then following the 8-week treatment (post-treatment); change in pain catastrophizing is assessed via the Pain Catastrophizing Scale |
| pre to post-treatment (at least 8 weeks) |
| Mindfulness assessed via the FFMQ | Participants are assessed pre-treatment and then following the 8-week treatment (post-treatment); change in mindfulness is assessed via the FFMQ | pre to post-treatment (at least 8 weeks) |
| Pain acceptance assessed via the CPAQ | Participants are assessed pre-treatment and then following the 8-week treatment (post-treatment); change in pain acceptance is assessed via the CPAQ | pre to post-treatment (at least 8 weeks) |
| Psychological functioning PROMIS scale | Participants are assessed pre-treatment and then following the 8-week treatment (post-treatment); change in psychological functioning is assessed via the PROMIS scale | pre to post-treatment (at least 8 weeks) |
| Emotional functioning PROMIS scale | Participants are assessed pre-treatment and then following the 8-week treatment (post-treatment); change in emotional functioning is assessed via the PROMIS scale | pre to post-treatment (at least 8 weeks) |
| Physical functioning PROMIS scale | Participants are assessed pre-treatment and then following the 8-week treatment (post-treatment); change in physical functioning is assessed via the PROMIS scale | pre to post-treatment (at least 8 weeks) |
| Delta, theta, alpha, beta, and gamma bands assessed via EEG | Participants are assessed pre-treatment and then following the 8-week treatment (post-treatment); change in brain state data is assessed via EEG | pre to post-treatment (at least 8 weeks) |
| D013568 |
| Pathological Conditions, Signs and Symptoms |