Coping Skills Training for Living With Chronic Low Back Pain

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Mechanisms of Mindfulness Meditation, Cognitive Therapy, and Mindfulness-Based Cognitive Therapy for Low Back Pain

Conditions
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Low Back Pain

Intervention / Treatment
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* Other: Cognitive Therapy
* Other: Mindfulness Meditation
* Other: Mindfulness-Based Cognitive Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥18 years of age Chronic pain of the low back (≥3 months) that is the primary source of reported pain Average pain intensity of ≥4 on a 10-point scale If currently taking analgesic or psychotropic medications, they must have been stabilised for ≥4 weeks prior to this study Be able to read, speak and understand English Be able to attend a weekly 2-hour therapy session for 8 concurrent weeks Exclusion Criteria: Cognitive impairment, uncontrolled psychotic symptoms or current elevated suicidal ideation as this may interfere with group-delivered therapy (as evidenced by the 6-item screener) Chronic pain due to malignancy History of a medical condition that could produce an abnormal EEG and interfere with the tests of the effects of treatment on EEG (e.g., epilepsy, history of traumatic brain injury) Currently receiving other psychosocial pain treatment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cognitive Therapy<br>Eight, 2-hours sessions of group delivered cognitive therapy. | Other: Cognitive Therapy<br> <br> |
| Active Comparator: Mindfulness Meditation<br>Eight, 2-hours sessions of group delivered mindfulness meditation. | Other: Mindfulness Meditation<br> <br> |
| Active Comparator: Mindfulness-Based Cognitive Therapy<br>Eight, 2-hours sessions of group delivered mindfulness-based cognitive therapy | Other: Mindfulness-Based Cognitive Therapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic low back pain, mindfulness meditation, cognitive therapy, mindfulness-based cognitive therapy, efficacy, mechanisms, coping