Clinical trial NCT02478307: Coping Skills Training for Living With Chronic Low Back Pain
Official title: Mechanisms of Mindfulness Meditation, Cognitive Therapy, and Mindfulness-Based Cognitive Therapy for Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Low Back Pain
Keywords: chronic low back pain
mindfulness meditation
cognitive therapy
mindfulness-based cognitive therapy
efficacy
mechanisms
coping
Lead sponsor: The University of Queensland
Sponsor class: OTHER
Collaborators: name: University of Washington
name: University of Alabama at Birmingham
name: Rush University Medical Center
First posted: 2015-06-23
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain interference PROMIS scale
timeFrame: pre to post-treatment (at least 8 weeks)
Secondary outcomes:
measure: Pain intensity assessed via the numerical rating scale (NRS)
timeFrame: pre to post-treatment (at least 8 weeks)
measure: Pain catastrophizing assessed via the Pain Catastrophizing Scale
timeFrame: pre to post-treatment (at least 8 weeks)
measure: Mindfulness assessed via the FFMQ
timeFrame: pre to post-treatment (at least 8 weeks)
measure: Pain acceptance assessed via the CPAQ
timeFrame: pre to post-treatment (at least 8 weeks)
measure: Psychological functioning PROMIS scale
timeFrame: pre to post-treatment (at least 8 weeks)
measure: Emotional functioning PROMIS scale
timeFrame: pre to post-treatment (at least 8 weeks)
measure: Physical functioning PROMIS scale
timeFrame: pre to post-treatment (at least 8 weeks)
measure: Delta, theta, alpha, beta, and gamma bands assessed via EEG
timeFrame: pre to post-treatment (at least 8 weeks)
Other outcomes:
Locations:
city: Brisbane
country: Australia
facility: The University of Queensland
state: Queensland
Study officials:
affiliation: The University of Queensland
name: Melissa Day, MA(Clin), PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.