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Coping Skills Training for Living With Chronic Low Back Pain

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The University of Queensland

Status and phase

Completed
Phase 2
Phase 1

Conditions

Low Back Pain

Treatments

Other: Mindfulness Meditation
Other: Mindfulness-Based Cognitive Therapy
Other: Cognitive Therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT02478307
UQueensland

Details and patient eligibility

About

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.

Full 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.

Enrollment

69 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

69 participants in 3 patient groups

Cognitive Therapy
Active Comparator group
Description:
Eight, 2-hours sessions of group delivered cognitive therapy.
Treatment:
Other: Cognitive Therapy
Mindfulness Meditation
Active Comparator group
Description:
Eight, 2-hours sessions of group delivered mindfulness meditation.
Treatment:
Other: Mindfulness Meditation
Mindfulness-Based Cognitive Therapy
Active Comparator group
Description:
Eight, 2-hours sessions of group delivered mindfulness-based cognitive therapy
Treatment:
Other: Mindfulness-Based Cognitive Therapy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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