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Completed

NCT Number: NCT02478307

Coping Skills Training for Living With Chronic Low Back Pain

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

The University of Queensland

Brisbane, Queensland, 4072, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive therapy

Other

Mindfulness meditation

Other

Mindfulness-based cognitive therapy

Other

Primary outcomes

  1. Pain interference PROMIS scale

    Time frame: pre to post-treatment (at least 8 weeks)

    Participants are assessed pre-treatment and then following the 8-week treatment (post-treatment); change in pain interference is assessed via the PROMIS scale

Secondary outcomes

  1. Pain intensity assessed via the numerical rating scale (NRS)

    Time frame: pre to post-treatment (at least 8 weeks)

    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)

  2. Pain catastrophizing assessed via the Pain Catastrophizing Scale

    Time frame: pre to post-treatment (at least 8 weeks)

    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

  3. Mindfulness assessed via the FFMQ

    Time frame: pre to post-treatment (at least 8 weeks)

    Participants are assessed pre-treatment and then following the 8-week treatment (post-treatment); change in mindfulness is assessed via the FFMQ

  4. Pain acceptance assessed via the CPAQ

    Time frame: pre to post-treatment (at least 8 weeks)

    Participants are assessed pre-treatment and then following the 8-week treatment (post-treatment); change in pain acceptance is assessed via the CPAQ

  5. Psychological functioning PROMIS scale

    Time frame: pre to post-treatment (at least 8 weeks)

    Participants are assessed pre-treatment and then following the 8-week treatment (post-treatment); change in psychological functioning is assessed via the PROMIS scale

  6. Emotional functioning PROMIS scale

    Time frame: pre to post-treatment (at least 8 weeks)

    Participants are assessed pre-treatment and then following the 8-week treatment (post-treatment); change in emotional functioning is assessed via the PROMIS scale

  7. Physical functioning PROMIS scale

    Time frame: pre to post-treatment (at least 8 weeks)

    Participants are assessed pre-treatment and then following the 8-week treatment (post-treatment); change in physical functioning is assessed via the PROMIS scale

  8. Delta, theta, alpha, beta, and gamma bands assessed via EEG

    Time frame: pre to post-treatment (at least 8 weeks)

    Participants are assessed pre-treatment and then following the 8-week treatment (post-treatment); change in brain state data is assessed via EEG

Sponsors and collaborators

Lead sponsor

The University of Queensland

Other

Collaborators

  • Rush University Medical Center
  • University of Alabama at Birmingham
  • University of Washington

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Jun 23, 2015
Registry last updated
May 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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