Coping Skills Training for Living With Chronic Low Back Pain

Mechanisms of Mindfulness Meditation, Cognitive Therapy, and Mindfulness-Based Cognitive Therapy for 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.

Study Overview

• Status: Completed
• Conditions: Low Back Pain
• Intervention / Treatment: Other: Mindfulness Meditation; Other: Cognitive Therapy; Other: Mindfulness-Based Cognitive Therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Australia
  • Queensland
    • Brisbane, Queensland, Australia, 4072
      • The University of Queensland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: The University of Queensland
• Collaborators: University of Alabama at Birmingham; Rush University Medical Center; University of Washington
• Investigators: Principal Investigator: Melissa Day, MA(Clin), PhD, The University of Queensland

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): June 30, 2018
• Study Completion (Actual): June 30, 2018

Study Registration Dates

• First Submitted: June 9, 2015
• First Submitted That Met QC Criteria: June 22, 2015
• First Posted (Estimate): June 23, 2015

Study Record Updates

• Last Update Posted (Actual): May 20, 2019
• Last Update Submitted That Met QC Criteria: May 16, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: chronic low back pain; coping; efficacy; mindfulness meditation; cognitive therapy; mindfulness-based cognitive therapy; mechanisms
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: UQueensland