Coping Skills Training for Living With Chronic Low Back Pain

NCT ID: NCT02478307

Last Updated: 2019-05-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 69 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2018-06-30

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.

Conditions

Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Cognitive Therapy

Eight, 2-hours sessions of group delivered cognitive therapy.

Group Type: ACTIVE_COMPARATOR

Cognitive Therapy

Intervention Type: OTHER

Mindfulness Meditation

Eight, 2-hours sessions of group delivered mindfulness meditation.

Group Type: ACTIVE_COMPARATOR

Mindfulness Meditation

Intervention Type: OTHER

Mindfulness-Based Cognitive Therapy

Eight, 2-hours sessions of group delivered mindfulness-based cognitive therapy

Group Type: ACTIVE_COMPARATOR

Mindfulness-Based Cognitive Therapy

Intervention Type: OTHER

Interventions

Cognitive Therapy

Intervention Type: OTHER

Mindfulness Meditation

Intervention Type: OTHER

Mindfulness-Based Cognitive Therapy

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Washington

OTHER

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: collaborator

Rush University Medical Center

OTHER

Sponsor Role: collaborator

The University of Queensland

OTHER

Sponsor Role: lead

Responsible Party

Dr Melissa Day

NHMRC Early Career Fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Melissa Day, MA(Clin), PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Queensland

Locations

The University of Queensland

Brisbane, Queensland, Australia

Countries

Australia

References

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.

Reference Type: DERIVED

PMID: 30920244 (View on PubMed)

Other Identifiers

UQueensland

Identifier Type: -

Identifier Source: org_study_id