Coping Skills Training for Living With Chronic Low Back Pain

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02478307
• Other study ID #: UQueensland
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: May 2015
• Est. completion date: June 30, 2018

Study information

• Verified date: May 2019
• Source: The University of Queensland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: June 30, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Other:
• Cognitive Therapy

• Mindfulness Meditation

• Mindfulness-Based Cognitive Therapy

Locations

Country	Name	City	State
Australia	The University of Queensland	Brisbane	Queensland

Sponsors (4)

Lead Sponsor	Collaborator
The University of Queensland	Rush University Medical Center, University of Alabama at Birmingham, University of Washington

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)