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Coping Skills Training for Living With Chronic Low Back Pain

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ClinicalTrials.gov Identifier: NCT02478307
Recruitment Status : Active, not recruiting
First Posted : June 23, 2015
Last Update Posted : November 13, 2017
Sponsor:
Collaborators:
University of Washington
University of Alabama at Birmingham
Rush University Medical Center
Information provided by (Responsible Party):
Dr Melissa Day, The University of Queensland

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.

Condition or disease Intervention/treatment Phase
Low Back Pain Other: Cognitive Therapy Other: Mindfulness Meditation Other: Mindfulness-Based Cognitive Therapy Phase 1 Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 69 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Mechanisms of Mindfulness Meditation, Cognitive Therapy, and Mindfulness-Based Cognitive Therapy for Low Back Pain
Study Start Date : May 2015
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

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



Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02478307


Locations
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Australia, Queensland
The University of Queensland
Brisbane, Queensland, Australia, 4072
Sponsors and Collaborators
The University of Queensland
University of Washington
University of Alabama at Birmingham
Rush University Medical Center
Investigators
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Principal Investigator: Melissa Day, MA(Clin), PhD The University of Queensland

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr Melissa Day, NHMRC Early Career Fellow, The University of Queensland
ClinicalTrials.gov Identifier: NCT02478307     History of Changes
Other Study ID Numbers: UQueensland
First Posted: June 23, 2015    Key Record Dates
Last Update Posted: November 13, 2017
Last Verified: November 2017

Keywords provided by Dr Melissa Day, The University of Queensland:
chronic low back pain
mindfulness meditation
cognitive therapy
mindfulness-based cognitive therapy
efficacy
mechanisms
coping

Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms