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Coping Skills Training for Living With Chronic Low Back Pain

Primary Purpose

Low Back Pain

Status
Completed
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
Cognitive Therapy
Mindfulness Meditation
Mindfulness-Based Cognitive Therapy
Sponsored by
The University of Queensland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring chronic low back pain, mindfulness meditation, cognitive therapy, mindfulness-based cognitive therapy, efficacy, mechanisms, coping

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The University of Queensland

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Cognitive Therapy

Mindfulness Meditation

Mindfulness-Based Cognitive Therapy

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)
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
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
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
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
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
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
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

Full Information

First Posted
June 9, 2015
Last Updated
May 16, 2019
Sponsor
The University of Queensland
Collaborators
University of Washington, University of Alabama at Birmingham, Rush University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02478307
Brief Title
Coping Skills Training for Living With Chronic Low Back Pain
Official Title
Mechanisms of Mindfulness Meditation, Cognitive Therapy, and Mindfulness-Based Cognitive Therapy for Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
June 30, 2018 (Actual)
Study Completion Date
June 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Queensland
Collaborators
University of Washington, University of Alabama at Birmingham, Rush University Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
chronic low back pain, mindfulness meditation, cognitive therapy, mindfulness-based cognitive therapy, efficacy, mechanisms, coping

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
69 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Therapy
Arm Type
Active Comparator
Arm Description
Eight, 2-hours sessions of group delivered cognitive therapy.
Arm Title
Mindfulness Meditation
Arm Type
Active Comparator
Arm Description
Eight, 2-hours sessions of group delivered mindfulness meditation.
Arm Title
Mindfulness-Based Cognitive Therapy
Arm Type
Active Comparator
Arm Description
Eight, 2-hours sessions of group delivered mindfulness-based cognitive therapy
Intervention Type
Other
Intervention Name(s)
Cognitive Therapy
Intervention Type
Other
Intervention Name(s)
Mindfulness Meditation
Intervention Type
Other
Intervention Name(s)
Mindfulness-Based Cognitive Therapy
Primary Outcome Measure Information:
Title
Pain interference PROMIS scale
Description
Participants are assessed pre-treatment and then following the 8-week treatment (post-treatment); change in pain interference is assessed via the PROMIS scale
Time Frame
pre to post-treatment (at least 8 weeks)
Secondary Outcome Measure Information:
Title
Pain intensity assessed via the numerical rating scale (NRS)
Description
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)
Time Frame
pre to post-treatment (at least 8 weeks)
Title
Pain catastrophizing assessed via the Pain Catastrophizing Scale
Description
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
Time Frame
pre to post-treatment (at least 8 weeks)
Title
Mindfulness assessed via the FFMQ
Description
Participants are assessed pre-treatment and then following the 8-week treatment (post-treatment); change in mindfulness is assessed via the FFMQ
Time Frame
pre to post-treatment (at least 8 weeks)
Title
Pain acceptance assessed via the CPAQ
Description
Participants are assessed pre-treatment and then following the 8-week treatment (post-treatment); change in pain acceptance is assessed via the CPAQ
Time Frame
pre to post-treatment (at least 8 weeks)
Title
Psychological functioning PROMIS scale
Description
Participants are assessed pre-treatment and then following the 8-week treatment (post-treatment); change in psychological functioning is assessed via the PROMIS scale
Time Frame
pre to post-treatment (at least 8 weeks)
Title
Emotional functioning PROMIS scale
Description
Participants are assessed pre-treatment and then following the 8-week treatment (post-treatment); change in emotional functioning is assessed via the PROMIS scale
Time Frame
pre to post-treatment (at least 8 weeks)
Title
Physical functioning PROMIS scale
Description
Participants are assessed pre-treatment and then following the 8-week treatment (post-treatment); change in physical functioning is assessed via the PROMIS scale
Time Frame
pre to post-treatment (at least 8 weeks)
Title
Delta, theta, alpha, beta, and gamma bands assessed via EEG
Description
Participants are assessed pre-treatment and then following the 8-week treatment (post-treatment); change in brain state data is assessed via EEG
Time Frame
pre to post-treatment (at least 8 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melissa Day, MA(Clin), PhD
Organizational Affiliation
The University of Queensland
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Queensland
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4072
Country
Australia

12. IPD Sharing Statement

Citations:
PubMed Identifier
30920244
Citation
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.
Results Reference
derived

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Coping Skills Training for Living With Chronic Low Back Pain

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