Coping Skills Training for Living With Chronic Low Back Pain

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12615000714583
• Date of registration: 10/07/2015
• Prospective Registration: Yes
• Primary sponsor: Dr Melissa Day
• Public title: Coping Skills Training for Living With Chronic Low Back Pain
• Scientific title: Mechanisms of Mindfulness Meditation, Cognitive Therapy, and Mindfulness-Based Cognitive Therapy for Low Back Pain
• Date of first enrolment: 20/01/2016
• Target sample size: 63
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12615000714583.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Not Applicable

Countries of recruitment

Australia

Contacts

• Name: Dr Melissa Day

• Name: Dr Melissa Day

Key inclusion & exclusion criteria

Inclusion criteria: (1) at least 18 years of age; (2) chronic pain of the low back (at least 3 months) that is the primary source of reported pain; (3) average pain intensity of at least 4 on a 10-point scale; (4) if currently taking analgesic or psychotropic medications, they must have been stabilised for at least 4 weeks prior to this study; (5) be able to read, speak and understand English; and (6) be able to attend a weekly 2-hour therapy session for 8 concurrent weeks.
Exclusion criteria: (1) 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); (2) chronic pain due to malignancy; (3) 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); and (4) currently receiving other psychosocial pain treatment.

Age minimum: 18 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Low back pain;
Low back pain

Alternative and Complementary Medicine - Other alternative and complementary medicine

Musculoskeletal - Other muscular and skeletal disorders

Intervention(s)

Eight, group delivered 2 hours sessions (1 per week) of either:

(1) mindfulness meditation - various mindfulness meditation techniques are taught as means to reduce stress and improve coping and management of pain.

or

(2) cognitive therapy - exercises such as cognitive restructuring are taught to change unhelpful ways of thinking and responding to pain to improve pain management.

or

(3) mindfulness-based cognitive therapy - both mindfulness meditation and cognitive coping techniques are taught to improve adaptive pain coping and management.

Each participant receives all 8 sessions for one of the above three interventions only. Between session practice is encouraged and recorded via participant self-report. All interventions are group delivered by a clinical psychologist.

Primary Outcome(s)

Pain Interference, assessed via the PROMIS pain interference scale[Pre to post-treatment, i.e., baseline and after 8 weeks of treatment]

Secondary Outcome(s)

Pain catastrophizing, assessed via the Pain Catastrophizing Scale[Pre to post-treatment, i.e., baseline and after 8 weeks of treatment]

Pain intensity, assessed via a numerical rating scale[Pre to post-treatment, i.e., baseline and after 8 weeks of treatment]

Psychological functioning, assessed via the PROMIS scale[Pre to post-treatment, i.e., baseline and after 8 weeks of treatment]

Pain acceptance, assessed via the CPAQ[Pre to post-treatment, i.e., baseline and after 8 weeks of treatment]

Physical functioning, assessed via the PROMIS scale[Pre to post-treatment, i.e., baseline and after 8 weeks of treatment]

Emotional functioning, assessed via the PROMIS scale[Pre to post-treatment, i.e., baseline and after 8 weeks of treatment]

Mindfulness, assessed via the FFMQ[Pre to post-treatment, i.e., baseline and after 8 weeks of treatment]

Secondary ID(s)

Nil Known

Source(s) of Monetary Support

National Health and Medical Research Council

Secondary Sponsor(s)

Nil known

Ethics review

Status: Approved
Approval date:
Contact:

Behavioural & Social Sciences Ethical Review Committee

Status: Approved
Approval date:
Contact:

Metro South Hospital and Health Service Human Research Ethics Committee

Results

• Results available: Yes
• Date Posted: 17/05/2019
• Date Completed: 30/06/2018