None listed
Conditions
Brief summary
Chronic pain affects millions of Australians and is the leading cause of disability globally. Frequently however, chronic pain is underdiagnosed and undertreated. In this pilot randomised controlled trial, we are investigating a co-designed, internet delivered mindfulness-based cognitive therapy (iMBCT) for chronic pain program to overcome these access barriers. From the inception of this research, we have adopted a community-based participatory research framework, which is a patient-centred and community driven approach that is well suited to treatment adaptation to improve access and uptake. Consumers and consumer representatives – including our partner, Chronic Pain Australia – are the grassroots voices that have shaped the development of this iMBCT program. In this trial, participants will be randomised to iMBCT or a delayed treatment control for process evaluation, and to determine the preliminary efficacy of iMBCT for reducing pain intensity (primary outcome) and improving quality of life indicators (secondary outcomes). We will also examine potential mediators and moderators underlying the expected improvements in pain-related outcomes.
Interventions
From the inception of this research program we have adopted a community-based participatory research (CBPR) framework. This is a patient-centred and community driven approach that is well suited to the adaptation of treatment to improve patient access and uptake, as is undertaken in this research.
In this trial, those assigned to the treatment condition will complete the co-designed 4-week, internet delivered mindfulness-based cognitive therapy (iMBCT) program. The iMBCT for chronic pain protoc
From the inception of this research program we have adopted a community-based participatory research (CBPR) framework. This is a patient-centred and community driven approach that is well suited to the adaptation of treatment to improve patient access and uptake, as is undertaken in this research. In this trial, those assigned to the treatment condition will complete the co-designed 4-week, internet delivered mindfulness-based cognitive therapy (iMBCT) program. The iMBCT for chronic pain protocol integrates psychoeducation and cognitive-behavioural therapy techniques with mindfulness-based interventional strategies to form a streamlined approach to training the mind to respond more adaptively to pain. Participants in MBCT will be taught to apply the skills they learn not only to pain but also the problems pain causes for them including sleep disturbance, depressed mood, stress, and other problems. Each of the four weekly modules will include mini-modules on pain psychoeducation (e.g., a neurological understanding of pain; the relationship between stress and pain etc.), cognitive-behavioural therapy exercises (e.g., stressful experiences diary; pleasant events activity scheduling), and mindfulness-based content and practices (e.g., videos describing the rationale for the meditation technique taught in that module, as well as then guided audio recordings of a 3-minute breathing space meditation and formal extended meditations). Handouts will be provided to accompany each online module to reinforce learning. All written content will be at the 7th grade reading level or lower for health literacy purposes. Between-module cognitive-behavioural exercises will be assigned, as well as mindfulness exercises which will be provided as digital recordings. In terms of the time commitment, completing each module involves listening to several brief videos which range from 2-10 minutes long, featuring Associate Professor Melissa Day who is a Clinical and Health Psychologist. For the guided meditation practices included in each module, options of a 20-minute or 45-minute recording are provided for daily practice. In total, we encourage participants to devote at least 40-50 minutes to the program daily for 6 days of the week for the 4-weeks. Website analytics will be used to monitor adherence to the intervention.
Sponsors
Chronic Pain Australia
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
(1) age of at least 18 years; (2) chronic pain (3 months or more, with pain experienced on at least 50% of days); (3) average intensity of pain 4 or higher on a 11-point NRS for most days of the previous 3 months; (4) able to read, speak, and understand English to comprehend the worksheets, measures and intervention implemented; (5) if currently taking analgesic or psychotropic medication, they must have been stabilized for at least 4 weeks prior to this study; (6) availability of a telephone, computer/laptop/tablet, and daily internet access; and (7) living in Australia at the time of study participation.
Exclusion criteria
(1) severe cognitive impairment, as evidenced by two or more error(s) on the Six-Item Screener; (2) current alcohol or substance dependence; (3) uncontrolled schizophrenia or bipolar affective disorder; (4) chronic pain due to malignancy (e.g., cancer) or autoimmune disorders (e.g., lupus), headache as the primary source of pain, or a pain condition for which surgery is recommended and/or planned; and, (5) currently receiving other psychosocial treatments for any pain condition (as this may influence the treatment results).
Outcome results
None listed