Internet delivered mindfulness-based cognitive therapy (iMBCT) for chronic pain: A pilot randomised controlled trial

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2023
INTERVENTION: 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 t CONDITION: Anaesthesiology ‐ Pain management Chronic Pain;Persistent Pain; ; Chronic Pain ; Persistent Pain Musculoskeletal ‐ Other muscular and skeletal disorders PRIMARY OUTCOME: Numerical Rating Scale (NRS) of current, least, worst & average pain in past week which will be calculated as a composite score of characteristic pain intensity[Pre‐treatment (baseline), mid‐treatment (2 weeks post‐commencement of iMBCT or the treatment as usual waiting period) and post‐treatment (post‐completion of final module, 4 weeks post‐commencement of iMBCT or the treatment as usual waiting period)] 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. SECONDARY OUTCOME: Mechanism: Chronic Pain Acceptance Questionnaire‐SF[Pre‐treatment (baseline), mid‐treatment (2 weeks post‐commencement of iMBCT or the treatment as usual waiting period) and post‐treatment (post‐completion of final module, 4 weeks post‐commencement of iMBCT or the treatment as usual waiting period)] Mechanism: Five facet mindfulness questionnaire (FFMQ) short form ; [Pre‐treatment (baseline), mid‐treatment (2 weeks post‐commencement of iMBCT or the treatment as usual waiting period) and post‐treatment (post‐completion of final module, 4 weeks post‐commencement of iMBCT or the treatment as usual waiting period) ; ] Mechanism: Metacognitive Processes of Decentering‐State (MPoD‐s)[Pre‐treatment (baseline), mid‐treatment (2 weeks post‐commencement of iMBCT or the treatment as usual waiting period) and post‐treatment (post‐completion of final module, 4 weeks post‐commencement of iMBCT or the treatment as usual waiting period)] Mechanism: Metacognitive Processes of Decentering‐Trait (MPoD‐t)[Pre‐treatment (baseline), mid‐treatment (2 weeks post‐commencement of iMBCT or the treatment as usual waiting period) and post‐treatment (post‐completion of final module, 4 weeks post‐commencement of iMBCT or the treatment as usual waiting period)] Mechanism: Pain Catastrophizing Scale[Pre‐treatment (baseline), mid‐treatment (2 weeks post‐commencement of iMBCT or the treatment as usual waiting period) and post‐treatment (post‐completion of final module, 4 weeks post‐commencement of iMBCT or the treatment as usual waiting period)] Mechanism: Pain Self‐Efficacy Questionnaire[Pre‐treatment (baseline), mid‐treatment (2 weeks post‐commencement of iMBCT or the treatment as usual waiting period) and post‐treatment (post‐completion of final module, 4 weeks post‐commencement of iMBCT or the treatment as usual waiting period)] Mechanism: State Mindfulness Scale[Pre‐treatment (baseline), mid‐treatment (2 weeks post‐commencement of iMBCT or the treatment as usual waiting period) and post‐treatment (post‐completion of final module, 4 weeks post‐commencement of iMBCT or the treatment as usual waiting period) ; ; ] Positive and Negative Affect Schedule (PANAS)[Pre‐treatment (baseline), mid‐treatment (2 weeks post‐commencement of iMBCT or the treatment as usual waiting period) and post‐treatment (post‐completion of final module, 4 weeks post‐commencement of iMBCT or the treatment as usual waiting period)] PROMIS Depression 4‐item scale[Pre‐treatment (baseline), mid‐treatment (2 weeks post‐commencement of iMBCT or the treatment as usual waiting period) and post‐treatment (post‐completion of final module, 4 weeks post‐commencement of iMBCT or the treatment as usual waiting period)] PROMIS Pain Interference 4‐item scale[Pre‐treatment (baseline), mid‐treatment (2 weeks post‐commencement of iMBCT or the treatment as usual waiting period) and post‐treatment (post‐completion of final module, 4 weeks post‐commencement of iMBCT or the treatment as usual waiting period)] PROMIS Sleep Interference 4‐item scale[Pre‐treatment (baseline), mid‐treatment (2 weeks post‐commencement of iMBCT or the treatment as usual waiting period) and post‐treatment (post‐completion of final module, 4 weeks post‐commencement of iMBCT or the treatment as usual waiting period)] Study specific questionnaire of self‐reported healthcare use, defined as the # of visits to a healthcare professional in the past week[Pre‐treatment (baseline), mid‐treatment (2 weeks post‐commencement of iMBCT or the treatment as usual waiting period) and post‐treatment (post‐completion of final module, 4 weeks post‐commencement of iMBCT or the treatment as usual waiting period)] Study specific questionnaire of self‐reported pain medication use[Pre‐treatment (baseline), mid‐treatment (2 weeks post‐commencement of iMBCT or the treatment as usual waiting period) and post‐treatment (post‐completion of final module, 4 weeks post‐commencement of iMBCT or the treatment as usual waiting period)]
Epistemonikos ID: 86a32d871f8bc5a9041360516629522e3e0946bd
First added on: Aug 26, 2024