Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2025-12-25 @ 1:10 AM
NCT ID:
NCT06186193
Brief Summary:
The usual coping mechanism with chronic pain is distraction, It is unclear whether the opposite, sensory monitoring, can benefit patients with chronic low back pain (cLBP). The study assesses the feasibility and acceptability of a 2-minute phone-based attention exercise, used several times a day over 8 weeks plus a 1-hour introduction, in patients with cLBP. The attention exercise is based on mindfulness-based interoceptive exposure, a task that has been tested before in a mixed pain population in Australia.
Detailed Description:
Mind your Pain (MyP), also known as Mindfulness-based Interoceptive Exposure Therapy (MIET) is an innovative brief mindfulness-based task, developed within the frame of mindfulness-based cognitive therapy, and has been pilot tested in a small cohort of 15 patients with chronic musculoskeletal pain, the majority with cLBP, in Australia. It consists of an individual guided 1-hour introduction session and a 1 to 2-minute attention task subsequently performed several times per day over 12 weeks. The task will be provided by a smart phone app and be sent to participants as phone message reminders at up to 5 times per day: according to participant preference once in the morning and once at bedtime, as well as up to 3 additional times when participants are asked to use the app whenever they perceive the pain at its worst. The task is to focus on the most intense pain sensation in a detached and equanimous way and carefully observe potential changes in five aspects of that sensation: space (region/ borders/ immobile/ moving); sense of mass (heavy/ neutral/ light), temperature (cold/ warm/ hot/ neutral); density (dense/ solid/ loose/ constricted), and borders (diffuse/ sharp). This neutral sensory-descriptive interoceptive attention focus is aiming at preventing the learned aversive response to pain that entails ruminating thoughts, and negative affect rather than immediate sensory awareness. The pilot study in 15 chronic pain patients showed significant beneficial pre-post effects (Cohen's d, ES) of 0.96 for pain anxiety, 0.86 for pain duration and 1.37 for pain intensity, maintained at 2-month follow-up. The investigators offer the MyP-MIET to patients in the US with clearly defined chronic low back pain over 8 weeks, validate it with 30 participants for feasibility and acceptability and exploratory self-report key pain outcomes and objectively (using QST and fMRI), who fit a low interoceptive awareness phenotype. The investigators also use qualitative exit interviews.
Study:
NCT06186193
Study Brief:
Protocol Section:
NCT06186193