Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2025-12-28 @ 2:52 AM
Study NCT ID:
NCT06186193
Status:
COMPLETED
Last Update Posted:
2023-12-29
First Post:
2023-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mind Your Pain: Validating a Mindful Interoceptive Exposure Task for Patients With Chronic Low Back Pain
Sponsor:
University of California, San Francisco
Organization:
Study Overview
Official Title:
Mind Your Pain: Validating the Mindful Interoceptive Exposure Task (MIET) for Patients With Chronic Low Back Pain
Status:
COMPLETED
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MyP
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| U19AR076737 | NIH | None | https://reporter.nih.gov/quic… | View |