Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:20 PM
Ignite Modification Date:
2025-12-24 @ 4:20 PM
NCT ID:
NCT04486066
Eligibility Criteria:
Inclusion Criteria:
All participants must meet criteria for chronic musculoskeletal pain, defined as:
* musculoskeletal pain of low back
* cervical spine, or extremities (hip, knee, or shoulder)
* pain for at least 3 months
* pain severity (worst or average pain score equal to or greater than 4)(i.e., score of 4 or greater on BPI items 3 or 5) and average pain interference (BPI items 9A-9G) rated equal to or great than 3 of 10 over prior week, as measured using the Brief Pain Inventory (BPI)
Exclusion Criteria:
At baseline, the MINI psychiatric interview will determine psychiatric exclusion criteria:
* uncontrolled psychotic disorder
* current bipolar affective disorder with mania
* current suicidal or homicidal ideation with intent in the last month
* inpatient psychiatric admission within the past month
* severe medical conditions that would limit participation (e.g., Class III or IV heart failure)
* pending back surgery
Additional exclusion criteria include prior formal participation in MBSR or CBT-CP. The investigators will include subjects with Alcohol Use Disorder (AUD; defined by the MINI) but exclude those for whom alcohol use poses a safety threat (defined as current drinking and a past-year history of alcohol-related seizures or delirium tremens). The investigators will also include those with Opioid Use Disorder (OUD) and other Substance Use Disorder (SUD; each defined by the MINI).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04486066
Study Brief:
Protocol Section:
NCT04486066