Table 2.
Exclusion criteria | Rationale | Sources |
Previous CBTa or MBSRb treatment or similar coursework in the last 2 years, or previous acupuncture treatment for any reason in the past 5 years, respectively, for the two projectsc | Possible bias due to prior exposure to treatment | Ad, TSe, Sf |
For the CBT and MBSR project, regular meditation practice (≥2 times/week, ≥15 minutes per meditation session, for ≥6 months) over the last 2 yearsc | Possible bias due to prior exposure to some essential aspects of MBSR | A, TS, S |
Participating in any interventional research study or completed participation in the last 2 months; enrollment in an observational study is acceptablec | Treatment interference | A, TS, S |
MRIg contraindications (eg, metal implants and claustrophobia)c | MRI safety | A, TS, S |
Neurologic disorder, history of seizures, stroke, or brain abnormalities, at the discretion of the study teamc | Brain integrity interference | A, TS, S |
Any radicular symptoms or other comorbid pain syndrome | Study restricted to low back pain | A, TS, S |
Any medical condition (eg, active infection and heart disease) that would interfere with study procedures, at the discretion of the study teamc | Medical conditions may confound mechanistic inferences | A, TS, S |
Mental health conditions or treatment for mental health problems that would interfere with study procedures, at the discretion of the study teamc | Mental health conditions may confound mechanistic inferences | A, TS, S |
Medications: starting new medical treatment or medication for pain 2 months prior to initiation of study procedures; opioids ≥60 mg morphine equivalent units/day, anticonvulsants, benzodiazepines, beta-blockers, some antipsychotics, diabetic medications, or other medications that may interfere with study procedures at the discretion of the study team. TCAsh, gabapentinoids, SSRIsi, and SNRIsj are not exclusionary if on a stable dose of at least 2 monthsc | Medications may confound mechanistic inferences | A, TS, S |
Ongoing legal or disability claim or worker’s compensation (permanent and stationary disability not exclusionary)c | Ongoing legal or disability claims may confound mechanistic inferences | A, TS, S |
Currently pregnant or planning to become pregnantc | Pregnancy may confound mechanistic inferences | A, TS, S |
Disorders indicated by the MINIk self-report questionnaire will be characterized and participants may be excluded at the discretion of the researcher | Condition that would make it difficult for a person to partake in treatments (eg, suicidality or psychotic disorders) | S |
aCBT: cognitive behavioral therapy.
bMBSR: mindfulness-based stress reduction.
cThis criterion was also applied to the healthy control group.
dA: automated data gathered from REDCap (Research Electronic Data Capture) surveys.
eTS: telephone screening.
fS: screening visit.
gMRI: magnetic resonance imaging.
hTCA: tricyclic antidepressant.
iSSRI: selective serotonin reuptake inhibitor.
jSNRI: serotonin and norepinephrine reuptake inhibitor.
kMINI: Mini–International Neuropsychiatric Interview.