Table 4 Baseline and follow-up measures a
Measures | Baseline | 4 wk | 8 wk | 26 wk | 52 wk |
|---|---|---|---|---|---|
Baseline characteristics | |||||
Patient characteristics (age, sex, education, race, ethnicity, marital status, income, work status, number of pain sites) | x | ||||
Back pain (pain duration, interference with activities, days of pain in previous 6 months, previous spinal injections, whether pain radiates into leg below knee) | x | ||||
Expectations for back pain improvement in general and as result of MBSR or CBT | x | ||||
Primary outcomes | |||||
Back pain-related activity limitations in past week (modified RDQ) | x | x | x | x | x |
Bothersomeness of back pain in past week (0 to 10 scale) | x | x | x | x | x |
Secondary outcomes | |||||
Characteristic pain intensity (GCPS) (average of pain now, worst pain, average pain) | x | x | x | x | |
Depression (PHQ-8) | x | x | x | x | |
Anxiety (GAD-2) | x | x | x | x | |
Medications used for back pain in past week | x | x | x | x | |
Exercise in past week (back pain–specific and general) | x | x | x | x | |
Global improvement (PGIC) | x | x | x | ||
Program’s impact on thoughts, feelings, reactions, activities (open-ended) | x | x | x | ||
Potential mediators | |||||
MBSR: mindfulness (FFMQ-SF), pain acceptance (CPAQ-8) | x | x | x | x | x |
CBT: pain beliefs and appraisals (PSEQ; SOPA 2-item control, disability and harm scales; PCS), pain coping strategies (CPCI activity pacing scale and 2-item relaxation scale) | x | x | x | x | x |
Cost-effectiveness outcomes | |||||
Quality of life (EQ-5D, SF-6D from the SF-12) | x | x | x | x | x |
Out-of-plan visits paid for by patients since previous follow-up interview | x | x | x | x | |
Absenteeism, presenteeism (WPAI-CLBP) | x | x | x | x | |
Costs paid by GHC (payer) for back-related utilization of services (visits, tests, prescriptions) and total costs (GHC members only) (from GHC electronic medical records for year prior to trial and for follow-up year) | |||||
Intervention-related information | |||||
Class attendance (class records) | |||||
Adverse experiences from classes or home practice | x | x | x | x | |
New serious health problems since entering study | x | x | x | x | |
Self-reported home practice | x | x | x | x | |
Perceived helpfulness of classes and home practice | x | x | x | ||
Would recommend program to friends | x | x | x | ||