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Table 4 Baseline and follow-up measures a

From: Comparison of complementary and alternative medicine with conventional mind–body therapies for chronic back pain: protocol for the Mind–body Approaches to Pain (MAP) randomized controlled trial

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
  1. aCBT, Cognitive-behavioral therapy; CPAQ-8, 8-item Chronic Pain Acceptance Questionnaire; CPCI, Chronic Pain Coping Inventory; EQ-5D, European Quality of Life (EuroQol) instrument in 5 dimensions; FFMQ, Five Facet Mindfulness Questionnaire; GAD-2, 2-item Generalized Anxiety Disorder scale; GCPS, Graded Chronic Pain Scale; MBSR, Mindfulness-based stress reduction; PCS, Pain Catastrophizing Scale; PGIC, Patient Global Impression of Change scale; PHQ-8,8 item Patient Health Questionnaire; PSEQ, Patient Self-efficacy Questionnaire; RDQ, Roland Disability Questionnaire; SF-6D, Short Form Health Survey in 6 dimensions; SF-12, 12-item Short Form Health Survey; SOPA, Survey of Pain Attitudes; WPAI-CLBP, Work Productivity and Activity Impairment Questionnaire–Chronic Low Back Pain.