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Table 4 Baseline and follow-up measures

From: Comparative Efficacy and Mechanisms of a Single-Session Pain Psychology Class in Chronic Low Back Pain: Study Protocol for a Randomized Controlled Trial

Measurement domain/ Name of measure Brief measure description Screening Baseline period Pre-treatment Mid-treatment Post-tx month 0 Post-tx months 1, 2 3, 5, 6
Demographics Age, gender, race, ethnicity, handedness, education level, household income, employment x      
Medical history and medications Height, weight, smoking, back pain etiology, pain duration, pain intensity, other pain conditions, pain treatments, psychological conditions, medications x      
Mini International Neuropsychiatric Interview (MINI) [36] A MINI screen will be administered for two reasons: (1) for exclusionary criteria assessment for suicidality and current substance abuse; (2) to characterize other psychiatric disorders. Positive items will be followed by administering relevant modules of the Structured Clinical Interview for DSM (SCID) by a trained member of the study team x      
Beck Depression Inventory-II (BDI-II) [37] BDI-II, the updated version of the 21 items questionnaire which assesses the intensity of depression in patients. It is the most widely used instrument for detecting depression (http://www.pearsonclinical.com/psychology/products/100000159/beck-depression-inventoryii-bdi-ii.html#tab-details) x      
Structured Clinical Interview for DSM-5 (SCID-5) [38] A semi-structured interview guide for making DSM-5 diagnoses. It is administered by a clinician or trained mental health professional that is familiar with the DSM-5 classification and diagnostic criteria (https://www.appi.org/products/structured-clinical-interview-for-dsm-5-scid-5) x      
Chronic Pain Acceptance Questionnaire (CPAQ-8) [39] Eight question version CPAQ has been designed to measure acceptance of pain. The acceptance of chronic pain is thought to reduce unsuccessful attempts to avoid or control pain and thus focus on engaging in valued activities and pursuing meaningful goals    x x x x
West Haven-Yale Multidimensional Pain Inventory (WHY-MPI) [40] West Haven-Yale MPI is designed to provide a brief, psychometric assessment of important components of the chronic pain experience. In particular, this study will be looking at how a significant other responds to a participant when they are in pain    x x x x
Body map Interactive map of male/female body to select regions that experience pain    x x x x
Back pain bothersomeness Single item measure of back pain bothersomeness in the past week from not at all bothersome to extremely bothersome    x x x x
Satisfaction with Life Scale [41] A 5-item scale designed to measure global cognitive judgments of one’s life satisfaction. Participants indicate how much they agree or disagree with each of the 5 items using a 7-point scale that ranges from 7 strongly agree to 1 strongly disagree    x x x x
Perceived Stress Scale [42] 10 items on a 5-point scale from never to very often measuring aspects of perceived stress in the past month. Items were designed to measure how unpredictable, uncontrollable, and overloaded respondents perceive their life to be    x x x x
Childhood Trauma Questionnaire [43] The self-report measure includes 28 items that measure 5 types of maltreatment: emotional, physical, and sexual abuse; and emotional and physical neglect. Items are measured on a 5-point Likert scale with responses ranging from never true to often true    x    
Positive and Negative Affect Schedule [44] 10 positive affect descriptors and 10 negative affect descriptors are measured for the resent moment on a 5-point scale ranging from very slightly or not at all to extremely    x x x x
Patient’s Global Impression of Change [45] One item measure of status change since start of treatment and one item measure of side effects      x x
Working Alliance Inventory [46] 12 items on 7-point scale from never to always measuring how the participant feels about the treatment group instructor     x x  
Treatment expectancies [47] Stanford Expectations of Treatment Scale, a 6-item tool our group developed and validated at SNAPL, will be used to assess participant expectations of treatment    x    
Mid Credibility Expectancy Questionnaire [48] 4 items assessing patient impressions of the treatment midway through treatment participation     x   
Post Credibility Expectancy Questionnaire [48] 4 items assessing patient impressions of the treatment post-treatment participation      x  
Tx satisfaction, utility, and knowledge 7 items assess participant satisfaction and perceived utility of treatment on a 7-point rating scale. For the SPP group, 5 items will assess knowledge acquired regarding PC and self-treatment      x  
Treatment and life event changes Assesses new treatments, major lifestyle changes, major or adverse life events (negative and positive), and new injuries at different time points throughout the study    x x x x
Skills use Single item measure assessing frequency of skills use learned in class over the past month from not at all to several times per day       x
Primary treatment outcome measures
Pain Catastrophizing Scale (PCS) [5] 13-item scale assesses severity of Trait PC tendencies on a 5-point scale (0 = “not at all” to 4 = “all the time”); sum scores are in the range of 0–52.The PCS has 3 factors (helplessness, magnification, rumination) and has good psychometrics [5]. The PCS total score at 3 months post treatment is our primary endpoint (Trait PC) x   x x x x
NIH PROMIS measures [49] NIH PROMIS measures have been successfully applied in pain research [49,50,51,52] and will be used to assess multiple variables of interest, including Pain Intensity, Pain Interference, Pain Behavior, Function, Depression, Anxiety, Sleep Disturbance, Sleep Interference, Anger, and Fatigue. Computerized automated testing [53] technology will be used to minimize participant burden. Participants also complete PROMIS Global Health at the same time points.    x x x x
Pain Self-Efficacy Questionnaire (PSEQ) [28] 10-item instrument measures self-confidence to manage pain and engage in life activities despite pain [24, 26,27,28,29, 54]. Pain self-efficacy be used as a mediating / moderating / process variable    x x x x
Daily Measures / ESM (2 week data waves)
Daily PCS The 5-item Daily PCS will be administered daily     0–3 mos.
Daily pain, mood, and function questions In a single question for each theme, for the past 24 h, average back pain, highest level of back pain, pain interference, stress, positive emotions, negative emotions, and satisfaction with life as assessed     0–3 mos
Skills use (only for SPP & CBT) SPP group will answer 3 questions assess use of cognitive, behavioral, and psychophysiological techniques over 24 h from 0 times to 5+ times. The pain-CBT group will complete these questions daily after the relevant material is covered in class       0–3 mos
Objective data
Sleep and activity Actigraphy devices will quantify 24 h sleep and activity variables including: total sleep time and efficiency, energy expenditure, MET rates, steps taken, physical activity intensity     0 and 3 mos
Guided relaxation (per participant discretion/ goal settings; continuous data) An app will timestamp each time an SPP participant accesses the “SPP Relaxation Resource” on their device, thus providing an objective measure of skills use       0–3 mos (SPP)
  1. MINI Mini International Neuropsychiatric Interview, WHYMPI/MPI West Haven–Yale Multidimensional Pain Inventory