Evaluation of a Mind-Body Based Approach for Chronic Pain Treatment

Change in Patient Reported Outcome Measurement Information System (PROMIS) Pain Intensity short form 3a

Measures self reported pain intensity over the past 7 days "on average" and "at its worst" along with an item to assess pain intensity "now". The three items are added together to produce a raw score which can be converted to a t-score. Each item uses 5-pt Likert scale from 1 = "had no pain" to 5 = "very severe". Raw scores range from 3 to 15. Higher scores indicate worse outcomes.

Time frame: Baseline, 6 weeks, 12 weeks

Change in Patient Reported Outcome Measurement Information System (PROMIS) Pain Interference short form 8a

Measures self reported pain interference in daily activities (over 7 days). 8 items are added together for a raw score, which can then be converted to a t-score. Each item uses 5-pt Likert scale from 1 = "not at all" to 5 = "very much" (regarding pain interference). Raw scores range from 8 to 40. Higher scores indicate worse outcomes.

Time frame: Baseline, 6 weeks, 12 weeks

Change in Pain Catastrophizing Questionnaire (PCS)

Measures thoughts and perceptions of pain, 13 items, scored using 5-pt Likert scale 0 = "not at all" to 4 = "all the time". Scores are the sum of all items. min score = 0; max score = 52. Higher scores indicate worse outcomes.

Time frame: Baseline, 6 and 12 weeks

Change in Depression, Anxiety, and Stress Scale (DASS-21)

Measures self reported emotional states, three subscales: depression, anxiety, stress (each 7 items) Items scored on 4-point Likert scale: 0 = "did not apply to me at all" to 3 = "applied to me very much or most of the time". Scores for each subscale are summed. Scores are then multiplied by 2 to calculate final score for each subscale. Scale ranges for each subscale is from 0 to 42 (after doubling of scores). Higher scores indicate worse outcomes.

Time frame: Baseline, 6 and 12 weeks

Change in Quality of Life Short Form 12 (SF-12) Physical Component Score

Measures self-reported impact of health on daily life. The SF-12 is a brief version of the SF-36 and contains 12 items measured using a variety of Likert scales and dichotomous yes/no scales, with each item response assigned a numerical weight. The Physical Component Score (PCS) is a summary score that is reported as a z-score. Scores are calculated using regression weights and constants that have been derived from a U.S. population. Each item response choice category is coded as an indicator variable (scored 1 / 0). Indicator variables are weighted using regression coefficients from the US population for the PCS. The weighted scores across all items are then summed and are added to a constant (regression intercept) to obtain a summary score. Score ranges 0 to 100. Normalized score such that component scales have a mean of 50 and standard deviation of 10 in the general population. Lower scores indicate worse outcomes. Higher scores indicate improved physical health.

Time frame: Baseline, 6 and 12 weeks

Change in Quality of Life Short Form 12 (SF-12) Mental Component Score

Measures self-reported impact of health on daily life. The SF-12 is a brief version of the SF-36 and contains 12 items measured using a variety of Likert scales and dichotomous yes/no scales, with each item response assigned a numerical weight. The Mental Component Score (MCS) is a summary score that is reported as a z-score. Scores are calculated using regression weights and constants that have been derived from a U.S. population. Each item response choice category is coded as an indicator variable (scored 1 / 0). Indicator variables are weighted using regression coefficients from the US population for the MCS. The weighted scores across all items are then summed and are added to a constant (regression intercept) to obtain a summary score. Score ranges 0 to 100. Normalized score such that component scales have a mean of 50 and standard deviation of 10 in the general population. Lower scores indicate worse outcomes. Higher scores indicate improved mental health.

Time frame: Baseline, 6 and 12 weeks

Change in Tampa Scale of Kinesiophobia Questionnaire (TSK)

Measured self-reported kinesiophobia assessing fear of movement or re-injury due to pain. Each item rated on a 4-point Likert scale: 1 = "strongly disagree" to 4 = "strongly agree." Total score range = (11, 44). Higher scores indicate greater fear of movement and worse outcomes.

Time frame: Baseline, 6 and 12 weeks

Change in Brief Pain Inventory Pain Severity Composite Score

A composite score derived from the average of four items that assesses at its "worst", "least", "average" over the past 24 hours, along with "now". Item scales range from 0 to 10. 0 = "no pain", 10 = "pain as bad as you can imagine". Higher scores indicate worse outcome, lower scores indicate better outcome. Item range = (0,10).

Time frame: baseline, 6 weeks, 12 weeks

Change in Brief Pain Inventory Pain Severity (from baseline to 12 weeks)

Note: This is a secondary outcome (change from 0 to 6 weeks is a primary outcome). Measures self reported pain severity and pain interference (over past 24 hours). BPI Pain Severity: single item scale within larger Brief Pain Inventory tool that inquires about "average" pain severity over the past 24 hours. Item scale ranges from 0 to 10. 0 = "no pain", 10 = "pain as bad as you can imagine". Higher scores indicate worse outcome, lower scores indicate better outcome. Item range = (0,10).

Time frame: baseline, 12 weeks

Change in Brief Pain Inventory Interference (from baseline to 12 weeks)

Note: This is a secondary outcome (change from 0 to 6 weeks is a primary outcome). Measures self reported pain interference (over past 24 hours). BPI Pain Interference: Item 9 on BPI measures interference with daily living. There are 7 items embedded within and each is scored on 11-point scales from 0 = "does not interfere" to 10 = "completely interferes" for interference with activities of daily living. Pain interference score is calculated as an average of the 7 items, with a range from 0 to 10. Higher scores represent worse outcomes.

Time frame: baseline, 12 weeks