We are investigating the effects of a mind-body based mobile application on the experience of chronic pain. Participants meeting our criteria for chronic pain (confirmed via self-report) will complete an online baseline questionnaire. Eligible participants will be enrolled in the study and randomized into control (usual care, waitlisted) or intervention group (6-week mind-body based mobile application intervention). Randomization will be stratified by pain intensity and gender using computer-generated block randomization to create varying block sizes of 4 and 8. We will run the trial in multiple cohorts in series to obtain desired sample size. All participants will complete online questionnaires at baseline and post-intervention at 6 weeks that measure pain intensity, interference with daily living, pain perceptions, mental health outcomes, and medication use. Participants will also complete weekly questionnaires on weeks 2 to 6 to gauge frequency of application usage (intervention) or other pain treatments (control). Participants in the intervention group will be asked to repeat the follow-up questionnaire at 12-weeks.
See protocol for more details. (submitted at time of registration)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
198
Self-directed; Study team will recommend daily use of mobile app for 6 weeks with a minimum of 4 times/week usage of mobile app for 6 weeks. Frequency will be monitored via weekly surveys.
University of the Fraser Valley
Chilliwack, British Columbia, Canada
Brief Pain Inventory-short Form (BPI-SF)
Primary outcome of Pain Severity: Single item scale within larger Brief Pain Inventory tool. 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). Primary outcome of 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, 6 weeks
Patient Reported Outcome Measurement Information System (PROMIS) Short Form for Pain Intensity on Average
Single item from PROMIS that measures self reported pain intensity on average over 7 days. 5-point scale: 1 = "had no pain" to 5 = "very severe pain" Scale range = (1,5). Higher score indicates worse outcome.
Time frame: baseline, 6 weeks
Patient Reported Outcome Measurement Information System (PROMIS) Short Form 8a Pain Interference
Measures self reported pain interference in daily activities (over 7 days). 8 items are added together for a sum score. Each item uses 5-pt Likert scale from 1 = "not at all" to 5 = "very much" (regarding pain interference). Scale range = 8 to 40. Higher scores indicate worse outcomes.
Time frame: baseline, 6 weeks
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 weeks
DASS-21 (Depression, Anxiety, and Stress Scale)
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 weeks
Quality of Life Short Form 12 (SF-12) Physical (PCS-12) and Mental (MCS-12) Component Summary Scores (Z-scores; Normalized Based on US General Population)
Measures self-reported impact of health on daily life. The SF-12 is a brief version of the longer 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. PCS and MCS are component z-scores that are calculated using regression weights and constants for each (mental and physical) which 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 and PCS. The weighted scores across all items are then summed and are added to a constant (regression intercept) to obtain summary scores. 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 better
Time frame: baseline, 6 weeks
Brief Pain Inventory-short Form (BPI-SF)
Measures self reported pain severity; Pain interference (over past 24 hours) Only measured in the intervention group (as wait-listed controls had accessed the mobile app and were released from the study). BPI Pain Severity: single item scale within larger Brief Pain Inventory tool. 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). 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: 12 weeks
PROMIS Pain Intensity Short Form
Single item from PROMIS that measures self reported pain intensity on average over 7 days. 5-point scale: 1 = "had no pain" to 5 = "very severe pain" Scale range = (1,5). Higher score indicates worse outcome.
Time frame: 12 weeks
Medication Use
Self-reported quantify of medication use (number of participant reporting regular usage). Note: this was a change from original plan for reporting. We have only reported frequencies of use (generally), and omitted details regarding dosage and number of pills as it was decided that this was beyond the scope of our team and trial. We also did not compare baseline to 6 weeks for the same reason.
Time frame: 6 weeks
PROMIS Pain Interference Short Form 8a
Measures self reported pain interference in daily activities (over 7 days). 8 items are added together for a sum score. Each item uses 5-pt Likert scale from 1 = "not at all" to 5 = "very much" (regarding pain interference). Scale range = 8 to 40. Higher scores indicate worse outcomes.
Time frame: 12 weeks
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: 12 weeks
Quality of Life Short Form 12 (SF-12) Physical (PCS-12) and Mental (MCS-12) Component Summary Scores (Z-scores; Normalized Based on US General Population)
Measures self-reported impact of health on daily life. The SF-12 is a brief version of the longer 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. PCS and MCS are component z-scores that are calculated using regression weights and constants for each (mental and physical) which 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 and PCS. The weighted scores across all items are then summed and are added to a constant (regression intercept) to obtain summary scores. 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 better outcomes.
Time frame: 12 weeks
DASS-21 (Depression, Anxiety, Stress Scale - 21 Items)
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: 12 weeks
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