An interventional study of Mind-body mobile application in Chronic Pain, Migraine and Chronic Pain Syndrome, sponsored by University of the Fraser Valley. Completed at 1 site in Canada. Open to participants aged 19 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-01-29.
Sponsored by University of the Fraser Valley · Not applicable, Interventional, and Treatment
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)
2,998 studies on the registry are indexed under Chronic Pain; 706 are open to participants now.
This study's enrollment of 198 is above the median of 60 across 2,209 interventional studies indexed under Chronic Pain.
Browse Chronic Pain studies →University of the Fraser Valley is the lead sponsor of 6 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
Participants are asked to engage with a user-guided mobile application (app) that employs mind-based techniques that include: expressive writing, meditation, cognitive behavioural therapy, and pain education. The app also includes access to podcasts that focus on pain counselling and pain education.
Behavioral: Mind-body mobile application
Participants are asked to continue with usual care for pain treatments. They are asked not to start any new forms of treatment.
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.
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
Three cohorts recruited in series for three study starts: Cohort 1: October 15 2021 Cohort 2: January 6 2022 Cohort 3: April 7 2022 Randomized on October 15, 2022 (1); January 6, 2022 (2); and April 7, 2022.
| Milestone | Mind-body Mobile Application | Control |
|---|---|---|
| Started | 98 | 100 |
| Completed | 73 | 98 |
| Not completed | 25 | 2 |
| Withdrew: Lost to follow-up | 10 | 2 |
| Withdrew: Withdrawal by subject | 15 | 0 |
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.
| score on a scale | Mind-body Mobile Application | Control |
|---|---|---|
| BPI Average Pain Severity at baseline | 5.33 ± 1.47 | 5.35 ± 1.51 |
| BPI Average Pain Severity at 6-weeks | 4.51 ± 1.74 | 5.16 ± 1.44 |
| BPI Pain Interference at baseline | 5.97 ± 2.14 | 6.05 ± 2.26 |
| BPI Pain interference at 6 weeks | 4.81 ± 2.32 | 5.49 ± 2.30 |
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.
| units on a scale | Mind-body Mobile Application | Control |
|---|---|---|
| PROMIS Pain Intensity on average at baseline | 2.99 ± 0.59 | 3.22 ± 0.60 |
| PROMIS Pain Intensity on average at 6-weeks | 2.81 ± 0.54 | 3.08 ± 0.61 |
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.
| score on a scale | Mind-body Mobile Application | Control |
|---|---|---|
| Total PROMIS Pain Interference at baseline | 28.22 ± 7.30 | 29.01 ± 7.46 |
| Total PROMIS Pain Interference at 6-weeks | 16.71 ± 8.36 | 19.63 ± 8.28 |
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.
| score on a scale | Mind-body Mobile Application | Control |
|---|---|---|
| Total PCS Scores at baseline | 22.55 ± 12.22 | 23.13 ± 11.30 |
| Total PCS Scores at 6-weeks | 15.92 ± 11.48 | 20.38 ± 12.0 |
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.
| score on a scale | Mind-body Mobile Application | Control |
|---|---|---|
| Total Depression Score at baseline | 14.57 ± 9.52 | 14.52 ± 9.84 |
| Total Depression Score at 6-weeks | 11.97 ± 9.09 | 14.85 ± 10.75 |
| Total Anxiety Score at baseline | 9.89 ± 7.85 | 8.92 ± 7.13 |
| Total Anxiety Score at 6-weeks | 7.31 ± 7.73 | 9.46 ± 7.74 |
| Total Stress Score at baseline | 16.54 ± 8.78 | 15.35 ± 8.33 |
| Total Stress Score at 6-weeks | 13.63 ± 8.14 | 15.46 ± 8.63 |
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
| score on a scale | Mind-body Mobile Application | Control |
|---|---|---|
| QOL Physical Component Score at baseline | 25.21 ± 11.07 | 21.60 ± 9.58 |
| QOL Physical Component Score at 6-weeks | 29.27 ± 11.37 | 23.89 ± 11.36 |
| QOL Mental Component Score at baseline | 47.83 ± 5.47 | 49.18 ± 6.74 |
| QOL Mental Component Score at 6-weeks | 49.22 ± 6.39 | 50.05 ± 6.97 |
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.
| score on a scale | Mind-body Mobile Application |
|---|---|
| BPI Pain intensity on average (24 hours) | 4.60 ± 1.70 |
| Pain interference (24 hours) | 4.85 ± 2.49 |
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.
| units on a scale | Mind-body Mobile Application |
|---|---|
| PROMIS Pain Intensity Short Form | 2.74 ± 0.54 |
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.
| participants | Mind-body Mobile Application | Control |
|---|---|---|
| Non-opioid analgesics | 48 | 59 |
| Opioid analgesics | 11 | 29 |
| Anti-depressants (SSRI, SSNI, TCA) | 20 | 27 |
| Anti-convulsants | 13 | 31 |
| Anti-spasmodics | 8 | 9 |
| Cannabanoids | 6 | 10 |
| CNS depressants | 5 | 8 |
| Other medicines related to pain | 9 | 5 |
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.
| score on a scale | Mind-body Mobile Application |
|---|---|
| PROMIS Pain Interference Short Form 8a | 24.34 ± 7.54 |
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.
| score on a scale | Mind-body Mobile Application |
|---|---|
| Pain Catastrophizing Questionnaire (PCS) | 16.46 ± 12.83 |
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.
| score on a scale | Mind-body Mobile Application |
|---|---|
| Physical Component Score (SF12) at 12 weeks | 27.66 ± 10.34 |
| Mental Component Score (SF12) at 12 weeks | 50.20 ± 7.63 |
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.
| score on a scale | Mind-body Mobile Application |
|---|---|
| Depression | 6.32 ± 4.99 |
| Anxiety | 4.20 ± 3.72 |
| Stress | 7.58 ± 4.71 |
Collected over 6 weeks.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Mind-body Mobile Application | 0/73 (0%) | 0/73 (0%) | 0/73 (0%) |
| Control | 0/98 (0%) | 0/98 (0%) | 0/98 (0%) |
We report baseline characteristics for the full randomized sample (n = 198).
| Age, Continuous(years) | Mind-body Mobile Application | Control | Total |
|---|---|---|---|
| Mean | 46.6 ± 13.3 | 46.9 ± 13.0 | 46.7 ± 13.1 |
| Sex/Gender, Customized(Participants) | Mind-body Mobile Application | Control | Total |
|---|---|---|---|
| Woman | 78 | 84 | 162 |
| Man | 15 | 14 | 29 |
| Non-binary | 3 | 2 | 5 |
| Prefer not to answer | 1 | 0 | 1 |
| Missing | 1 | 0 | 1 |
| Race and Ethnicity Not Collected(Participants) | Mind-body Mobile Application | Control | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(Participants) | Mind-body Mobile Application | Control | Total |
|---|---|---|---|
| Canada | 86 | 90 | 176 |
| France | 1 | 0 | 1 |
| United Kingdom | 2 | 0 | 2 |
| Israel | 1 | 0 | 1 |
| Jamaica | 1 | 0 | 1 |
| Trinidad and Tobago | 1 | 0 | 1 |
| United States | 4 | 8 | 12 |
| Greece | 0 | 1 | 1 |
| Estonia | 0 | 1 | 1 |
| Education(Participants) | Mind-body Mobile Application | Control | Total |
|---|---|---|---|
| High school or less | 13 | 10 | 23 |
| Trade or diploma | 30 | 33 | 63 |
| Bachelor degree or higher | 53 | 55 | 108 |
| Household income(Participants) | Mind-body Mobile Application | Control | Total |
|---|---|---|---|
| < $34 999 | 29 | 27 | 56 |
| $35 000 to $49 999 | 12 | 3 | 15 |
| $50 000 to $74 999 | 16 | 20 | 36 |
| $75 000 to $99 999 | 13 | 20 | 33 |
| > $100 000 | 25 | 26 | 51 |
| Chose not to answer. | 3 | 4 | 7 |
| Pain duration(years) | Mind-body Mobile Application | Control | Total |
|---|---|---|---|
| Mean | 13.0 ± 11.0 | 14.2 ± 11.4 | 13.6 ± 11.2 |
| Diagnoses(Participants) | Mind-body Mobile Application | Control | Total |
|---|---|---|---|
| Fibromyalgia | 19 | 21 | 40 |
| Myalgic Encephalomyelitis | 4 | 6 | 10 |
| Osteoarthritis | 6 | 7 | 13 |
| Migraine | 10 | 13 | 23 |
| No formal diagnosis | 66 | 64 | 130 |
| Other (not including above conditions) | 11 | 7 | 18 |
2 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
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University of the Fraser Valley