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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mind-body mobile application | Experimental | 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. |
|
| Control | No Intervention | Participants are asked to continue with usual care for pain treatments. They are asked not to start any new forms of treatment. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mind-body mobile application | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline, 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cynthia J Thomson, PhD | University of the Fraser Valley | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of the Fraser Valley | Chilliwack | British Columbia | V2R0N3 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34586357 | Background | Ashar YK, Gordon A, Schubiner H, Uipi C, Knight K, Anderson Z, Carlisle J, Polisky L, Geuter S, Flood TF, Kragel PA, Dimidjian S, Lumley MA, Wager TD. Effect of Pain Reprocessing Therapy vs Placebo and Usual Care for Patients With Chronic Back Pain: A Randomized Clinical Trial. JAMA Psychiatry. 2022 Jan 1;79(1):13-23. doi: 10.1001/jamapsychiatry.2021.2669. | |
| 33167300 |
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Participants completed a baseline questionnaire following initial interest in the study. If the participants did not meet the criteria for chronic/persistent pain based on their responses to this survey, they were automatically excluded. If participants did not complete baseline (pre-randomization) survey such that primary outcome and randomization data was incomplete, they were excluded.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Mind-body Mobile Application | 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. Mind-body mobile application: 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. |
| FG001 | Control | Participants are asked to continue with usual care for pain treatments. They are asked not to start any new forms of treatment. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
We report baseline characteristics for the full randomized sample (n = 198).
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| ID | Title | Description |
|---|---|---|
| BG000 | Mind-body Mobile Application | 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. Mind-body mobile application: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Missing age data for three participants in the intervention group, leaving n = 95 for mean age calculation. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Intervention period was 6 weeks, and questionnaires were completed at baseline and at 6-weeks. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 6 weeks |
|
6 weeks.
There were no adverse events reported at the 6-week follow up. We have data for completed cases (n = 73 intervention, n = 98 control. There was an open ended question to report anything not captured by our survey. No participants reported any adverse events due to the intervention. We do not have data for those that were lost to follow up.
Only the intervention group was followed at 12 weeks. No adverse events reported in the intervention group at 12 weeks (n = 65 completed survey).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mind-body Mobile Application | 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. Mind-body mobile application: 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. |
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Note the data reported here are for complete cases (n = 171) and represent means from raw data (not estimated means). n = 73 intervention, n = 98 usual care (with missing data in secondary outcomes noted). Formal analysis presented in reports include intention to treat sample (n = 198) and estimated marginal means are reported elsewhere.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Cynthia Thomson | University of the Fraser Valley | 6045047441 | 2518 | cynthia.thomson@ufv.ca |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 12, 2021 | Oct 13, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Participants will be randomized into one of two groups: control (usual care, waitlisted) or intervention group (6-week mind-body mobile application use). Randomization will be stratified on pain intensity and gender using computer generated block randomization to create varying block sizes of 4 and 8.
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Participants in the control group will be aware that they have are serving as controls that have been wait-listed for access to the mobile application.
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| 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. |
| 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. | 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. | 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 | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 12 weeks |
| Pfeifer AC, Uddin R, Schroder-Pfeifer P, Holl F, Swoboda W, Schiltenwolf M. Mobile Application-Based Interventions for Chronic Pain Patients: A Systematic Review and Meta-Analysis of Effectiveness. J Clin Med. 2020 Nov 5;9(11):3557. doi: 10.3390/jcm9113557. |
| 17610459 | Background | Morone NE, Greco CM. Mind-body interventions for chronic pain in older adults: a structured review. Pain Med. 2007 May-Jun;8(4):359-75. doi: 10.1111/j.1526-4637.2007.00312.x. |
| 25844555 | Background | Treede RD, Rief W, Barke A, Aziz Q, Bennett MI, Benoliel R, Cohen M, Evers S, Finnerup NB, First MB, Giamberardino MA, Kaasa S, Kosek E, Lavand'homme P, Nicholas M, Perrot S, Scholz J, Schug S, Smith BH, Svensson P, Vlaeyen JWS, Wang SJ. A classification of chronic pain for ICD-11. Pain. 2015 Jun;156(6):1003-1007. doi: 10.1097/j.pain.0000000000000160. No abstract available. |
| 17998077 | Background | Borm GF, Fransen J, Lemmens WA. A simple sample size formula for analysis of covariance in randomized clinical trials. J Clin Epidemiol. 2007 Dec;60(12):1234-8. doi: 10.1016/j.jclinepi.2007.02.006. Epub 2007 Jun 6. |
| 22184555 | Background | Schopflocher D, Taenzer P, Jovey R. The prevalence of chronic pain in Canada. Pain Res Manag. 2011 Nov-Dec;16(6):445-50. doi: 10.1155/2011/876306. |
| 28919117 | Background | GBD 2016 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 328 diseases and injuries for 195 countries, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet. 2017 Sep 16;390(10100):1211-1259. doi: 10.1016/S0140-6736(17)32154-2. |
| 8628042 | Background | Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. doi: 10.1097/00005650-199603000-00003. |
| 17592957 | Background | Gatchel RJ, Peng YB, Peters ML, Fuchs PN, Turk DC. The biopsychosocial approach to chronic pain: scientific advances and future directions. Psychol Bull. 2007 Jul;133(4):581-624. doi: 10.1037/0033-2909.133.4.581. |
| 7726811 | Background | Lovibond PF, Lovibond SH. The structure of negative emotional states: comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behav Res Ther. 1995 Mar;33(3):335-43. doi: 10.1016/0005-7967(94)00075-u. |
| 8080219 | Background | Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap. 1994 Mar;23(2):129-38. |
| 9429990 | Background | Osman A, Barrios FX, Kopper BA, Hauptmann W, Jones J, O'Neill E. Factor structure, reliability, and validity of the Pain Catastrophizing Scale. J Behav Med. 1997 Dec;20(6):589-605. doi: 10.1023/a:1025570508954. |
| 26807536 | Background | Kean J, Monahan PO, Kroenke K, Wu J, Yu Z, Stump TE, Krebs EE. Comparative Responsiveness of the PROMIS Pain Interference Short Forms, Brief Pain Inventory, PEG, and SF-36 Bodily Pain Subscale. Med Care. 2016 Apr;54(4):414-21. doi: 10.1097/MLR.0000000000000497. |
| BG001 | Control | Participants are asked to continue with usual care for pain treatments. They are asked not to start any new forms of treatment. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Missing data on region of enrolment for 2 participants in the intervention group, leaving n = 96 for descriptive statistics for region. | Count of Participants | Participants |
|
| Education | Missing data on education for n = 2 in intervention group and n = 2 in control group, leaving n = 96 intervention and n = 98 control. | Count of Participants | Participants |
|
| Household income | Count of Participants | Participants |
|
| Pain duration | Missing data for 1 participant. | Mean | Standard Deviation | years |
|
| Diagnoses | Diagnoses are not mutually exclusive as 24 participants had multiple diagnoses. | Count of Participants | Participants |
|
| Brief Pain Inventory (BPI) Pain Severity on average over past 24 hours | 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. | Mean | Standard Deviation | units on a scale |
|
| Employment status | Count of Participants | Participants |
|
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.
Mind-body mobile application: 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.
| OG001 | Control | Participants are asked to continue with usual care for pain treatments. They are asked not to start any new forms of treatment. |
|
|
| Secondary | 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. | Missing PROMIS intensity data for one participant in the control group at 6 weeks. | Posted | Mean | Standard Deviation | units on a scale | baseline, 6 weeks |
|
|
|
| Secondary | 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. | Missing PROMIS data for one participant in the control group at 6 weeks. | Posted | Mean | Standard Deviation | score on a scale | baseline, 6 weeks |
|
|
|
| Secondary | 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. | Missing PCS data for one participant in the control group at 6 weeks. | Posted | Mean | Standard Deviation | score on a scale | baseline, 6 weeks |
|
|
|
| Secondary | 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. | Missing depression data for two participants in the control group. Missing anxiety data for one participant in the intervention group and two participants in the control group. Missing stress data for two participants in the intervention group and two participants in the control group. | Posted | Mean | Standard Deviation | score on a scale | baseline, 6 weeks |
|
|
|
| Secondary | 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 | Missing Physical Component Score data for three participants in the control group. Missing Mental Component Score data for three participants in the control group. | Posted | Mean | Standard Deviation | score on a scale | baseline, 6 weeks |
|
|
|
| Secondary | 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. | Members of the intervention group who completed the additional 12 week follow up (intervention ended at 6 weeks). | Posted | Mean | Standard Deviation | score on a scale | 12 weeks |
|
|
|
| Secondary | 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. | Members of the intervention group who completed the additional 12 week follow up (intervention ended at 6 weeks). | Posted | Mean | Standard Deviation | units on a scale | 12 weeks |
|
|
|
| Secondary | 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. | Medication categories are not mutually exclusive as many report usage of multiple classes of drugs. | Posted | Number | participants | 6 weeks |
|
|
|
| Secondary | 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. | Members of the intervention group who completed the additional 12 week follow up (intervention ended at 6 weeks). | Posted | Mean | Standard Deviation | score on a scale | 12 weeks |
|
|
|
| Secondary | 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. | Members of the intervention group who completed the additional 12 week follow up (intervention ended at 6 weeks). | Posted | Mean | Standard Deviation | score on a scale | 12 weeks |
|
|
|
| Secondary | 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. | Members of the intervention group who completed the additional 12 week follow up (intervention ended at 6 weeks). | Posted | Mean | Standard Deviation | score on a scale | 12 weeks |
|
|
|
| Secondary | 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. | See above 12 week data. | Posted | Mean | Standard Deviation | score on a scale | 12 weeks |
|
|
|
| 0 |
| 73 |
| 0 |
| 73 |
| 0 |
| 73 |
| EG001 | Control | Participants are asked to continue with usual care for pain treatments. They are asked not to start any new forms of treatment. | 0 | 98 | 0 | 98 | 0 | 98 |
Not provided
Not provided
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| Total Depression Score at 6-weeks |
|
|
| Total Anxiety Score at baseline |
|
|
| Total Anxiety Score at 6-weeks |
|
|
| Total Stress Score at baseline |
|
|
| Total Stress Score at 6-weeks |
|
|
| QOL Mental Component Score at baseline |
|
| QOL Mental Component Score at 6-weeks |
|
| Anti-depressants (SSRI, SSNI, TCA) |
|
| Anti-convulsants |
|
| Anti-spasmodics |
|
| Cannabanoids |
|
| CNS depressants |
|
| Other medicines related to pain |
|
|
| Stress |
|
|