Chronic Pain, Chronic Pain Syndrome, Migraine
Conditions
Keywords
chronic pain, mind-body, mobile application
Brief summary
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.
Detailed description
See protocol for more details. (submitted at time of registration)
Interventions
BEHAVIORALMind-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.
Sponsors
University of the Fraser Valley
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
19 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Participants aged 19 to 75 years with chronic pain. * chronic pain is defined as having non-malignant chronic or persistent pain for at least 6 months. * Participants must experience pain at least half the days in the last 6 months. * Pain can include bodily pain or head (migraine) pain.
Exclusion criteria
* Individuals reporting a cognitive impairment that can interfere with completing questionnaires and using a mobile application. * Individuals reporting any of the following psychiatric illness: schizophrenia, dissociative or personality disorders, bipolar disorder. * Individuals reporting any of the following medical conditions: metastatic cancer, rheumatoid arthritis, lupus, scleroderma, polymyositis. * Individuals reporting substance use disorder (within the last 6 months). * Individuals that have previously used mind-body apps for the treatment of chronic pain.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Brief Pain Inventory-short Form (BPI-SF) | Baseline, 6 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Reported Outcome Measurement Information System (PROMIS) Short Form 8a Pain Interference | baseline, 6 weeks | 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. |
| Pain Catastrophizing Questionnaire (PCS) | baseline, 6 weeks | 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. |
| DASS-21 (Depression, Anxiety, and Stress Scale) | baseline, 6 weeks | 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. |
| 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) | baseline, 6 weeks | 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 |
| Patient Reported Outcome Measurement Information System (PROMIS) Short Form for Pain Intensity on Average | baseline, 6 weeks | 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. |
| PROMIS Pain Intensity Short Form | 12 weeks | 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. |
| Medication Use | 6 weeks | 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. |
| PROMIS Pain Interference Short Form 8a | 12 weeks | 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. |
| DASS-21 (Depression, Anxiety, Stress Scale - 21 Items) | 12 weeks | 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. |
| Brief Pain Inventory-short Form (BPI-SF) | 12 weeks | 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. |
Countries
Canada
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 98 |
| Control Participants are asked to continue with usual care for pain treatments. They are asked not to start any new forms of treatment. | 100 |
| Total | 198 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 10 | 2 |
| Overall Study | Withdrawal by Subject | 15 | 0 |
Baseline characteristics
| Characteristic | Control | Mind-body Mobile Application | Total |
|---|---|---|---|
| Age, Continuous | 46.9 years STANDARD_DEVIATION 13 | 46.6 years STANDARD_DEVIATION 13.3 | 46.7 years STANDARD_DEVIATION 13.1 |
| Brief Pain Inventory (BPI) Pain Severity on average over past 24 hours | 5.4 units on a scale STANDARD_DEVIATION 1.5 | 5.5 units on a scale STANDARD_DEVIATION 1.6 | 5.45 units on a scale STANDARD_DEVIATION 1.5 |
| Diagnoses Fibromyalgia | 21 Participants | 19 Participants | 40 Participants |
| Diagnoses Migraine | 13 Participants | 10 Participants | 23 Participants |
| Diagnoses Myalgic Encephalomyelitis | 6 Participants | 4 Participants | 10 Participants |
| Diagnoses No formal diagnosis | 64 Participants | 66 Participants | 130 Participants |
| Diagnoses Osteoarthritis | 7 Participants | 6 Participants | 13 Participants |
| Diagnoses Other (not including above conditions) | 7 Participants | 11 Participants | 18 Participants |
| Education Bachelor degree or higher | 55 Participants | 53 Participants | 108 Participants |
| Education High school or less | 10 Participants | 13 Participants | 23 Participants |
| Education Trade or diploma | 33 Participants | 30 Participants | 63 Participants |
| Employment status Did not respond | 0 Participants | 1 Participants | 1 Participants |
| Employment status Employed (full or part time) | 47 Participants | 50 Participants | 97 Participants |
| Employment status Not able to work/on disability | 27 Participants | 27 Participants | 54 Participants |
| Employment status Other (student, homemaker) | 13 Participants | 10 Participants | 23 Participants |
| Employment status Retired | 13 Participants | 10 Participants | 23 Participants |
| Household income > $100 000 | 26 Participants | 25 Participants | 51 Participants |
| Household income < $34 999 | 27 Participants | 29 Participants | 56 Participants |
| Household income $35 000 to $49 999 | 3 Participants | 12 Participants | 15 Participants |
| Household income $50 000 to $74 999 | 20 Participants | 16 Participants | 36 Participants |
| Household income $75 000 to $99 999 | 20 Participants | 13 Participants | 33 Participants |
| Household income Chose not to answer. | 4 Participants | 3 Participants | 7 Participants |
| Pain duration | 14.2 years STANDARD_DEVIATION 11.4 | 13.0 years STANDARD_DEVIATION 11 | 13.6 years STANDARD_DEVIATION 11.2 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Canada | 90 Participants | 86 Participants | 176 Participants |
| Region of Enrollment Estonia | 1 Participants | 0 Participants | 1 Participants |
| Region of Enrollment France | 0 Participants | 1 Participants | 1 Participants |
| Region of Enrollment Greece | 1 Participants | 0 Participants | 1 Participants |
| Region of Enrollment Israel | 0 Participants | 1 Participants | 1 Participants |
| Region of Enrollment Jamaica | 0 Participants | 1 Participants | 1 Participants |
| Region of Enrollment Trinidad and Tobago | 0 Participants | 1 Participants | 1 Participants |
| Region of Enrollment United Kingdom | 0 Participants | 2 Participants | 2 Participants |
| Region of Enrollment United States | 8 Participants | 4 Participants | 12 Participants |
| Sex/Gender, Customized Man | 14 Participants | 15 Participants | 29 Participants |
| Sex/Gender, Customized Missing | 0 Participants | 1 Participants | 1 Participants |
| Sex/Gender, Customized Non-binary | 2 Participants | 3 Participants | 5 Participants |
| Sex/Gender, Customized Prefer not to answer | 0 Participants | 1 Participants | 1 Participants |
| Sex/Gender, Customized Woman | 84 Participants | 78 Participants | 162 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 73 | 0 / 98 |
| other Total, other adverse events | 0 / 73 | 0 / 98 |
| serious Total, serious adverse events | 0 / 73 | 0 / 98 |
Outcome results
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.
Time frame: Baseline, 6 weeks
Population: Intervention period was 6 weeks, and questionnaires were completed at baseline and at 6-weeks.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mind-body Mobile Application | Brief Pain Inventory-short Form (BPI-SF) | BPI Pain interference at 6 weeks | 4.81 score on a scale | Standard Deviation 2.32 |
| Mind-body Mobile Application | Brief Pain Inventory-short Form (BPI-SF) | BPI Pain Interference at baseline | 5.97 score on a scale | Standard Deviation 2.14 |
| Mind-body Mobile Application | Brief Pain Inventory-short Form (BPI-SF) | BPI Average Pain Severity at baseline | 5.33 score on a scale | Standard Deviation 1.47 |
| Mind-body Mobile Application | Brief Pain Inventory-short Form (BPI-SF) | BPI Average Pain Severity at 6-weeks | 4.51 score on a scale | Standard Deviation 1.74 |
| Control | Brief Pain Inventory-short Form (BPI-SF) | BPI Pain interference at 6 weeks | 5.49 score on a scale | Standard Deviation 2.3 |
| Control | Brief Pain Inventory-short Form (BPI-SF) | BPI Average Pain Severity at 6-weeks | 5.16 score on a scale | Standard Deviation 1.44 |
| Control | Brief Pain Inventory-short Form (BPI-SF) | BPI Average Pain Severity at baseline | 5.35 score on a scale | Standard Deviation 1.51 |
| Control | Brief Pain Inventory-short Form (BPI-SF) | BPI Pain Interference at baseline | 6.05 score on a scale | Standard Deviation 2.26 |
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.
Time frame: 12 weeks
Population: Members of the intervention group who completed the additional 12 week follow up (intervention ended at 6 weeks).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mind-body Mobile Application | Brief Pain Inventory-short Form (BPI-SF) | Pain interference (24 hours) | 4.85 score on a scale | Standard Deviation 2.49 |
| Mind-body Mobile Application | Brief Pain Inventory-short Form (BPI-SF) | BPI Pain intensity on average (24 hours) | 4.60 score on a scale | Standard Deviation 1.7 |
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.
Time frame: baseline, 6 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mind-body Mobile Application | DASS-21 (Depression, Anxiety, and Stress Scale) | Total Anxiety Score at baseline | 9.89 score on a scale | Standard Deviation 7.85 |
| Mind-body Mobile Application | DASS-21 (Depression, Anxiety, and Stress Scale) | Total Anxiety Score at 6-weeks | 7.31 score on a scale | Standard Deviation 7.73 |
| Mind-body Mobile Application | DASS-21 (Depression, Anxiety, and Stress Scale) | Total Depression Score at baseline | 14.57 score on a scale | Standard Deviation 9.52 |
| Mind-body Mobile Application | DASS-21 (Depression, Anxiety, and Stress Scale) | Total Stress Score at baseline | 16.54 score on a scale | Standard Deviation 8.78 |
| Mind-body Mobile Application | DASS-21 (Depression, Anxiety, and Stress Scale) | Total Depression Score at 6-weeks | 11.97 score on a scale | Standard Deviation 9.09 |
| Mind-body Mobile Application | DASS-21 (Depression, Anxiety, and Stress Scale) | Total Stress Score at 6-weeks | 13.63 score on a scale | Standard Deviation 8.14 |
| Control | DASS-21 (Depression, Anxiety, and Stress Scale) | Total Stress Score at 6-weeks | 15.46 score on a scale | Standard Deviation 8.63 |
| Control | DASS-21 (Depression, Anxiety, and Stress Scale) | Total Anxiety Score at baseline | 8.92 score on a scale | Standard Deviation 7.13 |
| Control | DASS-21 (Depression, Anxiety, and Stress Scale) | Total Depression Score at 6-weeks | 14.85 score on a scale | Standard Deviation 10.75 |
| Control | DASS-21 (Depression, Anxiety, and Stress Scale) | Total Anxiety Score at 6-weeks | 9.46 score on a scale | Standard Deviation 7.74 |
| Control | DASS-21 (Depression, Anxiety, and Stress Scale) | Total Stress Score at baseline | 15.35 score on a scale | Standard Deviation 8.33 |
| Control | DASS-21 (Depression, Anxiety, and Stress Scale) | Total Depression Score at baseline | 14.52 score on a scale | Standard Deviation 9.84 |
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.
Time frame: 12 weeks
Population: See above 12 week data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mind-body Mobile Application | DASS-21 (Depression, Anxiety, Stress Scale - 21 Items) | Depression | 6.32 score on a scale | Standard Deviation 4.99 |
| Mind-body Mobile Application | DASS-21 (Depression, Anxiety, Stress Scale - 21 Items) | Anxiety | 4.20 score on a scale | Standard Deviation 3.72 |
| Mind-body Mobile Application | DASS-21 (Depression, Anxiety, Stress Scale - 21 Items) | Stress | 7.58 score on a scale | Standard Deviation 4.71 |
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.
Time frame: 6 weeks
Population: Medication categories are not mutually exclusive as many report usage of multiple classes of drugs.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mind-body Mobile Application | Medication Use | Non-opioid analgesics | 48 participants |
| Mind-body Mobile Application | Medication Use | Anti-convulsants | 13 participants |
| Mind-body Mobile Application | Medication Use | Opioid analgesics | 11 participants |
| Mind-body Mobile Application | Medication Use | Anti-depressants (SSRI, SSNI, TCA) | 20 participants |
| Mind-body Mobile Application | Medication Use | Anti-spasmodics | 8 participants |
| Mind-body Mobile Application | Medication Use | Cannabanoids | 6 participants |
| Mind-body Mobile Application | Medication Use | CNS depressants | 5 participants |
| Mind-body Mobile Application | Medication Use | Other medicines related to pain | 9 participants |
| Control | Medication Use | Other medicines related to pain | 5 participants |
| Control | Medication Use | Anti-spasmodics | 9 participants |
| Control | Medication Use | Non-opioid analgesics | 59 participants |
| Control | Medication Use | CNS depressants | 8 participants |
| Control | Medication Use | Opioid analgesics | 29 participants |
| Control | Medication Use | Cannabanoids | 10 participants |
| Control | Medication Use | Anti-depressants (SSRI, SSNI, TCA) | 27 participants |
| Control | Medication Use | Anti-convulsants | 31 participants |
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.
Time frame: baseline, 6 weeks
Population: Missing PCS data for one participant in the control group at 6 weeks.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mind-body Mobile Application | Pain Catastrophizing Questionnaire (PCS) | Total PCS Scores at baseline | 22.55 score on a scale | Standard Deviation 12.22 |
| Mind-body Mobile Application | Pain Catastrophizing Questionnaire (PCS) | Total PCS Scores at 6-weeks | 15.92 score on a scale | Standard Deviation 11.48 |
| Control | Pain Catastrophizing Questionnaire (PCS) | Total PCS Scores at baseline | 23.13 score on a scale | Standard Deviation 11.3 |
| Control | Pain Catastrophizing Questionnaire (PCS) | Total PCS Scores at 6-weeks | 20.38 score on a scale | Standard Deviation 12 |
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.
Time frame: 12 weeks
Population: Members of the intervention group who completed the additional 12 week follow up (intervention ended at 6 weeks).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mind-body Mobile Application | Pain Catastrophizing Questionnaire (PCS) | 16.46 score on a scale | Standard Deviation 12.83 |
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.
Time frame: baseline, 6 weeks
Population: Missing PROMIS data for one participant in the control group at 6 weeks.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mind-body Mobile Application | Patient Reported Outcome Measurement Information System (PROMIS) Short Form 8a Pain Interference | Total PROMIS Pain Interference at 6-weeks | 16.71 score on a scale | Standard Deviation 8.36 |
| Mind-body Mobile Application | Patient Reported Outcome Measurement Information System (PROMIS) Short Form 8a Pain Interference | Total PROMIS Pain Interference at baseline | 28.22 score on a scale | Standard Deviation 7.3 |
| Control | Patient Reported Outcome Measurement Information System (PROMIS) Short Form 8a Pain Interference | Total PROMIS Pain Interference at 6-weeks | 19.63 score on a scale | Standard Deviation 8.28 |
| Control | Patient Reported Outcome Measurement Information System (PROMIS) Short Form 8a Pain Interference | Total PROMIS Pain Interference at baseline | 29.01 score on a scale | Standard Deviation 7.46 |
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.
Time frame: baseline, 6 weeks
Population: Missing PROMIS intensity data for one participant in the control group at 6 weeks.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mind-body Mobile Application | Patient Reported Outcome Measurement Information System (PROMIS) Short Form for Pain Intensity on Average | PROMIS Pain Intensity on average at baseline | 2.99 units on a scale | Standard Deviation 0.59 |
| Mind-body Mobile Application | Patient Reported Outcome Measurement Information System (PROMIS) Short Form for Pain Intensity on Average | PROMIS Pain Intensity on average at 6-weeks | 2.81 units on a scale | Standard Deviation 0.54 |
| Control | Patient Reported Outcome Measurement Information System (PROMIS) Short Form for Pain Intensity on Average | PROMIS Pain Intensity on average at baseline | 3.22 units on a scale | Standard Deviation 0.6 |
| Control | Patient Reported Outcome Measurement Information System (PROMIS) Short Form for Pain Intensity on Average | PROMIS Pain Intensity on average at 6-weeks | 3.08 units on a scale | Standard Deviation 0.61 |
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.
Time frame: 12 weeks
Population: Members of the intervention group who completed the additional 12 week follow up (intervention ended at 6 weeks).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mind-body Mobile Application | PROMIS Pain Intensity Short Form | 2.74 units on a scale | Standard Deviation 0.54 |
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.
Time frame: 12 weeks
Population: Members of the intervention group who completed the additional 12 week follow up (intervention ended at 6 weeks).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mind-body Mobile Application | PROMIS Pain Interference Short Form 8a | 24.34 score on a scale | Standard Deviation 7.54 |
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.
Time frame: 12 weeks
Population: Members of the intervention group who completed the additional 12 week follow up (intervention ended at 6 weeks).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mind-body Mobile Application | 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) | Physical Component Score (SF12) at 12 weeks | 27.66 score on a scale | Standard Deviation 10.34 |
| Mind-body Mobile Application | 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) | Mental Component Score (SF12) at 12 weeks | 50.20 score on a scale | Standard Deviation 7.63 |
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
Time frame: baseline, 6 weeks
Population: Missing Physical Component Score data for three participants in the control group.~Missing Mental Component Score data for three participants in the control group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mind-body Mobile Application | 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) | QOL Physical Component Score at baseline | 25.21 score on a scale | Standard Deviation 11.07 |
| Mind-body Mobile Application | 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) | QOL Physical Component Score at 6-weeks | 29.27 score on a scale | Standard Deviation 11.37 |
| Mind-body Mobile Application | 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) | QOL Mental Component Score at baseline | 47.83 score on a scale | Standard Deviation 5.47 |
| Mind-body Mobile Application | 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) | QOL Mental Component Score at 6-weeks | 49.22 score on a scale | Standard Deviation 6.39 |
| Control | 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) | QOL Mental Component Score at 6-weeks | 50.05 score on a scale | Standard Deviation 6.97 |
| Control | 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) | QOL Physical Component Score at baseline | 21.60 score on a scale | Standard Deviation 9.58 |
| Control | 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) | QOL Mental Component Score at baseline | 49.18 score on a scale | Standard Deviation 6.74 |
| Control | 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) | QOL Physical Component Score at 6-weeks | 23.89 score on a scale | Standard Deviation 11.36 |