Trial Outcomes & Findings for Evaluation of a Mind-body Based Application for the Treatment of Chronic/Persistent Pain. (NCT NCT05090683)
NCT ID: NCT05090683
Last Updated: 2025-01-29
Results Overview
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.
COMPLETED
NA
198 participants
Baseline, 6 weeks
2025-01-29
Participant Flow
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.
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.
Participant milestones
| Measure |
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.
|
Control
Participants are asked to continue with usual care for pain treatments. They are asked not to start any new forms of treatment.
|
|---|---|---|
|
Overall Study
STARTED
|
98
|
100
|
|
Overall Study
COMPLETED
|
73
|
98
|
|
Overall Study
NOT COMPLETED
|
25
|
2
|
Reasons for withdrawal
| Measure |
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.
|
Control
Participants are asked to continue with usual care for pain treatments. They are asked not to start any new forms of treatment.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
10
|
2
|
|
Overall Study
Withdrawal by Subject
|
15
|
0
|
Baseline Characteristics
Missing age data for three participants in the intervention group, leaving n = 95 for mean age calculation.
Baseline characteristics by cohort
| Measure |
Mind-body Mobile Application
n=98 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.
|
Control
n=100 Participants
Participants are asked to continue with usual care for pain treatments. They are asked not to start any new forms of treatment.
|
Total
n=198 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.6 years
STANDARD_DEVIATION 13.3 • n=95 Participants • Missing age data for three participants in the intervention group, leaving n = 95 for mean age calculation.
|
46.9 years
STANDARD_DEVIATION 13.0 • n=100 Participants • Missing age data for three participants in the intervention group, leaving n = 95 for mean age calculation.
|
46.7 years
STANDARD_DEVIATION 13.1 • n=195 Participants • Missing age data for three participants in the intervention group, leaving n = 95 for mean age calculation.
|
|
Sex/Gender, Customized
Woman
|
78 Participants
n=98 Participants
|
84 Participants
n=100 Participants
|
162 Participants
n=198 Participants
|
|
Sex/Gender, Customized
Man
|
15 Participants
n=98 Participants
|
14 Participants
n=100 Participants
|
29 Participants
n=198 Participants
|
|
Sex/Gender, Customized
Non-binary
|
3 Participants
n=98 Participants
|
2 Participants
n=100 Participants
|
5 Participants
n=198 Participants
|
|
Sex/Gender, Customized
Prefer not to answer
|
1 Participants
n=98 Participants
|
0 Participants
n=100 Participants
|
1 Participants
n=198 Participants
|
|
Sex/Gender, Customized
Missing
|
1 Participants
n=98 Participants
|
0 Participants
n=100 Participants
|
1 Participants
n=198 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Canada
|
86 Participants
n=96 Participants • Missing data on region of enrolment for 2 participants in the intervention group, leaving n = 96 for descriptive statistics for region.
|
90 Participants
n=100 Participants • Missing data on region of enrolment for 2 participants in the intervention group, leaving n = 96 for descriptive statistics for region.
|
176 Participants
n=196 Participants • Missing data on region of enrolment for 2 participants in the intervention group, leaving n = 96 for descriptive statistics for region.
|
|
Region of Enrollment
France
|
1 Participants
n=96 Participants • Missing data on region of enrolment for 2 participants in the intervention group, leaving n = 96 for descriptive statistics for region.
|
0 Participants
n=100 Participants • Missing data on region of enrolment for 2 participants in the intervention group, leaving n = 96 for descriptive statistics for region.
|
1 Participants
n=196 Participants • Missing data on region of enrolment for 2 participants in the intervention group, leaving n = 96 for descriptive statistics for region.
|
|
Region of Enrollment
United Kingdom
|
2 Participants
n=96 Participants • Missing data on region of enrolment for 2 participants in the intervention group, leaving n = 96 for descriptive statistics for region.
|
0 Participants
n=100 Participants • Missing data on region of enrolment for 2 participants in the intervention group, leaving n = 96 for descriptive statistics for region.
|
2 Participants
n=196 Participants • Missing data on region of enrolment for 2 participants in the intervention group, leaving n = 96 for descriptive statistics for region.
|
|
Region of Enrollment
Israel
|
1 Participants
n=96 Participants • Missing data on region of enrolment for 2 participants in the intervention group, leaving n = 96 for descriptive statistics for region.
|
0 Participants
n=100 Participants • Missing data on region of enrolment for 2 participants in the intervention group, leaving n = 96 for descriptive statistics for region.
|
1 Participants
n=196 Participants • Missing data on region of enrolment for 2 participants in the intervention group, leaving n = 96 for descriptive statistics for region.
|
|
Region of Enrollment
Jamaica
|
1 Participants
n=96 Participants • Missing data on region of enrolment for 2 participants in the intervention group, leaving n = 96 for descriptive statistics for region.
|
0 Participants
n=100 Participants • Missing data on region of enrolment for 2 participants in the intervention group, leaving n = 96 for descriptive statistics for region.
|
1 Participants
n=196 Participants • Missing data on region of enrolment for 2 participants in the intervention group, leaving n = 96 for descriptive statistics for region.
|
|
Region of Enrollment
Trinidad and Tobago
|
1 Participants
n=96 Participants • Missing data on region of enrolment for 2 participants in the intervention group, leaving n = 96 for descriptive statistics for region.
|
0 Participants
n=100 Participants • Missing data on region of enrolment for 2 participants in the intervention group, leaving n = 96 for descriptive statistics for region.
|
1 Participants
n=196 Participants • Missing data on region of enrolment for 2 participants in the intervention group, leaving n = 96 for descriptive statistics for region.
|
|
Region of Enrollment
United States
|
4 Participants
n=96 Participants • Missing data on region of enrolment for 2 participants in the intervention group, leaving n = 96 for descriptive statistics for region.
|
8 Participants
n=100 Participants • Missing data on region of enrolment for 2 participants in the intervention group, leaving n = 96 for descriptive statistics for region.
|
12 Participants
n=196 Participants • Missing data on region of enrolment for 2 participants in the intervention group, leaving n = 96 for descriptive statistics for region.
|
|
Region of Enrollment
Greece
|
0 Participants
n=96 Participants • Missing data on region of enrolment for 2 participants in the intervention group, leaving n = 96 for descriptive statistics for region.
|
1 Participants
n=100 Participants • Missing data on region of enrolment for 2 participants in the intervention group, leaving n = 96 for descriptive statistics for region.
|
1 Participants
n=196 Participants • Missing data on region of enrolment for 2 participants in the intervention group, leaving n = 96 for descriptive statistics for region.
|
|
Region of Enrollment
Estonia
|
0 Participants
n=96 Participants • Missing data on region of enrolment for 2 participants in the intervention group, leaving n = 96 for descriptive statistics for region.
|
1 Participants
n=100 Participants • Missing data on region of enrolment for 2 participants in the intervention group, leaving n = 96 for descriptive statistics for region.
|
1 Participants
n=196 Participants • Missing data on region of enrolment for 2 participants in the intervention group, leaving n = 96 for descriptive statistics for region.
|
|
Education
High school or less
|
13 Participants
n=96 Participants • Missing data on education for n = 2 in intervention group and n = 2 in control group, leaving n = 96 intervention and n = 98 control.
|
10 Participants
n=98 Participants • Missing data on education for n = 2 in intervention group and n = 2 in control group, leaving n = 96 intervention and n = 98 control.
|
23 Participants
n=194 Participants • Missing data on education for n = 2 in intervention group and n = 2 in control group, leaving n = 96 intervention and n = 98 control.
|
|
Education
Trade or diploma
|
30 Participants
n=96 Participants • Missing data on education for n = 2 in intervention group and n = 2 in control group, leaving n = 96 intervention and n = 98 control.
|
33 Participants
n=98 Participants • Missing data on education for n = 2 in intervention group and n = 2 in control group, leaving n = 96 intervention and n = 98 control.
|
63 Participants
n=194 Participants • Missing data on education for n = 2 in intervention group and n = 2 in control group, leaving n = 96 intervention and n = 98 control.
|
|
Education
Bachelor degree or higher
|
53 Participants
n=96 Participants • Missing data on education for n = 2 in intervention group and n = 2 in control group, leaving n = 96 intervention and n = 98 control.
|
55 Participants
n=98 Participants • Missing data on education for n = 2 in intervention group and n = 2 in control group, leaving n = 96 intervention and n = 98 control.
|
108 Participants
n=194 Participants • Missing data on education for n = 2 in intervention group and n = 2 in control group, leaving n = 96 intervention and n = 98 control.
|
|
Household income
< $34 999
|
29 Participants
n=98 Participants
|
27 Participants
n=100 Participants
|
56 Participants
n=198 Participants
|
|
Household income
$35 000 to $49 999
|
12 Participants
n=98 Participants
|
3 Participants
n=100 Participants
|
15 Participants
n=198 Participants
|
|
Household income
$50 000 to $74 999
|
16 Participants
n=98 Participants
|
20 Participants
n=100 Participants
|
36 Participants
n=198 Participants
|
|
Household income
$75 000 to $99 999
|
13 Participants
n=98 Participants
|
20 Participants
n=100 Participants
|
33 Participants
n=198 Participants
|
|
Household income
> $100 000
|
25 Participants
n=98 Participants
|
26 Participants
n=100 Participants
|
51 Participants
n=198 Participants
|
|
Household income
Chose not to answer.
|
3 Participants
n=98 Participants
|
4 Participants
n=100 Participants
|
7 Participants
n=198 Participants
|
|
Pain duration
|
13.0 years
STANDARD_DEVIATION 11.0 • n=98 Participants • Missing data for 1 participant.
|
14.2 years
STANDARD_DEVIATION 11.4 • n=99 Participants • Missing data for 1 participant.
|
13.6 years
STANDARD_DEVIATION 11.2 • n=197 Participants • Missing data for 1 participant.
|
|
Diagnoses
Fibromyalgia
|
19 Participants
n=98 Participants
|
21 Participants
n=100 Participants
|
40 Participants
n=198 Participants
|
|
Diagnoses
Myalgic Encephalomyelitis
|
4 Participants
n=98 Participants
|
6 Participants
n=100 Participants
|
10 Participants
n=198 Participants
|
|
Diagnoses
Osteoarthritis
|
6 Participants
n=98 Participants
|
7 Participants
n=100 Participants
|
13 Participants
n=198 Participants
|
|
Diagnoses
Migraine
|
10 Participants
n=98 Participants
|
13 Participants
n=100 Participants
|
23 Participants
n=198 Participants
|
|
Diagnoses
No formal diagnosis
|
66 Participants
n=98 Participants
|
64 Participants
n=100 Participants
|
130 Participants
n=198 Participants
|
|
Diagnoses
Other (not including above conditions)
|
11 Participants
n=98 Participants
|
7 Participants
n=100 Participants
|
18 Participants
n=198 Participants
|
|
Brief Pain Inventory (BPI) Pain Severity on average over past 24 hours
|
5.5 units on a scale
STANDARD_DEVIATION 1.6 • n=98 Participants
|
5.4 units on a scale
STANDARD_DEVIATION 1.5 • n=100 Participants
|
5.45 units on a scale
STANDARD_DEVIATION 1.5 • n=198 Participants
|
|
Employment status
Employed (full or part time)
|
50 Participants
n=98 Participants
|
47 Participants
n=100 Participants
|
97 Participants
n=198 Participants
|
|
Employment status
Retired
|
10 Participants
n=98 Participants
|
13 Participants
n=100 Participants
|
23 Participants
n=198 Participants
|
|
Employment status
Other (student, homemaker)
|
10 Participants
n=98 Participants
|
13 Participants
n=100 Participants
|
23 Participants
n=198 Participants
|
|
Employment status
Not able to work/on disability
|
27 Participants
n=98 Participants
|
27 Participants
n=100 Participants
|
54 Participants
n=198 Participants
|
|
Employment status
Did not respond
|
1 Participants
n=98 Participants
|
0 Participants
n=100 Participants
|
1 Participants
n=198 Participants
|
PRIMARY outcome
Timeframe: Baseline, 6 weeksPopulation: Intervention period was 6 weeks, and questionnaires were completed at baseline and at 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.
Outcome measures
| Measure |
Mind-body Mobile Application
n=73 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.
|
Control
n=98 Participants
Participants are asked to continue with usual care for pain treatments. They are asked not to start any new forms of treatment.
|
|---|---|---|
|
Brief Pain Inventory-short Form (BPI-SF)
BPI Average Pain Severity at baseline
|
5.33 score on a scale
Standard Deviation 1.47
|
5.35 score on a scale
Standard Deviation 1.51
|
|
Brief Pain Inventory-short Form (BPI-SF)
BPI Average Pain Severity at 6-weeks
|
4.51 score on a scale
Standard Deviation 1.74
|
5.16 score on a scale
Standard Deviation 1.44
|
|
Brief Pain Inventory-short Form (BPI-SF)
BPI Pain Interference at baseline
|
5.97 score on a scale
Standard Deviation 2.14
|
6.05 score on a scale
Standard Deviation 2.26
|
|
Brief Pain Inventory-short Form (BPI-SF)
BPI Pain interference at 6 weeks
|
4.81 score on a scale
Standard Deviation 2.32
|
5.49 score on a scale
Standard Deviation 2.30
|
SECONDARY outcome
Timeframe: baseline, 6 weeksPopulation: Missing PROMIS intensity data for one participant in the control group at 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.
Outcome measures
| Measure |
Mind-body Mobile Application
n=73 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.
|
Control
n=97 Participants
Participants are asked to continue with usual care for pain treatments. They are asked not to start any new forms of treatment.
|
|---|---|---|
|
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
|
3.08 units on a scale
Standard Deviation 0.61
|
|
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
|
3.22 units on a scale
Standard Deviation 0.60
|
SECONDARY outcome
Timeframe: baseline, 6 weeksPopulation: Missing PROMIS data for one participant in the control group at 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.
Outcome measures
| Measure |
Mind-body Mobile Application
n=73 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.
|
Control
n=97 Participants
Participants are asked to continue with usual care for pain treatments. They are asked not to start any new forms of treatment.
|
|---|---|---|
|
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 7.30
|
29.01 score on a scale
Standard Deviation 7.46
|
|
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
|
19.63 score on a scale
Standard Deviation 8.28
|
SECONDARY outcome
Timeframe: baseline, 6 weeksPopulation: Missing PCS data for one participant in the control group at 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.
Outcome measures
| Measure |
Mind-body Mobile Application
n=73 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.
|
Control
n=97 Participants
Participants are asked to continue with usual care for pain treatments. They are asked not to start any new forms of treatment.
|
|---|---|---|
|
Pain Catastrophizing Questionnaire (PCS)
Total PCS Scores at baseline
|
22.55 score on a scale
Standard Deviation 12.22
|
23.13 score on a scale
Standard Deviation 11.30
|
|
Pain Catastrophizing Questionnaire (PCS)
Total PCS Scores at 6-weeks
|
15.92 score on a scale
Standard Deviation 11.48
|
20.38 score on a scale
Standard Deviation 12.0
|
SECONDARY outcome
Timeframe: baseline, 6 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Mind-body Mobile Application
n=73 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.
|
Control
n=96 Participants
Participants are asked to continue with usual care for pain treatments. They are asked not to start any new forms of treatment.
|
|---|---|---|
|
DASS-21 (Depression, Anxiety, and Stress Scale)
Total Depression Score at baseline
|
14.57 score on a scale
Standard Deviation 9.52
|
14.52 score on a scale
Standard Deviation 9.84
|
|
DASS-21 (Depression, Anxiety, and Stress Scale)
Total Depression Score at 6-weeks
|
11.97 score on a scale
Standard Deviation 9.09
|
14.85 score on a scale
Standard Deviation 10.75
|
|
DASS-21 (Depression, Anxiety, and Stress Scale)
Total Anxiety Score at baseline
|
9.89 score on a scale
Standard Deviation 7.85
|
8.92 score on a scale
Standard Deviation 7.13
|
|
DASS-21 (Depression, Anxiety, and Stress Scale)
Total Anxiety Score at 6-weeks
|
7.31 score on a scale
Standard Deviation 7.73
|
9.46 score on a scale
Standard Deviation 7.74
|
|
DASS-21 (Depression, Anxiety, and Stress Scale)
Total Stress Score at baseline
|
16.54 score on a scale
Standard Deviation 8.78
|
15.35 score on a scale
Standard Deviation 8.33
|
|
DASS-21 (Depression, Anxiety, and Stress Scale)
Total Stress Score at 6-weeks
|
13.63 score on a scale
Standard Deviation 8.14
|
15.46 score on a scale
Standard Deviation 8.63
|
SECONDARY outcome
Timeframe: baseline, 6 weeksPopulation: Missing Physical Component Score data for three participants in the control group. Missing Mental Component Score data for three participants in the control group.
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
Outcome measures
| Measure |
Mind-body Mobile Application
n=73 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.
|
Control
n=95 Participants
Participants are asked to continue with usual care for pain treatments. They are asked not to start any new forms of treatment.
|
|---|---|---|
|
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
|
21.60 score on a scale
Standard Deviation 9.58
|
|
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
|
23.89 score on a scale
Standard Deviation 11.36
|
|
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
|
49.18 score on a scale
Standard Deviation 6.74
|
|
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
|
50.05 score on a scale
Standard Deviation 6.97
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Members of the intervention group who completed the additional 12 week follow up (intervention ended at 6 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.
Outcome measures
| Measure |
Mind-body Mobile Application
n=65 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.
|
Control
Participants are asked to continue with usual care for pain treatments. They are asked not to start any new forms of treatment.
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|---|---|---|
|
Brief Pain Inventory-short Form (BPI-SF)
BPI Pain intensity on average (24 hours)
|
4.60 score on a scale
Standard Deviation 1.70
|
—
|
|
Brief Pain Inventory-short Form (BPI-SF)
Pain interference (24 hours)
|
4.85 score on a scale
Standard Deviation 2.49
|
—
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Members of the intervention group who completed the additional 12 week follow up (intervention ended at 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.
Outcome measures
| Measure |
Mind-body Mobile Application
n=65 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.
|
Control
Participants are asked to continue with usual care for pain treatments. They are asked not to start any new forms of treatment.
|
|---|---|---|
|
PROMIS Pain Intensity Short Form
|
2.74 units on a scale
Standard Deviation 0.54
|
—
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: Medication categories are not mutually exclusive as many report usage of multiple classes of drugs.
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.
Outcome measures
| Measure |
Mind-body Mobile Application
n=73 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.
|
Control
n=98 Participants
Participants are asked to continue with usual care for pain treatments. They are asked not to start any new forms of treatment.
|
|---|---|---|
|
Medication Use
Anti-depressants (SSRI, SSNI, TCA)
|
20 participants
|
27 participants
|
|
Medication Use
Non-opioid analgesics
|
48 participants
|
59 participants
|
|
Medication Use
Opioid analgesics
|
11 participants
|
29 participants
|
|
Medication Use
Anti-convulsants
|
13 participants
|
31 participants
|
|
Medication Use
Anti-spasmodics
|
8 participants
|
9 participants
|
|
Medication Use
Cannabanoids
|
6 participants
|
10 participants
|
|
Medication Use
CNS depressants
|
5 participants
|
8 participants
|
|
Medication Use
Other medicines related to pain
|
9 participants
|
5 participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Members of the intervention group who completed the additional 12 week follow up (intervention ended at 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.
Outcome measures
| Measure |
Mind-body Mobile Application
n=65 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.
|
Control
Participants are asked to continue with usual care for pain treatments. They are asked not to start any new forms of treatment.
|
|---|---|---|
|
PROMIS Pain Interference Short Form 8a
|
24.34 score on a scale
Standard Deviation 7.54
|
—
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Members of the intervention group who completed the additional 12 week follow up (intervention ended at 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.
Outcome measures
| Measure |
Mind-body Mobile Application
n=65 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.
|
Control
Participants are asked to continue with usual care for pain treatments. They are asked not to start any new forms of treatment.
|
|---|---|---|
|
Pain Catastrophizing Questionnaire (PCS)
|
16.46 score on a scale
Standard Deviation 12.83
|
—
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Members of the intervention group who completed the additional 12 week follow up (intervention ended at 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 outcomes.
Outcome measures
| Measure |
Mind-body Mobile Application
n=65 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.
|
Control
Participants are asked to continue with usual care for pain treatments. They are asked not to start any new forms of treatment.
|
|---|---|---|
|
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
|
—
|
|
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 outcome
Timeframe: 12 weeksPopulation: See above 12 week data.
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.
Outcome measures
| Measure |
Mind-body Mobile Application
n=65 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.
|
Control
Participants are asked to continue with usual care for pain treatments. They are asked not to start any new forms of treatment.
|
|---|---|---|
|
DASS-21 (Depression, Anxiety, Stress Scale - 21 Items)
Depression
|
6.32 score on a scale
Standard Deviation 4.99
|
—
|
|
DASS-21 (Depression, Anxiety, Stress Scale - 21 Items)
Anxiety
|
4.20 score on a scale
Standard Deviation 3.72
|
—
|
|
DASS-21 (Depression, Anxiety, Stress Scale - 21 Items)
Stress
|
7.58 score on a scale
Standard Deviation 4.71
|
—
|
Adverse Events
Mind-body Mobile Application
Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place