Chronic Pain, Chronic Pain Syndrome, Migraine
Conditions
Keywords
mind-body, mobile application, chronic pain, guided movement, Somatic Education
Brief summary
The investigators are evaluating the effects of a mind-body mobile application, in combination with a guided movement program, on the experience of chronic pain. Participants meeting the criteria for chronic/persistent pain (confirmed via self-report) will complete an online baseline questionnaire. Eligible participants will take part in an intervention that involves use of a 6-week free trial of a mind-body focused mobile application in combination with virtual asynchronous audio-guided somatic education sessions (gentle movement). External data from a usual care control arm and a mobile-app-only arm from a previous study by the same research team, National Clinical Trials (NCT) registry number NCT05090683, will be used for comparison with the current combined intervention. All participants will complete online surveys at the start of the study and after 6 weeks to measure pain intensity and interference (primary outcomes), mental health outcomes (depression, anxiety, stress), pain-related thoughts (pain catastrophizing), quality of life, and fear of movement (secondary outcomes). From weeks 2 to 6, participants will fill out weekly surveys to track how often they engage with each: the somatic education (gentle movement) program and the mobile app. Participants will also complete a follow-up survey at 12 weeks (6 weeks post-intervention conclusion).
Detailed description
See protocol for more details. (submitted at time of registration)
Interventions
BEHAVIORALMind-body mobile application and guided movement
Self-directed: The study team recommends daily use of the mobile app for 6 weeks, with a minimum of 4 times per week, and engagement with the somatic education program at least 3 times per week for 6 weeks. Frequency of app usage and somatic education engagement will be monitored via weekly surveys.
Sponsors
University of the Fraser Valley
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
All participants will be enrolled in the intervention arm: 6 weeks of engagement with a mind-body mobile application and virtual somatic education program. Results of the current study will be compared to two groups from the researcher's previous study, NCT05090683 (a usual care control group and a mobile app-only intervention group).
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 * Participants must have access to an electronic device * Participants must be willing to engage in weekly somatic education activities
Exclusion criteria
* Individuals reporting a cognitive impairment that can interfere with completing questionnaires and using a mobile application. * Individuals reporting substance use disorder (within the last 6 months). * Individuals reporting any of the following medical conditions: metastatic cancer, rheumatoid arthritis, lupus, scleroderma, polymyositis. * Individuals with previous experience with the mind-body app under study (Note: use of Calm or another meditation-only app is not an exclusion). * Individuals with current regular (at least once a week) engagement with a somatic movement program (e.g., Feldenkrais, Hanna Somatics, Somatic Yoga, Tai Chi, Pilates)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Brief Pain Inventory-short form (BPI-SF) Pain Severity | Baseline, 6 weeks. | Measures self reported pain severity (over past 24 hours). BPI Pain Severity: single item scale within larger Brief Pain Inventory tool that asses pain average pain severity. Item scale ranges from 0 to 10. 0 = no pain, 10 = pain as bad as you can imagine. Higher scores indicate worse outcome (pain severity), lower scores indicate better outcome. Item range = (0,10). |
| Change in Brief Pain Inventory-short form (BPI-SF) Pain Interference | Baseline, 6 weeks. | Item 9 on the BPI measures interference with daily living. There are 7 items (reflecting seven daily activities) 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 (higher interference). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Catastrophizing Questionnaire (PCS) | Baseline, 6 and 12 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. |
| Change in Depression, Anxiety, and Stress Scale (DASS-21) | Baseline, 6 and 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. |
| Change in Quality of Life Short Form 12 (SF-12) Physical Component Score | Baseline, 6 and 12 weeks | Measures self-reported impact of health on daily life. The SF-12 is a brief version of the 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. The Physical Component Score (PCS) is a summary score that is reported as a z-score. Scores are calculated using regression weights and constants that 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 PCS. The weighted scores across all items are then summed and are added to a constant (regression intercept) to obtain a summary score. 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 improved physical health. |
| Change in Quality of Life Short Form 12 (SF-12) Mental Component Score | Baseline, 6 and 12 weeks | Measures self-reported impact of health on daily life. The SF-12 is a brief version of the 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. The Mental Component Score (MCS) is a summary score that is reported as a z-score. Scores are calculated using regression weights and constants that 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. The weighted scores across all items are then summed and are added to a constant (regression intercept) to obtain a summary score. 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 improved mental health. |
| Change in Patient Reported Outcome Measurement Information System (PROMIS) Pain Intensity short form 3a | Baseline, 6 weeks, 12 weeks | Measures self reported pain intensity over the past 7 days on average and at its worst along with an item to assess pain intensity now. The three items are added together to produce a raw score which can be converted to a t-score. Each item uses 5-pt Likert scale from 1 = had no pain to 5 = very severe. Raw scores range from 3 to 15. Higher scores indicate worse outcomes. |
| Change in Brief Pain Inventory Pain Severity Composite Score | baseline, 6 weeks, 12 weeks | A composite score derived from the average of four items that assesses at its worst, least, average over the past 24 hours, along with now. Item scales range 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). |
| Change in Brief Pain Inventory Pain Severity (from baseline to 12 weeks) | baseline, 12 weeks | Note: This is a secondary outcome (change from 0 to 6 weeks is a primary outcome). Measures self reported pain severity and pain interference (over past 24 hours). BPI Pain Severity: single item scale within larger Brief Pain Inventory tool that inquires about average pain severity over the past 24 hours. 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). |
| Change in Brief Pain Inventory Interference (from baseline to 12 weeks) | baseline, 12 weeks | Note: This is a secondary outcome (change from 0 to 6 weeks is a primary outcome). Measures self reported pain interference (over past 24 hours). 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. |
| Change in Tampa Scale of Kinesiophobia Questionnaire (TSK) | Baseline, 6 and 12 weeks | Measured self-reported kinesiophobia assessing fear of movement or re-injury due to pain. Each item rated on a 4-point Likert scale: 1 = strongly disagree to 4 = strongly agree. Total score range = (11, 44). Higher scores indicate greater fear of movement and worse outcomes. |
| Change in Patient Reported Outcome Measurement Information System (PROMIS) Pain Interference short form 8a | Baseline, 6 weeks, 12 weeks | Measures self reported pain interference in daily activities (over 7 days). 8 items are added together for a raw score, which can then be converted to a t-score. Each item uses 5-pt Likert scale from 1 = not at all to 5 = very much (regarding pain interference). Raw scores range from 8 to 40. Higher scores indicate worse outcomes. |
Countries
Canada
Contacts
Primary ContactCynthia J Thomson, PhD
Outcome results
None listed