Evaluation of a Mind-body Based Application for the Treatment of Chronic/Persistent Pain.

Not Applicable

Completed

Conditions: Chronic Pain
Migraine
Chronic Pain Syndrome

Interventions: Behavioral: Mind-body mobile application

Registration Number: NCT05090683

Lead Sponsor: University of the Fraser Valley

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)

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 198

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mind-body mobile application	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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)	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.
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)	12 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.
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.
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.
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.
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.