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Completed

NCT Number: NCT05090683

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

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.

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Key information

Conditions

Chronic Pain Brain Diseases Central Nervous System Diseases Chronic Pain Syndrome Headache Disorders Headache Disorders, Primary Migraine Migraine Disorders Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

19 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of the Fraser Valley

Chilliwack, British Columbia, V2R0N3, Canada

About this study

See protocol for more details. (submitted at time of registration)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mind-body mobile application

Behavioral

Self-directed; Study team will recommend daily use of mobile app for 6 weeks with a minimum of 4 times/week usage of mobile app for 6 weeks. Frequency will be monitored via weekly surveys.

Primary outcomes

  1. Brief Pain Inventory-short Form (BPI-SF)

    Time frame: 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 outcomes

  1. Patient Reported Outcome Measurement Information System (PROMIS) Short Form for Pain Intensity on Average

    Time frame: 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.

  2. Patient Reported Outcome Measurement Information System (PROMIS) Short Form 8a Pain Interference

    Time frame: 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.

  3. Pain Catastrophizing Questionnaire (PCS)

    Time frame: 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.

  4. DASS-21 (Depression, Anxiety, and Stress Scale)

    Time frame: 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.

  5. 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)

    Time frame: 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

  6. Brief Pain Inventory-short Form (BPI-SF)

    Time frame: 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.

  7. PROMIS Pain Intensity Short Form

    Time frame: 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.

  8. Medication Use

    Time frame: 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.

  9. PROMIS Pain Interference Short Form 8a

    Time frame: 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.

  10. Pain Catastrophizing Questionnaire (PCS)

    Time frame: 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.

  11. 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)

    Time frame: 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.

  12. DASS-21 (Depression, Anxiety, Stress Scale - 21 Items)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of the Fraser Valley

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 25, 2021
Registry last updated
Jan 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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