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

December 12, 2024 updated by: University of the Fraser Valley

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

198

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Chilliwack, British Columbia, Canada, V2R0N3
        • University of the Fraser Valley

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: 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.
No Intervention: Control
Participants are asked to continue with usual care for pain treatments. They are asked not to start any new forms of treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline, 6 weeks
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.
baseline, 6 weeks
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.
baseline, 6 weeks
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.
baseline, 6 weeks
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
baseline, 6 weeks
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.
12 weeks
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.
12 weeks
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.
6 weeks
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.
12 weeks
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.
12 weeks
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 weeks
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.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of the Fraser Valley

Investigators

  • Principal Investigator: Cynthia J Thomson, PhD, University of the Fraser Valley

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2021

Primary Completion (Actual)

June 15, 2022

Study Completion (Actual)

July 15, 2022

Study Registration Dates

First Submitted

October 13, 2021

First Submitted That Met QC Criteria

October 13, 2021

First Posted (Actual)

October 25, 2021

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 12, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 100820

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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