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Chronic PainNCT07143396

Evaluation of a Mind-Body Based Approach for Chronic Pain Treatment

A study testing Mind-body mobile application and guided movement in people with Chronic Pain and Migraine, run by University of the Fraser Valley at 1 site in Canada.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 to 75 years
Conditions the study is for
Chronic Pain, Migraine, Chronic Pain Syndrome
What is being tested?
Mind-body mobile application and guided movement
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteCanada
Study dates
Oct 2025to Dec 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Cynthia J Thomson, PhD contact

604-792-0025 ext. 2518

cynthia.thomson@ufv.ca

Canada1 site
  • University of the Fraser Valley

    Chilliwack, British Columbia, V2R0N3

    Cynthia J Thomson, PhD, 604-792-0025 ext. 2518, cynthia.thomson@ufv.ca

Other trials in Canada

About this study

Official title: Evaluation of a Mind-Body Application in Combination With a Graded Movement Program for the Treatment of Chronic Pain

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).

Read the detailed description

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

Being tested
Mind-body mobile application and guided movement
Keywords
mind-body, mobile application, chronic pain, guided movement, Somatic Education
Medical subject headings
Chronic Pain, Migraine Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mind-body mobile application and guided movementBehavioural

    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.

Study groups in NCT07143396
Study groupRoleWhat they receive
Mind-body mobile application and guided movementExperimentalParticipants are asked to engage (minimum 4x per week) with a user-guided mobile application (app) that employs mind-body techniques including expressive writing, meditation, cognitive behavioural therapy, and pain education. The app also includes access to podcasts that focus on pain counselling and pain education. Participants are also asked to follow (3x per week) an audio-guided somatic education program (light-intensity graded movement).
Receives: Behavioral: Mind-body mobile application and guided movement

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Brief Pain Inventory-short form (BPI-SF) Pain Severity

    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).

    Measured: Baseline, 6 weeks.

  2. Change in Brief Pain Inventory-short form (BPI-SF) Pain Interference

    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).

    Measured: Baseline, 6 weeks.

Secondary outcomes (10)
  1. Change in Patient Reported Outcome Measurement Information System (PROMIS) Pain Intensity short form 3a

    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.

    Measured: Baseline, 6 weeks, 12 weeks

  2. Change in Patient Reported Outcome Measurement Information System (PROMIS) Pain Interference short form 8a

    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.

    Measured: Baseline, 6 weeks, 12 weeks

  3. Change in Pain Catastrophizing Questionnaire (PCS)

    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.

    Measured: Baseline, 6 and 12 weeks

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

    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.

    Measured: Baseline, 6 and 12 weeks

  5. Change in Quality of Life Short Form 12 (SF-12) Physical Component Score

    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.

    Measured: Baseline, 6 and 12 weeks

  6. Change in Quality of Life Short Form 12 (SF-12) Mental Component Score

    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.

    Measured: Baseline, 6 and 12 weeks

  7. Change in Tampa Scale of Kinesiophobia Questionnaire (TSK)

    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.

    Measured: Baseline, 6 and 12 weeks

  8. Change in Brief Pain Inventory Pain Severity Composite Score

    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).

    Measured: baseline, 6 weeks, 12 weeks

  9. Change in Brief Pain Inventory Pain Severity (from baseline to 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).

    Measured: baseline, 12 weeks

  10. Change in Brief Pain Inventory Interference (from baseline to 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.

    Measured: baseline, 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Aug 2025
  2. Study startOct 2025 (estimated)
  3. Primary completionNov 2025 (estimated)
  4. Study completionDec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
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).
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07143396
Sponsor's protocol ID
101806
Status last verified
Aug 2025
First submitted
19 Aug 2025
Last updated
8 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Roelofs J, Goubert L, Peters ML, Vlaeyen JW, Crombez G. The Tampa Scale for Kinesiophobia: further examination of psychometric properties in patients with chronic low back pain and fibromyalgia. Eur J Pain. 2004 Oct;8(5):495-502. doi: 10.1016/j.ejpain.2003.11.016.

    PubMed 15324781
  • Kean J, Monahan PO, Kroenke K, Wu J, Yu Z, Stump TE, Krebs EE. Comparative Responsiveness of the PROMIS Pain Interference Short Forms, Brief Pain Inventory, PEG, and SF-36 Bodily Pain Subscale. Med Care. 2016 Apr;54(4):414-21. doi: 10.1097/MLR.0000000000000497.

    PubMed 26807536
  • Osman A, Barrios FX, Kopper BA, Hauptmann W, Jones J, O'Neill E. Factor structure, reliability, and validity of the Pain Catastrophizing Scale. J Behav Med. 1997 Dec;20(6):589-605. doi: 10.1023/a:1025570508954.

    PubMed 9429990
  • Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap. 1994 Mar;23(2):129-38.

    PubMed 8080219
  • Gatchel RJ, Peng YB, Peters ML, Fuchs PN, Turk DC. The biopsychosocial approach to chronic pain: scientific advances and future directions. Psychol Bull. 2007 Jul;133(4):581-624. doi: 10.1037/0033-2909.133.4.581.

    PubMed 17592957
  • Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. doi: 10.1097/00005650-199603000-00003.

    PubMed 8628042
  • Devan H, Farmery D, Peebles L, Grainger R. Evaluation of Self-Management Support Functions in Apps for People With Persistent Pain: Systematic Review. JMIR Mhealth Uhealth. 2019 Feb 12;7(2):e13080. doi: 10.2196/13080.

    PubMed 30747715
  • Schopflocher D, Taenzer P, Jovey R. The prevalence of chronic pain in Canada. Pain Res Manag. 2011 Nov-Dec;16(6):445-50. doi: 10.1155/2011/876306.

    PubMed 22184555
  • Borm GF, Fransen J, Lemmens WA. A simple sample size formula for analysis of covariance in randomized clinical trials. J Clin Epidemiol. 2007 Dec;60(12):1234-8. doi: 10.1016/j.jclinepi.2007.02.006. Epub 2007 Jun 6.

    PubMed 17998077
  • Treede RD, Rief W, Barke A, Aziz Q, Bennett MI, Benoliel R, Cohen M, Evers S, Finnerup NB, First MB, Giamberardino MA, Kaasa S, Kosek E, Lavand'homme P, Nicholas M, Perrot S, Scholz J, Schug S, Smith BH, Svensson P, Vlaeyen JWS, Wang SJ. A classification of chronic pain for ICD-11. Pain. 2015 Jun;156(6):1003-1007. doi: 10.1097/j.pain.0000000000000160. No abstract available.

    PubMed 25844555
  • Morone NE, Greco CM. Mind-body interventions for chronic pain in older adults: a structured review. Pain Med. 2007 May-Jun;8(4):359-75. doi: 10.1111/j.1526-4637.2007.00312.x.

    PubMed 17610459
  • Pfeifer AC, Uddin R, Schroder-Pfeifer P, Holl F, Swoboda W, Schiltenwolf M. Mobile Application-Based Interventions for Chronic Pain Patients: A Systematic Review and Meta-Analysis of Effectiveness. J Clin Med. 2020 Nov 5;9(11):3557. doi: 10.3390/jcm9113557.

    PubMed 33167300
  • Ashar YK, Gordon A, Schubiner H, Uipi C, Knight K, Anderson Z, Carlisle J, Polisky L, Geuter S, Flood TF, Kragel PA, Dimidjian S, Lumley MA, Wager TD. Effect of Pain Reprocessing Therapy vs Placebo and Usual Care for Patients With Chronic Back Pain: A Randomized Clinical Trial. JAMA Psychiatry. 2022 Jan 1;79(1):13-23. doi: 10.1001/jamapsychiatry.2021.2669.

    PubMed 34586357
  • Thomson CJ, Pahl H, Giles LV. Randomized controlled trial investigating the effectiveness of a multimodal mobile application for the treatment of chronic pain. Can J Pain. 2024 Aug 19;8(1):2352399. doi: 10.1080/24740527.2024.2352399. eCollection 2024.

    PubMed 39175941

Questions about this trial

What is this clinical trial studying?

A study testing Mind-body mobile application and guided movement in people with Chronic Pain and Migraine, run by University of the Fraser Valley at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Cynthia J Thomson, PhD (604-792-0025 ext. 2518, cynthia.thomson@ufv.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Brief Pain Inventory-short form (BPI-SF) Pain Severity (time frame: Baseline, 6 weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07143396, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.

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