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

NCT ID: NCT07143396

Last Updated: 2025-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-31

Study Completion Date

2025-12-31

Brief Summary

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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

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

Conditions

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Chronic Pain Migraine Chronic Pain Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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).
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Mind-body mobile application and guided movement

Participants 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).

Group Type EXPERIMENTAL

Mind-body mobile application and guided movement

Intervention Type BEHAVIORAL

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.

Interventions

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Mind-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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

19 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of the Fraser Valley

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Cynthia J Thomson, PhD

Role: PRINCIPAL_INVESTIGATOR

University of the Fraser Valley

Locations

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University of the Fraser Valley

Chilliwack, British Columbia, Canada

Site Status

Countries

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Canada

Central Contacts

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Cynthia J Thomson, PhD

Role: CONTACT

604-792-0025 ext. 2518

Facility Contacts

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Cynthia J Thomson, PhD

Role: primary

604-792-0025 ext. 2518

References

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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.

Reference Type BACKGROUND
PMID: 15324781 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26807536 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9429990 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 8080219 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17592957 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8628042 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30747715 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22184555 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17998077 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25844555 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17610459 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33167300 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34586357 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 39175941 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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101806

Identifier Type: -

Identifier Source: org_study_id

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