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

NCT07143396 | Not Yet Recruiting

• 1 other identifier: 101806
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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).

Conditions

Chronic Pain; Migraine; Chronic Pain Syndrome

Keywords

mind-body; mobile application; chronic pain; guided movement; Somatic Education

Outcome Measures

Primary Outcomes (2)

• 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).

  Baseline, 6 weeks.

• 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).

  Baseline, 6 weeks.

Secondary Outcomes (10)

• Change in Patient Reported Outcome Measurement Information System (PROMIS) Pain Intensity short form 3a

  Baseline, 6 weeks, 12 weeks

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

  Baseline, 6 weeks, 12 weeks

• Change in Pain Catastrophizing Questionnaire (PCS)

  Baseline, 6 and 12 weeks

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

  Baseline, 6 and 12 weeks

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

  Baseline, 6 and 12 weeks

Study Arms (1)

Mind-body mobile application and guided movement

EXPERIMENTAL

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).

Behavioral: Mind-body mobile application and guided movement

Interventions

Mind-body mobile application and guided movement 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.

Mind-body mobile application and guided movement

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 current regular (at least once a week) engagement with a somatic movement program (e.g., Feldenkrais, Hanna Somatics, Somatic Yoga, Tai Chi, Pilates)

Sponsors & Collaborators

• University of the Fraser Valley: lead

Study Sites (1)

University of the Fraser Valley

Chilliwack, British Columbia, V2R0N3, Canada

Location

Related Publications (14)

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  PMID: 8628042 BACKGROUND

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• 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.

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• 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.

  PMID: 39175941 BACKGROUND

MeSH Terms

Conditions

Chronic Pain; Migraine Disorders

Condition Hierarchy (Ancestors)

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

Study Officials

• Cynthia J Thomson, PhD

  University of the Fraser Valley

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cynthia J Thomson, PhD

CONTACT

604-792-0025; cynthia.thomson@ufv.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: August 19, 2025
• First Posted: August 27, 2025
• Study Start: October 1, 2025
• Primary Completion: November 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)