NCT07818980

Brief Summary

The goal of this study is to gather feedback from Canadian Veterans living with chronic pain, and clinicians serving Canadian Veterans, on an existing digital psychology program for self-management of chronic pain delivered through the Manage My Pain app. This feedback will be used to adapt the program for the needs and experiences of Canadian Veterans. The main questions it aims to answer are:

  • How acceptable, feasible, and engaging is the existing digital psychology program for Canadian Veterans living with chronic pain?
  • What changes are needed to make the program more relevant and appropriate for Canadian Veterans living with chronic pain? Participants will:
  • Use the self-guided digital psychology program over a two-week period and complete questionnaires about the program's acceptability and feasibility. Veteran participants will also complete questionnaires about their pain and pain history.
  • Take part in a 30- to 45-minute virtual interview to provide feedback about the program and recommendations for its adaptation. The study does not include a comparison group.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for all trials

Timeline
12mo left

Started Sep 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress5%
Sep 2026Sep 2027

First Submitted

Initial submission to the registry

August 26, 2026

Completed
19 days until next milestone

First Posted

Study publicly available on registry

September 14, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

September 14, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2027

Last Updated

September 28, 2026

Status Verified

August 1, 2026

Enrollment Period

12 months

First QC Date

August 26, 2026

Last Update Submit

September 24, 2026

Conditions

Keywords

Canadian VeteransChronic painAcceptance and Commitment TherapyACTDigital health interventionDigital psychology interventionPain self-managementMobile healtheHealthManage My PainCo-adaptationPatient engagementVeterans' healthPain psychologyFeasibility StudiesMindfulnessInternet-based Intervention

Outcome Measures

Primary Outcomes (4)

  • Program Usage and Engagement as assessed by Manage My Pain Platform Usage Analytics

    Manage My Pain platform usage analytics will be used to assess engagement with the self-guided digital psychology program. Engagement metrics will include module access dates, time spent in each module, and the total number of modules completed by each participant. A greater number of completed modules will indicate greater program engagement.

    Participants will have their usage analytics tracked from access to the self-guided program to completion of the program, an average of 2 weeks.

  • Program Acceptability as assessed by the Treatment Evaluation Inventory-Short Form

    Program acceptability will be assessed using the 9-item Treatment Evaluation Inventory-Short Form (TEI-SF). Items are rated on a 5-point scale and summed to produce a total score ranging from 9 to 45. Higher scores indicate greater acceptability.

    Participants will be sent a link to fill out the measure within 1 week of completing the program.

  • Program Feasibility as assessed by the Feasibility Survey

    Participants' perceptions of program feasibility, acceptability, usability, and connection to the program will be assessed using a 13-item survey. Items are rated on a 7-point scale and may be examined individually or averaged to produce a mean score ranging from 1 to 7. The survey also includes an open-ended feedback question.

    Participants will be sent a link to fill out the measure within 1 week of completing the program.

  • Retrospective Semi-structured Interview

    A 30- to 45-minute semi-structured interview will explore participants' experiences with the existing program and their recommendations for adapting its content, language, format, and delivery for Canadian Veterans.

    Participants will be sent an invitation for an interview within 1 week after completing the survey questions.

Other Outcomes (3)

  • Pain Intensity as assessed by the PROMIS Pain Intensity-Short Form 3a - Veteran Participants Only

    Participants will be sent a link to fill out the measure within 1 week of completing the program.

  • Pain Interference as assessed by the PROMIS Pain Interference-Short Form 4a - Veteran Participants Only

    Participants will be sent a link to fill out the measure within 1 week of completing the program.

  • Chronic Pain History as assessed by the Chronic Pain History Questionnaire - Veteran Participants Only

    Participants will be sent a link to fill out the measure within 1 week of completing the program.

Study Arms (2)

Canadian Veterans

Adult Canadian Veterans living with chronic pain for at least 3 months. Participants will use the existing self-guided digital Acceptance and Commitment Therapy program through the Manage My Pain app over 2 weeks. They will then complete questionnaires assessing program acceptability, and feasibility, pain and pain history, as well as a semi-structured interview about their experiences with the program and recommended adaptations.

Other: Self-Guided Digital Acceptance and Commitment Therapy Program

Clinicians Serving Canadian Veterans

Canadian healthcare providers experienced in delivering evidence-based pain psychology interventions to Veterans. Participants will use the existing self-guided digital Acceptance and Commitment Therapy program through the Manage My Pain app over 2 weeks. They will then complete questionnaires assessing program acceptability and feasibility and participate in a semi-structured interview about recommended adaptations for Canadian Veterans.

Other: Self-Guided Digital Acceptance and Commitment Therapy Program

Interventions

A self-guided digital psychology program based on Acceptance and Commitment Therapy and delivered through the Manage My Pain app. The program includes interactive psychoeducation about chronic pain and Acceptance and Commitment Therapy, recognition of pain-related avoidance, clarification of personal values, identification of meaningful actions, strategies for making room for difficult experiences, and flexible persistence in meaningful activities.

Canadian VeteransClinicians Serving Canadian Veterans

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population will include two groups recruited in Canada: adult Canadian Armed Forces Veterans living with chronic pain for at least 3 months and healthcare providers experienced in delivering evidence-based pain psychology interventions to Canadian Veterans. Veterans will be recruited through Canadian Veteran organizations, social media, and existing lists of individuals who have expressed interest in research. Clinicians will be recruited through professional networks using snowball sampling.

You may qualify if:

  • Veterans of the Canadian Armed Forces who report having chronic pain (pain for 3 months or longer).
  • Have access to a device that can connect to the Internet.
  • Healthcare providers actively practicing in Canada.
  • Healthcare providers delivering evidence-based psychology interventions to Canadian Veterans (e.g., clinical psychologists, psychotherapists, social workers, counselors)
  • Have access to a device that can connect to the Internet.

You may not qualify if:

  • Individuals with a known history of serious mental illness (e.g., psychosis and/or active mania).
  • Individuals who have limited comprehension of English or comprehension deficits due to dementia.
  • Individuals with physical or cognitive impairments that prevent effective engagement with an online intervention (e.g., serious uncorrected visual or hearing impairment).
  • \- Healthcare providers who have limited comprehension of English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesia and Pain Management, Toronto General Hospital, University Health Network

Toronto, Ontario, M5G 2N2, Canada

RECRUITING

Related Publications (20)

  • Christo EM. Novel Applications of Virtual Communities in Healthcare Settings: Chapter 4: Manage My Pain. IGI Global; 2017. 271.

    BACKGROUND
  • Development & Usability of a Scalable Digital Psychology Intervention for Chronic Postsurgical Pain - IASP [Internet]. https://posters.worldcongress2024.org/. [cited 2025 Jun 24]. Available from: https://posters.worldcongress2024.org/poster/development-usability-of-a-scalable-digital-psychology-intervention-for-chronic-postsurgical-pain/

    BACKGROUND
  • Canadian Pain Task Force Report: March 2021 [Internet]. 2021 [cited 2025 Jun 23]. Available from: https://www.canada.ca/en/health-canada/corporate/about-health-canada/public-engagement/external-advisory-bodies/canadian-pain-task-force/report-2021.html

    RESULT
  • Qureshi AR, Patel M, Neumark S, Wang L, Couban RJ, Sadeghirad B, Bengizi A, Busse JW. Prevalence of chronic non-cancer pain among military veterans: a systematic review and meta-analysis of observational studies. BMJ Mil Health. 2025 Jul 23;171(4):310-314. doi: 10.1136/military-2023-002554.

  • Becker WC, Dorflinger L, Edmond SN, Islam L, Heapy AA, Fraenkel L. Barriers and facilitators to use of non-pharmacological treatments in chronic pain. BMC Fam Pract. 2017 Mar 20;18(1):41. doi: 10.1186/s12875-017-0608-2.

  • Simmonds MJ, Finley EP, Vale S, Pugh MJ, Turner BJ. A qualitative study of veterans on long-term opioid analgesics: barriers and facilitators to multimodality pain management. Pain Med. 2015 Apr;16(4):726-32. doi: 10.1111/pme.12626. Epub 2014 Dec 19.

  • Ul Haq MZ, Ashoorion V, Xi CE, Wang E, Ross N, Parakh N, Busse JW, Darzi AJ, Alvarez E. Canadian Veterans' Experiences of Living with Chronic Pain: A Descriptive Qualitative Study. Can J Pain. 2024 Jun 10;8(2):2361006. doi: 10.1080/24740527.2024.2361006. eCollection 2024.

  • King AC, Zahrai A, Bisson EJ, Shergill Y, Rice D, Wai E, Nedden NZ, Cooper L, James D, Rash JA, Bosma R, Ramsay T, Poulin P. Implementation-effectiveness of the power over pain portal for patients awaiting a tertiary care consultation for chronic pain: A pilot feasibility study. Digit Health. 2025 Mar 17;11:20552076251326229. doi: 10.1177/20552076251326229. eCollection 2025 Jan-Dec.

  • Thurnheer SE, Gravestock I, Pichierri G, Steurer J, Burgstaller JM. Benefits of Mobile Apps in Pain Management: Systematic Review. JMIR Mhealth Uhealth. 2018 Oct 22;6(10):e11231. doi: 10.2196/11231.

  • Pearson R, Carl E, Creech SK. Computerized Psychological Interventions in Veterans and Service Members: Systematic Review of Randomized Controlled Trials. J Med Internet Res. 2022 Jun 3;24(6):e30065. doi: 10.2196/30065.

  • Kroll-Desrosiers A, Finley EP, Hamilton AB, Cabassa LJ. Evidence-Based Intervention Adaptations Within the Veterans Health Administration: a Scoping Review. J Gen Intern Med. 2023 Aug;38(10):2383-2395. doi: 10.1007/s11606-023-08218-z. Epub 2023 May 30.

  • Bhatia A, Kara J, Janmohamed T, Prabhu A, Lebovic G, Katz J, Clarke H. User Engagement and Clinical Impact of the Manage My Pain App in Patients With Chronic Pain: A Real-World, Multi-site Trial. JMIR Mhealth Uhealth. 2021 Mar 4;9(3):e26528. doi: 10.2196/26528.

  • Slepian PM, Peng M, Janmohamed T, Kotteeswaran Y, Manoo V, Blades AM, Fiorellino J, Katznelson R, Tamir D, McRae K, Kahn M, Huang A, Kona S, Thaker S, Weinrib A, Katz J, Clarke H. Engagement with Manage My Pain mobile health application among patients at the Transitional Pain Service. Digit Health. 2020 Oct 13;6:2055207620962297. doi: 10.1177/2055207620962297. eCollection 2020 Jan-Dec.

  • Scott W, McCracken LM. Psychological flexibility, acceptance and commitment therapy, and chronic pain. Curr Opin Psychol. 2015 Apr 1;2:91-6.

    RESULT
  • Wang JQ, Wang XZ, Wang WX. Acceptance and commitment therapy for enhancing mental health in military personnel: A comprehensive review and meta-analysis. World J Psychiatry. 2025 Mar 19;15(3):100959. doi: 10.5498/wjp.v15.i3.100959. eCollection 2025 Mar 19.

  • Donahue ML, Fruge JE, Andresen FJ, Twohig MP. Acceptance and commitment therapy (ACT) among U.S. veterans: A systematic review. J Context Behav Sci. 2024 Apr 1;32:100731.

    RESULT
  • Hennink M, Kaiser BN. Sample sizes for saturation in qualitative research: A systematic review of empirical tests. Soc Sci Med. 2022 Jan;292:114523. doi: 10.1016/j.socscimed.2021.114523. Epub 2021 Nov 2.

  • Bell ML, Whitehead AL, Julious SA. Guidance for using pilot studies to inform the design of intervention trials with continuous outcomes. Clin Epidemiol. 2018 Jan 18;10:153-157. doi: 10.2147/CLEP.S146397. eCollection 2018.

  • Whitehead AL, Julious SA, Cooper CL, Campbell MJ. Estimating the sample size for a pilot randomised trial to minimise the overall trial sample size for the external pilot and main trial for a continuous outcome variable. Stat Methods Med Res. 2016 Jun;25(3):1057-73. doi: 10.1177/0962280215588241. Epub 2015 Jun 19.

  • Damschroder LJ, Reardon CM, Widerquist MAO, Lowery J. The updated Consolidated Framework for Implementation Research based on user feedback. Implement Sci. 2022 Oct 29;17(1):75. doi: 10.1186/s13012-022-01245-0.

MeSH Terms

Conditions

Chronic PainPatient Participation

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Hance Clarke, MD, PhD

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hance A Clarke, MD, PhD

CONTACT

Peter M Slepian, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2026

First Posted

September 14, 2026

Study Start

September 14, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 30, 2027

Last Updated

September 28, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations