- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07818980
Co-Adaptation of an Digital Pain Management Program for Canadian Veterans (ADOPTCanVets)
Co-Adaptation of a Digital Chronic Pain Self-Management Program for Canadian Veterans
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Hance A Clarke, MD, PhD
- Número de teléfono: 4251 416-340-4800
- Correo electrónico: hance.clarke@uhn.ca
Copia de seguridad de contactos de estudio
- Nombre: Peter M Slepian, PhD
- Correo electrónico: maxwell.slepian@uhn.ca
Ubicaciones de estudio
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Ontario
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Toronto, Ontario, Canadá, M5G 2N2
- Reclutamiento
- Department of Anesthesia and Pain Management, Toronto General Hospital, University Health Network
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Contacto:
- Deep Grewal
- Correo electrónico: deep.grewal@uhn.ca
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Contacto:
- Hance Clarke, MD, PhD
- Número de teléfono: 4251 416-340-4800
- Correo electrónico: hance.clarke@uhn.ca
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Investigador principal:
- Hance Clarke, MD, PhD
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria (Veterans):
- 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.
Inclusion Criteria (Clinicians):
- 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.
Exclusion Criteria (Veterans):
- 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).
Exclusion Criteria (Clinicians):
- Healthcare providers who have limited comprehension of English
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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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.
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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.
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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.
|
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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Program Usage and Engagement as assessed by Manage My Pain Platform Usage Analytics
Periodo de tiempo: Participants will have their usage analytics tracked from access to the self-guided program to completion of the program, an average of 2 weeks.
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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.
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Participants will have their usage analytics tracked from access to the self-guided program to completion of the program, an average of 2 weeks.
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Program Acceptability as assessed by the Treatment Evaluation Inventory-Short Form
Periodo de tiempo: Participants will be sent a link to fill out the measure within 1 week of completing the program.
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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.
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Participants will be sent a link to fill out the measure within 1 week of completing the program.
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Program Feasibility as assessed by the Feasibility Survey
Periodo de tiempo: Participants will be sent a link to fill out the measure within 1 week of completing the program.
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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.
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Participants will be sent a link to fill out the measure within 1 week of completing the program.
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Retrospective Semi-structured Interview
Periodo de tiempo: Participants will be sent an invitation for an interview within 1 week after completing the survey questions.
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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.
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Participants will be sent an invitation for an interview within 1 week after completing the survey questions.
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Pain Intensity as assessed by the PROMIS Pain Intensity-Short Form 3a - Veteran Participants Only
Periodo de tiempo: Participants will be sent a link to fill out the measure within 1 week of completing the program.
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Pain intensity among Veteran participants will be assessed using the 3-item Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity-Short Form 3a.
The measure assesses pain at its worst, average pain, and current pain.
Responses will be scored according to PROMIS scoring guidelines, with higher scores indicating greater pain intensity.
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Participants will be sent a link to fill out the measure within 1 week of completing the program.
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Pain Interference as assessed by the PROMIS Pain Interference-Short Form 4a - Veteran Participants Only
Periodo de tiempo: Participants will be sent a link to fill out the measure within 1 week of completing the program.
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Pain interference among Veteran participants will be assessed using the 4-item Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference-Short Form 4a.
The measure assesses pain interference in daily activities and social interactions.
Responses will be scored according to PROMIS scoring guidelines, with higher scores indicating greater pain interference.
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Participants will be sent a link to fill out the measure within 1 week of completing the program.
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Chronic Pain History as assessed by the Chronic Pain History Questionnaire - Veteran Participants Only
Periodo de tiempo: Participants will be sent a link to fill out the measure within 1 week of completing the program.
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Chronic pain history among Veteran participants will be characterized using a 4-item self-report questionnaire assessing the duration and frequency of ongoing pain and the type of pain condition experienced.
Responses will be summarized descriptively.
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Participants will be sent a link to fill out the measure within 1 week of completing the program.
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Hance Clarke, MD, PhD, University Health Network, Toronto
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
- 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.
- 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.
- Christo EM. Novel Applications of Virtual Communities in Healthcare Settings: Chapter 4: Manage My Pain. IGI Global; 2017. 271.
- 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/
- 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
- 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.
- 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.
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
- Terapia de Aceptación y Compromiso
- Dolor crónico
- Atención plena
- eSalud
- Estudios de viabilidad
- ACTUAR
- Salud móvil
- Compromiso del paciente
- Autogestión del dolor
- Intervención basada en Internet
- Intervención en salud digital
- Coadaptación
- Canadian Veterans
- Digital psychology intervention
- Manage My Pain
- Veterans' health
- Pain psychology
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 26-5032
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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