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Co-Adaptation of an Digital Pain Management Program for Canadian Veterans (ADOPTCanVets)

15. září 2026 aktualizováno: University Health Network, Toronto

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.

Přehled studie

Detailní popis

Chronic pain affects approximately 30% to 50% of Canadian Veterans, many of whom experience barriers to accessing interprofessional pain services, particularly when transitioning from military to civilian healthcare. Digital health interventions may help address gaps in care by providing accessible, evidence-based self-management support while Veterans await services or alongside their existing clinical care. However, these interventions must be adapted to reflect Veterans' needs and experiences, including military culture, values and language, pain- and mental health-related stigma, experiences of trauma, and challenges navigating the civilian healthcare system. Acceptance and Commitment Therapy (ACT) is an evidence-based psychological intervention that can improve pain-related functioning, pain acceptance, and quality of life among people living with chronic pain, including Veterans. The current study will support the co-adaptation of an existing self-guided digital ACT intervention delivered through the Manage My Pain mobile health platform. Canadian Veterans living with chronic pain and clinicians experienced in providing evidence-based pain psychology interventions to Veterans will use the existing program and provide feedback through questionnaires and semi-structured interviews. Their feedback will inform modifications to the program's content, language, format, and delivery to create Advancing Online Pain Psychology Tools for Canadian Veterans (ADOPT-CanVets). The adapted program will subsequently be ready for evaluation in a feasibility trial. Once evaluated, ADOPT-CanVets may provide a scalable approach to increasing Canadian Veterans' access to evidence-based psychological support for chronic pain.

Typ studie

Pozorovací

Zápis (Odhadovaný)

22

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

  • Jméno: Hance A Clarke, MD, PhD
  • Telefonní číslo: 4251 416-340-4800
  • E-mail: hance.clarke@uhn.ca

Studijní záloha kontaktů

Studijní místa

    • Ontario
      • Toronto, Ontario, Kanada, M5G 2N2
        • Nábor
        • Department of Anesthesia and Pain Management, Toronto General Hospital, University Health Network
        • Kontakt:
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Hance Clarke, MD, PhD

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

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.

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Kohorty a intervence

Skupina / kohorta
Intervence / Léčba
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.
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.
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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Program Usage and Engagement as assessed by Manage My Pain Platform Usage Analytics
Časové okno: Participants will have their usage analytics tracked from access to the self-guided program to completion of the program, an average of 2 weeks.
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
Časové okno: Participants will be sent a link to fill out the measure within 1 week of completing the program.
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
Časové okno: Participants will be sent a link to fill out the measure within 1 week of completing the program.
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
Časové okno: Participants will be sent an invitation for an interview within 1 week after completing the survey questions.
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.

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Pain Intensity as assessed by the PROMIS Pain Intensity-Short Form 3a - Veteran Participants Only
Časové okno: Participants will be sent a link to fill out the measure within 1 week of completing the program.
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.
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
Časové okno: Participants will be sent a link to fill out the measure within 1 week of completing the program.
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.
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
Časové okno: Participants will be sent a link to fill out the measure within 1 week of completing the program.
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.
Participants will be sent a link to fill out the measure within 1 week of completing the program.

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Vyšetřovatelé

  • Vrchní vyšetřovatel: Hance Clarke, MD, PhD, University Health Network, Toronto

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

14. září 2026

Primární dokončení (Odhadovaný)

1. září 2027

Dokončení studie (Odhadovaný)

30. září 2027

Termíny zápisu do studia

První předloženo

26. srpna 2026

První předloženo, které splnilo kritéria kontroly kvality

11. září 2026

První zveřejněno (Aktuální)

14. září 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

18. září 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

15. září 2026

Naposledy ověřeno

1. srpna 2026

Více informací

Termíny související s touto studií

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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