NCT Number: NCT07818980
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.
Interested in participating?
Request Info18 year–80 year
All sexes
Observational
Toronto, Ontario, M5G 2N2, Canada
Location status: Recruiting
Deep Grewal
CONTACT
Hance Clarke, MD, PhD
CONTACT
416-340-4800 ext. 4251
Hance Clarke, MD, PhD
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
(Veterans):
Inclusion criteria
(Clinicians):
Exclusion criteria
(Veterans):
Exclusion criteria
(Clinicians):
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
University Health Network, Toronto
Other
Co-Adaptation of a Digital Chronic Pain Self-Management Program for Canadian Veterans
Acronym: ADOPTCanVets
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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