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Chronic pain affects more than 20% of Canadians and is associated with significant impacts on physical function, mental health, and quality of life. Despite efforts to improve access to multidisciplinary pain care through centralized referral systems, many patients continue to experience prolonged wait times before receiving treatment.
This study evaluates a self-guided digital psychological intervention designed to support chronic pain self-management during the waiting period for specialized pain care. The intervention was developed through a collaboration between the Transitional Pain Service and ManagingLife and aims to improve access to evidence-based psychological support, enhance self-management skills, and reduce pain-related distress among individuals living with chronic pain.
The Advancing Online Psychology Tools for Chronic Pain (ADOPT-CP) intervention provides participants with access to the Manage My Pain (MMP) platform, including a self-guided Acceptance and Commitment Therapy (ACT)-based digital psychology program and Solace, an artificial intelligence (AI)-enabled conversational support tool for chronic pain. Together, these tools are designed to support pain self-management, emotional coping, and engagement in care.
This study will evaluate the feasibility, acceptability, and preliminary clinical effects of the ADOPT-CP intervention among individuals waiting to access multidisciplinary chronic pain services through the Toronto Academic Pain Medicine Institute (TAPMI). The intervention aims to provide accessible psychological support and self-management resources during the waiting period for specialized pain care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | The ADOPT-CP intervention includes the Manage My Pain (MMP) app with integrated tools: a customizable pain tracker for monitoring symptoms and generating reports, the Pain Guide with educational content on pain management, a self-guided Acceptance and Commitment Therapy (ACT)-based psychology program, and Solace, an AI-driven conversational agent designed to provide structured, evidence-based psychological support for chronic pain self-management. |
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| Control Group | Active Comparator | The control group will receive treatment as usual plus weekly emailed resources. These resources include materials introduced during the TAPMI orientation session, including Power Over Pain and Progress Over Pain. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digital psychology intervention (ADOPT-CP) | Other | The intervention, Manage My Pain (MMP), is a clinically validated app-based platform that supports individuals with chronic pain in self-managing their symptoms and improving communication and engagement with their care team. |
| Measure | Description | Time Frame |
|---|---|---|
| Trial feasibility | Measured according to the CONSORT criteria and include: eligibility rate, recruitment rate, retention rate, measure completion, absence of or minor adverse events. | 10 weeks |
| Engagement with the digital ADOPT-CP intervention | Measured via MMP app analytics (usage rates, completion of psychology program, etc.) | 10 weeks |
| Acceptability and Appropriateness of the ADOPT-CP intervention | The Treatment Evaluation Inventory-Short Form (TEI-SF) is a self-report measure assessing the acceptability and perceived appropriateness of a treatment or intervention, with higher scores indicating greater treatment acceptability. | 10 weeks |
| Acceptability and Adherence of the ADOPT-CP intervention | The Treatment Acceptability/Adherence Scale (TAAS) is a self-report measure assessing perceived acceptability of an intervention and anticipated or actual adherence, with higher scores indicating greater acceptability and adherence. | 10 weeks |
| Experience using the ADOPT-CP intervention | a semi-structured interview guide will be used to explore participant experiences, barriers and facilitators to use, acceptability, engagement, and opportunities to refine the digital intervention prior to a larger trial. | 14 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life and Pain Interference | Modified PROMIS-29 Health Domains (Quality of Life and Pain Interference 8a): A validated patient-reported outcome system assessing the impact of health conditions on physical, mental, and social functioning. Higher scores indicate greater pain interference and worse health-related quality of life, while lower scores indicate better functioning and quality of life. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Adriano Nella, MSc | Contact | 416-323-6400 | 5977 | Adriano.Nella@wchospital.ca |
| Didem Bozak | Contact | 416-323-6008 | didem.bozak@wchospital.ca |
| Name | Affiliation | Role |
|---|---|---|
| Tania Di Renna, MD, FRCPC | Women's College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Women's College Hospital | Toronto | Ontario | M5S 1B2 | Canada |
At this time, no external data sharing arrangements or future secondary use arrangements are planned. Study data will be retained and used only for the purposes described in this protocol. If future secondary use or collaboration with internal or external investigators is proposed at a later date, this would occur only in accordance with participant consent, WCH REB requirements, and any required data sharing agreements or institutional approvals.
Results from this study may be disseminated through academic publications, presentations, and reports. Only aggregate or de-identified information will be used for these purposes. No participant-identifiable information will be included in any publication or dissemination arising from this study. Study data will not be shared with individuals outside the research team for secondary use.
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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A 1:1 allocation ratio of intervention to control will be generated using a computer randomization sequence in REDCap prepared by an independent statistician. Randomization will be stratified by chronic pain condition, sex, and time on the waitlist.
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This is an open-label study. Participants and study personnel will not be blinded to study group assignment because of the nature of the intervention and control conditions and the feasibility-focused outcomes of the study.
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| Reminder Emails | Other | Weekly emailed pain self-management resources introduced during the Toronto Academic Pain Medicine Institute (TAPMI) orientation |
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| 10 weeks |
| Pain Acceptance | Measured by the Chronic Pain Acceptance Questionnaire-Short Form: A validated self-report measure of acceptance of chronic pain. Higher scores indicate greater acceptance of chronic pain, including continued activity engagement and reduced avoidance of pain-related experiences. | 10 weeks |
| Psychological Flexibility | Measured by the Acceptance and Action Questionnaire-II (AAQ-II): A validated self-report measure of psychological inflexibility and experiential avoidance. Higher scores indicate greater psychological inflexibility and experiential avoidance, while lower scores indicate greater psychological flexibility. | 10 weeks |
| Kinesiophobia | Measured by the Tampa Scale of Kinesiophobia (TSK): a validated self-report questionnaire used to assess fear of movement and fear of re-injury. Higher scores indicate greater fear of movement. | 10 weeks |
| Pain Resiliency | Measured by the Pain Resiliency Scale: Measures how well a person can adapt and maintain function despite chronic pain. Higher scores indicate greater resilience in coping with chronic pain, while lower scores indicate reduced adaptive coping. | 10 weeks |
| D009422 |
| Nervous System Diseases |