Chronic Pelvic Pain Syndrome, Fibromyalgia
Conditions
Brief summary
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.
Detailed description
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.
Interventions
OTHERDigital psychology intervention (ADOPT-CP)
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.
OTHERReminder Emails
Weekly emailed pain self-management resources introduced during the Toronto Academic Pain Medicine Institute (TAPMI) orientation
Sponsors
Women's College Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Must be deemed to have capacity to provide informed consent; 2. Must sign and date the informed consent form; 3. Must state willingness to comply with all study procedures; 4. Must be at least 18 years of age; 5. Must be referred to TAPMI; 6. Must have either fibromyalgia or chronic pelvic pain 7. Must be on the waitlist at TAPMI; 8. Must have access to a device that can connect to the Internet with access to email.
Exclusion criteria
1. Currently engaged in psychotherapy or engaged in psychotherapy within the last month at the time of enrolment; 2. Unable to read, understand, or communicate in English sufficiently to provide informed consent and complete the study procedures and questionnaires; 3. Has active serious mental illness or psychiatric instability that, in the opinion of the research team, may impair the ability to safely participate in the study or to provide informed consent (e.g., active psychosis, active mania); 4. Has a visual, auditory, or other functional impairment that would prevent independent access to and use of the digital intervention and study procedures on an internet-enabled device.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Trial feasibility | 10 weeks | Measured according to the CONSORT criteria and include: eligibility rate, recruitment rate, retention rate, measure completion, absence of or minor adverse events. |
| Engagement with the digital ADOPT-CP intervention | 10 weeks | Measured via MMP app analytics (usage rates, completion of psychology program, etc.) |
| Acceptability and Appropriateness of the ADOPT-CP intervention | 10 weeks | 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. |
| Acceptability and Adherence of the ADOPT-CP intervention | 10 weeks | 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. |
| Experience using the ADOPT-CP intervention | 14 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life and Pain Interference | 10 weeks | 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. |
| Pain Acceptance | 10 weeks | 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. |
| Psychological Flexibility | 10 weeks | 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. |
| Kinesiophobia | 10 weeks | 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. |
| Pain Resiliency | 10 weeks | 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. |
Countries
Canada
Contacts
CONTACTAdriano Nella, MSc
CONTACTDidem Bozak
PRINCIPAL_INVESTIGATORTania Di Renna, MD, FRCPC
Women's College Hospital
Outcome results
None listed