FibromyalgiaADOPT-CPNCT07659873
Advancing Online Psychology Tools for Chronic Pain
A study testing Digital psychology intervention (ADOPT-CP) and Reminder Emails in people with Fibromyalgia and Chronic Pelvic Pain Syndrome, run by Women's College Hospital at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia, Chronic Pelvic Pain Syndrome
- What is being tested?
- Digital psychology intervention (ADOPT-CP) and Reminder Emails
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2026to Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be deemed to have capacity to provide informed consent;
- Must sign and date the informed consent form;
- Must state willingness to comply with all study procedures;
- Must be at least 18 years of age;
- Must be referred to TAPMI;
- Must have either fibromyalgia or chronic pelvic pain
- Must be on the waitlist at TAPMI;
- Must have access to a device that can connect to the Internet with access to email.
Who cannot join
- Currently engaged in psychotherapy or engaged in psychotherapy within the last month at the time of enrolment;
- Unable to read, understand, or communicate in English sufficiently to provide informed consent and complete the study procedures and questionnaires;
- 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);
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Advancing Online Psychology Tools for Chronic Pain (ADOPT-CP): Feasibility of a Scalable Digital Psychology Intervention and AI-Powered Support for Patients on the Waitlist for Pain Services
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.
Read the 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.
- Conditions
- Fibromyalgia, Chronic Pelvic Pain Syndrome
- Being tested
- Digital psychology intervention (ADOPT-CP), Reminder Emails
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Reminder EmailsOther
Weekly emailed pain self-management resources introduced during the Toronto Academic Pain Medicine Institute (TAPMI) orientation
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Digital psychology intervention (ADOPT-CP) |
| 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. Receives: Other: Reminder Emails |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trial feasibility
Measured according to the CONSORT criteria and include: eligibility rate, recruitment rate, retention rate, measure completion, absence of or minor adverse events.
Measured: 10 weeks
Engagement with the digital ADOPT-CP intervention
Measured via MMP app analytics (usage rates, completion of psychology program, etc.)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 14 weeks
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Women's College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tania Di Renna, MD, FRCPC, Principal investigator, Women's College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07659873
- Sponsor's protocol ID
- 2026-
- Acronym
- ADOPT-CP
- Status last verified
- Jun 2026
- First submitted
- 15 Jun 2026
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advancing Online Psychology Tools for Chronic Pain (ADOPT-CP): Feasibility of a Scalable Digital Psychology Intervention and AI-Powered Support for Patients on the Waitlist for Pain Services
- ClinicalTrials.gov ID
- NCT07659873
- Acronym / sponsor ID
- ADOPT-CP / 2026-
- Conditions
- Fibromyalgia, Chronic Pelvic Pain Syndrome
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Women's College HospitalUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 22 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Digital psychology intervention (ADOPT-CP)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. |
| Control Group | Active comparator | Other: Reminder EmailsThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Must be deemed to have capacity to provide informed consent;
- Must sign and date the informed consent form;
- Must state willingness to comply with all study procedures;
- Must be at least 18 years of age;
- Must be referred to TAPMI;
Key exclusion criteria (4 listed)
- Currently engaged in psychotherapy or engaged in psychotherapy within the last month at the time of enrolment;
- Unable to read, understand, or communicate in English sufficiently to provide informed consent and complete the study procedures and questionnaires;
- 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);
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital 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. | Other | Intervention Group |
| Reminder EmailsWeekly emailed pain self-management resources introduced during the Toronto Academic Pain Medicine Institute (TAPMI) orientation | Other | Control Group |
Primary outcome
Trial feasibility
Time frame: 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
Time frame: 10 weeks
Measured via MMP app analytics (usage rates, completion of psychology program, etc.)
Acceptability and Appropriateness of the ADOPT-CP intervention
Time frame: 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
Time frame: 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
Time frame: 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.
5 secondary outcomes
Quality of Life and Pain Interference
Time frame: 10 weeks
Pain Acceptance
Time frame: 10 weeks
Psychological Flexibility
Time frame: 10 weeks
Kinesiophobia
Time frame: 10 weeks
Pain Resiliency
Time frame: 10 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tania Di Renna, MD, FRCPC principal investigator
Women's College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital psychology intervention (ADOPT-CP) and Reminder Emails in people with Fibromyalgia and Chronic Pelvic Pain Syndrome, run by Women's College Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Adriano Nella, MSc (416-323-6400 ext. 5977, Adriano.Nella@wchospital.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trial feasibility (time frame: 10 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.