NCT07659873

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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
17mo left

Started Oct 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 15, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 22, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2026

Expected
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2028

Last Updated

June 22, 2026

Status Verified

June 1, 2026

Enrollment Period

1 year

First QC Date

June 15, 2026

Last Update Submit

June 15, 2026

Conditions

Outcome Measures

Primary Outcomes (5)

  • 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

Secondary Outcomes (5)

  • Quality of Life and Pain Interference

    10 weeks

  • Pain Acceptance

    10 weeks

  • Psychological Flexibility

    10 weeks

  • Kinesiophobia

    10 weeks

  • Pain Resiliency

    10 weeks

Study Arms (2)

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.

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.

Other: Reminder Emails

Interventions

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.

Intervention Group

Weekly emailed pain self-management resources introduced during the Toronto Academic Pain Medicine Institute (TAPMI) orientation

Control Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Women's College Hospital

Toronto, Ontario, M5S 1B2, Canada

Location

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • Tania Di Renna, MD, FRCPC

    Women's College Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
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.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2026

First Posted

June 22, 2026

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

March 1, 2028

Last Updated

June 22, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

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.

Locations