Power Over Pain Portal: A Stepped-care Virtual Solution to Deliver Early Intervention to Canadian Youth With Chronic Pain

Recruiting

• Conditions: Chronic Pain

• Registration Number: NCT06076889
• Lead Sponsor: The Hospital for Sick Children

Brief Summary

The COVID-19 pandemic is presenting one of the greatest threats to youth mental health seen in generations. Pain is one of the most common symptoms of extreme stress in youth. In 2020, the investigators created an online "stepped-care" program called the Power over Pain Portal. Stepped care is a promising way to improve access to CP care. Stepped care tailors care based on a person's symptom severity. Like a ladder, a person must start with one type of care then "step up" or "step down" to more or less intense care depending on need. The investigators also summarized all online pain management programs for youth to find the best resources to embed into the Portal. The investigators will pilot-test the Portal with youth to ensure it can be implemented effectively and will be clinically beneficial. The investigators will recruit 100 youth with CP to use the Portal for 2 months and see how they interact with the features and if it helps to improve their pain and mental health. The investigators will include a mixture of youth who represent different ages, sexes, genders, sexual orientations, races, dwellings, and school/employment status.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-31
• Study First Submitted: 2023-09-13
• Study First Submitted QC: 2023-10-04
• Study First Posted: 2023-10-11
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-16
• Last Update Posted: 2024-04-17
• Primary Completion: 2025-03-31
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Experience chronic pain
• Speak and read English
• Access to Internet / Smartphone (or will be loaned study phone with data plan)
• Intend to use the portal for 2 months

Exclusion Criteria

• Youth self-reports:
• Receiving tertiary care or are on waitlists for tertiary care paediatric chronic pain programs
• Have moderate to severe cognitive impairment that may impact their ability to understand and use the Power over Pain Portal or complete self-reported outcomes
• Have untreated major psychiatric illness (e.g., anorexia, psychosis) and/or active suicidality at the time of screening

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adoption (i.e.,rate of uptake of the Power over Pain Portal)	8 weeks	Characterized via the user-level analytics of interactions with each feature. The benchmark will be 75% of users completing 3/4 portal assessment and accessing ≥ portal intervention.
Portal Feasibility as assessed by the extent to which the Power over Pain Portal can be used as planned	8 weeks	Assessed via characterization of the severity of encountered issues on the Power over Pain portal
Acceptability	8 weeks	This will be assessed using the Acceptability e-Scale administered at T2 and assessed during the post-implementation qualitative interview. The minimum value is 1 and the maximum value is 5. Higher scores on the Acceptability e-Scale indicate a better outcome.
Appropriateness (i.e., perceived fit and compatibility of the Power over Pain Portal to the needs of users)	8 weeks	Assessed via the post-implementation qualitative interview.
Fidelity	8 weeks	Characterized by intervention use analytics.

Secondary Outcome Measures

Name	Time	Method
Client outcomes	8 weeks	Insomnia as assessed by the the 7-item Insomnia Severity Index. The maximum score on the scale is 4 and the lowest score is 0, with higher scores indicating more severe levels of insomnia experienced by the patient. This will be administered at T1 and T2.

Trial Locations

Locations (1)

The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada