QoLibri digital therapy to reduce the functional and emotional impact of chronic pain
Evaluation of the Impact of the QoLibri Digital Therapy on Primary Care Patients With Chronic Pain: a Randomized Controlled Clinical Trial.
QoLibri digital therapy will be tried to see if it improves quality of life and reduces the day-to-day and emotional impact of chronic pain in adults seen in primary care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 410 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Novesia Industry-sponsored |
| Locations | 1 site (Nailloux) |
| Trial ID | NCT06841276 on ClinicalTrials.gov |
What this trial studies
This is a prospective, cluster-randomized, wait-list controlled multicentre study comparing the QoLibri Software as a Medical Device to a wait-list control in primary care settings. The main objective is to see if the QoLibri digital therapy improves quality of life and reduces functional and psychological consequences of chronic pain. Eligible participants are adults with at least moderate pain for more than three months and a BPI interference score of ≥3 in at least three of seven domains who have a smartphone and internet access. The intervention is delivered via the QoLibri digital platform and outcomes are measured against the wait-list group over the study period.
Who should consider this trial
Good fit: Adults with chronic pain lasting more than three months who report at least moderate pain and a BPI interference score ≥3 in three or more domains, and who own a smartphone with internet access, are ideal candidates.
Not a fit: Patients with severe anxiety or depressive disorders (including suicidal risk), significant cognitive or social barriers to engaging in cognitive-behavioral approaches, those under legal protection, or those without smartphone/internet access are unlikely to benefit or are excluded.
Why it matters
Potential benefit: If successful, QoLibri could help patients have better quality of life and less interference from pain in daily activities and mood through a guided digital therapy.
How similar studies have performed: Previous randomized trials of digital cognitive-behavioral and other digital therapies for chronic pain have shown modest to meaningful improvements in pain-related function and quality of life, so this approach builds on existing evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient experiencing at least moderate pain (on the Categorical Pain Scale) for more than 3 months * Patient with a BPI interference score ≥ 3 in at least 3 out of 7 dimensions * Patient with a smartphone and an internet connection at the place of use * Patient affiliated with a social security system or benefiting from such a system Exclusion Criteria: * Patient opposing participation in the study * Patient with severe anxiety and/or depressive disorders (especially a suicidal risk) * Patient presenting one or more barriers to the initiation of cognitive-behavioral therapy (significant social difficulties, low adherence to current care, insufficient memory or cognitive abilities, lack of time, lack of motivation...), * Adult patient under legal protection measures (guardianship, legal safeguard, psychiatric care, or deprived of liberty by judicial or administrative decision)
Where this trial is running
Nailloux
- Maison de santé Nailloux / Saint-Léon — Nailloux, France (Recruiting)
Study contacts
- Principal investigator: Antoine Elyn, MD
- Study coordinator: Alice Corteval, PharmD
- Email: a.corteval@novesia.fr
- Phone: +33 6 88 08 29 72
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.