Impact of QoLibri Medical Device on the Consequences of Chronic Pain: a Randomized Controlled Trial

Recruiting now · Not applicable

Conditions studied: Chronic Pain

In brief

A superiority study evaluating the impact of the QoLibri Software as Medical Device on functional and psychological consequences of chronic pain in primary care patients. A prospective, cluster-randomized, wait list, controlled multicentre study with the main objective of evaluating the effectiveness of the QoLibri Digital Therapy on Quality of Life improvement in patients living with chronic pain.

Key facts

Study ID

NCT06841276

Run by

Novesia

People needed

410

Starts

2025-02-28

Expected to finish

2027-04-01

Last updated by the study team

2026-02-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 it is running

• Maison de santé Nailloux / Saint-Léon — Nailloux, France (enrolling)

Full record on ClinicalTrials.gov

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