Bailleul

Researchers are conducting a multicenter, prospective, interventional clinical investigation in nine French healthcare establishments to assess the safety of the SECURIDRAP® SELFIA® bedding. This study follows the market withdrawal of the first version of this product and is carried out upon recommendation from the ASNM to evaluate the safety of the second version. The study involves patients with disorientation, cognitive impairment, or behavior disorders who have a medical prescription for the device. Participants will use the SECURIDRAP® SELFIA® bedding for 15 nights in real-life conditions within nursing homes and hospitals. During this time, an independent assessor will ensure that the device's usage conditions are properly followed. The study is interventional but non-comparative and is designed to pose minimal risks and constraints to participants. During the 15-night period, participants will be monitored for any adverse events related to the use of the SECURIDRAP® SELFIA®. Data collection will include safety evaluations to confirm the device's safe use in healthcare settings. The trial focuses on the occurrence rate of adverse events connected to the bedding's use, with close follow-up by researchers to ensure participant safety.

People with mental disorders tend to smoke more than the general population, which partly causes significant health differences and shorter life expectancy by 10 to 25 years. This gap is mainly due to heart and lung diseases, including bronchial cancers. Despite their motivation to quit, smoking is often overlooked or tolerated in psychiatric care, making quitting harder due to stronger withdrawal symptoms. This research evaluates a new intervention called "Tabapsy," designed with input from patients, mental health professionals, and general practitioners to support smoking cessation in adults receiving outpatient psychiatric care. The Tabapsy intervention includes a campaign to promote quitting smoking and a structured support program with multiple components: a general information meeting to boost motivation, an assessment workshop to personalize cessation plans, five thematic workshops covering treatments, emotional management, weight control, physical activity, and manual activities, plus peer support groups to encourage mutual help. A dedicated facilitator runs the program in psychiatric medical psychological centers (CMPs), supplemented by a website with resources. The study compares this intervention to usual care practices regarding smoking cessation in a cluster-randomized controlled trial involving psychiatric sectors in France. Participants are regular smokers aged 18 or older who receive outpatient psychiatric care at participating centers. They will complete questionnaires online at the start, and again at 3 and 6 months, covering smoking habits, nicotine dependence, motivation, use of quitting aids, mental and physical well-being, and knowledge about smoking. The main outcome is short-term smoking cessation lasting at least 7 days at 3 months. Secondary goals include assessing cost-effectiveness and how well the intervention is implemented. A total of 6,250 participants will be enrolled over 12 months across 22 sectors.