Effectiveness of a Post-discharge Phone-Based Smoking Cessation Intervention for Patients with Severe Mental Health Disorders: The 061 Quitmental Randomized Controlled Clinical Trial

Abstract

A pragmatic double-blind randomized controlled trial was conducted in Barcelona to assess a telephone-based smoking cessation intervention’s effectiveness for individuals with mental health disorders post-discharge. Participants were divided into an intervention group (IG) and control group (CG) with a 2:1 allocation ratio. The IG received proactive motivational assistance, while the CG received brief advice. Biochemically validated past 7-day abstinence was the main outcome measure. Of 530 screened individuals, 294 were enrolled (200 IG, 94 CG). During follow-up, participants reported 97 episodes of ≥ 7-day abstinence (IG, 51; CG, 26). Overall abstinence probability was 30–35%, with no difference between groups at 1-year follow-up. However, intervention participants were more likely to report abstinence if they quit during hospitalization or were considering quitting. The intervention effectively supported smoking abstinence in motivated individuals. Combining this with clinical and community-based interventions holds promise for aiding smoking cessation in those with mental disorders. ClinicalTrials.gov Identifier: NCT03230955.