Samenvatting

Abstract
Background Smoking among people with severe mental illness (SMI) is highly prevalent and strongly associated with poor physical health. Currently, evidence-based smoking cessation interventions are scarce and need to be inte grated into current mental health care treatment guidelines and clinical practice. Therefore, the present study aims to evaluate the implementation and efectiveness of a smoking cessation intervention in comparison with usual care in
people with SMI treated by Flexible Assertive Community Treatment (FACT) teams in the Netherlands.
Methods A pragmatic, cluster-randomised controlled trial with embedded process evaluation will be conducted. Randomisation will be performed at the level of FACT teams, which will be assigned to the KISMET intervention or a
control group (care as usual). The intervention will include pharmacological treatment combined with behavioural counselling and peer support provided by trained mental health care professionals. The intervention was developed
using a Delphi study, through which a consensus was reached on the core elements of the intervention. We aim to include a total of 318 people with SMI (aged 18–65 years) who smoke and desire to quit smoking. The primary
outcome is smoking status, as verifed by carbon monoxide measurements and self-report. The secondary outcomes are depression and anxiety, psychotic symptoms, physical ftness, cardiovascular risks, substance use, quality of life,
and health-related self-efcacy at 12months. Alongside the trial, a qualitative process evaluation will be conducted to evaluate the barriers to and facilitators of its implementation as well as the satisfaction and experiences of both
patients and mental health care professionals.
Discussion The results of the KISMET trial will contribute to the evidence gap of efective smoking cessation inter ventions for people treated by FACT teams. Moreover, insights will be obtained regarding the implementation process
of the intervention in current mental health care. The outcomes should advance the understanding of the interde pendence of physical and mental health and the gradual integration of both within the mental health care system.
Trial registration Netherlands Trial Register, NTR9783. Registered on 18 October 2021.