A smoking cessation intervention for people with severe mental illness treated in ambulatory mental health care (KISMET): study protocol of a randomised controlled trial.

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 integrated into current mental health care treatment guidelines and clinical practice. Therefore, the present study aims to evaluate the implementation and effectiveness 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 verified by carbon monoxide measurements and self-report. The secondary outcomes are depression and anxiety, psychotic symptoms, physical fitness, cardiovascular risks, substance use, quality of life, and health-related self-efficacy at 12 months. 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 effective smoking cessation interventions 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 interdependence 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.

Developing a Smoking Cessation Intervention for People With Severe Mental Illness Treated by Flexible Assertive Community Treatment Teams in the Netherlands: A Delphi Study.

Background: There is still limited evidence on the effectiveness and implementation of smoking cessation interventions for people with severe mental illness (SMI) in Dutch outpatient psychiatric settings. The present study aimed to establish expert consensus on the core components and strategies to optimise practical implementation of a smoking cessation intervention for people treated by Flexible Assertive Community Treatment (FACT) teams in the Netherlands. Design: A modified Delphi method was applied to reach consensus on three core components (behavioural counselling, pharmacological treatment and peer support) of the intervention. The Delphi panel comprised five experts with different professional backgrounds. We proposed a first intervention concept. The panel critically examined the evolving concept in three iterative rounds of 90 min each. Responses were recorded, transcribed verbatim and thematically analysed. Results: Overall, results yielded that behavioural counselling should focus on preparation for smoking cessation, guidance, relapse prevention and normalisation. Pharmacological treatment consisting of nicotine replacement therapy (NRT), Varenicline or Bupropion, under supervision of a psychiatrist, was recommended. The panel agreed on integrating peer support as a regular part of the intervention, thus fostering emotional and practical support among patients. Treatment of a co-morbid cannabis use disorder needs to be integrated into the intervention if indicated. Regarding implementation, staff's motivation to support smoking cessation was considered essential. For each ambulatory team, two mental health care professionals will have a central role in delivering the intervention. Conclusions: This study provides insight into expert consensus on the core components of a smoking cessation intervention for people with SMI. The results of this study were used for the development of a comprehensive smoking cessation program.