Department of Health Sciences and Amsterdam Public Health research institute, Faculty of Science, Vrije Universiteit Amsterdam, Van der Boechorststraat 7, 1081BT, Amsterdam, The Netherlands.
Department of Psychiatry, Amsterdam UMC and Amsterdam Public Health research institute, Amsterdam, Netherlands.
BMC Psychiatry. 2023 Feb 16;23(1):108. doi: 10.1186/s12888-023-04599-x.
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.
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.
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.
Netherlands Trial Register, NTR9783. Registered on 18 October 2021.
严重精神疾病（SMI）患者的吸烟率很高，与身体健康状况不佳密切相关。目前，基于证据的戒烟干预措施稀缺，需要将其纳入当前的精神卫生保健治疗指南和临床实践中。因此，本研究旨在评估在荷兰灵活强化社区治疗（FACT）团队治疗的 SMI 患者中，与常规护理相比，戒烟干预措施的实施情况和效果。
这是一项实用的、集群随机对照试验，嵌入了过程评估。将在 FACT 团队层面进行随机分组，FACT 团队将被分配到 KISMET 干预组或对照组（常规护理）。干预措施包括药物治疗，结合由经过培训的精神卫生保健专业人员提供的行为咨询和同伴支持。该干预措施是使用德尔菲研究开发的，通过该研究就干预措施的核心要素达成了共识。我们旨在纳入总共 318 名吸烟且希望戒烟的 SMI 患者（年龄 18-65 岁）。主要结局是通过一氧化碳测量和自我报告来验证的吸烟状况。次要结局包括抑郁和焦虑、精神病症状、身体健康、心血管风险、物质使用、生活质量以及 12 个月时的健康相关自我效能。在试验的同时，还将进行定性的过程评估，以评估其实施的障碍和促进因素，以及患者和精神卫生保健专业人员的满意度和体验。
KISMET 试验的结果将有助于填补 FACT 团队治疗患者有效的戒烟干预措施的证据空白。此外，还将深入了解干预措施在当前精神卫生保健中的实施过程。研究结果应增进对身心健康相互依存关系的理解，并在精神卫生保健系统中逐步整合两者。
荷兰试验注册处，NTR9783。于 2021 年 10 月 18 日注册。
