IMPORTANCE People with a severe mental illness (SMI) have a life expectancy reduced by 10 to 20 years compared with the general population, primarily attributable to cardiometabolic disorders. Lifestyle interventions for people with SMI can improve health and reduce cardiometabolic risk. OBJECTIVE To evaluate the effectiveness of a group-based lifestyle intervention among people with SMI in outpatient treatment settings compared with treatment as usual (TAU). DESIGN, SETTING, AND PARTICIPANTS The Severe Mental Illness Lifestyle Evaluation (SMILE) study is a pragmatic cluster randomized clinical trial performed in 8 mental health care centers with 21 flexible assertive community treatment teams in the Netherlands. Inclusion criteria were SMI, age of 18 years or older, and body mass index (calculated as weight in kilograms divided by height in meters squared) of 27 or greater. Data were collected from January 2018 to February 2020, and data were analyzed from September 2020 to February 2023. INTERVENTIONS Weekly 2-hour group sessions for 6 months followed by monthly 2-hour group sessions for another 6 months, delivered by trained mental health care workers. The intervention targeted overall lifestyle changes, emphasizing establishing a healthy diet and promoting physical activity. TAU (control) did not include structured interventions or advice on lifestyle. MAIN OUTCOMES AND MEASURES Crude and adjusted linear mixed models and multivariable logistic regression analyses were performed. The main outcome was body weight change. Secondary outcomes included changes in body mass index, blood pressure, lipid profiles, fasting glucose level, quality of life, self-management ability, and lifestyle behaviors (physical activity and health, mental health, nutrition, and sleep). RESULTS The study population included 11 lifestyle intervention teams (126 participants) and 10 TAU teams (98 participants). Of 224 included patients, 137 (61.2%) were female, and the mean (SD) age was 47.6 (11.1) years. From baseline to 12 months, participants in the lifestyle intervention group lost 3.3 kg (95%CI, −6.2 to −0.4) more than those in the control group. In the lifestyle intervention group, people with high attendance rates lost more weight than participants with medium and low rates (mean [SD] weight loss: high, −4.9 [8.1] kg; medium, −0.2 [7.8] kg; low, 0.8 [8.3] kg). Only small or no changes were found for secondary outcomes. CONCLUSIONS AND RELEVANCE In this trial, the lifestyle intervention significantly reduced weight from baseline to 12 months in overweight and obese adults with SMI. Tailoring lifestyle interventions and increasing attendance rates might be beneficial for people with SMI. TRIAL REGISTRATION Netherlands Trial Register Identifier: NTR6837
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Abstract Background: Several interventions have been developed to improve physical health and lifestyle behaviour of people with a severe mental illness (SMI). Recently, we conducted a pragmatic cluster-randomised controlled trial which evaluated the efects of the one-year Severe Mental Illness Lifestyle Evaluation (SMILE) lifestyle intervention compared with usual care in clients with SMI. The SMILE intervention is a 12-month group-based lifestyle intervention with a focus on increased physical activity and healthy food intake. The aim of the current study was to explore the experiences of people with SMI and healthcare professionals (HCPs) regarding implementation feasibility of the SMILE intervention and the fdelity to the SMILE intervention. Methods: A process evaluation was conducted alongside the pragmatic randomized controlled trial. The experiences of clients and HCPs in the lifestyle intervention group were studied. First, descriptive data on the implementation of the intervention were collected. Next, semi-structured interviews with clients (n=15) and HCPs (n=13) were performed. Interviews were audiotaped and transcribed verbatim. A thematic analysis of the interview data was performed using MAXQDA software. In addition, observations of group sessions were performed to determine the fdelity to the SMILE intervention using a standardised form. Results: Ten out of 26 HCPs who conducted the group sessions discontinued their involvement with the intervention, primarily due to changing jobs. 98% of all planned group sessions were performed. Four main themes emerged from the interviews: 1) Positive appraisal of the SMILE intervention, 2) Suggestions for improvement of the SMILE intervention 3) Facilitators of implementation and 4) Barriers of implementation. Both clients and HCPs had positive experiences regarding the SMILE intervention. Clients found the intervention useful and informative. The intervention was found suitable and interesting for all people with SMI, though HCPs sometimes had to tailor the intervention to individual characteristics of patients (e.g., with respect to cognitive functioning). The handbook of the SMILE intervention was perceived as user-friendly and helpful by HCPs. Combining SMILE with daily tasks, no support from other team members, and lack of staf and time were experienced as barriers for the delivery of the intervention Conclusion: The SMILE intervention was feasible and well-perceived by clients and HCPs. However, we also identifed some aspects that may have hindered efective implementation and needs to be considered when implementing the SMILE intervention in daily practice
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Abstract Background: Lifestyle interventions for severe mental illness (SMI) are known to have small to modest efect on physical health outcomes. Little attention has been given to patient-reported outcomes (PROs). Aim: To systematically review the use of PROs and their measures, and quantify the efects of lifestyle interventions in patients with SMI on these PROs. Methods: Five electronic databases were searched (PubMed/Medline, Embase, PsycINFO, CINAHL, and Web of Science) from inception until 12 November 2020 (PROSPERO: CRD42020212135). Randomised controlled trials (RCTs) evaluating the efcacy of lifestyle interventions focusing on healthy diet, physical activity, or both for patients with SMI were included. Outcomes of interest were PROs. Results: A total of 11.267 unique records were identifed from the database search, 66 full-text articles were assessed, and 36 RCTs were included, of which 21 were suitable for meta-analyses. In total, 5.907 participants were included across studies. Lifestyle interventions had no signifcant efect on quality of life (g=0.13; 95% CI=−0.02 to 0.27), with high heterogeneity (I2 =68.7%). We found a small efect on depression severity (g=0.30, 95% CI=0.00 to 0.58, I2 =65.2%) and a moderate efect on anxiety severity (g=0.56, 95% CI=0.16 to 0.95, I2 =0%). Discussion: This meta-analysis quantifes the efects of lifestyle interventions on PROs. Lifestyle interventions have no signifcant efect on quality of life, yet they could improve mental health outcomes such as depression and anxiety symptoms. Further use of patient-reported outcome measures in lifestyle research is recommended to fully capture the impact of lifestyle interventions.
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Severe mental illness (SMI) imposes a significant burden on individuals, resulting in long-lasting symptoms, lower social functioning and impaired physical health. Physical activity (PA) interventions can improve both mental and physical health and care workers can serve as healthy role models. Yet, individuals with SMI face barriers to PA participation. This study evaluated the effects of Muva, and assessed if mental health worker’s (MHW) characteristics were associated with clients’ change in social functioning. Muva, an intervention package primarily created to increase PA of people with SMI, places a special focus on MHWs as they might play a key role in overcoming barriers. Other PA barrier-decreasing elements of Muva were a serious game app, lifestyle education, and optimization of the medication regime. Method: This study is a pragmatic stepped wedge cluster controlled trial. Controls received care as usual. Mixedeffects linear regressions were performed to assess changes in the primary outcome social functioning, and secondary outcomes quality of life, psychiatric symptoms, PA, body mass index, waist circumference, and blood pressure. Results: 84 people with SMI were included in three intervention clusters, and 38 people with SMI in the control cluster. Compared to the control condition, there was significant clinical improvement of social functioning in interpersonal communication (p=<0.01) and independent competence (p=<0.01) in people receiving Muva. These outcomes were not associated with MHW’s characteristics. There were no changes in the other outcome measures. Conclusions: Muva improved social functioning in people with SMI compared to care as usual.
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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 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.
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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 integrated 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 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.
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Abstract Background: People with severe mental illness (SMI) often suffer from long-lasting symptoms that negatively influence their social functioning, their ability to live a meaningful life, and participation in society. Interventions aimed at increasing physical activity can improve social functioning, but people with SMI experience multiple barriers to becoming physically active. Besides, the implementation of physical activity interventions in day-to-day practice is difficult. In this study, we aim to evaluate the effectiveness and implementation of a physical activity intervention to improve social functioning, mental and physical health. Methods: In this pragmatic stepped wedge cluster randomized controlled trial we aim to include 100 people with SMI and their mental health workers from a supported housing organization. The intervention focuses on increasing physical activity by implementing group sports activities, active guidance meetings, and a serious game to set physical activity goals. We aim to decrease barriers to physical activity through active involvement of the mental health workers, lifestyle courses, and a medication review. Participating locations will be divided into four clusters and randomization will decide the start of the intervention. The primary outcome is social functioning. Secondary outcomes are quality of life, symptom severity, physical activity, cardiometabolic risk factors, cardiorespiratory fitness, and movement disturbances with specific attention to postural adjustment and movement sequencing in gait. In addition, we will assess the implementation by conducting semi-structured interviews with location managers and mental health workers and analyze them by direct content analysis. Discussion: This trial is innovative since it aims to improve social functioning in people with SMI through a physical activity intervention which aims to lower barriers to becoming physically active in a real-life setting. The strength of this trial is that we will also evaluate the implementation of the intervention. Limitations of this study are the risk of poor implementation of the intervention, and bias due to the inclusion of a medication review in the intervention that might impact outcomes. Trial registration: This trial was registered prospectively in The Netherlands Trial Register (NTR) as NTR NL9163 on December 20, 2020. As the The Netherlands Trial Register is no longer available, the trial can now be found in the International Clinical Trial Registry Platform via: https:// trial search. who. int/ Trial2. aspx? Trial ID= NL9163.
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Aim: Aim of this study was to provide insight into the costs associated with severe mental illnesses from a societal perspective. Insight into expenses is of value to policymakers and mental health institutions that are dealing with ongoing budget cuts. A reliable cost estimate is also necessary to assess the cost-effectiveness of interventions and make decisions on reimbursement. Methods: Baseline costs were calculated for 188 individuals with severe mental illness (SMI) who wish to increase their societal participation defined as paid or unpaid work, education and meaningful daily activities. Costs were measured from a societal perspective by means of the TIC-P questionnaire and expressed in Euros.
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Background: Increasing attention to palliative care for the general population has led to the development of various evidence-based or consensus-based tools and interventions. However, specific tools and interventions are needed for people with severe mental illness (SMI) who have a life-threatening illness. The aim of this systematic review is to summarize the scientific evidence on tools and interventions in palliative care for this group. Methods: Systematic searches were done in the PubMed, Cochrane Library, CINAHL, PsycINFO and Embase databases, supplemented by reference tracking, searches on the internet with free text terms, and consultations with experts to identify relevant literature. Empirical studies with qualitative, quantitative or mixed-methods designs concerning tools and interventions for use in palliative care for people with SMI were included. Methodological quality was assessed using a critical appraisal instrument for heterogeneous study designs. Stepwise study selection and the assessment of methodological quality were done independently by two review authors. Results: Four studies were included, reporting on a total of two tools and one multi-component intervention. One study concerned a tool to identify the palliative phase in patients with SMI. This tool appeared to be usable only in people with SMI with a cancer diagnosis. Furthermore, two related studies focused on a tool to involve people with SMI in discussions about medical decisions at the end of life. This tool was assessed as feasible and usable in the target group. One other study concerned the Dutch national Care Standard for palliative care, including a multicomponent intervention. The Palliative Care Standard also appeared to be feasible and usable in a mental healthcare setting, but required further tailoring to suit this specific setting. None of the included studies investigated the effects of the tools and interventions on quality of life or quality of care. Conclusions: Studies of palliative care tools and interventions for people with SMI are scarce. The existent tools and intervention need further development and should be tailored to the care needs and settings of these people. Further research is needed on the feasibility, usability and effects of tools and interventions for palliative care for people with SMI.
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Abstract Background Clients with severe mental illness (SMI) have overall poor physical health. SMI reduces life expectancy by 5–17 years, primarily due to physical comorbidity linked to cardiometabolic risks that are mainly driven by unhealthy lifestyle behaviours. To improve physical health in clients with SMI, key elements are systematic somatic screening and lifestyle promotion. The nurse-led GILL eHealth was developed for somatic screening and the imple‑ mentation of lifestyle activities in clients with SMI. Aims of this study are to evaluate the efectiveness of the GILL eHealth intervention in clients with SMI compared to usual care, and to evaluate the implementation process, and the experiences of clients and healthcare providers with GILL eHealth. Methods The GILL study encompasses a cluster-randomised controlled trial in approximately 20 mental health care facilities in the Netherlands. The randomisation takes place at the team level, assigning clients to the eHealth inter‑ vention or the usual care group. The GILL eHealth intervention consists of two complementary modules for somatic screening and lifestyle promotion, resulting in personalised somatic treatment and lifestyle plans. Trained mental health nurses and nurse practitioners will implement the intervention within the multidisciplinary treatment context, and will guide and support the participants in promoting their physical health, including cardiometabolic risk management. Usual care includes treatment as currently delivered, with national guidelines as frame of reference. We aim to include 258 clients with SMI and a BMI of 27 or higher. Primary outcome is the metabolic syndrome severity score. Secondary outcomes are physical health measurements and participants’ reports on physical activity, perceived lifestyle behaviours, quality of life, recovery, psychosocial functioning, and health-related self-efcacy. Measurements will be completed at baseline and at 6 and 12 months. A qualitative process evaluation will be conducted alongside, to evaluate the process of implementation and the experiences of clients and healthcare professionals with GILL eHealth. Discussion The GILL eHealth intervention is expected to be more efective than usual care in improving physical health and lifestyle behaviours among clients with SMI. It will also provide important information on implementation of GILL eHealth in mental health care. If proven efective, GILL eHealth ofers a clinically useful tool to improve physical health and lifestyle behaviours.
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