Design of the Lifestyle Interventions for severe mentally ill Outpatients in the Netherlands (LION) trial; a cluster randomised controlled study of a multidimensional web tool intervention to improve cardiometabolic health in patients with severe mental illness

Background: The cardiometabolic health of persons with a severe mental illness (SMI) is alarming with obesity rates of 45-55% and diabetes type 2 rates of 10-15%. Unhealthy lifestyle behaviours play a large role in this. Despite the multidisciplinary guideline for SMI patients recommending to monitor and address patients' lifestyle, most mental health care professionals have limited lifestyle-related knowledge and skills, and (lifestyle) treatment protocols are lacking. Evidence-based practical lifestyle tools may support both patients and staff in improving patients' lifestyle. This paper describes the Lifestyle Interventions for severe mentally ill Outpatients in the Netherlands (LION) trial, to investigate whether a multidimensional lifestyle intervention using a web tool can be effective in improving cardiometabolic health in SMI patients. Methods/Design: The LION study is a 12-month pragmatic single-blind multi-site cluster randomised controlled trial. 21 Flexible Assertive Community Treatment (ACT) teams and eight sheltered living teams of five mental health organizations in the Netherlands are invited to participate. Per team, nurses are trained in motivational interviewing and use of the multidimensional web tool, covering lifestyle behaviour awareness, lifestyle knowledge, motivation and goal setting. Nurses coach patients to change their lifestyle using the web tool, motivational interviewing and stages-of-change techniques during biweekly sessions in a) assessing current lifestyle behaviour using the traffic light method (healthy behaviours colour green, unhealthy behaviours colour red), b) creating a lifestyle plan with maximum three attainable lifestyle goals and c) discussing the lifestyle plan regularly. The study population is SMI patients and statistical inference is on patient level using multilevel analyses. Primary outcome is waist circumference and other cardiometabolic risk factors after six and twelve months intervention, which are measured as part of routine outcome monitoring using standard protocols. Secondary outcomes include depressive and negative symptoms, cost-effectiveness, and barriers and facilitators in intervention implementation. Discussion: Adequate health care should target both mental health and lifestyle behaviours in SMI patients. This trial contributes by studying a 12-month multidimensional lifestyle intervention as a potential evidence based (nursing) tool for targeting multiple lifestyle behaviours in SMI patients

Multimodal lifestyle intervention using a web-based tool to improve cardiometabolic health in patients with serious mental illness:results of a cluster randomized controlled trial (LION)

Background: Unhealthy lifestyle behaviours contribute to alarming cardiometabolic risk in patients with serious mental illness (SMI). Evidence-based practical lifestyle tools supporting patients and staff in improving patient lifestyle are lacking. Methods: This multi-site randomized controlled pragmatic trial determined the effectiveness of a twelve-month multimodal lifestyle approach, including a web-based tool to improve patients' cardiometabolic health, versus care-as-usual. Using the web tool, nurses (trained in motivational interviewing) assisted patients in assessing their lifestyle behaviours, creating a risk profile and constructing lifestyle goals, which were discussed during fortnightly regular care visits. Twenty-seven community-care and sheltered-living teams were randomized into intervention (N=17) or control (N=10) groups, including 244 patients (140 intervention/104 control, 49.2% male, 46.1 +/- 10.8 years) with increased waist circumference (WC), BMI or fasting glucose. The primary outcomes concerned differences in WC after six and twelve months intervention, while BMI and metabolic syndrome Z-score were secondary outcome measures. Results: General multilevel linear mixed models adjusted for antipsychotic medication showed that differences in WC change between intervention and control were-0.15 cm (95%CI: -2.49; 2.19) after six and -1.03 cm (95%CI: -3.42; 1.35) after twelve months intervention; however, the differences were not statistically significant. No intervention effects were found for secondary outcome measures. The intervention increased patients' readiness to change dietary behaviour. Conclusion: A multimodal web-based intervention facilitating nurses to address lifestyle changes in SMI patients did not improve patient cardiometabolic health. Web-tool use was lower than expected and nurses need more lifestyle coaching knowledge and skills. The type of intervention and delivery mode need optimization to realize effective lifestyle care for SMI patients

Real-World Treatment Costs and Care Utilization in Patients with Major Depressive Disorder With and Without Psychiatric Comorbidities in Specialist Mental Healthcare

BACKGROUND: The majority of patients with major depressive disorder (MDD) have comorbid mental conditions. OBJECTIVES: Since most cost-of-illness studies correct for comorbidity, this study focuses on mental healthcare utilization and treatment costs in patients with MDD including psychiatric comorbidities in specialist mental healthcare, particularly patients with a comorbid personality disorder (PD). METHODS: The Psychiatric Case Register North Netherlands contains administrative data of specialist mental healthcare providers. Treatment episodes were identified from uninterrupted healthcare use. Costs were calculated by multiplying care utilization with unit prices (price level year: 2018). Using generalized linear models, cost drivers were investigated for the entire cohort. RESULTS: A total of 34,713 patients had MDD as a primary diagnosis over the period 2000–2012. The number of patients with psychiatric comorbidities was 24,888 (71.7%), including 13,798 with PD. Costs were highly skewed, with an average ± standard deviation cost per treatment episode of €21,186 ± 74,192 (median €2320). Major cost drivers were inpatient days and daycare days (50 and 28% of total costs), occurring in 12.7 and 12.5% of episodes, respectively. Compared with patients with MDD only (€11,612), costs of patients with additional PD and with or without other comorbidities were, respectively, 2.71 (p < .001) and 2.06 (p < .001) times higher and were 1.36 (p < .001) times higher in patients with MDD and comorbidities other than PD. Other cost drivers were age, calendar year, and first episodes. CONCLUSIONS: Psychiatric comorbidities (especially PD) in addition to age and first episodes drive costs in patients with MDD. Knowledge of cost drivers may help in the development of future stratified disease management programs. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s40273-021-01012-x

Mental health care use in adolescents with and without mental disorders

The aim of the study was to estimate the proportion of adolescents with and without a psychiatric diagnosis receiving specialist mental health care and investigate their problem levels as well as utilization of other types of mental health care to detect possible over-and under-treatment. Care utilization data were linked to psychiatric diagnostic data of 2230 adolescents participating in the TRAILS cohort study, who were assessed biannually starting at age 11. Psychiatric diagnoses were established at the fourth wave by the Composite International Diagnostic Interview. Self-, parent-and teacher-reported emotional and behavioral problems and self-reported mental health care use were assessed at all four waves. Of all diagnosed adolescents, 35.3 % received specialist mental health care. This rate increased to 54.5 % when three or more disorders were diagnosed. Almost a third (28.5 %) of specialist care users had no psychiatric diagnosis; teachers gave them relatively high ratings on attention and impulsivity subscales. Diagnosed adolescents without specialist mental health care also reported low rates of other care use. We found no indication of overtreatment. Half of the adolescents with three or more disorders do not receive specialist mental health care nor any other type of care, which might indicate unmet needs

The effects of a computerized clinical decision aid on clinical decision-making in psychosis care

Objective Clinicians in mental healthcare have few objective tools to identify and analyze their patient's care needs. Clinical decision aids are tools that support this process. This study examines whether 1) clinicians working with a clinical decision aid (TREAT) discuss more of their patient's care needs compared to usual treatment, and 2) agree on more evidence-based treatment decisions. Methods Clinicians participated in consultations (n = 166) with patients diagnosed with psychotic disorders from four Dutch mental healthcare institutions (research registration number 201700763). Primary outcomes were measured with the modified Clinical Decision-making in Routine Care questionnaire and combined with psychiatric, physical and social wellbeing related care needs. A multilevel analysis compared discussed care needs and evidence-based treatment decisions between treatment as usual (TAU) before, TAU after and the TREAT condition. Results First, a significant increase in discussed care needs for TREAT compared to both TAU conditions (β = 20.2, SE = 5.2, p = 0.00 and β = 15.8, SE = 5.4, p = 0.01) was found. Next, a significant increase in evidence-based treatments decisions for care needs was observed for TREAT compared to both TAU conditions (β = 16.7, SE = 4.8, p = 0.00 and β = 16.0, SE = 5.1, p = 0.01). Conclusion TREAT improved the discussion about physical health issues and social wellbeing related topics. It also increased evidence-based treatment decisions for care needs which are sometimes overlooked and difficult to treat. Our findings suggest that TREAT makes sense of routine outcome monitoring data and improves guideline-informed care

Low Physical Activity and Cardiorespiratory Fitness in People With Schizophrenia: A Comparison With Matched Healthy Controls and Associations With Mental and Physical Health

Introduction: The aim of this study was to objectively assess time spent in physical activity (PA) and sedentary behavior (SB) in patients with schizophrenia compared to healthy controls matched for age, gender and socioeconomic status. Associations between both PA and cardiorespiratory fitness (CRF) and mental and physical health parameters in patients with schizophrenia were examined.Materials and Methods: Moderate and vigorous PA (MVPA), moderate PA, vigorous PA, total and active energy expenditure (TEE and AEE), number of steps, lying down and sleeping time was assessed with SenseWear Pro-2 body monitoring system for three 24-h bouts in patients with schizophrenia (n = 63) and matched healthy controls (n = 55). Severity of symptoms (Positive and Negative Syndrome Scale and Montgomery and Åsberg Depression Rating Scale), CRF (peak oxygen uptake, VO2peak), body mass index (BMI), and metabolic syndrome were assessed.Results: Patients with schizophrenia performed less MVPA and moderate activity had lower TEE and AEE, spent more time per day lying down and sleeping, and had poorer CRF compared to healthy controls. The amount of MVPA, but especially CRF was associated with severity of negative symptoms in patients with schizophrenia. Only CRF was associated with BMI.Discussion: The current data offer further evidence for interventions aiming to increase physical activity and decrease sedentary behavior. Given strong associations of CRF with both negative symptoms and BMI, treatment aimed at CRF-improvement may prove to be effective

Cost-effectiveness and budget impact of a lifestyle intervention to improve cardiometabolic health in patients with severe mental illness

Introduction: This study assessed the cost-effectiveness and budget impact of a lifestyle intervention to improve cardiometabolic health in severe mentally ill (SMI) patients in the LION trial.Methods: Patients (n = 244) were randomized to receive either care-as-usual or a lifestyle intervention in which mental health nurses coached patients in changing their lifestyle by using a web tool. Costs and quality of life were assessed at baseline and at 6 and 12 months. Incremental costs per centimeter waist circumference (WC) lost and per Quality-Adjusted Life Year (QALY) gained were assessed. Budget impact was estimated based on three intervention-uptake scenarios using a societal and a third-party payer perspective.Results: Costs and reduction in WC were higher in the intervention (n = 114) than in the control (n = 94) group after 12 months, although not statistically significant, resulting in (sic)1,370 per cm WC lost. QALYs did not differ between the groups, resulting in a low probability of the intervention being cost-effective in cost/QALY gained. The budget impact analysis showed that for a reasonable participation of 43%, total costs were around (sic)81 million over 5 years, or on average (sic)16 million annually (societal perspective).Conclusions: The intervention is not cost-effective at 12 months and the budget impact over 5 years is substantial. Possibly, 12 months was too short to implement the intervention, improve cardiometabolic health, and reduce care costs. Therefore, the incentive for this intervention cannot be found in short-term financial advantages. However, there may be benefits associated with lifestyle interventions in the long term that remain unclear.</p