Virtual Reality Breathing Interventions for Mental Health: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

Breathing exercises have been shown to reduce mental health problems among clinical and non-clinical populations. Although virtual reality (VR) breathing interventions are assumed to have potential benefits, it remains unclear whether VR breathing interventions are more effective at improving mental health than non-VR breathing interventions. We conducted a systematic literature search in six electronic databases (Web of Science, PsycINFO, Embase, Cochrane Central Register of Controlled Trials, Scopus, and PubMed) from inception to 30th September, 2022. We included randomized controlled trials in adults evaluating effects of VR compared to non-VR breathing interventions on primary outcomes of mental health (stress, anxiety and mood), and secondary outcomes of physiological stress measures (e.g., heart rate (HR), heart rate variability (HRV)). Within these selected studies, we explored differences in likeability and future use between VR and non-VR breathing interventions. 2.848 records were identified of which 65 full-text articles were assessed. Six RCTs were included, of which five were suitable for meta-analyses. Comparing VR to non-VR breathing interventions, there were no significant differences in overall mental health, stress, anxiety or mood, nor in HR or HRV. There was no evidence that participants liked VR breathing interventions more than non-VR, nor would use them more in the future. These results suggest that there is no evidence that VR breathing interventions are more effective than non-VR in improving mental health outcomes, HR, HRV. Further research is required to determine whether there may be advantages to longer-term VR-implementation and practice, and explore possible mechanisms.

Scalability of effective adherence interventions for patients using cardiovascular disease medication: A realist synthesis-inspired systematic review.

Upscaling of medication adherence interventions to routine care is still challenging. This realist theory-inspired review aimed to assess which intervention aspects are potentially important for the scalability of effective cardiovascular disease (CVD) medication adherence interventions and how they are reported in effectiveness studies. A total of 4097 articles from four databases were screened of which ultimately 31 studies were included. Relevant information on scalability was extracted using a theoretic framework based on the scalability assessment tool used in the QUALIDEC study for the following domains: (i) innovation, (ii) implementers and patients, (iii) adopting organizations and health system, and (iv) socio-political context. Extracted articles were analysed for themes and chains of inference, which were grouped based on commonality and source of evidence to form new hypotheses. Six different domains relevant for scalability of adherence interventions were identified: (1) Complexity of the intervention; (2) training; (3) customization of the intervention; (4) drivers of the intervention; (5) technical interventions; and (6) stakeholder involvement. These six domains might be useful for the development of more scalable interventions by bridging the gap between research and practice. Data relevant for scalability is not well reported on in effectiveness trials for CVD medication adherence interventions and only limited data on scalability has been published in additional papers. We believe the adoption and reach of effective CVD medication adherence interventions will improve with increased awareness for the necessity of scalability in all phases of intervention development.

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.

The nurse-led GILL eHealth intervention for improving physical health and lifestyle behaviours in clients with severe mental illness: design of a cluster-randomised controlled trial.

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 implementation of lifestyle activities in clients with SMI. Aims of this study are to evaluate the effectiveness 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 intervention 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-efficacy. 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 effective 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 effective, GILL eHealth offers a clinically useful tool to improve physical health and lifestyle behaviours. TRIAL REGISTRATION: Clinical trial registration NCT05533749, registration date: 8 September 2022.

Implementing medication adherence interventions in four Dutch living labs; context matters.

BACKGROUND: Despite the abundant availability of effective medication adherence interventions, uptake of these interventions into routine care often lacks. Examples of effective medication adherence interventions include telephone counseling, consult preparation and the teach-back method. Assessing context is an important step in understanding implementation success of interventions, but context is often not reported or only moderately described. This study aims to describe context-specific characteristics in four living labs prior to the implementation of evidence-based interventions aiming to improve medication adherence. METHODS: A qualitative study was conducted within four living labs using individual interviews (n = 12) and focus groups (n = 4) with project leaders and involved healthcare providers. The four living labs are multidisciplinary collaboratives that are early adopters of medication adherence interventions in the Dutch primary care system. Context is defined as the environment or setting in which the proposed change is to be implemented. Interview topics to assess context were formulated based on the 'inner setting' and 'outer setting' domains of the Consolidated Framework for Implementation Research (CFIR). Interviews were recorded and transcribed verbatim. Transcripts were deductively analyzed. RESULTS: A total of 39 community pharmacists, pharmacy technicians, general practitioners and a home care employee participated in the (focus group) interviews. All four living labs proved to be pharmacy-driven and characterized by a high regard for innovation by staff members, a positive implementation climate, high levels of leadership engagement and high compatibility between the living labs and the interventions. Two living labs were larger in size and characterized by more formal communication. Two living labs were characterized by higher levels of cosmopolitanism which resulted in more adaptable interventions. Worries about external policy, most notably lack of reimbursement for sustainment and upscaling of the interventions, were shared among all living labs. CONCLUSIONS: Contextual characteristics of four living labs that are early adopters of medication adherence interventions provide detailed examples of a positive implementation setting. These can be used to inform dissemination of medication adherence interventions in settings less experienced in implementing medication adherence interventions.

The bidirectional longitudinal association between depressive symptoms and HbA1c : A systematic review and meta-analysis.

AIM: To investigate whether there is a bidirectional longitudinal association of depression with HbA1c . METHODS: We conducted a systematic literature search in PubMed, PsycINFO, CINAHL and EMBASE for observational, longitudinal studies published from January 2000 to September 2020, assessing the association between depression and HbA1c in adults. We assessed study quality with the Newcastle-Ottawa-Scale. Pooled effect estimates were reported as partial correlation coefficients (rp ) or odds ratios (OR). RESULTS: We retrieved 1642 studies; 26 studies were included in the systematic review and eleven in the meta-analysis. Most studies (16/26) focused on type 2 diabetes. Study quality was rated as good (n = 19), fair (n = 2) and poor (n = 5). Of the meta-analysed studies, six investigated the longitudinal association between self-reported depressive symptoms and HbA1c and five the reverse longitudinal association, with a combined sample size of n = 48,793 and a mean follow-up of 2 years. Higher levels of baseline depressive symptoms were associated with subsequent higher levels of HbA1c (partial r = 0.07; [95% CI 0.03, 0.12]; I2 38%). Higher baseline HbA1c values were also associated with 18% increased risk of (probable) depression (OR = 1.18; [95% CI 1.12,1.25]; I2 0.0%). CONCLUSIONS: Our findings support a bidirectional longitudinal association between depressive symptoms and HbA1c . However, the observed effect sizes were small and future research in large-scale longitudinal studies is needed to confirm this association. Future studies should investigate the role of type of diabetes and depression, diabetes distress and diabetes self-management behaviours. Our results may have clinical implications, as depressive symptoms and HbA1c levels could be targeted concurrently in the prevention and treatment of diabetes and depression. REGISTRATION: PROSPERO ID CRD42019147551.

Patient-reported outcomes of lifestyle interventions in patients with severe mental illness: a systematic review and meta-analysis.

BACKGROUND: Lifestyle interventions for severe mental illness (SMI) are known to have small to modest effect 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 effects 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 efficacy 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 identified 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 significant effect on quality of life (g = 0.13; 95% CI = - 0.02 to 0.27), with high heterogeneity (I2 = 68.7%). We found a small effect on depression severity (g = 0.30, 95% CI = 0.00 to 0.58, I2 = 65.2%) and a moderate effect on anxiety severity (g = 0.56, 95% CI = 0.16 to 0.95, I2 = 0%). DISCUSSION: This meta-analysis quantifies the effects of lifestyle interventions on PROs. Lifestyle interventions have no significant effect 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.

Implementation of a lifestyle intervention for people with a severe mental illness (SMILE): a process evaluation.

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 effects 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 fidelity 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 fidelity 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 staff 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 identified some aspects that may have hindered effective implementation and needs to be considered when implementing the SMILE intervention in daily practice.

Comparing the EQ-5D-5L crosswalks and value sets for England, the Netherlands and Spain: Exploring their impact on cost-utility results.

This study compares the five-level EuroQol five-dimension questionnaire (EQ-5D-5L) crosswalks and the 5L value sets for England, the Netherlands, and Spain and explores the implication of using one or the other for the results of cost-utility analyses. Data from two randomized controlled trials in depression and diabetes were used. Utility value distributions were compared, and mean differences in utility values between the EQ-5D-5L crosswalk and the 5L value set were described by country. Quality-adjusted life years (QALYs) were calculated using the area-under-the-curve method. Incremental cost-effectiveness ratios (ICERs) were calculated, and uncertainty around ICERs was estimated using bootstrapping and graphically shown in cost-effectiveness acceptability curves. For all countries investigated, utility value distributions differed between the EQ-5D-5L crosswalk and 5L value set. In both case studies, mean utility values were lower for the EQ-5D-5L crosswalk compared with the 5L value set in England and Spain, but higher in the Netherlands. However, these differences in utility values did not translate into relevant differences across utility estimation methods in incremental QALYs and the interventions' probability of cost-effectiveness. Thus, our results suggest that EQ-5D-5L crosswalks and 5L value sets can be used interchangeably in patients affected by mild or moderate conditions. Further research is needed to establish whether these findings are generalizable to economic evaluations among severely ill patients.

Cost-effectiveness of a lifestyle intervention for people with a serious mental illness (SMILE): design of a pragmatic cluster-randomised controlled trial.

BACKGROUND: Cardiovascular disease is the leading cause of the estimated 11-25 years reduced life expectancy for persons with serious mental illness (SMI). This excess cardiovascular mortality is primarily attributable to obesity, diabetes, hypertension, and dyslipidaemia. Obesity is associated with a sedentary lifestyle, limited physical activity and an unhealthy diet. Lifestyle interventions for persons with SMI seem promising in reducing weight and cardiovascular risk. The aim of this study is to evaluate the effectiveness and cost-effectiveness of a lifestyle intervention among persons with SMI in an outpatient treatment setting. METHODS: The Serious Mental Illness Lifestyle Evaluation (SMILE) study is a cluster-randomized controlled trial including an economic evaluation in approximately 18 Flexible Assertive Community Treatment (FACT) teams in the Netherlands. The intervention aims at a healthy diet and increased physical activity. Randomisation takes place at the level of participating FACT-teams. We aim to include 260 outpatients with SMI and a body mass index of 27 or higher who will either receive the lifestyle intervention or usual care. The intervention will last 12 months and consists of weekly 2-h group meetings delivered over the first 6 months. The next 6 months will include monthly group meetings, supplemented with regular individual contacts. Primary outcome is weight loss. Secondary outcomes are metabolic parameters (waist circumference, lipids, blood pressure, glucose), quality of life and health related self-efficacy. Costs will be measured from a societal perspective and include costs of the lifestyle program, health care utilization, medication and lost productivity. Measurements will be performed at baseline and 3, 6 and 12 months. DISCUSSION: The SMILE intervention for persons with SMI will provide important information on the effectiveness, cost-effectiveness, feasibility and delivery of a group-based lifestyle intervention in a Dutch outpatient treatment setting. TRIAL REGISTRATION: Dutch Trial Registration NL6660 , registration date: 16 November 2017.

Measurement properties of depression questionnaires in patients with diabetes: a systematic review.

PURPOSE: To conduct a systematic review on measurement properties of questionnaires measuring depressive symptoms in adult patients with type 1 or type 2 diabetes. METHODS: A systematic review of the literature in MEDLINE, EMbase and PsycINFO was performed. Full text, original articles, published in any language up to October 2016 were included. Eligibility for inclusion was independently assessed by three reviewers who worked in pairs. Methodological quality of the studies was evaluated by two independent reviewers using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist. Quality of the questionnaires was rated per measurement property, based on the number and quality of the included studies and the reported results. RESULTS: Of 6286 unique hits, 21 studies met our criteria evaluating nine different questionnaires in multiple settings and languages. The methodological quality of the included studies was variable for the different measurement properties: 9/15 studies scored 'good' or 'excellent' on internal consistency, 2/5 on reliability, 0/1 on content validity, 10/10 on structural validity, 8/11 on hypothesis testing, 1/5 on cross-cultural validity, and 4/9 on criterion validity. For the CES-D, there was strong evidence for good internal consistency, structural validity, and construct validity; moderate evidence for good criterion validity; and limited evidence for good cross-cultural validity. The PHQ-9 and WHO-5 also performed well on several measurement properties. However, the evidence for structural validity of the PHQ-9 was inconclusive. The WHO-5 was less extensively researched and originally not developed to measure depression. CONCLUSION: Currently, the CES-D is best supported for measuring depressive symptoms in diabetes patients.

The association of depression and posttraumatic stress disorder with the metabolic syndrome in a multi-ethnic cohort: the HELIUS study.

PURPOSE: Depression and posttraumatic stress disorder (PTSD) may be linked to the metabolic syndrome (MetS). Consistency of this association across ethnic groups and the influence of comorbidity of depression/PTSD were examined. METHODS: Cross-sectional baseline data from the HELIUS study were used (4527 Dutch, 2999 South-Asian Surinamese, 4058 African Surinamese, 2251 Ghanaian, 3522 Turkish and 3825 Moroccan participants). The Patient Health Questionnaire-9 (PHQ-9) (score range 0-27) measured depressive symptoms. A 9-item questionnaire (score range 0-9) measured PTSD symptoms. The MetS was defined according to the International Diabetes Federation. The association of a depressed mood (PHQ-9 sum score ≥ 10) and severe PTSD symptoms (sum score ≥ 7) with the MetS was examined using logistic regression. Interaction with ethnicity and between a depressed mood and severe PTSD symptoms was tested. RESULTS: A depressed mood was associated with the MetS [OR (95% CI) = 1.37 (1.24-1.51)] in the total sample and consistent across ethnic groups (p values for interaction all > 0.05). Severe PTSD symptoms were significantly associated with the MetS in the Dutch [OR (95% CI) = 1.71 (1.07-2.73)]. The South-Asian Surinamese, Turks and Moroccans showed weaker associations than the Dutch (p values for interaction all < 0.05). A depressed mood and severe PTSD symptoms did not interact in the association with the MetS (p values for interaction > 0.05). CONCLUSIONS: A depressed mood was consistently associated with the MetS across ethnic groups, but the association between severe PTSD symptoms and the MetS maybe ethnicity dependent. The association with the MetS was not different in case of depressed mood/severe PTSD symptoms comorbidity.

Patients' and practice nurses' perceptions of depression in patients with type 2 diabetes and/or coronary heart disease screened for subthreshold depression.

BACKGROUND: Comorbid depression is common in patients with type 2 diabetes (DM2) and/or coronary heart disease (CHD) and is associated with poor quality of life and adverse health outcomes. However, little is known about patients' and practice nurses' (PNs) perceptions of depression. Tailoring care to these perceptions may affect depression detection and patient engagement with treatment and prevention programs. This study aimed to explore patients' and PNs' perceptions of depression in patients with DM2/CHD screened for subthreshold depression. METHODS: A qualitative study was conducted as part of a Dutch stepped-care prevention project. Using a purposive sampling strategy, data were collected through semi-structured interviews with 15 patients and 9 PNs. After consent, all interviews were recorded, transcribed verbatim and analyzed independently by two researchers with Atlas.ti.5.7.1 software. The patient and PN datasets were inspected for commonalities using a constant comparative method, from which a final thematic framework was generated. RESULTS: Main themes were: illness perception, need for care and causes of depression. Patients generally considered themselves at least mildly depressed, but perceived severity levels were not always congruent with Patient Health Questionnaire 9 scores at inclusion. Initially recognizing or naming their mental state as a (subthreshold) depression was difficult for some. Having trouble sleeping was frequently experienced as the most burdensome symptom. Most experienced a need for care; psycho-educational advice and talking therapy were preferred. Perceived symptom severity corresponded with perceived need for care, but did not necessarily match help-seeking behaviour. Main named barriers to help-seeking were experienced stigma and lack of awareness of depression and mental health care possibilities. PNs frequently perceived patients as not depressed and with minimal need for specific care except for attention. Participants pointed to a mix of causes of depression, most related to negative life events and circumstances and perceived indirect links with DM2/CHD. CONCLUSION: Data of the interviewed patients and PNs suggest that they have different perceptions about (subthreshold) depressive illness and the need for care, although views on its causes seem to overlap more.

Process evaluation of a stepped-care program to prevent depression in primary care: patients' and practice nurses' experiences.

BACKGROUND: Depression is common in patients with diabetes type 2 (DM2) and/or coronary heart disease (CHD), with high personal and societal burden and may even be preventable. Recently, a cluster randomized trial of stepped care to prevent depression among patients with DM2 and/or CHD and subthreshold depression in Dutch primary care (Step-Dep) versus usual care showed no effectiveness. This paper presents its process evaluation, exploring in-depth experiences from a patient and practice nurse perspective to further understand the results. METHODS: A qualitative study was conducted. Using a purposive sampling strategy, data were collected through semi-structured interviews with 24 participants (15 patients and nine practice nurses). All interviews were audiotaped and transcribed verbatim. Atlas.ti 5.7.1 software was used for coding and structuring of themes. A thematic analysis of the data was performed. RESULTS: The process evaluation showed, even through a negative trial, that Step-Dep was perceived as valuable by both patients and practice nurses; perceived effectiveness on improving depressive symptoms varied greatly, but most felt that it had been beneficial for patients' well-being. Facilitators were: increased awareness of mental health problems in chronic disease management and improved accessibility and decreased experienced stigma of receiving mental health care. The Patient Health Questionnaire 9 (PHQ-9), used to determine depression severity, functioned as a useful starting point for the conversation on mental health and patients gained more insight into their mental health by regularly filling out the PHQ-9. However, patients and practice nurses did not widely support its use for monitoring depressive symptoms or making treatment decisions. Monitoring mental health was deemed important in chronically ill patients by both patients and practice nurses and was suggested to start at the time of diagnosis of a chronic disease. Appointed barriers were that patients were primarily motivated to participate in scientific research rather than their intrinsic need to improve depressive symptoms. Additionally, various practice nurses preferred offering individually based therapy over pre-determined interventions in a protocolled sequence and somatic practice nurses expressed a lack of competence to recognise and treat mental health problems. CONCLUSION: This study demonstrates both the benefits and unique demands of programs such as Step-Dep. The appointed facilitators and barriers could guide the development of future studies aiming to prevent depression in similar patient groups.

The impact of comorbid chronic conditions on quality of life in type 2 diabetes patients.

OBJECTIVE: To study the prevalence, impact and dose-response relationship of comorbid chronic conditions on quality of life of type 2 diabetes patients. RESEARCH DESIGN AND METHODS: Cross-sectional data of 1676 type 2 diabetes patients, aged 31-96 years, and treated in primary care, were analyzed. Quality of life (QoL) was measured using the mental component summary (MCS) and the physical component summary (PCS) scores of the Short Form-12. Diagnosis of type 2 diabetes was obtained from medical records and comorbidities from self-reports. RESULTS: Only 361 (21.5%) of the patients reported no comorbidities. Diabetes patients with comorbidities showed significantly lower mean difference in PCS [-8.5; 95% confidence interval (CI) -9.8 to -7.3] and MCS scores (-1.9; 95% CI -3.0 to -0.9), compared to diabetes patients without. Additional adjustments did not substantially change these associations. Both MCS and PCS scores decrease significantly with the number of comorbid conditions, yet most pronounced regarding physical QoL. Comorbidities that reduced physical QoL most significantly were retinopathy, heart diseases, atherosclerosis in abdomen or legs, lung diseases, incontinence, back, neck and shoulder disorder, osteoarthritis and chronic rheumatoid arthritis, using the backwards stepwise regression procedure. CONCLUSION: Comorbidities are highly prevalent among type 2 diabetes patients and have a negative impact on the patient's QoL. A strong dose-response relationship between comorbidities and physical QoL was found. Reduced physical QoL is mainly determined by musculoskeletal and cardiovascular disorders.

Cost-effectiveness of a stepped-care intervention to prevent major depression in patients with type 2 diabetes mellitus and/or coronary heart disease and subthreshold depression: design of a cluster-randomized controlled trial.

BACKGROUND: Co-morbid major depression is a significant problem among patients with type 2 diabetes mellitus and/or coronary heart disease and this negatively impacts quality of life. Subthreshold depression is the most important risk factor for the development of major depression. Given the highly significant association between depression and adverse health outcomes and the limited capacity for depression treatment in primary care, there is an urgent need for interventions that successfully prevent the transition from subthreshold depression into a major depressive disorder. Nurse led stepped-care is a promising way to accomplish this. The aim of this study is to evaluate the cost-effectiveness of a nurse-led indicated stepped-care program to prevent major depression among patients with type 2 diabetes mellitus and/or coronary heart disease in primary care who also have subthreshold depressive symptoms. METHODS/DESIGN: An economic evaluation will be conducted alongside a cluster-randomized controlled trial in approximately thirty general practices in the Netherlands. Randomization takes place at the level of participating practice nurses. We aim to include 236 participants who will either receive a nurse-led indicated stepped-care program for depressive symptoms or care as usual. The stepped-care program consists of four sequential but flexible treatment steps: 1) watchful waiting, 2) guided self-help treatment, 3) problem solving treatment and 4) referral to the general practitioner. The primary clinical outcome measure is the cumulative incidence of major depressive disorder as measured with the Mini International Neuropsychiatric Interview. Secondary outcomes include severity of depressive symptoms, quality of life, anxiety and physical outcomes. Costs will be measured from a societal perspective and include health care utilization, medication and lost productivity costs. Measurements will be performed at baseline and 3, 6, 9 and 12 months. DISCUSSION: The intervention being investigated is expected to prevent new cases of depression among people with type 2 diabetes mellitus and/or coronary heart disease and subthreshold depression, with subsequent beneficial effects on quality of life, clinical outcomes and health care costs. When proven cost-effective, the program provides a viable treatment option in the Dutch primary care system. TRIAL REGISTRATION: Dutch Trial Register NTR3715.

Longitudinal relation between weight change and quality of life in a community-based population: a prospective cohort study.

BACKGROUND: Previous cross-sectional studies revealed that obesity is associated with lower health-related quality of life (HRQOL). This study aimed to investigate the longitudinal association between 5-year weight change and HRQOL. METHODS: Data from 2414 Dutch men and women was collected. HRQOL was measured with the RAND-36. Weight change was calculated as change in weight between 1998 and 2003. Using generalized estimation equations, we primarily analyzed the influence of weight change on HRQOL for the total population and additionally, by change groups (weight losers, weight maintainers and weight gainers) using regression analysis. All analyses were stratified for gender. RESULTS: After 5 years, 598 men (50%) and 646 women (54%) maintained their weight, 177 men (15%) and 163 women (14%) lost >2.5 kg and 410 men (35%) and 379 women (32%) gained >2.5 kg. Longitudinal associations of 5-year weight change and HRQOL were found for mental component score (MCS) in women (ß = 0.13; 95% CI: 0.02-0.24), and physical component score (PCS) in men (ß = -0.09; 95% CI: -0.17 to -0.00) and women (ß = -0.10; 95% CI: -0.19 to -0.01). Categorizing for 5-year weight change showed that weight gainers and weight losers did not significantly differ from weight maintainers on both MCS and PCS for both men and women. CONCLUSION: Weight change over 5 years leaded to a slight, though significant reduction on the PCS in both genders. In women, we found a positive association between weight change and MCS.

Effectiveness of a Lifestyle Intervention for People With a Severe Mental Illness in Dutch Outpatient Mental Health Care: A Randomized Clinical Trial.

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.

Outpatient costs in pharmaceutically treated diabetes patients with and without a diagnosis of depression in a Dutch primary care setting.

BACKGROUND: To assess differences in outpatient costs among pharmaceutically treated diabetes patients with and without a diagnosis of depression in a Dutch primary care setting. METHODS: A retrospective case control study over 3 years (2002-2004). Data on 7128 depressed patients and 23772 non-depressed matched controls were available from the electronic medical record system of 20 general practices organized in one large primary care organization in the Netherlands. A total of 393 depressed patients with diabetes and 494 non-depressed patients with diabetes were identified in these records. The data that were extracted from the medical record system concerned only outpatient costs, which included GP care, referrals, and medication. RESULTS: Mean total outpatient costs per year in depressed diabetes patients were €1039 (SD 743) in the period 2002-2004, which was more than two times as high as in non-depressed diabetes patients (€492, SD 434). After correction for age, sex, type of insurance, diabetes treatment, and comorbidity, the difference in total annual costs between depressed and non-depressed diabetes patients changed from €408 (uncorrected) to €463 (corrected) in multilevel analyses. Correction for comorbidity had the largest impact on the difference in costs between both groups. CONCLUSIONS: Outpatient costs in depressed patients with diabetes are substantially higher than in non-depressed patients with diabetes even after adjusting for confounders. Future research should investigate whether effective treatment of depression among diabetes patients can reduce health care costs in the long term.

Social and emotional loneliness in a large sample of Dutch adults aged 19-65: Associations with risk factors.

Loneliness is common in adults of all ages. Prior research among older adults has shown that social loneliness (feelings of missing a wider social network) and emotional loneliness (missing an intimate relationship) differ in risk factors. Therefore, this study examined risk factors of social and emotional loneliness among adults aged 19-65 years. This study was conducted within the framework of a community-based health study in the northwest of the Netherlands in 2016. Cross-sectional data of 7,885 participants were analysed using structural equation modelling. Social and emotional loneliness were measured using the validated scale of de Jong-Gierveld. Socio-demographic and health-related risk factors were self-reported. Multiple socio-demographic, health indicators and health behaviours were associated with higher scores on both types of loneliness, although the predictive power of multiple risk factors differed by type. Additionally, female gender, younger age, medium or high educational level and smoking were associated with lower social loneliness scores specifically, while having a paid job and lower body mass index were associated with lower emotional loneliness scores. To conclude, associations with risk factors were partly consistent across social and emotional loneliness, however, some important differences have been shown. These differences are important to consider when developing targeted prevention and intervention strategies.