Economic evaluation of intensive home treatment in comparison to care as usual alongside a randomised controlled trial.

BACKGROUND: There is a dearth of research on the cost-effectiveness of intensive home treatment (IHT), an alternative to psychiatric hospitalisation for patients experiencing psychiatric crises. We therefore present a health economic evaluation alongside a pre-randomised controlled trial of IHT compared to care as usual (CAU). METHOD: Patients were pre-randomised to IHT or CAU using a double-consent open-label Zelen design. For the cost-utility analysis, the EuroQol 5-dimensional instrument was used. The cost-effectiveness was assessed using the Brief Psychiatric Rating Scale (BPRS). RESULTS: Data of 198 patients showed that each additional QALY gained from offering IHT instead of CAU was on average associated with an extra cost of €48,003. There is a 38% likelihood that IHT will lead to more QALYs at lower costs compared to CAU. An improvement of one additional point on the BPRS by offering IHT instead of CAU was associated with an extra cost of €19,203. There is a 38% likelihood that IHT will lead to higher BPRS score improvements at lower costs. Based on the NICE willingness-to-pay threshold of £30,000 (€35,000) per QALY, IHT could potentially be considered cost-effective with a likelihood of 55-60% when viewed from a societal perspective, and > 75% from a health care perspective. CONCLUSIONS: IHT appears slightly more attractive in terms of cost-utility and cost-effectiveness than CAU, although differences in both costs and effects are small especially when viewed from the societal costs perspective. From the health care sector costs perspective, IHT has a higher probability of being cost-effective compared to CAU. TRIALS REGISTRATION: Netherlands Trial Register: NTR6151.

The development and psychometric evaluation of the Questionnaire Epistemic Trust (QET): A self-report assessment of epistemic trust.

Epistemic trust (ET) refers to the predisposition to trust information as authentic, trustworthy and relevant to the self. Epistemic distrust - resulting from early adversity - may interfere with openness to social learning within the therapeutic encounter, reducing the ability to benefit from treatment. The self-report Questionnaire Epistemic Trust (QET) is a newly developed instrument that aims to assess ET. This study presents the first results on the psychometric properties of the QET in both a community and a clinical sample. Our findings indicate that the QET is composed of four meaningful subscales with good to excellent internal consistency. The QET shows relevant associations with related constructs like personality functioning, symptom distress and quality of life. QET scores clearly distinguish between a clinical and community sample and are associated with the quality of the therapeutic alliance. The QET provides a promising, brief and user-friendly instrument that could be used for a range of clinical and research purposes. Future studies with larger samples are needed to strengthen construct validity and to investigate the value of the QET to predict differential treatment responses or to study mechanisms of change.

Irremediable Psychiatric Suffering in The Context of Medical Assistance in Dying: A Delphi-Study.

OBJECTIVE: Patients with a psychiatric disorder are eligible to request medical assistance in dying (MAID) in a small but growing number of jurisdictions, including the Netherlands and Belgium. In Canada, MAID for mental illness will become possible in 2023. For this request to be granted, most of these jurisdictions demand that the patient is competent in her request, and that the suffering experienced is unbearable and irremediable. Especially the criterion of irremediability is challenging to establish in patients with psychiatric disorders. The aim of this research is to establish what criteria Dutch and Belgian experts agree to be necessary in characterising irremediable psychiatric suffering (IPS) in the context of MAID. METHODS: A two-round Delphi procedure among psychiatrists with relevant experience. RESULTS: Thirteen consensus criteria were established: five diagnostic and eight treatment-related criteria. Diagnostically, the participants deem a narrative description and attention to contextual and systemic factors necessary. Also, a mandatory second opinion is required. The criteria concerning treatment show that extensive biopsychosocial treatment is needed, and the suffering must be present for several years. Finally, in the case of refusal, the participants agree that there are limits to the number of diagnostic procedures or treatments a patient must undergo. CONCLUSIONS: Consensus was found among a Dutch and Belgian expert group on potential criteria for establishing IPS in the context of MAID. These criteria can be used in clinical decision-making and can inform future procedural demands and research.

Establishing irremediable psychiatric suffering in the context of medical assistance in dying in the Netherlands: a qualitative study.

BACKGROUND: Establishing irremediability of suffering is a central challenge in determining the appropriateness of medical assistance in dying (MAiD) for patients with a psychiatric disorder. We sought to evaluate how experienced psychiatrists define irremediable psychiatric suffering in the context of MAiD and what challenges they face while establishing irremediable psychiatric suffering. METHODS: We conducted a qualitative study of psychiatrists in the Netherlands with experience assessing irremediable psychiatric suffering in the context of MAiD. We collected data from in-depth, semistructured interviews focused on the definition of irremediable psychiatric suffering and on the challenges in establishing irremediability. We analyzed themes using a modified grounded theory approach. RESULTS: The study included 11 psychiatrists. Although irremediable psychiatric suffering is a prospective concept, most participants relied on retrospective dimensions to define it, such as a history of failed treatments, and expressed that uncertainty was inevitable in this process. When establishing irremediable psychiatric suffering, participants identified challenges related to diagnosis and treatment. The main diagnostic challenge identified was the frequent co-occurrence of more than 1 psychiatric diagnosis. Important challenges related to treatment included assessing the quality of past treatments, establishing when limits of treatment had been reached and managing "treatment fatigue." INTERPRETATION: Challenges regarding the definition, diagnosis and treatment of irremediable psychiatric suffering complicate the process of establishing it in the context of MAiD. Development of consensus clinical criteria for irremediable psychiatric suffering in this context and further research to understand "treatment fatigue" among patients with psychiatric disorders may help address these challenges. Registration: This study was preregistered under osf.io/2jrnd.

The Montreal Cognitive Assessment (MoCA) with a double threshold: improving the MoCA for triaging patients in need of a neuropsychological assessment.

OBJECTIVES: Diagnosis of patients suspected of mild dementia (MD) is a challenge and patient numbers continue to rise. A short test triaging patients in need of a neuropsychological assessment (NPA) is welcome. The Montreal cognitive assessment (MoCA) has high sensitivity at the original cutoff <26 for MD, but results in too many false-positive (FP) referrals in clinical practice (low specificity). A cutoff that finds all patients at high risk of MD without referring to many patients not (yet) in need of an NPA is needed. A difficulty is who is to be considered at risk, as definitions for disease (e.g. MD) do not always define health at the same time and thereby create subthreshold disorders. DESIGN: In this study, we compared different selection strategies to efficiently identify patients in need of an NPA. Using the MoCA with a double threshold tackles the dilemma of increasing the specificity without decreasing the sensitivity and creates the opportunity to distinguish the clinical (MD) and subclinical (MCI) state and hence to get their appropriate policy. SETTING/PARTICIPANTS: Patients referred to old-age psychiatry suspected of cognitive impairment that could benefit from an NPA (n = 693). RESULTS: The optimal strategy was a two-stage selection process using the MoCA with a double threshold as an add-on after initial assessment. By selecting who is likely to have dementia and should be assessed further (MoCA<21), who should be discharged (≥26), and who's course should be monitored actively as they are at increased risk (21<26). CONCLUSION: By using two cutoffs, the clinical value of the MoCA improved for triaging. A double-threshold MoCA not only gave the best results; accuracy, PPV, NPV, and reducing FP referrals by 65%, still correctly triaging most MD patients. It also identified most MCIs whose intermediate state justifies active monitoring.

The Impact of Antipsychotic Formulations on Time to Medication Discontinuation in Patients with Schizophrenia: A Dutch Registry-Based Retrospective Cohort Study.

BACKGROUND: Many patients with schizophrenia discontinue antipsychotic medication, frequently with adverse outcomes. Although different antipsychotic formulations are associated with different times to discontinuation, not much is known about discontinuation rates with oral-weekly formulations. Such a formulation of penfluridol is available in both the Netherlands and several other countries. OBJECTIVES: We aimed to investigate the impact of antipsychotic formulations on time to discontinuation, especially the oral-weekly formulation. METHODS: In a large, registry-based, retrospective cohort study from 1 January 2013 to 31 December 2016, we determined the time to medication discontinuation during the follow-up period with antipsychotic formulations, including oral-daily, oral-weekly, depot, or a combination of these. Patients with schizophrenia aged between 18 and 69 years were included and stratified according to the duration of recent antipsychotic use (taking the same formulation for ≤ 60 days or > 60 days before follow-up: short-term or long-term recent antipsychotic use). Medication discontinuation was defined as discontinuation of current antipsychotic formulation. RESULTS: Overall, 8257 patients were included for analyses, with 80% of patients discontinuing antipsychotic medication. Time to discontinuation was longer in those with long-term recent antipsychotic use before the follow-up period and longest for oral-daily formulations. Patterns for discontinuation of oral-weekly and depot formulations were similar, regardless of the duration of recent antipsychotic use before follow-up. More prior discontinuations were associated with shorter time to discontinuation. CONCLUSIONS: Time to discontinuation differed considerably between formulations. The duration of recent antipsychotic use was a strong predictor of time to discontinuation. While oral-daily formulations had the longest time to discontinuation in the long-term recent antipsychotic use group, discontinuation trends were similar for oral-weekly and depot formulations. An oral-weekly formulation, whose administration route is noninvasive, might therefore be considered an alternative to depot formulations.

Clinical Efficacy and Cost-Effectiveness of Imagery Rescripting Only Compared to Imagery Rescripting and Schema Therapy in Adult Patients With PTSD and Comorbid Cluster C Personality Disorder: Study Design of a Randomized Controlled Trial.

Background: Posttraumatic stress disorder (PTSD) is a serious and relatively common mental disorder causing a high burden of suffering. Whereas evidence-based treatments are available, dropout and non-response rates remain high. PTSD and Cluster C personality disorders (avoidant, dependent or obsessive-compulsive personality disorder; CPD) are highly comorbid and there is evidence for suboptimal treatment effects in this subgroup of patients. An integrated PTSD and CPD treatment may be needed to increase treatment efficacy. However, no studies directly comparing the efficacy of regular PTSD treatment and treatment tailored to PTSD and comorbid CPD are available. Whether integrated treatment is more effective than treatment focused on PTSD alone is important, since (1) no evidence-based guideline for PTSD and comorbid CPD treatment exists, and (2) treatment approaches to CPD are costly and time consuming. Present study design describes a randomized controlled trial (RCT) directly comparing trauma focused treatment with integrated trauma focused and personality focused treatment. Methods: An RCT with two parallel groups design will be used to compare the clinical efficacy and cost-effectiveness of "standalone" imagery rescripting (n = 63) with integrated imagery rescripting and schema therapy (n = 63). This trial is part of a larger research project on PTSD and personality disorders. Predictors, mediators and outcome variables are measured at regular intervals over the course of 18 months. The main outcome is PTSD severity at 12 months. Additionally, machine-learning techniques will be used to predict treatment outcome using biopsychosocial variables. Discussion: This study protocol outlines the first RCT aimed at directly comparing the clinical efficacy and cost-effectiveness of imagery rescripting and integrated imagery rescripting and schema therapy for treatment seeking adult patients with PTSD and comorbid cluster C personality pathology. Additionally, biopsychosocial variables will be used to predict treatment outcome. As such, the trial adds to the development of an empirically informed and individualized treatment indication process. Clinical Trial registration: ClinicalTrials.gov, NCT03833531.

Clinical value of the Montreal Cognitive Assessment (MoCA) in patients suspected of cognitive impairment in old age psychiatry. Using the MoCA for triaging to a memory clinic.

Objectives: Diagnostic pathways are limited. A validated instrument that can triage patients when they are suspected of mild dementia (MD) is necessary to optimise referrals. Method: The MoCA is validated for identifying MD and mild cognitive impairment (MCI) in a cohort of patients suspected of cognitive impairment (CI) after initial assessment in old age psychiatry. The reference standard was the consensus-based diagnoses for MD and MCI, adhering to the international criteria and using suspected patients, but without CI as comparisons (NoCI). Results: The mean MoCA scores differ significantly between the groups: 24(SE: .59) in NoCI, 21(SE: .31) in MCI and 16,7(SE: .45) in MD (p < .05). The AUC of MD against non-demented (MCI + NoCI) was 0.83(95%CI: 0.78-0.88) resulting in 90% sensitivity, 65% specificity, 50%PPV and 94%NPV at a "best" cutoff of <21 according the Youden index and respectively 0.77(95%CI: 0.69-0.85), 56%, 73%, 90%, 28% for CI (MD + MCI) against NoCI at <21. Conclusion: 90% of individuals with a MoCA of <21 will have CI (MD + MCI), while 94% with a MoCA of ≥21 will not have dementia. The MoCA can reduce referrals substantially (50%) by selecting who don't need further work up in a memory clinic, even if they were suspected of CI after initial assessment.

Agreement between patients and mental healthcare providers on unmet care needs in child and adolescent psychiatry.

PURPOSE: In mental health care, patients and their care providers may conceptualize the nature of the disorder and appropriate action in profoundly different ways. This may lead to dropout and lack of compliance with the treatments being provided, in particular in young patients with more severe disorders. This study provides detailed information about patient-provider (dis)agreement regarding the care needs of children and adolescents. METHODS: We used the Camberwell Assessment of Need (CANSAS) to assess the met and unmet needs of 244 patients aged between 6 and 18 years. These needs were assessed from the perspectives of both patients and their care providers. Our primary outcome measure was agreement between the patient and care provider on unmet need. By comparing a general outpatient sample (n = 123) with a youth-ACT sample (n = 121), we were able to assess the influence of severity of psychiatric and psychosocial problems on the extent of agreement on patient's unmet care needs. RESULTS: In general, patients reported unmet care needs less often than care providers did. Patients and care providers had the lowest extents of agreement on unmet needs with regard to "mental health problems" (k = 0.113) and "information regarding diagnosis/treatment" (k = 0.171). Comparison of the two mental healthcare settings highlighted differences for three-quarters of the unmet care needs that were examined. Agreement was lower in the youth-ACT setting. CONCLUSIONS: Clarification of different views on patients' unmet needs may help reduce nonattendance of appointments, noncompliance, or dropout. Routine assessment of patients' and care providers' perceptions of patients' unmet care needs may also help provide information on areas of disagreement.

A randomized controlled trial comparing the clinical efficacy and cost-effectiveness of eye movement desensitization and reprocessing (EMDR) and integrated EMDR-Dialectical Behavioural Therapy (DBT) in the treatment of patients with post-traumatic stress disorder and comorbid (Sub)clinical borderline personality disorder: study design.

BACKGROUND: Comorbidity between Posttraumatic Stress Disorder (PTSD) and Borderline Personality Disorder (BPD) is high. There is growing motivation among clinicians to offer PTSD treatments - such as Eye Movement Desensitization and Reprocessing (EMDR) - to patients with PTSD and comorbid BPD. However, a large subgroup with comorbid BPD does not sufficiently respond to PTSD treatment and is more likely to be excluded or to dropout from treatment. Dialectical Behaviour Therapy (DBT) for BPD is well established and although there is some evidence that DBT combined with DBT Prolonged Exposure (DBT + DBT PE) is twice as effective in reducing PTSD symptoms than DBT alone, the comparative efficacy of integrated PTSD-DBT and PTSD-only treatment has not been investigated yet. The current study will therefore evaluate the comparative clinical efficacy and cost-effectiveness of EMDR-DBT and EMDR-only in patients with PTSD and comorbid (sub)clinical BPD. Moreover, it is not clear yet what treatment works best for which individual patient. The current study will therefore evaluate neurobiological predictors and mediators of the individual response to treatment. METHOD: A randomized controlled trial comparing the clinical efficacy and cost-effectiveness of integrated EMDR-DBT (n = 63) and EMDR-only (n = 63) in treatment-seeking adult patients with PTSD and comorbid (sub)clinical BPD. In addition, neurobiological predictors and mediators of treatment outcome, such as hair cortisol, FKBP5 and BDNF protein levels and FKBP5 and BDNF methylation status, are measured through hair and blood samples. DISCUSSION: This is the first study to compare the clinical efficacy and cost-effectiveness of integrated EMDR-DBT and EMDR-only in patients with PTSD and comorbid (sub)clinical BPD, while simultaneously identifying individual predictors and mediators of treatment response. Results will reveal which treatment works best for which individual patient, thereby guiding individual treatment choices and personalizing psychiatry. TRIAL REGISTRATION: Clinical Trials, NCT03833453 . Retrospectively registered, 15 March 2019.

Economic evaluation of a combined screening and stepped-care treatment program targeting psychological distress in patients with metastatic colorectal cancer: A cluster randomized controlled trial.

BACKGROUND: Psychological distress is highly prevalent among patients with metastatic colorectal cancer. AIMS: To perform an economic evaluation of a combined screening and treatment program targeting psychological distress in patients with metastatic colorectal cancer in comparison with usual care. DESIGN: Societal costs were collected alongside a cluster randomized controlled trial for 48 weeks. A total of 349 participants were included. SETTING: Participants were recruited from oncology departments at 16 participating hospitals in the Netherlands. METHODS: Outcome measures were the Hospital Anxiety and Depression Scale and quality-adjusted life-years. Missing data were imputed using multiple imputation. Uncertainty was estimated using bootstrapping. Cost-effectiveness planes and cost-effectiveness acceptability curves were estimated to show uncertainty surrounding the cost-effectiveness estimates. Sensitivity analyses were performed to check robustness of results. RESULTS: Between treatment arms, no significant differences were found in Hospital Anxiety and Depression Scale score (mean difference: -0.058; 95% confidence interval: -0.13 to 0.011), quality-adjusted life-years (mean difference: 0.042; 95% confidence interval: -0.015 to 0.099), and societal costs (mean difference: -1152; 95% confidence interval: -5058 to 2214). Cost-effectiveness acceptability curves showed that the probability of cost-effectiveness was 0.64 and 0.74 at willingness-to-pay values of €0 and €10,000 per point improvement on the Hospital Anxiety and Depression Scale, respectively. The probability that the intervention was cost-effective compared to usual care for quality-adjusted life-years was 0.64 and 0.79 at willingness-to-pay values of €0 and €20,000 per quality-adjusted life-year, respectively. CONCLUSION: The intervention is dominant over usual care, primarily due to lower costs in the intervention group. However, there were no statistically significant differences in clinical effects and the uptake of the intervention was quite low. Therefore, widespread implementation cannot be recommended.

Unmet care needs of children with ADHD.

BACKGROUND: Non-compliance to, or drop-out from treatment for childhood ADHD, result in suboptimal outcome. Non-compliance and drop-out may be due to mismatches between patients' care needs and treatments provided. This study investigated unmet care needs in ADHD patients. Unmet needs were assessed in two different treatment settings (general outpatient setting versus youth-ACT). Youth-ACT treatment is an intensive outreach-oriented treatment for patients with severe psychiatric and psychosocial problems. Comparison of a general outpatient sample with a youth-ACT sample enabled us to assess the influence of severity of psychiatric and psychosocial problems on perceived care needs. METHODS: Self-reported unmet care needs were assessed among 105 ADHD patients between 6 and 17 years of age in a general outpatient (n = 52) and a youth-ACT setting (n = 53). RESULTS: ADHD patients most frequently reported unmet needs regarding mental health problems, information on diagnosis/treatment, and future prospects. Outpatients differed from youth-ACT patients with respect to 30% of the unmet care needs that were investigated. Outpatients perceived more unmet needs regarding information on diagnosis/treatment (p = 0.014). Youth-ACT patients perceived more unmet needs concerning medication side effects (p = 0.038), quality and/or quantity of food (p = 0.016), self-care abilities (p = 0.016), regular/suitable school or other daytime activities (p = 0.013), making and/or keeping friends (p = 0.049), and future prospects (p = 0.045). CONCLUSIONS: Focusing treatment of ADHD patients on unmet needs may reduce non-compliance and drop-out. In clinical practice, systematic assessment of unmet care needs in all ADHD patients may be warranted, e.g. using the CANSAS questionnaire during the screening/intake phase.

Diagnostic accuracy of the Montreal Cognitive Assessment (MoCA) for cognitive screening in old age psychiatry: Determining cutoff scores in clinical practice. Avoiding spectrum bias caused by healthy controls.

OBJECTIVE/METHODS: The Montreal Cognitive Assessment (MoCA) is an increasingly used screening tool for cognitive impairment. While it has been validated in multiple settings and languages, most studies have used a biased case-control design including healthy controls as comparisons not representing a clinical setting. The purpose of the present cross-sectional study is to test the criterion validity of the MoCA for mild cognitive impairment (MCI) and mild dementia (MD) in an old age psychiatry cohort (n = 710). The reference standard consists of a multidisciplinary, consensus-based diagnosis in accordance with international criteria. As a secondary outcome, the use of healthy community older adults as additional comparisons allowed us to underscore the effects of case-control spectrum-bias. RESULTS: The criterion validity of the MoCA for cognitive impairment (MCI + MD) in a case-control design, using healthy controls, was satisfactory (area under the curve [AUC] 0.93; specificity of 73% less than 26), but declined in the cross-sectional design using referred but not cognitive impaired as comparisons (AUC 0.77; specificity of 37% less than 26). In an old age psychiatry setting, the MoCA is valuable for confirming normal cognition (greater than or equal to 26, 95% sensitivity), excluding MD (greater than or equal to 21; negative predictive value [NPV] 98%) and excluding MCI (greater than or equal to 26;NPV 94%); but not for diagnosing MD (less than 21; positive predictive value [PPV] 31%) or MCI (less than 26; PPV 33%). CONCLUSIONS: This study shows that validating the MoCA using healthy controls overestimates specificity. Taking clinical and demographic characteristics into account, the MoCA is a suitable screening tool-in an old age psychiatry setting-for distinguishing between those in need of further diagnostic investigations and those who are not but not for diagnosing cognitive impairment.

Rising co-payments coincide with unwanted effects on continuity of healthcare for patients with schizophrenia in the Netherlands.

BACKGROUND: Co-payments, used to control rising costs of healthcare, may lead to disruption of appropriate outpatient care and to increases in acute crisis treatment or hospital admission in patients with schizophrenia. An abrupt rise in co-payments in 2012 in the Netherlands offered a natural experiment to study the effects of co-payments on continuity of healthcare in schizophrenia. METHODS: Retrospective longitudinal registry-based cohort study. Outcome measures were (i) continuity of elective (planned) psychiatric care (outpatient care and/or antipsychotic medication); (ii) acute psychiatric care (crisis treatment and hospital admission); and (iii) somatic care per quarter of the years 2009-2014. RESULTS: 10 911 patients with schizophrenia were included. During the six-year follow-up period the level of elective psychiatric outpatient care (-20%); and acute psychiatric care (-37%) decreased. Treatment restricted to antipsychotic medication (without concurrent outpatient psychiatric care) increased (67%). The use of somatic care also increased (24%). Use of acute psychiatric care was highest in quarters when only antipsychotic medication was received. The majority (59%) of patients received continuous elective psychiatric care in 2009-2014. Patients receiving continuous care needed only half the acute psychiatric care needed by patients not in continuous care. On top of these trends time series analysis (ARIMA) showed that the abrupt rise in co-payments from 2012 onwards coincided with significant increases in stand-alone treatment with antipsychotic medication and acute psychiatric care. CONCLUSIONS: The use of psychiatric care decreased substantially among a cohort of patients with schizophrenia. The high rise in co-payments from 2012 onwards coincided with significant increases in stand-alone treatment with antipsychotic medication and acute psychiatric care.

Sleep, circadian rhythm, and physical activity patterns in depressive and anxiety disorders: A 2-week ambulatory assessment study.

BACKGROUND: Actigraphy may provide a more valid assessment of sleep, circadian rhythm (CR), and physical activity (PA) than self-reported questionnaires, but has not been used widely to study the association with depression/anxiety and their clinical characteristics. METHODS: Fourteen-day actigraphy data of 359 participants with current (n = 93), remitted (n = 176), or no (n = 90) composite international diagnostic interview depression/anxiety diagnoses were obtained from the Netherlands Study of Depression and Anxiety. Objective estimates included sleep duration (SD), sleep efficiency, relative amplitude (RA) between day-time and night-time activity, mid sleep on free days (MSF), gross motor activity (GMA), and moderate-to-vigorous PA (MVPA). Self-reported measures included insomnia rating scale, SD, MSF, metabolic equivalent total, and MVPA. RESULTS: Compared to controls, individuals with current depression/anxiety had a significantly different objective, but not self-reported, PA and CR: lower GMA (23.83 vs. 27.4 milli-gravity/day, p = .022), lower MVPA (35.32 vs. 47.64 min/day, p = .023), lower RA (0.82 vs. 0.83, p = .033). In contrast, self-reported, but not objective, sleep differed between people with current depression/anxiety compared to those without current disorders; people with current depression/anxiety reported both shorter and longer SD and more insomnia. More depressive/anxiety symptoms and number of depressive/anxiety diagnoses were associated with larger disturbances of the actigraphy measures. CONCLUSION: Actigraphy provides ecologically valid information on sleep, CR, and PA that enhances data from self-reported questionnaires. As those with more severe or comorbid forms showed the lowest PA and most CR disruptions, the potential for adjunctive behavioral and chronotherapy interventions should be explored, as well as the potential of actigraphy to monitor treatment response to such interventions.

Shared decision-making in mental health care using routine outcome monitoring: results of a cluster randomised-controlled trial.

PURPOSE: To investigate the effects of Shared Decision-Making (SDM) using Routine Outcome Monitoring (ROM) primary on patients' perception of Decisional Conflict (DC), which measures patients' engagement in and satisfaction with clinical decisions, and secondary on working alliance and treatment outcomes. METHOD: Multi-centre two-arm matched-paired cluster randomised-controlled trial in Dutch specialist mental health care. SDM using ROM (SDMR) was compared with Decision-Making As Usual (DMAU). Outcomes were measured at baseline (T0) and 6 months (T1). Multilevel regression and intention-to-treat analyses were used. Post hoc analyses were performed on influence of subgroups and application of SDMR on DC. RESULTS: Seven teams were randomised to each arm. T0 was completed by 186 patients (51% intervention; 49% control) and T1 by 158 patients (51% intervention, 49% control). DC, working alliance, and treatment outcomes reported by patients did not differ significantly between two arms. Post hoc analyses revealed that SDMR led to less DC among depressed patients (p = 0.047, d =- 0.69). If SDMR was applied well, patients reported less DC (SDM: p = 0.000, d = - 0.45; ROM: p = 0.021, d = - 0.32), which was associated with better treatment outcomes. CONCLUSION: Except for patients with mood disorders, we found no difference between the arms for patient-reported DC. This might be explained by the less than optimal uptake of this generic intervention, which did not support patients directly. Regarding the positive influence of a higher level of applying SDM and ROM on less DC and better treatment outcomes, the results are encouraging for further investments in patient-oriented development and implementation of SDMR.

Intensive home treatment for patients in acute psychiatric crisis situations: a multicentre randomized controlled trial.

BACKGROUND: Hospitalization is a common method to intensify care for patients experiencing a psychiatric crisis. A short-term, specialised, out-patient crisis intervention by a Crisis Resolution Team (CRT) in the Netherlands, called Intensive Home Treatment (IHT), is a viable intervention which may help reduce hospital admission days. However, research on the (cost-)effectiveness of alternatives to hospitalisation such as IHT are scarce. In the study presented in this protocol, IHT will be compared to care-as-usual (CAU) in a randomized controlled trial (RCT). CAU comprises low-intensity outpatient care and hospitalisation if necessary. In this RCT it is hypothesized that IHT will reduce inpatient days by 33% compared to CAU while safety and clinical outcomes will be non-inferior. Secondary hypotheses are that treatment satisfaction of patients and their relatives are expected to be higher in the IHT condition compared to CAU. METHODS: A 2-centre, 2-arm Zelen double consent RCT will be employed. Participants will be recruited in the Amsterdam area, the Netherlands. Clinical assessments will be carried out at baseline and at 6, 26 and 52 weeks post treatment allocation. The primary outcome measure is the number of admission days. Secondary outcomes include psychological well-being, safety and patients' and their relatives' treatment satisfaction. Alongside this RCT an economic evaluation will be carried out to assess the cost-effectiveness and cost-utility of IHT compared to CAU. DISCUSSION: RCTs on the effectiveness of crisis treatment in psychiatry are scarce and including patients in studies performed in acute psychiatric crisis care is a challenge due to the ethical and practical hurdles. The Zelen design may offer a feasible opportunity to carry out such an RCT. If our study finds that IHT is a safe and cost-effective alternative for CAU it may help support a further decrease of in-patient bed days and may foster the widespread implementation of IHT by mental health care organisations internationally. TRIAL REGISTRATION: The trial is registered in the Netherlands Trial Register as # NTR-6151 . Registered 23 November 2016.

Prevention of violent revictimization in depressed patients with an add-on internet-based emotion regulation training (iERT): study protocol for a multicenter randomized controlled trial.

BACKGROUND: Psychiatric patients are at high risk of becoming victim of a violent crime compared to the general population. Although most research has focused on patients with severe mental illness, depressed patients have been demonstrated to be prone to victimization as well. Victimization is associated with more severe symptomatology, decreased quality of life, and high risk of revictimization. Hence, there is a strong need for interventions that focus on preventing violent revictimization. Since emotion dysregulation is associated with both victimization and depression, we developed an internet-based Emotion Regulation Training (iERT) to reduce revictimization in depressed patients. This study aims to evaluate the clinical and cost-effectiveness of iERT added to Treatment As Usual (TAU) in reducing incidents of violent revictimization among depressed patients with a recent history of victimization. Furthermore, this study aims to examine secondary clinical outcomes, and moderators and mediators that may be associated with treatment outcomes. METHODS: In a multicenter randomized controlled trial with parallel group design, patients with a major depressive disorder and a history of violent victimization over the past three years (N = 200) will be allocated to either TAU + iERT (N = 100) or TAU only (N = 100), based on computer-generated stratified block randomization. Assessments will take place at baseline, 8 weeks, 14 weeks, and 6 months after start of treatment, and 12, 24, and 36 months after baseline. The primary outcome measure is the total number of violent victimization incidents at 12 months after baseline, measured with the Safety Monitor: an adequate self-report questionnaire that assesses victimization over the preceding 12 months. Secondary outcome measures and mediators include emotion dysregulation and depressive symptomatology. An economic evaluation with the societal perspective will be performed alongside the trial. DISCUSSION: This study is the first to examine the effectiveness of an intervention aimed at reducing violent revictimization in depressed patients. If effective, iERT can be implemented in mental health care, and contribute to the well-being of depressed patients. Furthermore, the results will provide insight into underlying mechanisms of revictimization. TRIAL REGISTRATION: The study is registered at the Netherlands Trial Register ( NTR5822 ). Date of registration: 4 April 2016.

Return-to-work intervention versus usual care for sick-listed employees: health-economic investment appraisal alongside a cluster randomised trial.

OBJECTIVE: To evaluate the health-economic costs and benefits of a guided eHealth intervention (E-health module embedded in Collaborative Occupational healthcare (ECO)) encouraging sick-listed employees to a faster return to work. DESIGN: A two-armed cluster randomised trial with occupational physicians (OPs) (n=62), clustered and randomised by region into an experimental and a control group, to conduct a health-economic investment appraisal. Online self-reported data were collected from employees at baseline, after 3, 6, 9 and 12 months. SETTING: Occupational health care in the Netherlands. PARTICIPANTS: Employees from small-sized and medium-sized companies (≥18 years), sick-listed between 4 and 26 weeks with (symptoms of) common mental disorders visiting their OP. INTERVENTIONS: In the intervention group, employees (N=131) received an eHealth module aimed at changing cognitions regarding return to work, while OPs were supported by a decision aid for treatment and referral options. Employees in the control condition (N=89) received usual sickness guidance. OUTCOMES MEASURES: Net benefits and return on investment based on absenteeism, presenteeism, health care use and quality-adjusted life years (QALYs) gained. RESULTS: From the employer's perspective, the incremental net benefits were €3187 per employee over a single year, representing a return of investment of €11 per invested Euro, with a break-even point at 6 months. The economic case was also favourable from the employee's perspective, partly because of QALY health gains. The intervention was costing €234 per employee from a health service financier's perspective. The incremental net benefits from a social perspective were €4210. This amount dropped to €3559 in the sensitivity analysis trimming the 5% highest costs. CONCLUSIONS: The data suggest that the ECO intervention offers good value for money for virtually all stakeholders involved, because initial investments were more than recouped within a single year. The sometimes wide 95% CIs suggest that the costs and benefits are not always very precise estimates and real benefits could vary considerably. TRIAL REGISTRATION: NTR2108; Results.