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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. [ABSTRACT FROM AUTHOR]

Background: Psychiatric patients are more likely to be victims of crime than others in the community. Dual diagnosis patients with comorbid psychiatric and substance use disorders are especially prone to victimization. Victimization is associated with substance abuse, more severe symptomatology and homelessness. There is a strong need for interventions to reduce victimization in this population. We developed the Self-wise, Other-wise, Streetwise (SOS) training to reduce victimization in patients with dual diagnosis. Methods/design: This study is a randomized controlled trial using a parallel group design to determine the effectiveness of adding the SOS training to care as usual. Patients with dual diagnosis (N = 250) will be allocated to either care as usual plus SOS training (N = 125) or care as usual only (N = 125) using computer-generated stratified block randomization. To compare effectiveness participants will be interviewed at baseline and 2, 8 and 14 months follow-up. The primary outcome measure is treatment response (yes/no), defined as either no victimization at 14 months follow-up or at least a 50% reduction in incidents of victimization at 14 months follow-up compared to baseline assessment. Victimization is measured with the Safety Monitor, an adequate self-report instrument used by Statistics Netherlands to measure victimization on a large scale in the Netherlands. Outcome assessors are blind to treatment allocation. An economic evaluation will be performed alongside the randomized controlled trial and will take the societal perspective. Discussion: This study is the first randomized controlled trial to examine the effectiveness of an intervention that aims to reduce victimization in patients with dual diagnosis. If the intervention is effective it can be implemented in mental health care and contribute to the safety and well-being of patients. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]