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Background: Intensive home treatment (IHT) aims to prevent psychiatric hospitalisation. Although this intervention is well tested, it is still unknown for whom this intervention works best. Therefore, this study aims to explore prescriptive factors that moderate the effect of IHT compared to care as usual (CAU) on symptom severity. Methods: Using data from a randomised controlled trial, 198 participants that experience an exacerbation of acute psychiatric symptoms were included in this secondary analysis. In order to maximise clinical relevance, generally available environmental and clinical baseline factors were included as tentative moderators: age, gender, employment status, domestic situation, psychiatric disorders, psychological symptoms, psychosocial functioning, alcohol and other substance use. The outcome variable symptom severity was measured using the Brief Psychiatric Rating Scale (BPRS) and collected at 26 and 52 weeks post-randomisation. Multiple regression analysis was used to examine which participants' characteristics moderate the effect of IHT on the total BPRS score. Results: Our results suggest that being employed (B = 0.28, SE = 0.13, 95% CI = 0.03–0.53, p = 0.03) at baseline seems to have a moderation effect, which result in lower symptom severity scores at 26 weeks follow-up for patients who received IHT. This effect was not found at 52 weeks. Conclusions: On the basis of the number of factors tested, there is no evidence for robust outcome moderators of the effect of IHT versus CAU. Our conclusion is therefore that IHT can be offered to a diverse target population with comparable clinical results. Trial registration: This trial is registered (date of registration: 2016-11-23) at the international clinical trials registry platform (NTR6151). [ABSTRACT FROM AUTHOR]

Background: Digital interventions may provide low-threshold support for smoking cessation (SC) and alcohol moderation (AM) to the growing population of cancer survivors. The objective was to explore preconditions of successful AM and SC digital interventions for cancer survivors.Methods: Using a multi-method approach we conducted a survey (n = 240), a qualitative study consisting of four focus groups (n = 15) and semi-structured interviews with Dutch cancer survivors (n = 8). To help interpretation of our results we interviewed experts in the field of eHealth and cancer survivors (n = 6) and we organized an expert meeting (n = 7). Qualitative data were analysed using the Framework approach and were double-coded by two coders.Results: Survey results show the majority of drinkers had not previously considered AM (n = 158, 84.9%), often because they deemed their alcohol use to be non-problematic. All current smokers in the survey had considered SC before. In focus groups and interviews it became clear that SC efforts did not always stem from their own willingness to quit smoking, but originated from a wish to please their social environment. Main themes to be addressed in digital SC and AM that emerged from the interviews and focus groups, centred on the different ways of identification as cancer survivors, need for autonomy, differential beliefs about SC and AM, and the importance of a positive, non-patronizing tone-of-voice. Several specific preferences for digital interventions were formulated, although some cancer survivors prefer no support or face-to-face contact.Conclusions: Cancer survivors are a diverse group with diverse preferences for AM and SC support. Digital AM and SC interventions for cancer survivors are perceived to be of value by some, especially when they incorporate a positive, non-judgemental and non-patronizing tone-of-voice, address concerns specifically relevant to cancer survivors, offer possibilities for personalization, and emphasize autonomy throughout. To encourage AM specifically, problem recognition and awareness of the health benefits of AM should be improved. [ABSTRACT FROM AUTHOR]

Background: Alcohol use disorders (AUD) have the worst impact in low-middle-income countries (LMICs), where the disease burden per liter of alcohol consumed is higher than in wealthy populations. Furthermore, the median treatment gap for AUDs in LMICs is 78.1%. The highest prevalence of AUDs worldwide in 2004 was found in the western Pacific region, Southeast Asia, and the Americas. The main aim of this study was to estimate and compare the prevalence of risky alcohol use and the extent of the treatment gap in a rural (Nickerie) and in an urban (Paramaribo) area in Suriname, a LMICs country with a wide variety of ethnic groups. Methods: The respondents were randomly recruited using a specific sampling method of the National Census Bureau. The final samples were 1837 households for Paramaribo and 1026 for Nickerie, reflecting the populations in both regions. The Alcohol Use Disorder Identification Test (AUDIT) and the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) were used to assess the likelihood of the presence of alcohol use disorder. A score of > 7 for the AUDIT implies risky alcohol use. Results: The results indicated that 2% of the women and 15% of the men in the rural area scored 8 or higher on the AUDIT. In the urban area, these numbers were 3% and 17%, respectively. In both samples, the men had the highest addiction risk at about 16% compared with 2% for females. Married persons are significantly less likely to become alcoholic than singles and other groups in Paramaribo. In both areas, higher education was associated with a lower probability of alcohol abuse and dependence, while handymen showed a higher odd. A treatment gap of 50% was found for alcohol use disorders in the rural area. The corresponding gap in the urban area was 64%. Conclusions: Surinamese men show a high prevalence of the likelihood of AUD. In addition, the treatment gap for these possible patients is large. It is therefore of paramount importance to develop therapeutic strategies with the aim of tackling this physically and mentally disabling disorder. Tailored E-health programs may be of benefit. [ABSTRACT FROM AUTHOR]

Background: This study evaluated whether providing intensive home treatment (IHT) to patients experiencing a psychiatric crisis has more effect on self-efficacy when compared to care as usual (CAU). Self-efficacy is a psychological concept closely related to one of the aims of IHT. Additionally, differential effects on self-efficacy among patients with different mental disorders and associations between self-efficacy and symptomatic recovery or quality of life were examined. Methods: Data stem from a Zelen double consent randomised controlled trial (RCT), which assesses the effects of IHT compared to CAU on patients who experienced a psychiatric crisis. Data were collected at baseline, 6 and 26 weeks follow-up. Self-efficacy was measured using the Mental Health Confidence Scale. The 5-dimensional EuroQol instrument and the Brief Psychiatric Rating Scale (BPRS) were used to measure quality of life and symptomatic recovery, respectively. We used linear mixed modelling to estimate the associations with self-efficacy. Results: Data of 142 participants were used. Overall, no difference between IHT and CAU was found with respect to self-efficacy (B = − 0.08, SE = 0.15, p = 0.57), and self-efficacy did not change over the period of 26 weeks (B = − 0.01, SE = 0.12, t (103.95) = − 0.06, p = 0.95). However, differential effects on self-efficacy over time were found for patients with different mental disorders (F(8, 219.33) = 3.75, p < 0.001). Additionally, self-efficacy was strongly associated with symptomatic recovery (total BPRS B = − 0.10, SE = 0.02, p < 0.00) and quality of life (B = 0.14, SE = 0.01, p < 0.001). Conclusions: Although self-efficacy was associated with symptomatic recovery and quality of life, IHT does not have a supplementary effect on self-efficacy when compared to CAU. This result raises the question whether, and how, crisis care could be adapted to enhance self-efficacy, keeping in mind the development of self-efficacy in depressive, bipolar, personality, and schizophrenia spectrum and other psychotic disorders. The findings should be considered with some caution. This study lacked sufficient power to test small changes in self-efficacy and some mental disorders had a small sample size. Trial registration This trial is registered at Trialregister.nl, number NL6020. [ABSTRACT FROM AUTHOR]

Background: Heavy cannabis use is associated with adverse physical and mental health effects. Despite available effective treatments, the majority of heavy cannabis users does not seek professional help. Web-based interventions can provide an alternative for cannabis users who are reluctant to seek professional help. Several web-based cannabis interventions are effective in reducing cannabis use; however, the effect sizes are typically small and attrition rates are typically high. This suggests that web-based programs can be an effective cannabis use intervention for some, while others may need additional substance use treatment after completing a web-based intervention. Therefore, it is important that web-based interventions do not solely focus on reducing cannabis use, but also on improving attitudes towards substance use treatment. The Screening Brief Intervention and Referral to Treatment (SBIRT) approach appears to be well suited for the purpose of reducing cannabis use and improving substance use treatment utilization. Based on the SBIRT approach-and based on cognitive behavioral therapy (CBT) and motivational interviewing (MI)-we developed the Internet-based cannabis reduction intervention ICan.Methods/design: This protocol paper presents the design of a randomized controlled trial (RCT) in which we evaluate the effectiveness of the ICan intervention compared to four online modules of educational information on cannabis in a sample of Dutch frequent cannabis users. The primary outcome measure is frequency of cannabis use. Secondary outcome measures include the quantity of cannabis used (grams), the attitudes towards seeking help and the number of participants who enter specialized treatment services for cannabis use-related problems.Discussion: To the best of our knowledge, ICan is the first Internet-based intervention for cannabis users that combines screening, a brief intervention-based on CBT and MI-and referral to treatment options.Trial Registration: The study is registered in the Netherlands Trial Register; identifier NL7668 . Registered on 17 April 2019. [ABSTRACT FROM AUTHOR]

Background: Accurate prediction models for whether patients on the verge of a psychiatric criseis need hospitalization are lacking and machine learning methods may help improve the accuracy of psychiatric hospitalization prediction models. In this paper we evaluate the accuracy of ten machine learning algorithms, including the generalized linear model (GLM/logistic regression) to predict psychiatric hospitalization in the first 12 months after a psychiatric crisis care contact. We also evaluate an ensemble model to optimize the accuracy and we explore individual predictors of hospitalization.Methods: Data from 2084 patients included in the longitudinal Amsterdam Study of Acute Psychiatry with at least one reported psychiatric crisis care contact were included. Target variable for the prediction models was whether the patient was hospitalized in the 12 months following inclusion. The predictive power of 39 variables related to patients' socio-demographics, clinical characteristics and previous mental health care contacts was evaluated. The accuracy and area under the receiver operating characteristic curve (AUC) of the machine learning algorithms were compared and we also estimated the relative importance of each predictor variable. The best and least performing algorithms were compared with GLM/logistic regression using net reclassification improvement analysis and the five best performing algorithms were combined in an ensemble model using stacking.Results: All models performed above chance level. We found Gradient Boosting to be the best performing algorithm (AUC = 0.774) and K-Nearest Neighbors to be the least performing (AUC = 0.702). The performance of GLM/logistic regression (AUC = 0.76) was slightly above average among the tested algorithms. In a Net Reclassification Improvement analysis Gradient Boosting outperformed GLM/logistic regression by 2.9% and K-Nearest Neighbors by 11.3%. GLM/logistic regression outperformed K-Nearest Neighbors by 8.7%. Nine of the top-10 most important predictor variables were related to previous mental health care use.Conclusions: Gradient Boosting led to the highest predictive accuracy and AUC while GLM/logistic regression performed average among the tested algorithms. Although statistically significant, the magnitude of the differences between the machine learning algorithms was in most cases modest. The results show that a predictive accuracy similar to the best performing model can be achieved when combining multiple algorithms in an ensemble model. [ABSTRACT FROM AUTHOR]

Background The present study investigates the suitability of various treatment outcome indicators to evaluate performance of mental health institutions that provide care to patients with severe mental illness. Several categorical approaches are compared to a reference indicator (continuous outcome) using pretest-posttest data of the Health of Nation Outcome Scales (HoNOS). Methods Data from 10 institutions and 3189 patients were used, comprising outcomes of the first year of treatment by teams providing long-term care. Results Findings revealed differences between continuous indicators (standardized pre-post difference score ES and ΔT) and categorical indicators (SEM, JTRCI, JTCS, JTRCI&CS, JTrevised) on their ranking of institutions, as well as substantial differences among categorical indicators; the outcome according to the traditional JT approach was most concordant with the continuous outcome indicators. Conclusions For research comparing group averages, a continuous outcome indicator such as ES or ΔT is preferred, as this best preserves information from the original variable. Categorical outcomes can be used to illustrate what is accomplished in clinical terms. For categorical outcome, the classical Jacobson-Truax approach is preferred over the more complex method of Parabiaghi et al. with eight outcome categories. The latter may be valuable in clinical practice as it allows for a more detailed characterization of individual patients. [ABSTRACT FROM AUTHOR]

Background: Brief interventions for smoking cessation and alcohol moderation may contribute considerably to the prevention of cancer among populations at risk, such as cancer survivors, in addition to improving their general wellbeing. There is accumulating evidence for the effectiveness of internet-based brief health behaviour interventions. The objective of this study is to assess the effectiveness, patient-level cost-effectiveness and cost-utility of two new online theory-based self-help interventions among adult cancer survivors in the Netherlands. One of the interventions focuses on alcohol moderation, the other on smoking cessation. Both interventions are tailored to cancer survivors.Methods: Effectiveness will be assessed in two separate, nearly identical 2-armed RCTs: alcohol moderation (AM RCT) and smoking cessation (SC RCT). Participants are randomly allocated to either the intervention groups or the control groups. In the intervention groups, participants have access to one of the newly developed interventions. In the control groups, participants receive an online static information brochure on alcohol (AM RCT) or smoking (SC RCT). Main study outcome parameters are the number of drinks post-randomisation (AM RCT) and tobacco abstinence (SC RCT). In addition, cost-data and possible effect moderators and mediators will be assessed. Both treatments are internet-based minimally guided self-help interventions: MyCourse - Moderate Drinking (in Dutch: MijnKoers - Minderen met Drinken) and MyCourse - Quit Smoking (MijnKoers - Stoppen met Roken). They are based on cognitive behaviour therapy (CBT), motivational interviewing (MI) and acceptance and commitment therapy (ACT). Both interventions are optimized in collaboration with the target population of cancer survivors in focus groups and interviews, and in collaboration with several experts on eHealth, smoking cessation, alcohol misuse and cancer survivorship.Discussion: The present study will add to scientific knowledge on the (cost-)effectiveness of internet-based self-help interventions to aid in smoking cessation or alcohol moderation, working mechanisms and impact on quality of life of cancer survivors. If found effective, these interventions can contribute to providing evidence-based psychosocial oncology care to a growing population of cancer survivors.Trial Registration: Trials are prospectively registered in The Netherlands Trial Register (NTR): NTR6011 (SC RCT), NTR6010 (AM RCT) on 1 September 2016. [ABSTRACT FROM AUTHOR]

Background: Children of parents with post-traumatic stress disorder (PTSD) are at increased risk of adverse psychological outcomes. An important risk mechanism is impaired parental functioning, including negative parenting behavior, perceived incompetence, and lack of social support. Several parenting interventions for trauma-exposed parents and parents with psychiatric disorders exist, but none have specifically targeted parents with PTSD. Our objective is to evaluate the effectiveness of a blended care preventive parenting intervention for parents with PTSD. Methods: The intervention was adapted from an existing online intervention, KopOpOuders Self-Help. In co-creation with parents with PTSD and partners, the intervention was adapted into KopOpOuders-PTSD, by adding PTSD-specific content and three in-person-sessions with a mental health prevention professional. Effectiveness will be tested in a randomized controlled trial among N = 142 parents being treated for PTSD at Arkin Mental Health Care (control condition: treatment as usual, n = 71; intervention condition: treatment as usual + intervention, n = 71). Online questionnaires at pretest, posttest, and three-month follow-up and ecological momentary assessment at pretest and posttest will be used. Intervention effects on primary (parenting behavior) and secondary outcomes (perceived parenting competence, parental social support, parenting stress, child overall psychological problems and PTSD symptoms) will be analyzed using generalized linear mixed modeling. We will also analyze possible moderation effects of parental PTSD symptoms at pretest on primary and secondary outcomes. Discussion: This study protocol describes the randomized controlled trial of KopOpOuders-PTSD, a blended care preventive parenting intervention for parents with PTSD. Findings can contribute to understanding of the effectiveness of parenting support in clinical practice for PTSD. Trial registration: This protocol (Version 1) was registered on 11-02-2022 at ClinicalTrials.gov under identification number NCT05237999. [ABSTRACT FROM AUTHOR]

Background: Internet-based interventions are seen as attractive for harmful users of alcohol and lead to desirable clinical outcomes. Some participants will however not achieve the desired results. In this study, harmful users of alcohol have been partitioned in subgroups with low, intermediate or high probability of positive treatment outcome, using recursive partitioning classification tree analysis. Methods: Data were obtained from a randomized controlled trial assessing the effectiveness of two Internet-based alcohol interventions. The main outcome variable was treatment response, a dichotomous outcome measure for treatment success. Candidate predictors for the classification analysis were first selected using univariate regression. Next, a tree decision model to classify participants in categories with a low, medium and high probability of treatment response was constructed using recursive partitioning software. Results: Based on literature review, 46 potentially relevant baseline predictors were identified. Five variables were selected using univariate regression as candidate predictors for the classification analysis. Two variables were found most relevant for classification and selected for the decision tree model: 'living alone', and 'interpersonal sensitivity'. Using sensitivity analysis, the robustness of the decision tree model was supported. Conclusions: Harmful alcohol users in a shared living situation, with high interpersonal sensitivity, have a significantly higher probability of positive treatment outcome. The resulting decision tree model may be used as part of a decision support system but is on its own insufficient as a screening algorithm with satisfactory clinical utility. [ABSTRACT FROM AUTHOR]

Background: Only a minority of all alcohol- and drug abusers is receiving professional care. In an attempt to narrow this treatment gap, treatment facilities experiment with online healthcare. Therefore, it is important to test the (cost-)effectiveness of online health interventions in a randomized clinical trial. Methods: This paper presents the protocol of a three-arm randomized clinical trial to test the (cost-) effectiveness of online treatment for problem drinkers. Self-help online, therapy online and a waiting list are tested against each other. Primary outcome is change in alcohol consumption. Secondary outcome measures include quality of life and working ability. Incremental cost-effectiveness ratios for self-help online alcohol and therapy online alcohol will be calculated. The predictive validity of participant characteristics on treatment adherence and outcome will be explored. Discussion: To our best knowledge, this randomized clinical trial will be the first to test the effectiveness of therapy online against both self-help online and a waiting-list. It will provide evidence on (cost-) effectiveness of online treatment for problem drinkers and investigate outcome predictors. Trial registration: This trial is registered in the Dutch Trialregister (Cochrane Collaboration) and traceable as NTR-TC1155. [ABSTRACT FROM AUTHOR]

Background: Internet-based interventions are seen as attractive for harmful users of alcohol and lead to desirable clinical outcomes. Some participants will however not achieve the desired results. In this study, harmful users of alcohol have been partitioned in subgroups with low, intermediate or high probability of positive treatment outcome, using recursive partitioning classification tree analysis.Methods: Data were obtained from a randomized controlled trial assessing the effectiveness of two Internet-based alcohol interventions. The main outcome variable was treatment response, a dichotomous outcome measure for treatment success. Candidate predictors for the classification analysis were first selected using univariate regression. Next, a tree decision model to classify participants in categories with a low, medium and high probability of treatment response was constructed using recursive partitioning software.Results: Based on literature review, 46 potentially relevant baseline predictors were identified. Five variables were selected using univariate regression as candidate predictors for the classification analysis. Two variables were found most relevant for classification and selected for the decision tree model: 'living alone', and 'interpersonal sensitivity'. Using sensitivity analysis, the robustness of the decision tree model was supported.Conclusions: Harmful alcohol users in a shared living situation, with high interpersonal sensitivity, have a significantly higher probability of positive treatment outcome. The resulting decision tree model may be used as part of a decision support system but is on its own insufficient as a screening algorithm with satisfactory clinical utility.Trial Registration: Netherlands Trial Register (Cochrane Collaboration): NTR-TC1155. [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: Suriname is a Low-middle income country consisting of diverse population groups. Epidemiological studies concerning mental disorders like depression and anxiety had not been conducted until 2015. The treatment gap for mental disorders in Low and middle-income countries (LMICs) may reach 76-80% as treatment is not always readily available. In this study, we estimate and compare the prevalence of potential cases of depression and anxiety, as well as the size of the treatment gap in a rural (Nickerie) and urban (Paramaribo) region of Suriname, a lower middle-income country.Methods: Subjects were selected by a specific sampling method of the national census bureau. The Center for Epidemiological Studies-Depression (CES-D) was used to assess depression. Generalized anxiety disorder was assessed with the Generalized Anxiety Disorder 7 (GAD-7) and The Agoraphobic Cognitions Questionnaire (ACQ), the Body Sensations Questionnaire (BSQ) were used to assess Panic disorder. The treatment gap was calculated by estimating the percentage of subjects with depression or anxiety that did not seek out professional help.Results: About 18% of the respondents from Nickerie and 16% from Paramaribo were at risk of depression and the established cut-off values of the instruments used indicate that about 3-4% in both regions may suffer from Generalized Anxiety Disorder. Women in both samples were most at risk of high anxiety about body sensations and maladaptive thoughts about panic. The treatment gap varies between 78 and 100% for the two disorders.Conclusions: A high depression rate has been found in both areas, especially among young females. In addition, a high treatment gap is noted which insinuates that more therapeutic strategies are required to tackle depression and anxiety in Suriname. [ABSTRACT FROM AUTHOR]

Background: For anorexia nervosa, firm evidence of the superiority of specialized psychological treatments is limited and economic evaluations of such treatments in real world settings are scarce. This consecutive cohort study examined differential (cost-)effectiveness for adult inpatients and outpatients with anorexia nervosa, after implementing cognitive behavioral therapy-enhanced (CBT-E) throughout a routine setting. Methods: Differences in remission, weight regain and direct eating disorder treatment costs were examined between one cohort (N = 75) receiving treatment-as-usual (TAU) between 2012–2014, and the other (N = 88) CBT-E between 2015–2017. The economic evaluation was performed from a health care perspective with a one-year time horizon, using EDE global score < 2.77, the absence of eating disorder behaviors combined with a BMI ≥ 18.5, as effect measure. Incremental cost-effectiveness ratios were calculated and cost-effectiveness planes and cost-effectiveness acceptability curves were displayed to assess the probability that CBT-E is cost effective compared to TAU. Results: Using direct eating disorder treatment costs in the cost-effectiveness analysis, the cost-effectiveness plane of the base case scenario for all patients indicated a 84% likelihood of CBT-E generating better health gain at additional costs. The median ICER is €51,081, indicating a probable preference for CBT-E (> 50% probability of cost-effectiveness) assuming a WTP of €51,081 or more for each additional remission, On remission, no difference was found with 9.3% remission during TAU and 14.6% during CBT-E (p =.304). Weight regain was higher during CBT-E (EMD = 1.33 kg/m2, SE =.29, 95% CI [0.76–1.9], p <.001). Conclusions: In this mixed inpatient and outpatient cohort study, findings indicate a probability of CBT-Ebeing more effective at higher costs. These findings may contribute to the knowledge of effectiveness and cost-effectiveness of specialized psychological treatments. Plain English Summary: In this study, the effectiveness and treatment costs of a specialized psychological treatment for adult clients with anorexia nervosa were compared with a regular, non-specialist treatment. One group of inpatients and outpatients did receive non-specialist treatment, the next group of inpatients and outpatients received CBT-E, a specialized treatment, later on. CBT-E is recommended for clients with bulimia and with binge eating disorder, for clients with anorexia nervosa it is less clear which specialized psychological treatment should be recommended. Results indicate that at end-of-treatment, CBT-E was not superior on remission. When looking at weight regain, CBT-E seemed superior than the treatment offered earlier. Economic evaluation suggests that CBT-E generates better health gain, but at additional costs. This study contributes to the knowledge on the effectiveness and treatment costs of psychological treatments, as they are offered in routine practice, to adults with anorexia nervosa. [ABSTRACT FROM AUTHOR]

Background: Depressive disorders and problematic drinking often co-occur, also among young adults. These co-occurring conditions are associated with various negative health outcomes compared to both conditions alone. Early intervention by addressing alcohol use and depressive symptoms simultaneously in the same treatment might improve both conditions. However, evidence on the (cost-) effectiveness of digital combined depression and alcohol interventions for young adults is currently insufficient. We therefore developed an add-on digital alcohol moderation adherence-focussed guided intervention to complement treatment as usual (TAU) for depressive disorders. The digital intervention is a web-app, including 6 modules based on motivational interviewing and cognitive behavioural therapy. This study aims to evaluate the (cost-)effectiveness of a digital alcohol moderation intervention + TAU compared to TAU on alcohol and depression outcomes among young adults with co-occurring depressive disorders and problematic alcohol use. Methods: One hundred fifty-six participants, aged 18–35 years, with problematic alcohol use and a diagnosed depressive disorder will participate in a pragmatic multicentre two-arm randomized controlled trial. Problematic alcohol use is operationalised as scoring ≥5 for women and ≥ 8 for men on the Alcohol Use Disorder Identification Test (AUDIT). Participants will be randomized to either the experimental group (digital alcohol intervention + TAU) or control group (TAU only). Participants will be recruited at three Dutch mental health care centres and through social media. Assessments take place at baseline and after 3, 6 and 12 months post-randomization. The primary outcome is treatment response at 6-month follow-up, operationalized as a composite score that combines alcohol use and depression measures and indicates whether treatment has been successful or not. Secondary outcomes are depressive symptoms and alcohol use (i.e. number of weekly standard drinks and AUDIT score). An economic evaluation will be conducted alongside the trial. Discussion: This study evaluates the (cost-) effectiveness of an add-on digital alcohol moderation intervention for young adults who are in treatment for depressive disorders. If proven effective, the digital intervention could be implemented in mental health care and improve treatment for people with co-occurring depressive disorders and problematic alcohol use. Trial registration: Pre-registered on October 29, 2019 in The Netherlands Trial Register (NL8122). [ABSTRACT FROM AUTHOR]

Background: A major challenge to psychological treatment for alcohol use disorder (AUD) is patient non-compliance. A promising new treatment approach that is hypothesized to increase patient compliance is blended treatment, consisting of face-to-face contact with a therapist combined with modules delivered over the internet within the same protocol. While this treatment concept has been developed and proven effective for a variety of mental disorders, it has not yet been examined for AUD. Aims: The study described in this protocol aims to examine and evaluate patient compliance with blended AUD treatment as well as the clinical and cost effectiveness of such treatment compared to face-to-face treatment only. Methods: The study design is a pragmatic, stepped-wedge cluster randomized controlled trial. The included outpatient institutions (planned number of patients: n = 1800) will be randomized in clusters to implement either blended AUD treatment or face-to-face treatment only, i.e. treatment as usual (TAU). Both treatment approaches consist of motivational interviewing and cognitive behavioral therapy. Data on sociodemographics, treatment (e.g. intensity, duration), type of treatment conclusion (compliance vs. dropout), alcohol consumption, addiction severity, consequences of drinking, and quality of life, will be collected at treatment entry, at treatment conclusion, and 6 months after treatment conclusion. The primary outcome is compliance at treatment conclusion, and the secondary outcomes include alcohol consumption and quality of life at six-months follow-up. Data will be analyzed with an Intention-to-treat approach by means of generalized linear mixed models with a random effect for cluster and fixed effect for each step. Also, analyses evaluating cost-effectiveness will be conducted. Discussion: Blended treatment may increase treatment compliance and thus improve treatment outcomes due to increased flexibility of the treatment course. Since this study is conducted within an implementation framework it can easily be scaled up, and when successful, blended treatment has the potential to become an alternative offer in many outpatient clinics nationwide and internationally. Trial registration: Clinicaltrials.gov.: NCT04535258, retrospectively registered 01.09.20. [ABSTRACT FROM AUTHOR]

Optimizing psychotherapy dosage for comorbid depression and personality disorders (PsyDos): a pragmatic randomized factorial trial using schema therapy and short-term psychodynamic psychotherapy. Block randomization The sentence currently reads: Patients will then be randomized by one of two research department employees in one of four groups (with a 1:1:1:1 allocation) using a computer script performing block randomization (25 vs 50-sessions; ST vs SPSP). [Extracted from the article]

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. [ABSTRACT FROM AUTHOR]

Background: In the Netherlands, midwives are required to use the 'V-MIS' (Minimal Intervention Strategy for Midwives) smoking cessation counselling protocol to help pregnant women quit smoking. This counselling protocol is often poorly implemented in midwifery practices. It may also be less suitable for pregnant woman with low socioeconomic status or functional health illiteracy. We created an adapted version of the V-MIS protocol that is intended to facilitate implementation in midwifery practices: PROMISE (PROtocol for growing up smokefree using a Minimal smoking cessation Intervention Strategy in the Early stages of life). For this adapted protocol, midwives use carbon monoxide meters, storyboard leaflets, and specific communication techniques for women with functional health illiteracy. They will receive a face-to-face training in using these materials and communication techniques.Methods: The effectiveness and implementation of PROMISE will be tested in a stepped-wedge cluster randomised controlled trial. We will randomise clusters of midwifery practices and departments in hospitals. We will then train them, subsequently, at regular intervals ('steps'). At each step, practices that will receive training cross over from the control condition to the experimental condition. We will measure how well the PROMISE protocol has been implemented by assessing the rate of pregnant women that received detailed smoking cessation counselling from their midwives (primary outcome). Our secondary target group is pregnant women with functional health illiteracy and low socioeconomic status. Among them, we will assess smoking status and health-related outcome before and after pregnancy.Discussion: The PROMISE smoking cessation counselling protocol is intended to help midwives, OB-GYNs, and other obstetrics professionals to support pregnant women with smoking cessation.Trial Registration: Dutch Trial Registry: NTR 6305/NL6158 . Registered on 20 December 2016. [ABSTRACT FROM AUTHOR]

Background: Binge eating disorder is characterized by recurrent episodes of binge eating accompanied by a sense of lack of control. Of the different treatments available, Cognitive Behavioral Therapy-Enhanced and guided self-help treatment are recommended. As online treatment offers several additional advantages, we have developed a CBT-Enhanced online guided self-help intervention. The aim of this study is to determine whether this intervention reduces eating disorder pathology and increases the amount of binge free days in adults classified with binge eating disorder or other specified feeding or eating disorder- binge eating disorder, compared to an untreated waiting list condition. The experimental condition is hypothesized to be superior to the waiting list condition. Methods: The efficacy of an online guided self-help intervention for binge eating disorder will be assessed by conducting a randomized controlled trial. The trial will target adult individuals classified with binge eating disorder or other specified feeding or eating disorder- binge eating disorder with a body mass index between 19.5 and 40, referred to an eating disorder treatment center. Dual arm allotment will be performed in a 1:1 ratio stratified for BMI above or below 30. Randomization will be blinded to the online intervention (n = 90), or to the control waiting list condition (n = 90). Assessors will be blinded and assessments will be administered at baseline, week 5, at end-of-treatment, and at 12 and 24 weeks follow-up. Primary outcome will be eating disorder pathology, operationalized as number of days on which binge eating occurred between the two conditions during the period of the intervention. Secondary outcome measures will be differences in other eating disorder pathology, clinical impairment and in quality of life, while therapeutic alliance, demographic characteristics and followed treatment module will serve as effect moderators. Several types of costs will be assessed. Discussion: This paper presents an online guided self-help Cognitive Behavioral Therapy- Enhanced study protocol for individuals classified with binge eating disorder or other specified feeding or eating disorder. Efficacy will be examined through a Randomized Controlled Trial. Trial registration: The study protocol is registered with the Netherlands Trial Registry NTR (NTR 7994) since 6 September 2019. [ABSTRACT FROM AUTHOR]

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: Despite an initial steep decrease in alcohol misuse among Estonians through structural intervention means and the scaling up of alcohol counselling in the mid-2000's, most of the country's alcohol misuse indicators remain clearly higher than European averages. Consequently, an online self-help program was launched as part of an initial behavioral intervention initiative to foster progress in alcohol prevention on a population level.Methods: A two-arm randomized controlled trial (RCT) has been designed to compare the efficacy of a culturally-adapted minimal-guidance online self-help program, the 8-week "Selge" online program against a control condition that consists of a self-administered test of alcohol use and advice regarding usual treatment in Estonia. A target sample of 600 individuals will be recruited and randomly assigned to either condition. The program will contain 10 modules based on principles of cognitive behavioural therapy (CBT) and motivational interviewing (MI). Participants in the control group will have access to the full treatment after they complete their final follow-up assessment. The primary outcome will be change in the Alcohol Use Disorders Identification Test (AUDIT) score between the 6-month follow-up and baseline assessments. Secondary outcomes will include the number of standard drinks consumed and alcohol-free days, drinking motives and motivation for change, as well as changes in mental health. Assessments will be completed at baseline, at the end of treatment, and at 6 months follow-up. Data analysis will follow the intention-to-treat principle and employ (generalised) linear mixed models.Discussion: The "Selge" program is the first and only internet program for the intervention of alcohol misuse in Estonia. If proven effective, it will foster progress in the intervention of alcohol misuse in the Estonian population and be implemented as a standard program amidst the continuum of intervention and care.Trial Registration: Current Controlled Trials ISRCTN48753339 registered 04/06/2019 retrospectively. [ABSTRACT FROM AUTHOR]

Background: Patients with comorbid depression and personality disorders suffer from a heavy disease burden while tailored treatment options are limited, accounting for a high psychological and economic burden. Little is known about the effect of treatment dosage and type of psychotherapy for this specific co-morbid patient population, in terms of treatment-effect and cost-effectiveness. This study aims to compare treatment outcome of 25 versus 50 individual therapy sessions in a year. We expect the 50-session condition to be more effective in treating depression and maintaining the effect. Secondary objectives will be addressed in order to find therapy-specific and non-specific mechanisms of change. Methods: In a mono-center pragmatic randomized controlled trial with a 2 × 2 factorial design, 200 patients with a depressive disorder and personality disorder(s) will be included. Patients will be recruited from a Dutch mental health care institute for personality disorders. They will be randomized over therapy dosage (25 vs 50 sessions in a year) and type of therapy (schema therapy vs short-term psychodynamic supportive psychotherapy). The primary clinical outcome measure will be depression severity and remission. Changes in personality functioning and quality of life will be investigated as secondary outcomes. A priori postulated effect moderators and mediators will be collected as well. All patients are assessed at baseline and at 1, 2, 3, 6, 9–12 months (end of therapy) and at follow up (6 and 12 months after end of treatment). Alongside the trial, an economic evaluation will be conducted. Costs will be collected from a societal perspective. Discussion: This trial will be the first to compare two psychotherapy dosages in patients with both depression and personality disorders. Insight in the effect of treatment dosage for this patient group will contribute to both higher treatment effectiveness and lower costs. In addition, this study will contribute to the limited evidence base on treating patients with both depression and personality disorders. Understanding the processes that account for the therapeutic changes could help to gain insight in what works for whom. Trial registration: This trial has been registered on July 20th 2016, Netherlands Trial Register, part of the Dutch Cochrane Centre (NTR5941). [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]