European COMPARative Effectiveness research on blended Depression treatment versus treatment-as-usual (E-COMPARED): study protocol for a randomized controlled, non-inferiority trial in eight European countries.

BACKGROUND: Effective, accessible, and affordable depression treatment is of high importance considering the large personal and economic burden of depression. Internet-based treatment is considered a promising clinical and cost-effective alternative to current routine depression treatment strategies such as face-to-face psychotherapy. However, it is not clear whether research findings translate to routine clinical practice such as primary or specialized mental health care. The E-COMPARED project aims to gain knowledge on the clinical and cost-effectiveness of blended depression treatment compared to treatment-as-usual in routine care. METHODS/DESIGN: E-COMPARED will employ a pragmatic, multinational, randomized controlled, non-inferiority trial in eight European countries. Adults diagnosed with major depressive disorder (MDD) will be recruited in primary care (Germany, Poland, Spain, Sweden, and the United Kingdom) or specialized mental health care (France, The Netherlands, and Switzerland). Regular care for depression is compared to "blended" service delivery combining mobile and Internet technologies with face-to-face treatment in one treatment protocol. Participants will be followed up at 3, 6, and 12 months after baseline to determine clinical improvements in symptoms of depression (primary outcome: Patient Health Questionnaire-9), remission of depression, and cost-effectiveness. Main analyses will be conducted on the pooled data from the eight countries (n = 1200 in total, 150 participants in each country). DISCUSSION: The E-COMPARED project will provide mental health care stakeholders with evidence-based information and recommendations on the clinical and cost-effectiveness of blended depression treatment. TRIAL REGISTRATION: France: ClinicalTrials.gov NCT02542891 . Registered on 4 September 2015; Germany: German Clinical Trials Register DRKS00006866 . Registered on 2 December 2014; The Netherlands: Netherlands Trials Register NTR4962 . Registered on 5 January 2015; Poland: ClinicalTrials.Gov NCT02389660 . Registered on 18 February 2015; Spain: ClinicalTrials.gov NCT02361684 . Registered on 8 January 2015; Sweden: ClinicalTrials.gov NCT02449447 . Registered on 30 March 2015; Switzerland: ClinicalTrials.gov NCT02410616 . Registered on 2 April 2015; United Kingdom: ISRCTN registry, ISRCTN12388725 . Registered on 20 March 2015

Development of a novel benchmark method to identify and characterize best practices in home care across six European countries: design, baseline, and rationale of the IBenC project.

To access publisher's full text version of this article, please click on the hyperlink in Additional Links field or click on the hyperlink at the top of the page marked DownloadBACKGROUND: Europe's ageing society leads to an increased demand for long-term care, thereby putting a strain on the sustainability of health care systems. The 'Identifying best practices for care-dependent elderly by Benchmarking Costs and outcomes of Community Care' (IBenC) project aims to develop a new benchmark methodology based on quality of care and cost of care utilization to identify best practices in home care. The study's baseline data, methodology, and rationale are reported. METHODS: Home care organizations in Belgium, Finland, Germany, Iceland, Italy, and the Netherlands, home care clients of 65 years and over receiving home care, and professionals working in these organizations were included. Client data were collected according to a prospective longitudinal design with the interRAI Home Care instrument. Assessments were performed at baseline, after six and 12 months by trained (research) nurses. Characteristics of home care organizations and professionals were collected cross-sectionally with online surveys. RESULTS: Thirty-eight home care organizations, 2884 home care clients, and 1067 professionals were enrolled. Home care clients were mainly female (66.9%), on average 82.9 years (± 7.3). Extensive support in activities of daily living was needed for 41.6% of the sample, and 17.6% suffered cognitive decline. Care professionals were mainly female (93.4%), and over 45 years (52.8%). Considerable country differences were found. CONCLUSION: A unique, international, comprehensive database is established, containing in-depth information on home care organizations, their clients and staff members. The variety of data enables the development of a novel cost-quality benchmark method, based on interRAI-HC data. This benchmark can be used to explore relevant links between organizational efficiency and organizational and staff characteristics.7th Framework Programme of the European Commissio

Construct Validity and Responsiveness of Instruments Measuring Depression and Anxiety in Pregnancy: A Comparison of EPDS, HADS-A and CES-D

Depression and anxiety occur frequently in pregnancy and may have unfavourable consequences for mother and child. Therefore, adequate symptom measurement seems important. Commonly used instruments are the Center for Epidemiologic Studies Depression Scale (CES-D), the Edinburgh Postpartum Depression Scale (EPDS), and the Hospital Anxiety and Depression Scale, anxiety subscale (HADS-A). We compared the (1) structural and (2) longitudinal validity of these instruments. The data originated from a study on the effectiveness of an Internet intervention for pregnant women with affective symptoms. (1) A confirmatory factor analysis was used to estimate the construct validity. The theoretical factorial structure that was defined in earlier studies of the CES-D and the EPDS, but not the HADS-A, could be sufficiently replicated with acceptable CFI and RMSEA values. (2) Since there were two measurements in time, the hypotheses concerning plausible directions of the change scores of subscales that were (un)related to each other could be formulated and tested. In this way, longitudinal validity in the form of responsiveness was estimated. Ten of sixteen hypotheses were confirmed, corroborating the longitudinal validity of all constructs, except anhedonia, probably due to inconsistent conceptualization. The HADS-A seems less suitable to screen for anxiety in pregnancy. Anhedonia needs better conceptualisation to assess the change of symptoms over time with the CES-D and the EPDS

Construct Validity and Responsiveness of Instruments Measuring Depression and Anxiety in Pregnancy: A Comparison of EPDS, HADS-A and CES-D

Depression and anxiety occur frequently in pregnancy and may have unfavourable consequences for mother and child. Therefore, adequate symptom measurement seems important. Commonly used instruments are the Center for Epidemiologic Studies Depression Scale (CES-D), the Edinburgh Postpartum Depression Scale (EPDS), and the Hospital Anxiety and Depression Scale, anxiety subscale (HADS-A). We compared the (1) structural and (2) longitudinal validity of these instruments. The data originated from a study on the effectiveness of an Internet intervention for pregnant women with affective symptoms. (1) A confirmatory factor analysis was used to estimate the construct validity. The theoretical factorial structure that was defined in earlier studies of the CES-D and the EPDS, but not the HADS-A, could be sufficiently replicated with acceptable CFI and RMSEA values. (2) Since there were two measurements in time, the hypotheses concerning plausible directions of the change scores of subscales that were (un)related to each other could be formulated and tested. In this way, longitudinal validity in the form of responsiveness was estimated. Ten of sixteen hypotheses were confirmed, corroborating the longitudinal validity of all constructs, except anhedonia, probably due to inconsistent conceptualization. The HADS-A seems less suitable to screen for anxiety in pregnancy. Anhedonia needs better conceptualisation to assess the change of symptoms over time with the CES-D and the EPDS

Investigating people’s lifetime history of suicide attempts: a roadmap for studying interviewer-related error

It is critically important to correctly identify persons with a lifetime history (LTH) of suicide attempts (SA) from both a clinical and research perspective. Face-to-face interviews are often the best available method for researchers to collect data about a complex phenomenon like a LTH of SA. However, extensive survey methodology research has shown that probing sensitive topics like a LTH of SA are sensitive for interviewer-related errors or interviewer effects. Studies investigating these interviewer effects are scarce in the field of suicide studies. This study presents a possible roadmap for study of interviewerrelated measurement error and an exploration of role-dependent behaviour of interviewers by assessing the LTH of SA through an epidemiological design. Data from the baseline assessment of the Netherlands Study of Depression and Anxiety (N = 2981) was used to illustrate the proposed roadmap to study interviewer effects. Results show: : (1) that it was possible to identify the existence of interviewer effects in assessing a LTH of SA; (2) that interviewer effects occurred by probing and clarification activities of the interviewer but not with inadequate formulation of the original question and so give a possible explanation for these effects; and (3) that it was possible to study the impact of these effects on the association between a well-known risk factor and LTH of SA. Applying the Measurement Error framework for systematically examining errors in data collection on suicidality seems a promising method

Does the number of previous mood episodes moderate the relationship between alcohol use, smoking and mood in bipolar outpatients?

Abstract Background Evidence suggests that alcohol use and smoking are negatively associated with mood in bipolar disorders (BD). It is unknown if this relationship is moderated by the number of previous mood episodes. Therefore, this paper aims to examine whether the number of previous mood episodes moderates the relationship between alcohol use and smoking, and mood. Method This study assessed the outcomes of 108 outpatients with BD I and II in a prospective observational cohort study. For 1 year, subjects daily registered mood symptoms and substance use with the prospective Life Chart Method. The relationship between the average daily consumption of alcohol and tobacco units in the whole year and mood were examined by multiple linear regression analyses. Number of previous mood episodes, grouped into its quartiles, was added as effect moderator. Outcome was the number of depressive, hypomanic and manic days in that year. Results The number of depressive days in a year increased by 4% (adjusted β per unit tobacco = 1.040; 95% CI 1.003–1.079; p = 0.033) per unit increase in average daily tobacco consumption in that same year. Interaction analyses showed that in those subjects with less than 7 previous mood episodes, the number of manic and hypomanic days increased by 100.3% per unit increase in alcohol consumption (adjusted β per unit alcohol = 2.003; 95% CI 1.225–3.274; p = 0.006). In those with 7 to 13 previous mood episodes, the number of manic and hypomanic days decreased by 28.7% per unit increase in alcohol consumption (adjusted β per unit alcohol = 0.713; 95% CI 0.539–0.944; p = 0.019); and in subjects with 14 to 44 previous mood episodes, the number of manic and hypomanic days decreased by 7.2% per unit increase in tobacco consumption (adjusted β per unit tobacco = 0.928; 95% CI 0.871–0.989; p = 0.021). Conclusions The number of previous mood episodes moderates the relationship between alcohol use and smoking and mood; and smoking is adversely associated with the number of depressive days

Development and Validation of the ‘Self-Efficacy in Dealing with Self-Harm Questionnaire’ (SEDSHQ)

Clinicians find it challenging to engage with patients who engage in self-harm. Improving the self-efficacy of professionals who treat self-harm patients may be an important step toward accomplishing better treatment of self-harm. However, there is no instrument available that assesses the self-efficacy of clinicians dealing with self-harm. The aim of this study is to describe the development and validation of the Self-Efficacy in Dealing with Self-Harm Questionnaire (SEDSHQ). This study tests the questionnaire’s feasibility, test-retest reliability, internal consistency, content validity, construct validity (factor analysis and convergent validity) and sensitivity to change. The Self-Efficacy in Dealing with Self-Harm Questionnaire is a 27-item instrument which has a 3-factor structure, as found in confirmatory factor analysis. Testing revealed high content validity, significant correlation with a subscale of the Attitude Towards Deliberate Self-Harm Questionnaire (ADSHQ), satisfactory test-retest correlation and a Cronbach’s alpha of 0.95. Additionally, the questionnaire was able to measure significant changes after an intervention took place, indicating sensitivity to change. We conclude that the present study indicates that the Self-Efficacy in Dealing with Self-Harm Questionnaire is a valid and reliable instrument for assessing the level of self-efficacy in response to self-harm

Why uptake of blended internet-based interventions for depression is challenging:A qualitative study on therapists’ perspectives

(1) Background: Blended cognitive behavioral therapy (bCBT; online and face-to-face sessions) seems a promising alternative alongside regular face-to-face CBT depression treatment in specialized mental health care organizations. Therapists are key in the uptake of bCBT. This study focuses on therapists’ perspectives on usability, satisfaction, and factors that promote or hinder the use of bCBT in routine practice; (2) Methods: Three focus groups (n = 8, n = 7, n = 6) and semi-structured in-depth interviews (n = 15) were held throughout the Netherlands. Beforehand, the participating therapists (n = 36) completed online questionnaires on usability and satisfaction. Interviews were analyzed by thematic analysis; (3) Results: Therapists found the usability sufficient and were generally satisfied with providing bCBT. The thematic analysis showed three main themes on promoting and hindering factors: (1) therapists’ needs regarding bCBT uptake, (2) therapists’ role in motivating patients for bCBT, and (3) therapists’ experiences with bCBT; (4) Conclusions: Overall, therapists were positive; bCBT can be offered by all CBT-trained therapists and future higher uptake is expected. Especially the pre-set structure of bCBT was found beneficial for both therapists and patients. Nevertheless, therapists did not experience promised time-savings—rather, the opposite. Besides, there are still teething problems and therapeutic shortcomings that need improvement in order to motivate therapists to use bCBT