Reductions in inpatient and outpatient mental health care in germany during the first year of the COVID-19 pandemic - What can we learn for a better crisis preparedness?

BACKGROUND: During the COVID-19 pandemic, reports from several European mental health care systems hinted at important changes in utilization. So far, no study examined changes in utilization in the German mental health care inpatient and outpatient mental health care system comprehensively. METHODS: This longitudinal observational study used claims data from two major German statutory health insurances, AOK PLUS and BKK, covering 162,905 inpatients and 2,131,186 outpatients with mental disorders nationwide. We analyzed changes in inpatient and outpatient mental health service utilization over the course of the first two lockdown phases (LDPs) of the pandemic in 2020 compared to a pre-COVID-19 reference period dating from March 2019 to February 2020 using a time series forecast model. RESULTS: We observed significant decreases in the number of inpatient hospital admissions by 24-28% compared to the reference period. Day clinic admissions were even further reduced by 44-61%. Length of stay was significantly decreased for day clinic care but not for inpatient care. In the outpatient sector, the data showed a significant reduction in the number of incident outpatient diagnoses. CONCLUSION: Indirect evidence regarding the consequences of the reductions in both the inpatient and outpatient sector of care described in this study is ambiguous and direct evidence on treatment outcomes and quality of trans-sectoral mental healthcare is sparse. In line with WHO and OECD we propose a comprehensive mental health system surveillance to prepare for a better oversight and thereby a better resilience during future global major disruptions.

Outpatient mental health care during high incidence phases of the COVID-19 pandemic in Germany - changes in utilization, challenges and post-COVID care.

BACKGROUND: As only a few studies have examined the impact of the COVID-19 pandemic on the mental health outpatient system so far, the aim of the COVID Ψ Outpatient Survey was to gain insight from outpatient providers in Germany regarding changes in utilization; associated problems and challenges; telemedicine services; interactions with inpatient and nursing home services; and experiences with post-COVID syndromes. METHODS: Between July and September 2021, we invited 351 randomly selected outpatient mental health specialists to take part in the online survey via e-mail. Additionally, we extended an invitation to professional associations to encourage their members to participate. N = 105 physicians of most regions of Germany took part in the survey. RESULTS: Survey participants reported changes in utilization during the high incidence phases (HIP) of the pandemic using pre-formulated categories: For the first HIP in spring 2020, 31% of the survey participants reported a decrease > 20% and 5% an increase > 20% of patient contacts. For the third HIP in spring 2021, 4% reported a decrease > 20% of contacts, while 30% an increase > 20%. Participants chose "patient's fears of infection" and "providers protection measures" as reasons for decreases, and "pandemic related anxieties", "economic stressors", and "capacity reductions of the inpatient system" as reasons for increases of patient contact. Many providers introduced telemedicine services. A majority reported consultations for post-COVID syndromes already in spring 2021. CONCLUSIONS: The survey hinted at changes in utilization, multiple problems but as well good-practice-solutions in the mental health outpatient system during the COVID-19 pandemic.

[COVID-19 vaccination for people with severe mental diseases : Results of the COVID Ψ outpatient survey and recommendations for psychiatry]. / COVID-19-Impfung für Menschen mit schweren psychischen Erkrankungen : Ergebnisse des COVID-Ψ-Ambulant-Surveys und Empfehlungen für die Psychiatrie.

BACKGROUND: Severe mental illnesses are risk factors for SARS-CoV-2-related morbidity and mortality. Vaccination is an effective protection; therefore, high vaccination rates should be a major priority for people with mental illnesses. OBJECTIVES: (1) Identification of at-risk groups for non-vaccination and structures and interventions needed for widespread vaccination among people with mental illnesses from the perspective of outpatient psychiatrists and neurologists, (2) discussion of the results in the context of the international literature and (3) recommendations derived from them. MATERIAL AND METHODS: Qualitative content analysis of COVID-19 vaccination-related questions from the COVID Ψ online survey of n = 85 psychiatrists and neurologists in Germany. RESULTS: In the survey, people with schizophrenia, severe lack of drive, low socioeconomic status and homelessness were seen as risk groups for non-vaccination. Increased and targeted information, education, addressing and motivation and easily accessible vaccination offers by general practitioners, psychiatrists, and neurologists as well as complementary institutions were considered as important interventions. DISCUSSION: COVID-19 vaccinations as well as information, motivation and access support should be systematically offered by as many institutions of the psychiatric, psychotherapeutic and complementary care systems in Germany as possible.

COVID-19 vaccination rates in hospitalized mentally ill patients compared to the general population in Germany: Results from the COVID Ψ Vac study.

BACKGROUND: Mental illness is known to come along with a large mortality gap compared to thegeneral population and it is a risk for COVID-19 related morbidity andmortality. Achieving high vaccination rates in people with mental illness is therefore important. Reports are conflicting on whether vaccination rates comparable to those of the general population can be achieved and which variables represent risk factors for nonvaccination in people with mental illness. METHODS: The COVID Ψ Vac study collected routine data on vaccination status, diagnostic groups, sociodemographics, and setting characteristics from in- and day-clinic patients of 10 psychiatric hospitals in Germany in August 2021. Logistic regression modeling was used to determine risk factors for nonvaccination. RESULTS: Complete vaccination rates were 59% (n = 776) for the hospitalized patients with mental illness versus 64% for the regionally and age-matched general population. Partial vaccination rates were 68% (n = 893) for the hospitalised patients with mental illness versus 67% for the respective general population and six percentage (n = 74) of this hospitalized population were vaccinated during the hospital stay. Rates showed a large variation between hospital sites. An ICD-10 group F1, F2, or F4 main diagnosis, younger age, and coercive accommodation were further risk factors for nonvaccination in the model. CONCLUSIONS: Vaccination rates were lower in hospitalized people with mental illness than in the general population. By targeting at-risk groups with low-threshold vaccination programs in all health institutions they get in contact with, vaccination rates comparable to those in the general population can be achieved.

Changes and Challenges in Inpatient Mental Health Care During the First Two High Incidence Phases of the COVID-19 Pandemic in Germany - Results From the COVID Ψ Psychiatry Survey.

Psychiatric inpatient treatment, an important pillar of mental health care, is often of longer duration in Germany than in other countries. The COVID-19 pandemic called for infection prevention and control measures and thereby led to shifts in demand and inpatient capacities. The Germany-wide COVID Ψ Psychiatry Survey surveyed department heads of German psychiatric inpatient institutions. It assessed changes in utilization during the first two high incidence phases of the pandemic (spring 2020 and winter 2020/21) and also consequences for care, telemedicine experiences, hygiene measures, treatment of patients with mental illness and co-occuring SARS-CoV-2, and coercive measures in such patients. A total of n = 71 psychiatric departments (of 346 contacted) participated in the survey. The results showed a median decrease of inpatient treatment to 80% of 2019 levels and of day hospital treatment to 50% (first phase) and 70% (second phase). Reductions were mainly due to decreases in elective admissions, and emergency admissions remained unchanged or increased in 87% of departments. Utilization was reduced for affective, anxiety, personality, and addiction disorders but appeared roughly unaffected for psychotic disorders. A lack of integration of patients into their living environment, disease exacerbations, loss of contact, and suicide attempts were reported as problems resulting from reduced capacities and insufficient outpatient treatment alternatives. Almost all departments (96%) treated patients with severe mental illness and co-occurring SARS-CoV-2 infection. The majority established special wards and separate areas for (potentially) infectious patients. Telephone and video consultations were found to provide benefits in affective and anxiety disorders. Involuntary admissions of persons without mental illness because of infection protection law violations were reported by 6% of the hospitals. The survey showed high adaptability of psychiatric departments, which managed large capacity shifts and introduced new services for infectious patients, which include telemedicine services. However, the pandemic exacerbated some of the shortcomings of the German mental health system: Avoidable complications resulted from the lack of cooperation and integrated care sequences between in- and outpatient sectors and limited options for psychiatric hospitals to provide outpatient services. Preventive approaches to handle comparable pandemic situations in the future should focus on addressing these shortcomings.

Challenges in the Transition from In-Patient to Out-Patient Treatment in Depression.

BACKGROUND: Few data are available on the characteristics of inpatient treatment and subsequent outpatient treatment for depression in Germany. In this study, we aimed to characterize the inpatient and outpatient treatment phases, to determine the rates of readmission and mortality, and to identify risk factors. METHODS: We carried out a descriptive statistical analysis of routine administrative data from a large health-insurance carrier (BARMER). All insurees aged 18 to 65 who were treated in 2015 as inpatients on a psychiatry and psychotherapy service or on a psychosomatic medicine and psychotherapy service with a main diagnosis of depression were included in the analysis. Risk factors for readmission and death were determined with the aid of mixed logistic regression. RESULTS: Of the 22 893 patients whose data were analyzed, 78% had been hospitalized on a psychiatry and psychotherapy service and 22% on a psychosomatic medicine and psychotherapy service. The median length of hospital stay was 42 days. Follow-up care in the outpatient setting failed to conform with the recommendations of the pertinent guidelines in 92% of the patients with a main diagnosis of severe depression during hospitalization, and in 50% of those with moderate depression. 21% of the patients were readmitted within a year. The mortality at one year was 961 per 100 000 individuals (adjusted for the age and sex structure of the German population), or 3.4 times the mortality of the population at large. In the regression model, more treatment units during hospitalization and subsequent treatment with psychotherapy were associated with a lower probability of readmission, while longer hospitalization with subsequent pharmacotherapy or psychotherapy was associated with lower mortality. CONCLUSION: The recommendations of the national (German) S3 guidelines for the further care of patients who have been hospitalized for depression are inadequately implemented at present in the sectored structures of in- and outpatient care in the German health care system. This patient group has marked excess mortality.

Prevalence, symptomatology, risk factors and healthcare services utilization regarding paternal depression in Germany: study protocol of a controlled cross-sectional epidemiological study.

BACKGROUND: While postpartum depression is a well-researched disorder in mothers, there is growing evidence indicating that some fathers also develop depressive symptoms (paternal postpartum depression, PPD). A recent meta-analysis revealed a total prevalence of paternal depression during pregnancy and up to one year postpartum of 8.4%, with significant heterogeneity observed among prevalence rates. International studies suggest that PPD is characterized by additional symptoms compared to maternal postpartum depression. Furthermore, various risk factors of PPD have been identified. However, the prevalence, symptomatology, risk factors and healthcare situation of fathers affected by PPD in Germany are unknown. METHODS/DESIGN: This study comprises a controlled, cross-sectional epidemiological survey administered via postal questionnaires. The primary objective is to compare the prevalence of depressive symptoms in fathers with a 0-12-month-old infant to the prevalence of depressive symptoms in men without recent paternity. Two structurally differing regions (concerning birthrate, employment status, socioeconomic structure, and nationality of inhabitants) will be included. A random sample of 4600 fathers (2300 in each region) in the postpartum period and 4600 men without recent paternity matched by age, nationality and marital status will be assessed regarding depressive symptoms using the PHQ-9. Contact data will be extracted from residents' registration offices. As secondary objectives, the study aims to provide insights into symptoms and risk factors of PPD in fathers and to assess the current healthcare situation of fathers with PPD in Germany. In an add-on study, genetic and epigenetic mechanisms of PPD will be explored. DISCUSSION: This study will conduct the first direct comparison between fathers in the postpartum period of one year after childbirth and a matched sample of men without a newborn child. Besides closing this research gap, the findings will provide prevalence estimates as well as insights into specific symptomatology, risk factors, and the current healthcare situation regarding fathers with PPD in Germany. The results will identify low-threshold approaches as a relevant issue for healthcare. Moreover, the findings should inform the development of PPD-specific screening instruments and healthcare offers addressing fathers with PPD. TRIAL REGISTRATION: German Clinical Trials Register (DRKS): DRKS00013339 ; Trial registration date: August 20, 2018; Universal Trial Number (UTN): U1111-1218-8185.

Cost-effectiveness analysis of collaborative treatment of late-life depression in primary care (GermanIMPACT).

BACKGROUND: Late-life depression is a highly prevalent disorder that causes a large economic burden. A stepped collaborative care program was set up in order to improve care for patients with late-life depression in primary care in Germany: GermanIMPACT is the adaption of the Improving Mood-Promoting Access to Collaborative Treatment (IMPACT) program that has already been established in primary care in the USA. The aim of this study was to determine the cost-effectiveness of GermanIMPACT compared with treatment as usual from a societal perspective. METHODS: This study is part of a 12-month bi-centric cluster-randomized controlled trial aiming to assess the effectiveness of GermanIMPACT compared with treatment as usual among patients with late-life depression. A cost-effectiveness analysis using depression-free days (DFDs) was performed. Net-monetary benefit (NMB) regressions adjusted for baseline differences for different willingness-to-pay (WTP) thresholds were conducted and cost-effectiveness acceptability curves were constructed. RESULTS: In total, n = 246 patients (intervention group: n = 139; control group: n = 107) with a mean age of 71 from 71 primary care practices were included in the analysis. After 12 months, adjusted mean differences in costs and DFDs between intervention group and control group were +€354 and +21.4, respectively. Only the difference in DFDs was significant (p = 0.022). According to the unadjusted incremental cost-effectiveness ratio, GermanIMPACT was dominant compared with treatment as usual. The probability of GermanIMPACT being cost-effective was 80%, 90% or 95% if societal WTP per DFD was ≥€70, ≥€110 or ≥€180, respectively. CONCLUSION: Evidence for cost-effectiveness of GermanIMPACT relative to treatment as usual is not clear. Only if societal WTP was ≥€180 for an additional DFD, GermanIMPACT could be considered cost-effective with certainty.

Coordinated Treatment of Depression in Elderly People in Primary Care.

BACKGROUND: Depression in the elderly is mainly treated by primary care physicians; the treatment is often suboptimal because of the limited resources available in pri- mary care. New models of care in which treatment by a primary care physician is supplemented by the provision of brief, low-threshold interventions mediated by care managers are showing themselves to be a promising approach. METHODS: In this open, cluster-randomized, controlled study, we sought to determine the superiority of a model of this type over the usual form of treatment by a primary care physician. Patients in primary care aged 60 and above with moderate depres- sive manifestations (PHQ-9: 10-14 points) were included in the study. The primary endpoint was the percentage of patients in remission (score <5 on the Patient Health Questionnaire, PHQ-9) after the end of the intervention (12 months after baseline). The study was registered in the German Clinical Studies Registry (Deutsches Register für Klinische Studien) with the number DRKS00003589. RESULTS: 71 primary care physicians entered 248 patients in the study, of whom 109 were in the control group and 139 in the intervention group. In an intention-to-treat analysis, the remission rate at 12 months was 25.6% (95% confidence interval [18.3; 32.8]) in the intervention group and 10.9% [5.4; 16.5]) in the control group (p = 0.004). CONCLUSION: This study demonstrates the superiority of the new care model in the primary care setting in Germany, as has been found in other countries.

[Implementation of the GermanIMPACT collaborative care program: A qualitative study on the perspective of care managers and supervisors]. / Implementierbarkeit des GermanIMPACT Collaborative Care Programms zur Unterstützung der hausärztlichen Versorgung älterer depressiver Menschen - eine qualitative Interviewstudie.

BACKGROUND: Collaborative Care programs like the Improving Mood Promoting Access to Collaborative Care Program (IMPACT) present an opportunity to support primary care for elderly depressed patients. The GermanIMPACT study evaluates whether this low-threshold model using short behavioral interventions that are conducted by care managers and supervised by a psychotherapist/psychiatrist, is as effective as in other countries. Besides effectiveness, the feasibility of the intervention is also essential for the implementation of the program. METHOD: Care managers and supervisors were interviewed using a qualitative interview guide with questions concerning feasibility and effectiveness of the GermanIMPACT intervention, and the interviews were then evaluated using qualitative content analysis. RESULTS: The interviewees provided important information on how to optimize the realization of the intervention by selecting patients more carefully and by providing case managers with more training. Moreover, the intervention was described as being supportive of patients and as providing relief for general practitioners. Whereas interviewees wanted the intervention to be expanded to other disorders, they simultaneously highlighted the limits of the intervention. CONCLUSIONS: The present study provides practical information for implementing the GermanIMPACT model. Thus, specific recommendations for implementation into standard care can be derived.

Education and employment status of adults with autism spectrum disorders in Germany - a cross-sectional-survey.

BACKGROUND: Adults with autism spectrum disorders (ASD) experience challenges in participating in the labour market and struggle to achieve and maintain appropriate professional positions, possibly due to impairments of communication and social interaction. Studies have shown high rates of unemployment as well as evidence of inadequate employment. As knowledge on the participation in the German labour market is scarce, the aim of our study was to examine employment status, type of occupation and inadequate employment in a sample of clinically mostly late-diagnosed and most likely not intellectually disabled adults with ASD in Germany. METHODS: We conducted a cross-sectional-survey in clinically mostly late-diagnosed adults with ASD. Employment status, type of occupation, and the level of formal education and training were examined through a postal questionnaire. Inadequate employment regarding participants' current and longest practised occupation was assessed by transforming participants' information into skill levels of the "Classification of Occupations 2010" of the German Federal Employment Agency, and comparing these with participants' level of formal education and training. RESULTS: The response rate was 43.2% (N = 185 of N = 428 potential participants). 94.6% were first-time diagnosed when being 18 years of age or older. 56.8% held a general university entrance-level qualification and 24.9% had obtained a Masters' or diploma degree as their highest vocational qualification. 94.1% had been employed at some time. Of these, 68.4% reported being currently employed, 13.5% being currently unemployed and 17.0% being retired for health reasons. Regarding the longest-practised and the current occupation, the highest proportion of participants was found in the occupational area "health and social sector, teaching and education" (22.4% and 23.3%, respectively). With respect to inadequate employment, 22.1% were found to be overeducated in relation to their longest-practised occupation and 31.3% in relation to their current occupation. This is significantly higher than the percentage of overeducation in the general population. CONCLUSIONS: Despite largely high formal qualifications, the clinically mostly late-diagnosed adults with ASD represented in our sample are disadvantaged regarding their participation in the German labour market, especially with respect to rates of unemployment, early retirement and overeducation. Employment support programs should be developed to improve employment outcomes.

[Attendance for Using Internet-Based Support After Inpatient Treatment - A Cross-Sectional Survey]. / Bereitschaft zur Inanspruchnahme internetbasierter Unterstützung nach stationärer Behandlung ­ eine Querschnittstudie.

OBJECTIVE: Examination of the attendance for using internet-based measures after inpatient treatment. METHODS: Cross-sectional-survey in former inpatients (N = 247). RESULTS: 44.9 % are willing to use measures via videoconference, 34.7 % via Chat, 50.0 % via E-Mail and 38.0 % as onlinetherapy. Attendance is lower in older age groups. Benefits regarding the introduced measures are seen mainly in the flexibility and disadvantages in the impersonal character. CONCLUSIONS: A relevant share of especially younger patients is willing to use internet-based measures.

[On the Way to Culture-Sensitive Patient Information Materials: Results of a Focus Group Study]. / Auf dem Weg zu kultursensitiven Patienteninformationsmaterialien: Ergebnisse einer Fokusgruppenuntersuchung.

AIM: This study was part of a double-blind randomised controlled trial aimed to evaluate the effects of culture-sensitive patient information materials (PIM) compared with standard translated material. The study aimed to obtain the data for the development of culture sensitive PIM about unipolar depression for the 4 largest migrant groups in Germany (Turkish, Polish, Russian and Italian migration background). METHOD: A qualitative study using 4 manual-based focus groups (FG), one for each migrant group, with 29 participants (9 with a Turkish (TüG), 8 with a Polish (PoG), 5 with a Russian (RuG) and 7 with an Italian (ItG) migration background) was conducted. The discussions were recorded, transcribed and analyzed using qualitative content analysis. RESULTS: 7 categories were identified. For the (1.) development of a good culture-sensitive PIM an easy language, a clear structure, an assessable extent of information and the avoidance of stereotypes were highlighted cross-culturally in all four FG. RuG and PoG had the largest (2.) lack of information about the German health care system. Concerning the (3.) illness perception RuG named problems with recognizing and understanding depression. PoG, RuG and TüG thematized (4.) feared consequences of the illness and of professional helpseeking. ItG, PoG, RuG had fears concerning (5.) psychotropic drugs as a result from insufficient knowledge about medication. For (6.) doctor-patient relationship cultural specifics were identified in RuG and TüG and for (7.) migration or culture specific reasons for depression in RuG, ItG and TüG. CONCLUSION: Although the identified categories were relevant for all or for the majority of migrant groups, for most categories specific cultural aspects were discovered. These findings show the importance of a culture sensitive adaptation of PIM.

[What Determines Treatment Recommendations of Relatives: The Role of Expectations, Negative Consequences and Control Attributions for the Treatment of Patients with Psychosis]. / Was führt zu Behandlungsempfehlungen von Angehörigen: Die Rolle von Erfolgserwartung, negativen Folgen und Kontrollattributionen bei der Behandlung von Patienten mit Psychosen.

Objective Therapy recommendations of relatives of individuals with psychotic disorders. Method A total of n = 52 inpatient relatives were interviewed about their attitude towards psychotherapy and antipsychotics. Results Over 80 % of the relatives recommended psycho- and pharmacotherapy. Concerns reduced recommendations for pharmacotherapy, poor/lack of hope for improvement reduced recommendations for psychotherapy. Conclusion The relatives' therapy recommendations could be influenced by discussing their concerns and expectations of success.

Effects of culture-sensitive adaptation of patient information material on usefulness in migrants: a multicentre, blinded randomised controlled trial.

OBJECTIVES: To evaluate the usefulness of culture-sensitive patient information material compared with standard translated material. DESIGN: Multicentre, double-blind randomised controlled trial. SETTING: 37 primary care practices. PARTICIPANTS: 435 adult primary care patients with a migration background with unipolar depressive disorder or non-specific chronic low back pain were randomised. Patients who were unable to read in the language of their respective migration background were excluded. Sufficient data were obtained from 203 women and 106 men. The largest group was of Russian origin (202 patients), followed by those of Turkish (52), Polish (30) and Italian (25) origin. INTERVENTIONS: Intervention group: provision of culture-sensitive adapted material. CONTROL GROUP: provision of standard translated material. MAIN OUTCOME MEASURES: Primary outcome: patient-rated usefulness (USE) assessed immediately after patients received the material. SECONDARY OUTCOMES: patient-rated usefulness after 8 weeks and 6 months, symptoms of depression (PHQ-9), back pain (Back Pain Core Set) and quality of life (WHO-5) assessed at all time points. RESULTS: Usefulness was found to be significantly higher (t=1.708, one-sided p=0.04) in the intervention group (USE-score=65.08, SE=1.43), compared with the control group (61.43, SE=1.63), immediately after patients received the material, in the intention-to-treat analysis, with a mean difference of 3.65 (one-sided 95% lower confidence limit=0.13). No significant differences were found for usefulness at follow-up (p=0.16, p=0.71). No significant effect was found for symptom severity in depression (p=0.95, p=0.66, p=0.58), back pain (p=0.40, p=0.45, p=0.32) or quality of life (p=0.76, p=0.86, p=0.21), either immediately after receiving the material, or at follow-up (8 weeks; 6 months). Patients with a lower level of dominant society immersion benefited substantially and significantly more from the intervention than patients with a high level of immersion (p=0.005). CONCLUSION: Cultural adaptation of patient information material provides benefits over high quality translations. Clinicians are encouraged to use culture-sensitive material in their consultations, particularly with low-acculturated patients. TRIAL REGISTRATION NUMBER: German Register for Clinical Trials: DRKS00004241, Universal Trial Number: U1111-1135-8043, Results.

Comparative Safety of Pharmacologic Treatments for Persistent Depressive Disorder: A Systematic Review and Network Meta-Analysis.

We aimed to compare the safety of antidepressants for the treatment of persistent depressive disorder (PDD) with each other and with placebo. We conducted a systematic electronic search and included randomized controlled trials that investigated antidepressants for the treatment of PDD in adults. Outcomes were the incidence of experiencing any adverse event, specific adverse events and related treatment discontinuations. We analyzed the data using traditional and network meta-analyses. Thirty-four studies that comprised 4,769 patients and examined 20 individual agents in nine substance classes were included. Almost all analyzed substance classes were associated with higher discontinuation rates than placebo including tricyclic antidepressants (TCAs), selective serotonin reuptake inhibitors (SSRIs), monoamine oxidase inhibitors (MAOIs), antipsychotics, and the serotonin antagonist and reuptake inhibitor (SARI) trazodone. The odds of experiencing any adverse event were significantly higher for TCAs and serotonin noradrenaline reuptake inhibitors (SNRIs) compared to placebo. Pairwise comparisons among the substance classes revealed that more patients receiving TCAs or SNRIs experienced any adverse event and that more patients receiving TCAs or the SARI trazodone discontinued treatment. The complementary treatment with acetyl-l-carnitine showed lower rates of experiencing any adverse event and related discontinuations than all other comparators. TCAs were primarily associated with (anti-)cholinergic and sedating adverse events. SSRIs primarily showed gastrointestinal adverse events. Patients treated with the antipsychotic amisulpride were more likely to manifest weight gain and endocrine adverse events. The comparative evidence for further agents was insufficient or lacking. The identified safety differences may be used to inform the selection among the antidepressants.

Adverse event methods were heterogeneous and insufficiently reported in randomized trials on persistent depressive disorder.

OBJECTIVES: To investigate adverse event (AE) reporting practices in a systematic review of randomized controlled trials for persistent depressive disorder (PDD). STUDY DESIGN AND SETTING: A systematic electronic database search was conducted up to October 2014 to identify randomized controlled trials investigating pharmacologic, psychotherapeutic, and combined treatments for PDD in adults. We calculated the number and percentage of studies that reported predefined AE information. All calculations were carried out including all studies and stratified for study type (pharmacologic, psychotherapeutic, and mixed) and publication year [before and after the publication of the Consolidated Standards of Reporting Trials (CONSORT) extension for harms in 2004], respectively. RESULTS: Sixty studies, reported in 126 publications, were included. Across all studies, reporting of AE information was insufficient. Substantial differences between studies that investigated different treatments emerged. Most pharmacologic studies (39/42) and mixed studies (7/9) reported any AE information, although the amount of information varied and the reported methods to assess and analyze AEs were heterogeneous. We found no substantial change in reporting practices after the publication of the CONSORT extension. Psychotherapeutic studies, although almost entirely published after the CONSORT extension, largely neglected reporting of any AE information (1/9). CONCLUSIONS: There is a strong need to improve the current practice of assessing, analyzing, and reporting AEs, especially for psychotherapeutic studies.

Effectiveness of a brief psychoeducational group intervention for relatives on the course of disease in patients after inpatient depression treatment compared with treatment as usual--study protocol of a multisite randomised controlled trial.

BACKGROUND: Relapses and rehospitalisations are common after acute inpatient treatment in depressive disorders. Interventions for stabilising treatment outcomes are urgently needed. Psychoeducational group interventions for relatives were shown to be suitable for improving the course of disease in schizophrenia and bipolar disorders. A small Japanese monocentre randomised controlled trial also showed promising results for depressive disorders. However, the evidence regarding psychoeducation for relatives of patients with depressive disorders is unclear. METHODS/DESIGN: The study is conducted as a two-arm multisite randomised controlled trial to evaluate the incremental effect of a brief psychoeducational group intervention for relatives as a maintenance treatment on the course of disease compared to treatment as usual. Primary outcome is the estimated number of depression-free-days in patients within one year after discharge from inpatient treatment. 180 patients diagnosed with unipolar depressive disorders as well as one key relative per patient will be included during inpatient treatment and randomly allocated to the conditions at discharge. In the intervention group, relatives will participate in a brief psychoeducational group intervention following the patient's discharge. The intervention consists of four group sessions lasting 90 to 120 min each. Every group session contains informational parts as well as structured training in problem-solving. In both study conditions, patients will receive treatment as usual. Patients as well as relatives will be surveyed by means of questionnaires at discharge and three, six, nine and twelve months after discharge. In addition to the primary outcome, several patient-related and relative-related secondary outcomes will be considered and health economics will be investigated. DISCUSSION: Our study will provide evidence on the incremental effect of a brief psychoeducational intervention for relatives as a maintenance treatment after inpatient depression treatment. Positive results may have a major impact on health care for depression. TRIAL REGISTRATION: German Clinical Trials Register (DRKS): DRKS00006819; Trial registration date: 2014 Oktober 31; Universal Trial Number (UTN): U1111-1163-5391.