[Influence of guideline recommendations, care structures and individual factors on the use of psychosocial therapies in severely mentally ill people]. / Einfluss von Leitlinienempfehlungen, Versorgungsstrukturen und individuellen Faktoren auf die Inanspruchnahme von psychosozialen Therapien bei schwer psychisch kranken Menschen.

OBJECTIVE: The influence of guideline recommendations and other factors on the utilization of psychosocial interventions in people with severe mental illness was examined. METHODS: Data from a cross-sectional study of 397 people with severe mental illness were analysed descriptively. RESULTS: Patients are less likely to receive therapies with a strong recommendation compared to other levels of recommendation. Various other factors are diffusely associated with utilization rates, but no ubiquitous predictors could be identified across all therapies. CONCLUSION: Current practice in the use of psychosocial interventions does not follow guideline recommendation strength. Interventions with strong recommendations are probably not available across services. Consequently, routine practice is not able to follow guideline recommendations according to their strength. Other consistent predictors could not be identified.

[Patient Preferences for Exercise Therapy in People with Severe Mental Illness in Germany]. / Der subjektive Stellenwert von Bewegungs- und Sporttherapie bei Menschen mit schwerer psychischer Erkrankung in Deutschland.

PURPOSE: Assessing the experience with and the attitudes towards exercise therapy in persons with severe mental illness (SMI). Furthermore, potential variables of high preference towards exercise therapy are investigated. METHODS: Cross-sectional observational study of SMI patients aged between 18 and 65 years (n=385). Patients were interviewed by trained staff using standardised instruments. Potential variables were analysed using a hierarchic binary logistic regression model. RESULTS: 84,4% of SMI patients had a high preference for exercise therapy; of these, 44,1% exercised regularly. Among patients with severe mental illness especially a higher value in the GAF-assessment (p=0,041) and living in a metropolitan area (p=0,011) predict a high preference for exercise therapy. CONCLUSION: Most of the patients with severe mental illness interviewed in this study place a surprisingly high value on sports and exercise therapy. Due to the increasing evidence with regard to positive effects of these therapies, it may be an excellent starting point to expand sports and exercise therapy as part of a comprehensive treatment plan. At the same time, strategies for everyday transfer need to be implemented more rigorously.

The role of migration in mental healthcare: treatment satisfaction and utilization.

Migration rates increase globally and require an adaption of national mental health services to the needs of persons with migration background. Therefore, we aimed to identify differences between persons with and without migratory background regarding (1) treatment satisfaction, (2) needed and received mental healthcare and (3) utilization of mental healthcare.In the context of a cross-sectional multicenter study, inpatients and day hospital patients of psychiatric settings in Southern Germany with severe affective and non-affective psychoses were included. Patients' satisfaction with and their use of mental healthcare services were assessed by VSSS-54 and CSSRI-EU; patients' needs were measured via CAN-EU.In total, 387 participants (migratory background: n = 72; 19%) provided sufficient responses for analyses. Migrant patients were more satisfied with the overall treatment in the past year compared to non-migrant patients. No differences between both groups were identified in met and unmet treatment needs and use of supply services (psychiatric, psychotherapeutic, and psychosocial treatment).Despite a comparable degree of met and unmet treatment needs and mental health service use among migrants and non-migrants, patients with migration background showed higher overall treatment satisfaction compared to non-migrants. The role of sociocultural and migrant-related factors may explain our findings.

Predictors of competitive employment in individuals with severe mental illness: results from an observational, cross-sectional study in Germany.

BACKGROUND: Employment is of great importance as it is associated with various positive effects. Individuals with severe mental illness (SMI) are often excluded from competitive employment. Current data on employment of individuals with mental illness are rare, and influencing factors are under-researched. The present study examines possible predictors of competitive employment among individuals with SMI. METHODS: This was a cross-sectional and multicentered study of 300 individuals with SMI aged 18 to 65 years. The following inclusion criteria were used: (I) diagnosis of schizophrenia, schizotypal and delusional disorders (ICD-10 F2x), or affective disorders (ICD-10 F3x), (II) duration of psychiatric illness ≥ 2 years, and (III) substantial impact of illness on social functioning. Participants were interviewed by trained staff using standardised instruments. The relationship between potential predictors (age, sex, education, marital status, living situation, migration background, psychosocial functioning, age at first mental problem, physical illness, work ability) and employment was analysed using a hierarchic binary logistic regression model. RESULTS: Only one-third (34%) of participants were competitively employed. Almost one-third were unemployed (30%), and 28% reported early retirement due to mental illness. Psychosocial functioning was positively associated with competitive employment (OR = 1.09, 95% CI: 1.05 - 1.13, p < 0.001); concurrent chronic physical illness was negatively associated with competitive employment (OR = 0.38, 95% CI: 0.21 - 0.71, p = 0.002). CONCLUSIONS: Findings confirm a high risk of exclusion from competitive employment among individuals with SMI. Nonetheless, a substantial proportion of individuals are employed. Findings call for efforts to maintain or enhance workforce participation among individuals with SMI. A special focus should be placed on improving physical health and strengthening psychosocial functioning. TRIAL REGISTRATION: The study was registered in the German Clinical Trials Register (DRKS) under the registration number DRKS00015801 before the start of recruitment (Registration date: 21.02.2019).

[Peer Support: Utilization and Benefit in Severe Mental Illness - Results from an Observational, Cross-Sectional Study]. / Genesungsbegleitung: Inanspruchnahme und Nutzenbewertung aus Betroffenenperspektive ­ Ergebnisse einer Beobachtungsstudie.

OBJECTIVE: Peer support is playing an increasing role in the treatment of severely mentally ill people. International findings are available on its effectiveness. However, little is known about knowledge, use and benefit assessment in Germany. This paper addresses this question and presents results from an observational study with 10 participating clinics in southern Germany. METHODS: As part of the observational cross-sectional study with people with severe mental illness (IMPPETUS, N=359), sociodemographic and illness- and treatment-associated data were collected by trained study staff between March 2019 and September 2019. Binary logistic regression was used to analyse a possible association with peer support use. RESULTS: 38% (N=138) of respondents reported knowledge about the possibility of peer support; 15% (N=55) affirmed its use. Use of peer support varied across sites (between 6.5 and 37.5%) and was associated with household income. Significantly less frequent use of peer support was among those with high versus low household income (OR=0.20 [95% CI: 0.06-0.68], p=0.01). Of respondents with peer support use (N=55), 78% reported perceiving peer support to be helpful or highly helpful. DISCUSSION: Peer support not only proves to be effective under study conditions with regard to various outcomes, but is also assessed as beneficial under routine conditions in a defined care region by the majority of users. However, only a few respondents knew and used the possibility of peer support. CONCLUSION: In order to implement peer support more strongly, information about this kind of service should be provided more effectively and a dialogue about successful implementation experiences should be initiated on a regional level.

Employment status and desire for work in severe mental illness: results from an observational, cross-sectional study.

PURPOSE: People with a severe mental illness (SMI) are at particular risk of occupational exclusion. Among the approaches to occupational rehabilitation, supported employment (SE) has been proven to be the most effective. A requirement to enter SE-programs is that individuals must want to seek competitive employment. The aim of this work is to investigate the relationship between serious mental illness and the desire to work including potential predictors. METHODS: This is a cross-sectional observational study of patients with SMI aged 18-65 years (n = 397). Patients were interviewed by trained staff using standardised instruments. The relationship between potential predictors and a strong preference for employment were analysed using a hierarchic binary logistic regression model. RESULTS: Only about one-quarter (27.9%) of SMI patients is in competitive employment. Another quarter is unemployed (25.9%). Results show that the desire for competitive employment is strong among more than half of the SMI patients. Among the unemployed, two-thirds express a strong desire for work. These individuals are an ideal target group for SE interventions. Comorbid chronic physical illness, diagnosis, and the subjectively judged ability to work are associated with the desire for work. CONCLUSION: Our data confirm a substantial exclusion of individuals with SMI from the workforce. In general, care needs for workplace interventions are not being met and leave much room for improvement. In addition to employment status, the desire for work should be routinely assessed. STUDY REGISTRATION: The study was registered in the German Clinical Trials Register (DRKS) ( https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00015801 ) and under the WHO-Platform "International Clinical Trials Registry Platform" (ICTRP) ( https://apps.who.int/trialsearch/Trial2.aspx?TrialID=DRKS00015801 ) under the registration number DRKS00015801 before the start of recruitment (Registration date: 21.02.2019).

Systematic evaluation of the 'efficacy-effectiveness gap' in the treatment of depression with venlafaxine and duloxetine.

OBJECTIVE: Evidence of larger drug effects in highly standardized studies (efficacy) compared to clinical routine (effectiveness) is discussed as efficacy-effectiveness gap. This study aimed to quantify effect size differences of RCTs and non-RCTs in the treatment of depression with venlafaxine and duloxetine and to identify effect modifying predictors. METHODS: A comprehensive systematic review and meta-analysis was conducted, including all prospective trials, which evaluated the treatment effects of duloxetine or venlafaxine in patients with depression. The primary outcome was the pre-post effect size after acute therapy, which were compared between RCTs and non-RCTs. Moreover, an exploratory analysis of predictors in a mixed meta-regression model within an information-theoretic approach was performed. RESULTS: 171 RCTs and 74 non-RCTs were included. The pre-post effect size differed significantly between RCTs and non-RCTs (-3.04 vs. -2.62, Δ = 0.41, p = 0.012, high heterogeneity). Study characteristics were very similar between RCTs and non-RCTs. Most important variables to predict effect sizes were 'depression severity', 'dose' and 'number of participants'. CONCLUSION: Despite differences in effect sizes between RCTs and non-RCTs, study design is not clearly an important predictor for the effect sizes. Our results question the common assumption that non-RCTs are generally better suited to describe a drug's effectiveness in clinical practice than RCTs. Future studies and their reporting should put more emphasis on the description of external validity, in order to allow better assessments of clinical relevance.

Implementation of the patient version of the evidence-based (S3) guideline for psychosocial interventions for patients with severe mental illness (IMPPETUS): study protocol for a cluster randomised controlled trial.

BACKGROUND: The German guideline on psychosocial interventions for people with severe mental disorders recommends a broad spectrum of evidence-based treatments. Structured implementation of the associated patient version of the guideline is missing to date. The study aims to assess whether structured implementation of a patient guideline improves the empowerment of patients with severe mental disorders, as well as knowledge, attitudes and experiences regarding psychosocial interventions, service use, treatment satisfaction, treatment needs, quality of life and burden of care. METHODS: The study is a multicentre, cluster-randomised, controlled study with two parallel groups. Inpatients and day hospital patients (all sexes; 18-65 years) with severe mental disorders will be included. Additionally, relatives of patients with mental disorders (all sexes; ≥ 18 years) will be included. In the experimental group, the patient guideline will be implemented using a multimodal strategy. Participants in the control group will receive treatment as usual but will be made aware of the patient guideline. The primary outcome is the change of empowerment, assessed by using the 'empowerment in the process of psychiatric treatment of patients with affective and schizophrenia disorders' (EPAS) scale. In addition, knowledge, attitudes and experiences regarding psychosocial interventions will be assessed as secondary outcomes, as well as service use, satisfaction with care, patient need and quality of life and participation and social inclusion. For relatives, the perceived burden of care also will be recorded. Results will be analysed using hierarchical linear models. For the health economic evaluation, the incremental cost-utility ratios will be computed using the differences in total costs of illness and the differences in quality-adjusted life years (QALY) between study groups. DISCUSSION: The study will be the first to assess the effects of a structured implementation of the patient version of a psychiatric treatment guideline. The study has some limitations regarding the transferability of the results to other patients and other regions. Furthermore, problems with the recruitment of patients and relatives and with the implementation of intervention could occur during the study. TRIAL REGISTRATION: The study is registered in the German Clinical Trials Register (DRKS) and the WHO International Clinical Trials Registry Platform (ICTRP) under registration number DRKS00017577 (Date of registration: 23 October 2019.

Benzodiazepines versus placebo for panic disorder in adults.

BACKGROUND: Panic disorder is characterised by recurrent unexpected panic attacks consisting of a wave of intense fear that reaches a peak within a few minutes. Panic disorder is a common disorder, with an estimated lifetime prevalence of 1% to 5% in the general population and a 7% to 10% prevalence in primary care settings. Its aetiology is not fully understood and is probably heterogeneous.Panic disorder is treated with psychological and pharmacological interventions, often used in combination. Although benzodiazepines are frequently used in the treatment of panic disorder, guidelines recommend antidepressants, mainly selective serotonin reuptake inhibitors (SSRIs), as first-line treatment for panic disorder, particularly due to their lower incidence of dependence and withdrawal reaction when compared to benzodiazepines. Despite these recommendations, benzodiazepines are widely used in the treatment of panic disorder, probably because of their rapid onset of action. OBJECTIVES: To assess the efficacy and acceptability of benzodiazepines versus placebo in the treatment of panic disorder with or without agoraphobia in adults. SEARCH METHODS: We searched the Cochrane Common Mental Disorders Controlled Trials Register (CCMDCTR Studies and References), the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (1950-), Embase (1974-), and PsycINFO (1967-) up to 29 May 2018. We handsearched reference lists of relevant papers and previous systematic reviews. We contacted experts in the field for supplemental data. SELECTION CRITERIA: All double-blind (blinding of patients and personnel) controlled trials randomising adults with panic disorder with or without agoraphobia to benzodiazepine or placebo. DATA COLLECTION AND ANALYSIS: Two review authors independently checked the eligibility of studies and extracted data using a standardised form. Data were then entered data into Review Manager 5 using a double-check procedure. Information extracted included study characteristics, participant characteristics, intervention details, settings, and outcome measures in terms of efficacy, acceptability, and tolerability. MAIN RESULTS: We included 24 studies in the review with a total of 4233 participants, of which 2124 were randomised to benzodiazepines and 1475 to placebo. The remaining 634 participants were randomised to other active treatments in three-arm trials. We assessed the overall methodological quality of the included studies as poor. We rated all studies as at unclear risk of bias in at least three domains. In addition, we judged 20 of the 24 included studies as having a high risk of bias in at least one domain.Two primary outcomes of efficacy and acceptability showed a possible advantage of benzodiazepines over placebo. The estimated risk ratio (RR) for a response to treatment was 1.65 (95% confidence interval (CI) 1.39 to 1.96) in favour of benzodiazepines, which corresponds to an estimated number needed to treat for an additional beneficial outcome (NNTB) of 4 (95% CI 3 to 7). The dropout rate was lower among participants treated with benzodiazepines (RR 0.50, 95% CI 0.39 to 0.64); the estimated NNTB was 6 (95% CI 5 to 9). We rated the quality of the evidence as low for both primary outcomes. The possible advantage of benzodiazepine was also seen for remission (RR 1.61, 95% CI 1.38 to 1.88) and the endpoint data for social functioning (standardised mean difference (SMD) -0.53, 95% CI -0.65 to -0.42), both with low-quality evidence. We assessed the evidence for the other secondary outcomes as of very low quality. With the exception of the analyses of the change score data for depression (SMD -0.22, 95% CI -0.48 to 0.04) and social functioning (SMD -0.32, 95% CI -0.88 to 0.24), all secondary outcome analyses showed an effect in favour of benzodiazepines compared to placebo. However, the number of dropouts due to adverse effects was higher with benzodiazepines than with placebo (RR 1.58, 95% CI 1.16 to 2.15; low-quality evidence). Furthermore, our analyses of adverse events showed that a higher proportion of participants experienced at least one adverse effect when treated with benzodiazepines (RR 1.18, 95% CI 1.02 to 1.37; low-quality evidence). AUTHORS' CONCLUSIONS: Low-quality evidence shows a possible superiority of benzodiazepine over placebo in the short-term treatment of panic disorders. The validity of the included studies is questionable due to possible unmasking of allocated treatments, high dropout rates, and probable publication bias. Moreover, the included studies were only short-term studies and did not examine the long-term efficacy nor the risks of dependency and withdrawal symptoms. Due to these limitations, our results regarding the efficacy of benzodiazepines versus placebo provide only limited guidance for clinical practice. Furthermore, the clinician's choice is not between benzodiazepines and placebo, but between benzodiazepines and other agents, notably SSRIs, both in terms of efficacy and adverse effects. The choice of treatment should therefore be guided by the patient's preference and should balance benefits and harms from treatment in a long-term perspective.

Vortioxetine for depression in adults.

BACKGROUND: Major depressive disorder is a common mental disorder affecting a person's mind, behaviour and body. It is expressed as a variety of symptoms and is associated with substantial impairment. Despite a range of pharmacological and non-pharmacological treatment options, there is still room for improvement of the pharmacological treatment of depression in terms of efficacy and tolerability. The latest available antidepressant is vortioxetine. It is assumed that vortioxetine's antidepressant action is related to a direct modulation of serotonergic receptor activity and inhibition of the serotonin transporter. The mechanism of action is not fully understood, but it is claimed to be novel. Vortioxetine was placed in the category of "Other" antidepressants and may therefore provide an alternative to existing antidepressant drugs. OBJECTIVES: To assess the efficacy and acceptability of vortioxetine compared with placebo and other antidepressant drugs in the treatment of acute depression in adults. SEARCH METHODS: We searched Cochrane's Depression, Anxiety and Neurosis Review Group's Specialised Register to May 2016 without applying any restrictions to date, language or publication status. We checked reference lists of relevant studies and reviews, regulatory agency reports and trial databases. SELECTION CRITERIA: We included randomised controlled trials comparing the efficacy, tolerability, or both of vortioxetine versus placebo or any other antidepressant agent in the treatment of acute depression in adults. DATA COLLECTION AND ANALYSIS: Two review authors independently selected the studies and extracted data. We extracted data on study characteristics, participant characteristics, intervention details and outcome measures in terms of efficacy, acceptability and tolerability. We analysed intention-to-treat (ITT) data only and used risk ratios (RR) as effect sizes for dichotomous data and mean differences (MD) for continuous data with 95% confidence intervals (CI). Meta-analyses used random-effects models. MAIN RESULTS: We included 15 studies (7746 participants) in this review. Seven studies were placebo controlled; eight studies compared vortioxetine to serotonin-norepinephrine reuptake inhibitors (SNRIs). We were unable to identify any study that compared vortioxetine to antidepressant drugs from other classes, such as selective serotonin reuptake inhibitors (SSRIs).Vortioxetine may be more effective than placebo across the three efficacy outcomes: response (Mantel-Haenszel RR 1.35, 95% CI 1.22 to 1.49; 14 studies, 6220 participants), remission (RR 1.32, 95% CI 1.15 to 1.53; 14 studies, 6220 participants) and depressive symptoms measured using the Montgomery-Åsberg Depression Scale (MADRS) (score range: 0 to 34; higher score means worse outcome: MD -2.94, 95% CI -4.07 to -1.80; 14 studies, 5566 participants). The quality of the evidence was low for response and remission and very low for depressive symptoms. We found no evidence of a difference in total dropout rates (RR 1.05, 95% CI 0.93 to 1.19; 14 studies, 6220 participants). More participants discontinued vortioxetine than placebo because of adverse effects (RR 1.41, 95% CI 1.09 to 1.81; 14 studies, 6220 participants) but fewer discontinued due to inefficacy (RR 0.56, 95% CI 0.34 to 0.90, P = 0.02; 14 studies, 6220 participants). The quality of the evidence for dropouts was moderate.The subgroup and sensitivity analyses did not reveal factors that significantly influenced the results.In comparison with other antidepressants, very low-quality evidence from eight studies showed no clinically significant difference between vortioxetine and SNRIs as a class for response (RR 0.91, 95% CI 0.82 to 1.00; 3159 participants) or remission (RR 0.89, 95% CI 0.77 to 1.03; 3155 participants). There was a small difference favouring SNRIs for depressive symptom scores on the MADRS (MD 1.52, 95% CI 0.50 to 2.53; 8 studies, 2807 participants). Very low quality evidence from eight studies (3159 participants) showed no significant differences between vortioxetine and the SNRIs as a class for total dropout rates (RR 0.89, 95% CI 0.73 to 1.08), dropouts due to adverse events (RR 0.74, 95% CI 0.51 to 1.08) and dropouts due to inefficacy (RR 1.52, 95% CI 0.70 to 3.30).Against individual antidepressants, analyses suggested that vortioxetine may be less effective than duloxetine in terms of response rates (RR 0.86, 95% CI 0.79 to 0.94; 6 studies, 2392 participants) and depressive symptoms scores on the MADRS scale (MD 1.99, 95% CI 1.15 to 2.83; 6 studies; 2106 participants). Against venlafaxine, meta-analysis of two studies found no statistically significant differences (response: RR 1.03, 95% CI 0.85 to 1.25; 767 participants; depressive symptom scores: MD 0.02, 95% CI -2.49 to 2.54; 701 participants). In terms of number of participants reporting at least one adverse effect (tolerability), vortioxetine was better than the SNRIs as a class (RR 0.90, 95% CI 0.86 to 0.94; 8 studies, 3134 participants) and duloxetine (RR 0.89, 95% CI 0.84 to 0.95; 6 studies; 2376 participants). However, the sensitivity analysis casts some doubts on this result, as only two studies used comparable dosing.We judged none of the studies to have a high risk of bias for any domain, but we rated all studies to have an unclear risk of bias of selective reporting and other biases. AUTHORS' CONCLUSIONS: The place of vortioxetine in the treatment of acute depression is unclear. Our analyses showed vortioxetine may be more effective than placebo in terms of response, remission and depressive symptoms, but the clinical relevance of these effects is uncertain. Furthermore, the quality of evidence to support these findings was generally low. In comparison to SNRIs, we found no advantage for vortioxetine. Vortioxetine was less effective than duloxetine, but fewer people reported adverse effects when treated with vortioxetine compared to duloxetine. However, these findings are uncertain and not well supported by evidence. A major limitation of the current evidence is the lack of comparisons with the SSRIs, which are usually recommended as first-line treatments for acute depression. Studies with direct comparisons to SSRIs are needed to address this gap and may be supplemented by network meta-analyses to define the role of vortioxetine in the treatment of depression.

Effect of antioxidant vitamins on the plasma homocysteine level in a free-living elderly population.

BACKGROUND: The factors influencing total plasma homocysteine levels (tHcy) are of special interest in the attempt to reduce cardiovascular risk. AIM: This investigation aimed to assess the independent effects of antioxidant vitamins on tHcy in elderly people. METHODS: Our cross-sectional analysis included data of 184 subjects (≥60 years) from the longitudinal study in an aging population in Giessen (GISELA), Germany. We examined the effects of plasma levels, intake and supplementation of vitamin C, vitamin E, and ß-carotene on tHcy. RESULTS: The mean tHcy was within the normal range in this population. Serum folate, the estimated glomerular filtration rate (eGFR), and plasma vitamin C showed a negative association with tHcy in simple regression analysis. In a subsequent multiple regression analysis, eGFR, serum folate, and plasma vitamin C were the relevant independent predictors of tHcy. Intake and supplementation of vitamin C, as well as plasma levels, intake and supplementation of vitamin E, and ß-carotene were not associated with tHcy. CONCLUSION: Vitamin C may be an independent predictor of tHcy in free-living elderly people and, therefore, should be considered in attempts to reduce tHcy.