Stepped, evidence-based and integrated care service model vs. usual care for mental disorders: A randomized controlled trial (RECOVER).

Stepped, evidence-based and integrated care service models have the potential to be used as a reference for mental health services. RECOVER aimed to evaluate cost savings, effectiveness, and cost-effectiveness of such a model within a two arm, assessor- and data analysist-blinded RCT in Hamburg, Germany. Participants aged 16-79 years with mental disorders were randomly assigned either to RECOVER or treatment as usual (TAU). Primary outcomes comprised costs, effectiveness (combined symptoms, functioning, quality of life), and cost-effectiveness, hierarchically ordered. Outcomes were evaluated according to the ITT principle, group differences regarding costs with adjusted generalized linear models, effectiveness with ANCOVA models, and cost-effectiveness with the incremental cost-effectiveness ratio (ICER) and cost-effectiveness acceptability curves (CEACs). Between 1/1/2018 and 12/31/2020, n = 891 were finally included (n = 477 in RECOVER, n = 444 in TAU). RECOVER was associated with significantly lower annual total costs (-22 %), health and social care costs (-25 %) and hospital costs (-50 %). Effectiveness analyses showed a significantly better outcome for RECOVER with the fully imputed data . The CEACs descriptively demonstrated that RECOVER was cost-effective with a probability of >95 %. Treatment in RECOVER resulted in substantial cost reductions with better cost-effectiveness. RECOVER can be recommended as a reference model for comprehensive and integrated mental health services.

Prevention of First-Episode Psychosis in People at Clinical High Risk: A Randomized Controlled, Multicentre Trial Comparing Cognitive-Behavioral Therapy and Clinical Management Plus Low-Dose Aripiprazole or Placebo (PREVENT).

BACKGROUND: There is limited knowledge of whether cognitive-behavioral therapy (CBT) or second-generation antipsychotics (SGAs) should be recommended as the first-line treatment in individuals at clinical high risk for psychosis (CHRp). HYPOTHESIS: To examine whether individual treatment arms are superior to placebo and whether CBT is non-inferior to SGAs in preventing psychosis over 12 months of treatment. STUDY DESIGN: PREVENT was a blinded, 3-armed, randomized controlled trial comparing CBT to clinical management plus aripiprazole (CM + ARI) or plus placebo (CM + PLC) at 11 CHRp services. The primary outcome was transition to psychosis at 12 months. Analyses were by intention-to-treat. STUDY RESULTS: Two hundred eighty CHRp individuals were randomized: 129 in CBT, 96 in CM + ARI, and 55 in CM + PLC. In week 52, 21 patients in CBT, 19 in CM + ARI, and 7 in CM + PLC had transitioned to psychosis, with no significant differences between treatment arms (P = .342). Psychopathology and psychosocial functioning levels improved in all treatment arms, with no significant differences. CONCLUSIONS: The analysis of the primary outcome transition to psychosis at 12 months and secondary outcomes symptoms and functioning did not demonstrate significant advantages of the active treatments over placebo. The conclusion is that within this trial, neither low-dose aripiprazole nor CBT offered additional benefits over clinical management and placebo.

In the eyes of the beholders: Subjective experiences of positive symptoms among patients with symptoms of psychosis seeking psychotherapy.

BACKGROUND: Reduction of positive symptoms is often the focus of psychiatric treatment for patients with psychosis; however, it is becoming increasingly clear that some patients experience ambivalence towards positive symptoms or may even experience them as pleasant. The present study extends upon work from online studies of patients without verified diagnoses. The first aim was to examine the frequency with which patients report negative, neutral or even positive appraisals of positive symptoms. A second aim was to identify whether these appraisals were associated with medication adherence. METHODS: One-hundred twelve treatment-seeking patients with current symptoms of psychosis completed the Subjective Perception of Positive Symptoms-Revised (SUPPOSY-R), a scale assessing appraisals of positive symptoms (e.g., gain from illness, impact on daily life), as well as questions regarding medication adherence. RESULTS: Although most patients reported experiencing positive symptoms as predominantly unpleasant, appraisals differed between symptom clusters and up to 54.4 % reported that they would miss at least some aspects of positive symptoms should they disappear. Patients particularly welcomed the disappearance of auditory hallucinations (71.2 %). Symptom appraisal was not significantly associated with medication compliance (p > .17); however, more patients with low medication adherence reported they would feel at least some regret if their symptoms were to completely disappear (48.9 %, n = 23) versus patients with high adherence (41.7 %, n = 20). DISCUSSION: Ambivalent or positive appraisals of positive symptoms are lower among treatment-seeking patients compared to patients recruited for online studies, who may not be actively seeking treatment. Auditory hallucinations may cause most distress among treatment-seeking patients. A collaborative approach including assessment of possible positive appraisals of symptoms is important when identifying treatment goals.

Excess costs of mental disorders by level of severity.

INTRODUCTION: Mental disorders are highly prevalent in Germany, and associated with decreased quality of life for those affected as well as high economic burden for the society. The purpose of this study was to determine the excess costs of mental disorders and to examine how these differ with respect to disease severity. METHODS: We analyzed mean 6-month costs using the baseline data from the RECOVER trial in Hamburg, Germany, which evaluates an innovative stepped-care model for mental disorders. Four severity levels were classified based on the current level of mental illness, loss of functioning, and psychiatric diagnosis. In this work, direct costs (outpatient, inpatient, and social/informal care) and indirect costs (sick leave, unemployment, and early retirement) were estimated using interview-based data on health care utilization and productivity losses. Excess costs were determined by matching a comparison group of the German general population without mental disorders. Group differences in sociodemographic covariates and somatic comorbidities were balanced using entropy balancing. Excess costs by severity levels were estimated using generalized linear models (GLM) with gamma distribution and log-link function. RESULTS: Overall, the RECOVER group included n = 816 and the comparison group included n = 3226 individuals. Mean total 6-month excess costs amounted to 19,075€, with higher indirect excess costs (13,331€) than direct excess costs (5744€) in total excess costs. The excess costs increased with increasing disease severity, ranging from 6,123€ with mild disease severity (level 1) to 31,883€ with severe mental illness (level 4). Indirect excess costs ranged from 5612€ in level 1 to 21,399€ in level 4, and were statistically significant for all disease severity levels. In contrast, direct excess costs were only statistically significant for the levels 2 to 4, and ranged from 511€ in level 1 to 10,485€ in level 4. The main cost drivers were hospital stays (level 2-4), sick leave and unemployment (all levels), and early retirement (level 3-4). DISCUSSION: Mental disorders are associated with high costs that increase with the level of disease severity, which was also shown for individual ICD-10 diagnosis groups. Due to their influence on costs, indirect costs and disease severity levels should be considered in future cost-of-illness studies of mental disorders. CLINICAL TRIAL REGISTRATION: clinicaltrials.gov, trial registration number NCT03459664.

Psychometric evaluation of the German version of the Recovering Quality of Life (ReQoL) measures in patients with affective disorders.

BACKGROUND: The generic self-reported Recovering Quality of Life (ReQoL) measures were developed for measuring recovery-focused health-related quality of life (HrQoL) in persons with mental health conditions. The aim of this study was to assess the psychometric properties of the German version of the ReQoL measures in patients with affective disorders in Germany. METHODS: Data from a patient sub-sample in a randomized controlled trial have been used (N = 393). The internal consistency and the test-retest reliability of the ReQoL measures were assessed using Cronbach's Alpha and the intra-class correlation coefficient (ICC). The concurrent validity and the known-group validity of the ReQoL measures were assessed using Pearson's Correlation coefficient and Cohen's d. The responsiveness was assessed using Glass' Δ and the standardized response mean (SRM). RESULTS: The reliability among the items of the ReQoL-20 was overall excellent. The ICC of the ReQoL-20 was r = 0.70, indicating moderate test-retest reliability. The concurrent validity of the ReQoL-20 with the clinical measure PHQ-9 was strong with a correlation coefficient of r = - 0.76. The known-group validity of the ReQoL-20 using PHQ-9 cut-off points was large with an effect size of d = 1.63. The ReQoL measures were sensitive to treatment response and remission of symptoms measured by the PHQ-9 with large effect sizes/SRM. DISCUSSION: The psychometric properties of the ReQoL measures for the assessment of patients with affective disorders were overall good. With the ReQoL, valid and reliable measures for the assessment of recovery-focused HrQoL for persons with affective disorders are available in German language.

Validation of the Recovering Quality of Life (ReQoL) questionnaires for patients with anxiety, obsessive-compulsive, stress-related, somatoform and personality disorders in Germany.

The health-related quality of life (HrQoL) and the recovery process of persons with mental health conditions can be assessed with the Recovering Quality of Life questionnaires (ReQoL-20 and ReQoL-10). The aim of this study was to assess the psychometric properties of the German version of the ReQoL measures in patients with anxiety, obsessive-compulsive, stress-related, and somatoform disorders and in patients with disorders of adult personality and behavior. This study was based on a sub-sample of patients that were included in a randomized controlled trial evaluating an evidence-based, stepped and coordinated care service model for mental disorders (RECOVER). The internal consistency was assessed using Cronbach's Alpha and the test-retest reliability was assessed by the intra-class correlation coefficient (ICC). Concurrent validity was assessed by Pearson's Correlation Coefficient and the known-group validity was assessed using the Cohen's d. The internal consistency of the ReQoL-20 and ReQoL-10 was excellent and good with Cronbach's alpha of α = 0.91 and α = 0.83 for all items. The test-retest reliability of the ReQoL measures was moderate with ICC of r = 0.72 to 0.74. The concurrent validity of the ReQoL measures with the Global Severity Index was overall high with a correlation coefficient of r = -0.70. In conclusion, for patients with anxiety, obsessive-compulsive, stress-related, somatoform and personality disorders, the German version of the ReQoL measures is valid and reliable for the assessment of HrQoL and the recovery process.

Remission with or without comorbid substance use disorders in early psychosis: long-term outcome in integrated care (ACCESS III study).

Introduction: Schizophrenia-Spectrum-Disorders are associated with poor long-term outcome as well as disability and often severely affect the lives of patients and their families often from symptom onset. Up to 70% of first episode psychosis (FEP) patients suffer from comorbid substance use disorders (SUD). We aimed at studying the course of illness in FEP patients within evidence-based care, with and without comorbid SUD, to examine how decreased, remitted or persistent substance use impacted rates of a combined symptomatic and functional long-term recovery compared with patients without SUD. Methods: ACCESS III is an integrated care model for FEP or patients in the early phase of non-affective and affective psychotic disorders. Treatment trajectories of patients, who had been in ACCESS care for 1 year, with and without SUD were compared with regard to the course of illness and quality of life using Mixed Model Repeated Measures (MMRM) and recovery rates were compared using binary logistic regression. Change in substance use was coded as either persistent, decreased/remitted or no use. Results: ACCESS III was a prospective 1-year study (N = 120) in patients aged 12-29 years. Of these, 74 (61.6%) had a comorbid SUD at admission. There were no group differences regarding the course of illness between patients with or without comorbid SUD or between patients with a substance abuse or substance dependence. The only outcome parameter that was affected by SUD was quality of life, with larger improvement found in the group without substance use (p = 0.05) compared to persistent and remitted users. Using LOCF, 44 patients (48.9%) fulfilled recovery criteria at the endpoint; recovery did not differ based on substance use status. Discussion: SUD and especially substance dependence are common in psychotic disorders even in FEP patients. Evidence-based integrated care led to long-term improvement in patients with comorbid SUD and rate of recovery did not differ for patients with substance use.

Service users' perceptions of relevant and helpful components of an integrated care concept (ACCESS) for psychosis.

Introduction: Psychotic disorders have a significant impact on patients' lives and their families, and long-term treatment with individually tailored multimodal combinations of therapies is often required. Integrated care (IC) concepts such as the "Hamburg Model (ACCESS)" with a focus on psychotic disorders, includes different (therapeutic) components with pharmaco- and psychotherapy, family involvement, home treatment and the option of using a 24/7 crisis hotline. All components are offered by a therapeutically-oriented assertive community treatment (TACT) team in a need-adapted manner. So far, however, little is known about which specific components are regarded as especially relevant and helpful by the users of IC. Methods: Patients currently participating in IC completed a questionnaire as part of the continuous quality assurance study (ACCESS II) in which they were asked to rate the different components of treatment according to their relevance and helpfulness, considering the individual's unique experiences with IC and needs in mental health care. Furthermore, they were asked to make suggestions regarding additional helpful components of treatment. Results: Fifty patients participated in this survey (23% of the patients currently participating in the IC concept). For participants, the most helpful and important factors were having the same therapist in the long-term and the 24/7 crisis telephone. Additional components suggested by patients included more addiction-specific therapies and increased focus on vocational rehabilitation and integration. Conclusion: From the perspective of the users of IC, long-term care from a trusted therapist with whom there is a therapeutic relationship and the possibility to reach someone they already know from the TACT team 24/7 serves as the best basis for effective care, fostering trust, understanding, and open communication. In contrast, home treatment remains a relevant aspect of evidence-based care for people with severe mental illness, but perhaps surprisingly, is not viewed as the most important issue.

Mediators of quality of life change in people with severe psychotic disorders treated in integrated care: ACCESS II study.

BACKGROUND: Patients with severe psychotic disorders exhibit a severely reduced quality of life (QoL) at all stages of the disease. Integrated care often led to an improvement in QoL. However, the specific mediators of QoL change are not yet well understood. METHODS: The ACCESS II study is a prospective, long-term study investigating the effectiveness of an integrated care program for people with severe psychotic disorders (IC-TACT) that includes Therapeutic Assertive Community Treatment within a care network of in- and outpatient services at the University Medical Center Hamburg-Eppendorf, Germany. We examined longitudinal associations between QoL and the hypothesized mediators of change (i.e., negative symptoms, depression, and anxiety), using cross-lagged panel models. RESULTS: The sample includes 418 severely ill patients treated in IC-TACT for at least 1 year. QoL increased, whereas symptom severity decreased significantly from baseline to 6-month follow-up (p-values ≤ 0.001), and remained stable until 12-month follow-up. QoL and symptom severity demonstrated significant auto-correlated effects and significant cross-lagged effects from QoL at baseline to negative symptoms (6 months, ß = -0.20, p < 0.001) to QoL (12 months, ß = -0.19, p < 0.01) resulting in a significant indirect, mediated effect. Additionally, negative symptoms after 6 months had a significant effect on the severity of depression after 12 months (ß = 0.13, p < 0.05). CONCLUSIONS: Negative symptoms appear to represent an important mechanism of change in IC-TACT indicating that improvement of QoL could potentially be achieved through optimized intervention on negative symptoms. Moreover, this may lead to a reduction in the severity of depression after 12 months.

[Mental Diseases in Adolescence - Approaches of Treatment and Clinical Insights]. / Psychische Erkrankungen in der Adoleszenz ­ Behandlungsansätze und klinische Erfahrungen.

Adolescents and young adults with mental illness have an increased risk of long-term unfavourable development and show high clinical severity and multiple psychosocial needs at an early age. In this context, several specific transitional psychiatric treatment services have been developed during the last years. The experience gained so far in adolescent psychiatry shows that a close interdisciplinary cooperation of child and adolescent psychiatry and adult psychiatry is necessary to address interface problems with the aim of a successful transition, as well as to prevent the development of severe and chronicmental illnesses. At the same time, there are many structural and content-related challenges that need to be integrated and addressed. In this review, different treatment models are presented and the requirements for successful transition psychiatry are discussed in the context of the existing evidence.

Health-related quality of life in severe psychotic disorders during integrated care: 5-year course, prediction and treatment implications (ACCESS II).

PURPOSE: Studies on outcomes mapping Quality of Life (QoL) as patient-reported outcome over a longer period in severe psychotic disorders are scarce. However, such data would be particularly important for structuring, implementing and operating effective and efficient care models and for promoting satisfaction with care, service engagement and adherence. METHODS: The ACCESS II study is a prospective long-term study of an integrated care model for people with severe psychotic disorders. The model includes Therapeutic Assertive Community Treatment within a cross-sectoral and interdisciplinary network. This publication analyses the course of QoL assessed with the Q-LES-Q-18 using a mixed model for repeated measures. RESULTS: Mapping the course of QoL in N = 329 participants, there is a significant increase in the first 6 weeks of treatment (early course). Comparison to a published norm show significant lower QoL for severe psychotic disorders. The variable having a traumatic event before the age of 18 was significantly negatively associated with QoL. A decrease in the severity of depressive as well as in positive symptomatology in the first six weeks after admission was associated with increase of QoL. CONCLUSION: Results indicate that the overall symptom burden at time of inclusion is not decisive for the perceived QoL in the long-term course while the reduction in the severity of depressive and positive symptoms is important. This means focusing even more on the treatment of depressive symptoms and include traumatherapeutic aspects in the long-term treatment of severe psychotic disorders if needed. TRAIL REGISTRATION: ClinicalTrials.gov (identifier: NCT01888627).

Study protocol of a randomized controlled trial evaluating home treatment with peer support for acute mental health crises (HoPe).

BACKGROUND: Home treatment (HT) is a treatment modality for patients with severe mental illness (SMI) in acute mental crises. It is frequently considered equivalent to psychiatric inpatient treatment in terms of treatment outcome. Peer Support (PS) means that people with lived experience of a mental illness are trained to support others on their way towards recovery. While PS is growing in international importance and despite a growing number of studies supporting its benefits, it is still not comprehensively implemented into routine care. The HoPe (Home Treatment with Peer Support) study investigates a combination of both - HT and PS - to provide further evidence for a recovery-oriented treatment of psychiatric patients. METHODS: In our randomized controlled trial (RCT), HT with PS is compared with HT without PS within a network of eight psychiatric clinical centers from the North, South and East of Germany. We investigate the effects of a combination of both approaches with respect to the prevention of relapse/recurrence defined as first hospitalization after randomization (primary outcome), disease severity, general functioning, self-efficacy, psychosocial health, stigma resistance, recovery support, and service satisfaction (secondary outcomes). A sample of 286 patients will be assessed at baseline after admission to HT care (data point t0) and randomized into the intervention (HT + PS) and control arm (HT). Follow-Up assessments will be conducted 2, 6 and 12 months after admission (resulting in three further data points, t1 to t3) and will be analyzed via intention-to-treat approach. DISCUSSION: This study may determine the positive effects of PS added to HT, prove additional evidence for the efficacy of PS and thereby facilitate its further implementation into psychiatric settings. The aim is to improve quality of mental health care and patients' recovery as well as to reduce the risk of relapses and hospitalizations for patients with SMI. TRIAL REGISTRATION: The trial is registered with ClinicalTrials.gov: NCT04336527 , April 7, 2020.

[Characteristics of psychoses in adolescence-Longitudinal data of integrated care]. / Charakteristika von Psychosen in der Adoleszenz ­ longitudinale Daten der Integrierten Versorgung.

BACKGROUND: Integrated care according to the Hamburg model combines therapeutic assertive community treatment (TACT) with initiatives for early detection and early treatment of schizophrenia and affective psychoses. The aim of this study was to identify the clinical characteristics of adolescents in comparison to adult patients and to derive knowledge for transition-specific treatment approaches. METHODOLOGY: Sociodemographic and clinical variables as well as treatment performance and clinical outcome were investigated over a period of 12 months in 167 patients with psychoses (16-25 years, n = 88; and >25 years, n = 79). RESULTS: Patients with psychosis in adolescence had significantly more outpatient treatment contacts (3.5/week vs. 1.6/week; p < 0.001), while adults were hospitalized for twice as long (10 days vs. 21 days; p = 0.003). The duration of untreated psychoses was significantly shorter in the adolescent group than in adults (122 weeks vs. 208 weeks; p = 0.002). The proportion of comorbid mental disorders was significantly higher in the adolescent group (87% vs. 63%; p < 0.001). In addition, the adolescence patients already showed greater impairment of daily functions and a higher severity of illness at the start of treatment. DISCUSSION: The treatment of psychoses in adolescence was characterized by a particularly high need for flexibility across all sectors and support systems, taking comorbid problem areas into account. Care models for adolescents and young adults with psychoses should therefore combine treatment approaches for severely ill patients with transition psychiatric interventions to avoid breaks in care and to meet the complex requirements of young patients with severe mental illnesses.

Treatment Approaches for First Episode and Early-Phase Schizophrenia in Adolescents and Young Adults: A Delphi Consensus Report from Europe.

PURPOSE: Although first-episode psychosis (FEP) in youth, particularly early-onset schizophrenia (EOS), is managed similarly to adult-onset schizophrenia, few antipsychotics are approved for people aged 13-18 years. We aimed to explore areas of uncertainty in EOS management and provide evidence-based recommendations to mental health specialists. We used the Delphi methodology to gain knowledge in areas lacking evidence-based strategies. This standardized methodology consists of the development of a questionnaire by content experts, which is then submitted to a broader panel of professionals (panelists) to survey their level of agreement on the topics proposed. MATERIALS AND METHODS: The developed questionnaire covered patient management from diagnosis to maintenance treatment and was administered to a broader panel of specialists across Europe. Based on an analysis of responses received in this first round, the items that needed further insight were submitted to the panel for a second round and then reanalysed. RESULTS: An initial set of 90 items was developed; in round I, consensus was reached for 83/90 items (92%), while it was reached for 7/11 (64%) of the items sent out for rerating in round II. Feedback for rounds I and II was obtained from 54/92 and 48/54 approached experts, respectively. There was broad agreement on diagnostic standards, multimodal approaches and focus on adverse events, but uncertainty in terms of pharmacological strategies (including clozapine) in case of failure and antipsychotic dosing in younger patients. CONCLUSION: Despite knowledge about diagnostic clues and integrated management of EOS, this study highlights the lack of standardization in treating EOS, with safety arguments having a major role in the decision-making process. Targeted clinical trials and systematic dissemination across Europe of current scientific evidence on the value of early intervention services is hoped to contribute to standardized and improved quality care for patients with early-phase psychosis and schizophrenia.

Anomalous self-experiences (ASE) in relation to clinical high risk for psychosis (CHRP), childhood trauma and general psychopathology among adolescent and young adult help seekers.

BACKGROUND: Anomalous self-experiences (ASE) are suggested as a phenotypic core feature of schizophrenia spectrum disorders and present in at risk samples as well. In our study, we investigated the relation between ASE and clinical high risk state for psychosis (CHRP) against the background of further influencing factors like childhood trauma and general psychopathology. METHODS: 126 help-seeking adolescents were included. CHR-P patients were identified using the Structured Interview for Psychosis-Risk Syndromes (SIPS). ASE were assessed with the Inventory of Psychotic-like Anomalous Self-Experiences (IPASE). Childhood trauma, depression and anxiety were assessed with well-established questionnaires (CTQ; PHQ-9; GAD-7). RESULTS: CHR-P subgroup (n = 50, 39.7%) show significantly higher scores in IPASE total (t (81.07) = -5.150, p = .000) and CTQ total (t (85.95) = -2.75, p = .007) in comparison with the non CHR-P subgroup. Logistic regression analysis confirmed that IPASE total could predict CHR-P status (OR 1.03, 95% CI 1.01-1.04, p = .000). Furthermore, CTQ total and IPASE total show moderate to strong positive correlation (r = 0.44, p < .001) as well as CTQ total with both IPASE subdomains Cognition (r = 0.404, p < .001) and Self- Awareness (r = 0.443, p < .001). CONCLUSION: The CHR-P subgroup shows significantly more ASE than the non CHR-P subgroup. Further, ASE predicted CHR-P status. Our results indicated that ASE could play a considerable role in the identification of high risk for developing schizophrenia spectrum disorder and could complement CHR-P testing. Importantly, it seems that ASE may be related to exposure to childhood trauma.