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1.
Psychiatr Prax ; 51(2): 92-98, 2024 Mar.
Artículo en Alemán | MEDLINE | ID: mdl-37944945

RESUMEN

AIM OF THE STUDY: Comparison of psychiatric services use in the 12-month follow-up period between Inpatient Equivalent Home Treatment (IEHT) and inpatient psychiatric treatment. METHODS: In a retrospective 12-month follow-up study, 223 patients from the Inpatient Equivalent Home Treatment (IEHT) intervention group (IG) were compared to a matched inpatient control group (CG) on their utilization of psychiatric services. RESULTS: The inpatient readmission rate in the IG was significantly 11% lower than in the CG. The number of treatment days in the IG was significantly lower than in the CG. In the IG, psychiatric services at the outpatient clinic were used significantly more often for the first time than in the CG. CONCLUSION: The present study suggests that IEHT is superior to inpatient treatment in terms of the risk of inpatient readmission and the duration of inpatient treatment days. An outpatient services use effect following IEHT is observed.


Asunto(s)
Pacientes Internos , Humanos , Estudios de Seguimiento , Estudios Retrospectivos , Estudios de Cohortes , Puntaje de Propensión , Alemania
2.
Psychiatr Prax ; 51(2): 104-109, 2024 Mar.
Artículo en Alemán | MEDLINE | ID: mdl-38159564

RESUMEN

The equality of mentally ill people with somatically ill people and the provision of community care were central topics of the Psychiatry-Enquête. With regard to medical rehabilitation services, this goal has not been implemented to date. The amendments to the Ninth Book of the Social Code (SGB IX) made by the Federal Participation Act (BTHG) again open up the possibility of making outreach medical rehabilitation services accessible to people with severe mental illnesses.


Asunto(s)
Trastornos Mentales , Pacientes Ambulatorios , Humanos , Alemania , Psicoterapia , Trastornos Mentales/rehabilitación
3.
Psychiatr Prax ; 2023 Nov 21.
Artículo en Alemán | MEDLINE | ID: mdl-37989203

RESUMEN

This part of the AKtiV Study focuses on treatment satisfaction of patients and their relatives within Inpatient Equivalent Home Treatment (IEHT) and regular treatment. Stress of relatives and job satisfaction and workload of employees in IEHT is also considered. Relevant Parameters were collected via established as well as newly adapted questionnaires at the end of treatment. Patients and relatives in IEHT are significantly more satisfied. The stress experienced by relatives is reduced in both forms of treatment. Employees in IEHT are generally very satisfied, although there is no correlation with the satisfaction of relatives and patients. Known limitations of satisfaction surveys must be taken into account. In general these results encourage the expansion and continuous development of this new form of treatment in Germany.

4.
Eur Psychiatry ; 66(1): e71, 2023 09 08.
Artículo en Inglés | MEDLINE | ID: mdl-37681407

RESUMEN

BACKGROUND: Inpatient equivalent home treatment (IEHT), implemented in Germany since 2018, is a specific form of home treatment. Between 2021 and 2022, IEHT was compared to inpatient psychiatric treatment in a 12-months follow-up quasi-experimental study with two propensity score matched cohorts in 10 psychiatric centers in Germany. This article reports results on the treatment during the acute episode and focuses on involvement in decision-making, patient satisfaction, and drop-out rates. METHODS: A total of 200 service users receiving IEHT were compared with 200 matched statistical "twins" in standard inpatient treatment. Premature termination of treatment as well as reasons for this was assessed using routine data and a questionnaire. In addition, we measured patient satisfaction with care with a specific scale. For the evaluation of patient involvement in treatment decisions, we used the 9-item Shared Decision Making Questionnaire (SDM-Q-9). RESULTS: Patients were comparable in both groups with regard to sociodemographic and clinical characteristics. Mean length-of-stay was 37 days for IEHT and 28 days for inpatient treatment. In both groups, a similar proportion of participants stopped treatment prematurely. At the end of the acute episode, patient involvement in decision-making (SDM-Q-9) as well as treatment satisfaction scores were significantly higher for IEHT patients compared to inpatients. CONCLUSIONS: Compared to inpatient care, IEHT treatment for acute psychiatric episodes was associated with higher treatment satisfaction and more involvement in clinical decisions.


Asunto(s)
Toma de Decisiones Conjunta , Pacientes Internos , Humanos , Pacientes Internos/psicología , Participación del Paciente , Satisfacción del Paciente , Satisfacción Personal , Toma de Decisiones
5.
Psychiatr Prax ; 50(8): 407-414, 2023 Nov.
Artículo en Alemán | MEDLINE | ID: mdl-37683674

RESUMEN

AIM: The quasi-experimental AKtiV study investigates the effects inpatient-equivalent home treatment (IEHT). This paper describes the study population based on demographic and clinical parameters at baseline and compares the index treatment. METHODS: Over a period of 12 months 200 IEHT users were included in the intervention group (IG) and 200 inpatients were included in the control group (CG). The comparability of the two groups was ensured by propensity score matching (PSM). RESULTS: In addition to the PSM variables, IG and CG did not differ significantly from each other variables at study inclusion. The duration of the index treatment was significantly longer in the IG (M=37.2 days) compared to the CG (M=27.9 days; p<0.001). CONCLUSION: The similarity of the two groups enables comparisons over 12 months, investigating IEHT effects on long-term outcomes.


Asunto(s)
Hospitalización , Pacientes Internos , Humanos , Resultado del Tratamiento , Alemania
6.
Front Psychiatry ; 14: 1089484, 2023.
Artículo en Inglés | MEDLINE | ID: mdl-36824670

RESUMEN

Introduction: The use of restraint as a means of managing patients is considered a critical factor that interferes with recovery. Strategies to create a less restrictive environment within psychiatric facilities are therefore eagerly sought. Peer support workers (PSWs) are increasingly employed in mental health settings. The prevailing theory is that PSWs have the potential to contribute to conflict and restraint prevention efforts in acute psychiatric wards. However, to date, research in support of this claim remains limited. Objective: The present study aimed at assessing the effectiveness of employing peer support workers with regard to reducing the use of restraint. Methods: This prospective controlled pre-post study sought to evaluate the implementation of peer support in one locked ward compared to treatment as usual (TAU) with no implementation of peer support in a second locked ward of a psychiatry department in Berlin, Germany. The pre-post comparison was planned to consist of two assessment periods of 3 months each, taking place directly before and after peer support implementation or TAU. Both assessments were extended to a period of 6 months, before and after the initially planned 12-month implementation process, in order to balance the effects of disruptions and of the COVID-19 pandemic. Using routine data, the proportion, frequency, and duration of mechanical restraint, forced medication as well as mechanical restraint in combination with forced medication, were evaluated. Results: In the control group, an increase in the proportion of patients subjected to measures of restraint was found between pre- and post-assessment, which was accompanied by a further increase in the mean number of events of restraint per patient within this group. In the intervention group, no significant change in the application of restraint was observed during the study period. Discussion: There is some indication that peer support may be protective with regard to restraint in acute wards. However, our study faced major challenges during the implementation process and the post-assessment period, such as COVID-19 and staff reorganization. This may have led to peer support not reaching its full potential. The relationship between the implementation of peer support and the use of restraint therefore merits further investigation.

7.
Psychiatr Prax ; 50(2): 98-102, 2023 Mar.
Artículo en Alemán | MEDLINE | ID: mdl-36455601

RESUMEN

OBJECTIVE: Evaluation of long-term effects of the implementation of the Safewards Model (SM) among staff and patients in acute psychiatry in Germany. METHOD: Assessment of ward atmosphere, job satisfaction, fidelity, and coercive interventions in 2 locked wards directly before and 15 months after implementation of the SM. RESULTS: Ward atmosphere was assessed significantly better after implementation, job satisfaction was still above-average at both times, coercive interventions declined significantly in one ward, fidelity and degree of implementation were still high. CONCLUSIONS: The implementing of the SM in locked wards in acute psychiatry can also have positive effects in long run.


Asunto(s)
Servicio de Psiquiatría en Hospital , Psiquiatría , Humanos , Estudios de Seguimiento , Alemania , Coerción
9.
Front Sociol ; 7: 805604, 2022.
Artículo en Inglés | MEDLINE | ID: mdl-35755483

RESUMEN

The perception of mental distress varies with time and culture, e.g., concerning its origin as either social or medical. This may be one reason for the moderate reliability of descriptive psychiatric diagnoses. Additionally, the mechanisms of action of most psychiatric treatments and psychotherapeutic interventions are generally unknown. Thus, these treatments have to be labeled as mostly unspecific even if they help in coping with mental distress. The psychiatric concept of mental disorders therefore has inherent limitations of precision and comprises rather fuzzy boundaries. Against this background, many people question the current process of diagnosing and categorizing mental illnesses. However, many scholars reject new approaches discussed in this context. They rather hold on to traditional diagnostic categories which therefore still play a central role in mental health practice and research and. In order to better understand the adherence to traditional psychiatric concepts, we take a closer look at one of the most widely adopted traditional concepts - the Stress-Vulnerability Model. This model has originally been introduced to tackle some problems of biological psychiatry. However, it has been misapplied with the result of drawing attention preferentially to biological vulnerability instead of a wider array of vulnerability factors including social adversity. Thus, in its current use, the Stress-Vulnerability Model provides only a vague theory for understanding mental phenomena. Therefore, we discuss the advantages and allegedly limited applicability of Crisis Theory as an alternative heuristic model for understanding the nature and development of mental distress. We outline the problems of this theory especially in applying it to severe mental disorders. We finally argue that an understanding of Crisis Theory supported by a systemic approach can be applied to most types of severe psychological disturbances implying that such an understanding may prevent or manage some negative aspects of the psychiatrization of psychosocial problems.

10.
PLoS One ; 17(4): e0266352, 2022.
Artículo en Inglés | MEDLINE | ID: mdl-35363806

RESUMEN

High utilizers (HU) are patients with an above-average use of psychiatric inpatient treatment. A precise characterization of this patient group is important when tailoring specific treatment approaches for them. While the current literature reports evidence of sociodemographic, and socio-clinical characteristics of HU, knowledge regarding their psychological characteristics is sparse. This study aimed to investigate the association between patients' psychological characteristics and their utilization of psychiatric inpatient treatment. Patients from the University Psychiatric Clinics (UPK) Basel diagnosed with schizophrenia spectrum or bipolar affective disorders participated in a survey at the end of their inpatient treatment stay. The survey included assessments of psychological characteristics such as quality of life, self-esteem, self-stigma, subjective experience and meaning of psychoses, insight into the disease, and patients' utilization of psychiatric inpatient treatment in the last 30 months. The outcome variables were two indicators of utilization of psychiatric inpatient treatment, viz. "utilization pattern" (defined as HU vs. Non-HU [NHU]) and "length of stay" (number of inpatient treatment days in the last 30 months). Statistical analyses included multiple regression models, the least absolute shrinkage and selection operator (lasso) method, and the random forest model. We included 112 inpatients, of which 50 were classified as HU and 62 as NHU. The low performance of all statistical models used after cross-validation suggests that none of the estimated psychological variables showed predictive accuracy and hence clinical relevance regarding these two outcomes. Results indicate no link between psychological characteristics and inpatient treatment utilization in patients diagnosed with schizophrenia spectrum or bipolar affective disorders. Thus, in this study, the examined psychological variables do not seem to play an important role in patients' use of psychiatric inpatient treatment; this highlights the need for additional research to further examine underlying mechanisms of high utilization of psychiatric inpatient treatment.


Asunto(s)
Pacientes Internos , Calidad de Vida , Estudios Transversales , Hospitalización , Humanos , Aprendizaje Automático
11.
Psychiatr Prax ; 49(4): 188-197, 2022 May.
Artículo en Alemán | MEDLINE | ID: mdl-34015850

RESUMEN

To get information about different ways inpatient equivalent treatment (IET) is implemented and organized eight specialized psychiatric hospitals and departments in Germany were asked to report on implementation details. OUTCOME: Organization and treatment processes depend on local conditions and existing structures. Legal barriers complicate the implementation process, however patients as well as team members report very positive experiences.Current data only give first hints but aren't sufficient to draw viable conclusions. Consequential issues will be picked up within the AKtiV-Study of the Innovationsfonds.


Asunto(s)
Hospitales Psiquiátricos , Pacientes Internos , Alemania , Hospitalización , Humanos , Encuestas y Cuestionarios
12.
Psychiatr Prax ; 49(8): 405-410, 2022 Nov.
Artículo en Alemán | MEDLINE | ID: mdl-34674201

RESUMEN

OBJECTIVE: Effectiveness of Inpatient Equivalent Home Treatment (IEHT) was examined in comparison to standard psychiatric inpatient treatment. IEHT is similar to the internationally known Home Treatment or Crisis Resolution Teams. It provides acute psychiatric treatment at the user's home, similar to inpatient hospital treatment in terms of content, flexibility, and complexity. METHODS: This retrospective matched control study used routine data of 86 patients (IEHT, n = 43, standard inpatient treatment n = 43). Readmission rates and cumulative hospital days were compared within a 12-month-follow-up time period. RESULTS: The readmission rate was lower and cumulative treatment days were longer after IETH. However, both group differences were not statistically significant. CONCLUSION: The present study indicates that IEHT is not inferior to standard inpatient treatment in terms of the risk of readmission.


Asunto(s)
Hospitalización , Pacientes Internos , Humanos , Estudios de Cohortes , Estudios Retrospectivos , Alemania , Readmisión del Paciente
13.
Nervenarzt ; 93(5): 488-498, 2022 May.
Artículo en Alemán | MEDLINE | ID: mdl-34114073

RESUMEN

BACKGROUND: Based on international randomized controlled trials (RCT) the German Association for Psychiatry, Psychotherapy and Psychosomatics (DGPPN) recommends acute treatment in the domestic environment (AHU) and intensive outreach treatment (IAB) with the highest level of evidence; however, due to large differences in national healthcare systems the transference of results from international studies to the healthcare systems in Germany, Austria and Switzerland could be limited. OBJECTIVE: Evaluation of studies on outreach psychiatric treatment forms in Germany, Austria and Switzerland and discussion of the results in the light of international evidence. MATERIAL AND METHODS: A systematic literature search for clinical trials on outreach community treatment from Germany, Austria and Switzerland was conducted in the PubMed database. RESULTS: A total of 19 publications were identified which could be assigned to 5 publications on 4 studies with 2857 patients on AHU and 14 publications on 10 studies with 3207 patients on IAB. The studies on AHU showed this treatment form to be superior regarding the duration of inpatient stay and healthcare costs. The studies on IAB showed more positive outcomes in comparison to controls regarding symptoms, severity of illness, substance abuse, functioning level, remission, satisfaction with treatment, quality of life, healthcare costs, work and housing situations. CONCLUSION: The studies from Germany, Austria, and Switzerland suggest that outreach community treatment is superior regarding several outcome parameters. Thus, there are no indications suggesting that international evidence could not be valid for these countries. Additionally, with one RCT for AHU and one for IAB the requirements for an evidence level of 1b for outreach community treatment in the healthcare systems in question are fulfilled.


Asunto(s)
Trastornos Mentales , Austria , Alemania , Humanos , Trastornos Mentales/diagnóstico , Trastornos Mentales/epidemiología , Trastornos Mentales/terapia , Calidad de Vida , Suiza
14.
Nervenarzt ; 93(5): 450-458, 2022 May.
Artículo en Alemán | MEDLINE | ID: mdl-34905064

RESUMEN

OBJECTIVE: To investigate whether implementation recommendations derived from the German guidelines "Prevention of coercion" can be implemented on acute psychiatric wards by means of implementation consultants into ward work and if this contributes to an increased level of adherence to guideline intervention recommendations approved by the DGPPN (Deutsche Gesellschaft für Psychiatrie und Psychotherapie, Psychosomatik und Nervenheilkunde)? MATERIAL AND METHODS: Two medical or nursing experts advised ward teams on the implementation of three individually selected recommendations from the guidelines in a structured consulting process over 6 months. The degree of implementation of the recommendations was assessed before and after the intervention by the ward teams together with the implementation consultants using a tool developed for this purpose (PreVCo rating tool). RESULTS: A total of five wards responsible for compulsorily admitted patients took part in the pilot study; three of them completed the intervention. On all three wards, implementation of the guideline recommendations improved for both selected and unselected recommendations. The strategy of using implementation consultants as well as the application of the PreVCo rating tool were well accepted and considered feasible by both the treatment teams and the implementation consultants. CONCLUSION: This pilot study showed that an implementation of recommendations on psychiatric wards derived from the German guidelines "Prevention of coercion" supported by implementation consultants is feasible, well acceptable among treatment teams and can lead to positive changes. The sample of five wards with diverse patient profiles was convincing. The efficacy in terms of reduction of coercive measures is currently being investigated in a randomized controlled trial on 55 psychiatric wards in different parts of Germany, with an intervention based on this pilot study.


Asunto(s)
Coerción , Servicio de Psiquiatría en Hospital , Adulto , Agresión , Alemania , Humanos , Proyectos Piloto
15.
Acta Psychiatr Scand ; 144(3): 277-287, 2021 09.
Artículo en Inglés | MEDLINE | ID: mdl-34139020

RESUMEN

OBJECTIVE: In recent decades, significant numbers of pharmaceutical trials have gradually been relocated to low- and middle-income countries. However, there is little evidence regarding the transferability of trial outcomes across countries. Analysing duloxetine randomised controlled trials (RCTs) conducted in different countries, we investigated whether per capita gross national income (GNI) and healthcare expenditure (HE) are associated with pre-post mean changes of depression severity and differences in duloxetine-placebo effect sizes. METHOD: Meta-analyses included RCTs investigating duloxetine efficacy in patients with depression. Individual participant data (IPD) from multi-centre duloxetine trials were provided by the manufacturer. Data extracted from published reports also entered analyses in case of trials conducted in only one country. A meta-regression approach was applied to analyse associations of GNI and HE with standardised pre-post mean change using raw score standardisation (SMCR) and comparative effect size, that is, the mean differences (MD) in pre-post effect size between duloxetine and placebo treatment. RESULTS: 23 trials with 8417 randomised participants entered analyses. Regression coefficients indicated a negative linear relationship of SMCR with GNI (z-standardised ß = -3.61, R2  = 14.8%, p < 0.001) and HE (ß = -4.72, R2  = 24.8%, p < 0.001) for participants treated with duloxetine. Similar associations were found for placebo treatment (GNI: ß = -3.52, R2  = 23.8%, p < 0.001; ß = -3.34, R2  = 21.0% p < 0.001). Neither GNI nor HE was associated with the MD between duloxetine and placebo pre-post differences. CONCLUSIONS: Findings challenge the idea of the universal transferability of antidepressant trial outcomes across countries. Understanding the results of antidepressant RCTs demands more sophisticated clarification of context factors involved in determining effectiveness of antidepressant medication and should be discussed with a view to socio-economic context in their countries of origin.


Asunto(s)
Antidepresivos , Efecto Placebo , Antidepresivos/uso terapéutico , Clorhidrato de Duloxetina , Humanos , Análisis de Regresión
16.
Stud Health Technol Inform ; 281: 1017-1018, 2021 May 27.
Artículo en Inglés | MEDLINE | ID: mdl-34042829

RESUMEN

This paper reports findings from a case study on the use of information systems in Germany's mental health home treatment. Data were collected following an ethnographic approach, three themes were identified: (i) misfit of systems, (ii) whiteboards as central planning tools, and (iii) patients and their environment. We conclude by highlighting the specific nature of home treatment.


Asunto(s)
Sistemas de Información , Salud Mental , Antropología Cultural , Humanos , Psicoterapia
18.
BMC Psychiatry ; 21(1): 173, 2021 03 30.
Artículo en Inglés | MEDLINE | ID: mdl-33781237

RESUMEN

BACKGROUND: Over the last decades, many high-income countries have successfully implemented assertive outreach mental health services for acute care. Despite evidence that these services entail several benefits for service users, Germany has lagged behind and has been slow in implementing outreach services. In 2018, a new law enabled national mental health care providers to implement team-based crisis intervention services on a regular basis, allowing for different forms of Inpatient Equivalent Home Treatment (IEHT). IEHT is similar to the internationally known Home Treatment or Crisis Resolution Teams. It provides acute psychiatric treatment at the user's home, similar to inpatient hospital treatment in terms of content, flexibility, and complexity. METHODS/DESIGN: The presented naturalistic, quasi-experimental cohort study will evaluate IEHT in ten hospitals running IEHT services in different German regions. Within a multi-method research approach, it will evaluate stakeholders' experiences of care, service use, efficacy, costs, treatment processes and implementation processes of IEHT from different perspectives. Quantitative surveys will be used to recruit 360 service users. Subsequently, 180 service users receiving IEHT will be compared with 180 matched statistical 'twins' receiving standard inpatient treatment. Assessments will take place at baseline as well as after 6 and 12 months. The primary outcome is the hospital re-admission rate within 12 months. Secondary outcomes include the combined readmission rate, total number of inpatient hospital days, treatment discontinuation rate, quality of life, psycho-social functioning, job integration, recovery, satisfaction with care, shared decision-making, and treatment costs. Additionally, the study will assess the burden of care and satisfaction with care among relatives or informal caregivers. A collaborative research team made up of researchers with and without lived experience of mental distress will conduct qualitative investigations with service users, caregivers and IEHT staff teams to explore critical ingredients and interactions between implementation processes, treatment processes, and outcomes from a stakeholder perspective. DISCUSSION: By integrating outcome, process and implementation research as well as different stakeholder perspectives and experiences in one study, this trial captures the various facets of IEHT as a special form of home treatment. Therefore, it allows for an adequate, comprehensive evaluation on different levels of this complex intervention. TRIAL REGISTRATION: Trial registrations: 1) German Clinical Trials Register (DRKS), DRKS000224769. Registered December 3rd 2020, https://www.drks.de/drks_web/setLocale_EN.do ; 2) ClinicalTrials.gov, Identifier: NCT0474550 . Registered February 9th 2021.


Asunto(s)
Salud Mental , Calidad de Vida , Estudios de Cohortes , Alemania , Humanos , Pacientes Internos
19.
Psychiatr Prax ; 48(4): 193-200, 2021 May.
Artículo en Alemán | MEDLINE | ID: mdl-33307566

RESUMEN

OBJECTIVE: The obstacles to implementation of a German variation of psychiatric Home-Treatment (HT), called "Inpatient Equivalent Home-Treatment" (IEHT) are examined. METHOD: 43 employees from 11 psychiatric hospitals in the federal states of Berlin and Brandenburg were questioned using interviews and focus groups. A thematic analysis was conducted using the socio-institutional theoretical model. RESULTS: At system-level, implementation is hampered by an inadequate service definition, staff shortages, as well as performance assessments by health insurances. This leads to reluctant implementation at hospital-level with insufficient staffing of the teams. Other barriers include a lack of mobile devices for documentation and team communication. At the level of employees, poor information, and cooperation as well as unclear assignment of tasks are impeding factors. CONCLUSION: For a more needs-oriented, flexible, and nationwide introduction of HT according to IEHT, improvements to the underlying framework conditions and further research addressing efficacy, effectiveness and implementation are necessary.


Asunto(s)
Hospitales Psiquiátricos , Psicoterapia , Berlin , Grupos Focales , Alemania , Humanos , Investigación Cualitativa
20.
Front Psychiatry ; 11: 579176, 2020.
Artículo en Inglés | MEDLINE | ID: mdl-33101091

RESUMEN

BACKGROUND: Coercive measures are among the most controversial interventions in psychiatry. There is a large discrepancy between the sheer number of high-quality guidelines and the small number of scientifically accompanied initiatives to promote and evaluate their implementation into clinical routine. In Germany, an expert group developed guidelines to provide evidence- and consensus-based recommendations on how to deal with violence and coercion in psychiatry. METHODS: The study presented examines whether coercive measures on psychiatric wards can be reduced by means of an operationalized implementation of the guidelines "Prevention of coercion: prevention and therapy of aggressive behavior in adults". Out of a set of 12 interventions offered, wards are free to choose three interventions they want to implement. The primary outcome is the number of coercive measures per bed and month/year. Secondary outcomes are cumulative duration of coercive measures per bed and month/year. The most important control variable is the number of aggressive incidents. We plan to recruit 52 wards in Germany. Wards treating both voluntary and compulsorily admitted patients will be included. A 1:1 stratified randomized controlled trial will be conducted stratified by the amount of coercive measures and implemented aspects of the guidelines. In addition to the control group analysis, a waiting list design allows a pre-post analysis for all participating wards of the waiting list group. A parallel qualitative study will examine factors related to successful implementation and to successful reduction of coercion as well as relevant barriers. DISCUSSION: We are planning a nationwide study on the implementation of evidence- and consensus-based guidelines in psychiatric hospitals. This study intends to promote the transfer of expert knowledge as well as results from clinical trials into clinical routine with the potential to change supply structures in mental health sector. CLINICAL TRIAL REGISTRATION: www.isrctn.com, identifier ISRCTN71467851.

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