Sustainability of Community-Based Specialized Mental Health Services in Five European Countries: Protocol for Five Randomized Controlled Trial-Based Health-Economic Evaluations Embedded in the RECOVER-E Program.
ABSTRACT: BACKGROUND:Community-based recovery-oriented mental health services for people with severe mental disorders have not been fully implemented in Bulgaria, Croatia, Macedonia, Montenegro, and Romania. The RECOVER-E project facilitates the implementation of specialized mental health care delivered by setting up services, implementing the services, and evaluating multidisciplinary community mental health teams. The outcomes of the RECOVER-E project are assessed in a trial-based outcome evaluation in each of the participating countries with a health-economic evaluation linked to these trials. OBJECTIVE:The aim of this protocol paper is to describe the methodology that will be used for the health-economic evaluation alongside the trials. METHODS:Implementation sites have been selected in each of the five countries where hospital-based mental health services are available (care as usual [CAU]) for patients with severe mental disorders (severe depression, bipolar disorder, schizophrenia, and other psychotic disorders). The newly implemented health care system will involve community-based recovery-oriented mental health care (CMHC). At each site, 180 consenting patients will be randomized to either CAU or CMHC. Patient-level outcomes are personal and social functioning and quality-adjusted life years (QALYs). Data on participants' health care use will be collected and corresponding health care costs will be computed. This enables evaluation of health care costs of CMHC as compared with CAU, and these costs can be related to patient-level outcomes (functioning and QALY gains) in health-economic evaluation. RESULTS:Data collection was started in December 2018 (Croatia), February 2019 (Montenegro), April 2019 (Romania), June 2019 (North Macedonia), and October 2019 (Bulgaria). The findings of the outcome evaluations will be reported for each of the five countries separately, and the five trials will be pooled for multilevel analysis on a combined dataset. CONCLUSIONS:The results of the health-economic evaluation of the RECOVER-E project will contribute to the growing evidence base on the health and economic benefits of recovery-oriented and community-based service models for health systems in transition. TRIAL REGISTRATION:(1) ClinicalTrials.gov NCT03922425 (Bulgaria); https://clinicaltrials.gov/ct2/show/NCT03922425 (2) ClinicalTrials.gov NCT03862209 (Croatia); https://clinicaltrials.gov/ct2/show/NCT03862209 (3) ClinicalTrials.gov NCT03892473 (Macedonia); https://clinicaltrials.gov/ct2/show/NCT03892473 (4) ClinicalTrials.gov NCT03837340 (Montenegro); https://clinicaltrials.gov/ct2/show/NCT03837340 (5) ClinicalTrials.gov NCT03884933 (Romania); https://clinicaltrials.gov/ct2/show/NCT03884933. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/17454.
Project description:Background:Substantial strides have been made around the world in reforming mental health systems by shifting away from institutional care towards community-based services. Despite an extensive evidence base on what constitutes effective care for people with severe mental ill-health, many people in Europe do not have access to optimal mental health care. In an effort to consolidate previous efforts to improve community mental health care and support the complex transition from hospital-based to community-based care delivery, the RECOVER-E (LaRge-scalE implementation of COmmunity based mental health care for people with seVere and Enduring mental ill health in EuRopE) project aims to implement and evaluate multidisciplinary community mental health teams in five countries in Central and Eastern Europe. This paper provides a brief overview of the RECOVER-E project and its methods. Methods:Five implementation sites were selected (Sofia, Bulgaria; Zagreb, Croatia; Skopje, North Macedonia; Kotor, Montenegro; Siret-Suceava, Romania) where hospital-based mental health services are available (care as usual, CAU) for patients with severe mental disorders (severe depression, bipolar disorder, schizophrenia). The intervention consists of the introduction of a new service delivery model in each site, consisting of community-based recovery-oriented care delivered by trained multidisciplinary community mental health teams (including a peer worker with lived experience of a severe mental disorder). The implementation outcomes of the teams and the effect of the team's approach on patient and service utilisation outcomes will be evaluated using a mix of research methods. The study includes five planned hybrid implementation-effectiveness trials (1 per site) with patient-level randomization (n?=?180, with patients randomised to either care as usual or intervention condition). Effectiveness is evaluated using a pragmatic non-blinded design with patients randomised into two parallel groups: receiving new community-based care or receiving usual care in the form of institutional, hospital-based mental health care. Trial-based health economic evaluation will be conducted; implementation outcomes will be evaluated, with data aligned with dimensions from the RE-AIM framework. Pathways to sustaining project results will be developed through policy dialogue sessions, which will be carried out in each country and through ongoing policy engagement activities at the European level. Discussion:The RECOVER-E project has been developed and conducted to demonstrate the impact of implementing an evidence-based service delivery model for people with severe mental illness in different contexts in middle-income countries in Central and Eastern Europe. It is expected that the results will contribute to the growing evidence-base on the health and economic benefits of recovery-oriented and community-based service models for health systems in transition.Trial registration Each trial was registered before participant enrolment in the clinicaltrials.gov database: Site-Croatia, Zagreb (Trial Reg. No. NCT03862209); Montenegro, Kotor (Trial Reg. No. NCT03837340); Romania, Suceava (Trial Reg. No. NCT03884933); Macedonia, Skopje (Trial Reg. No. NCT03892473); Bulgaria, Sofia (Trial Reg. No. NCT03922425).
Project description:This study aimed to analyze treatment guidelines of 12 SEE countries to identify non-pharmacological interventions recommended for schizophrenia, explore the evidence base supporting recommendations, and assess the implementation of recommended interventions. Desk and content analysis were employed to analyze the guidelines. Experts were surveyed across the 12 countries to assess availability of non-pharmacological treatments in leading mental health institutions, staff training, and inclusion in the official service price list. Most SEE countries have published treatment guidelines for schizophrenia focused on pharmacotherapy. Nine countries-Albania, Bosnia and Herzegovina, Bulgaria, Croatia, Greece, Moldova, Montenegro, North Macedonia, and Serbia-included non-pharmacological interventions. The remaining three countries-Kosovo (UN Resolution), Romania, and Slovenia-have not published such treatment guidelines, however they are on offer in leading institutions. The median number of recommended interventions was seven (range 5-11). Family therapy and psychoeducation were recommended in most treatment guidelines. The majority of recommended interventions have a negative or mixed randomized controlled trial evidence base. A small proportion of leading mental health institutions includes these interventions in their official service price list. The interventions recommended in the treatment guidelines seem to be rarely implemented within mental health services in the SEE countries.
Project description:Background:Due to an increase in PTSD patients seeking help in the Danish mental health sector and the addition of Complex PTSD to the ICD-11, there is a need to increase efficiency of existing treatments for PTSD. mHealth interventions have been shown to reduce PTSD symptoms. Therefore, the implementation of a mHealth intervention designed for psychiatric PTSD patients as a therapy add-on may improve treatment outcome. No study to date has explored the effects of mHealth interventions for PTSD in the Danish mental health sector, the feasibility and effect of this type of intervention needs testing. Methods:The study is an investigator-initiated randomized controlled feasibility trial investigating the clinical mHealth tool PTSD help combined with care as usual (CAU) compared to CAU for adults with PTSD. Seventy patients will be recruited and receive either the mHealth intervention combined with CAU or CAU alone. The primary feasibility outcome is the proportion of eligible patients that participate in the study until the end assessment. Secondary outcome data consists of the fraction of compliant patients in the experimental group and exploratory data on PTSD help on PTSD symptom severity, level of psychological distress, sleep quality, dissociation symptoms, therapy readiness, quality of life, disability levels, and recovery. Discussion:This study may help increase our knowledge of possible benefits of, as well as potential barriers to, the implementation of mHealth tools in the psychiatric sector. It may also provide a cost-efficient means to increase therapy outcomes and decrease the duration of suffering for PTSD patients in the psychiatric sector. Trial registration:The trial is registered at ClinicalTrials.gov (ID: NCT03862703) https://clinicaltrials.gov/ct2/show/NCT03862703 on the 27 of February 2019 and has been approved by the Danish Data Protection Agency (journal number: VD-2018-200 ISuite number 6443). Referring to the committee law §2, the National Committee on Health Research Ethics (DNVK) [H-18024180] decided that the study could proceed without approval as the use of PTSD help did not constitute a health science intervention according to Danish health science legislation.
Project description:BACKGROUND:Cognitive behavioral therapy (CBT) is the gold standard treatment for adult anxiety disorders but is often not readily available in a scalable manner in many clinical settings. OBJECTIVE:This study examines the feasibility, acceptability, and effectiveness of a coach-facilitated digital cognitive behavioral program for anxious adults in primary care. METHODS:In an open trial, patients who screened positive for anxiety (General Anxiety Disorder-7 [GAD7] score ?5) were offered the digital cognitive behavioral program (active group, n=593). Primary outcomes included anxiety, quality of life (QoL), and ambulatory medical use over 6 months. Intent-to-treat (ITT) and modified intent-to-treat (mITT) analyses were completed. Subsequently, we compared the outcomes of participants with those of a matched control group receiving primary care as usual (CAU; n=316). RESULTS:More than half of the patients downloaded the cognitive behavioral mobile app program and about 60% of these were considered engaged, which was defined as completion of ?3 techniques. The active group demonstrated medium size effects on reducing anxiety symptoms (effect size d=0.44; P<.001) and improving mental health QoL (d=0.49; P<.001) and showed significantly improved physical health QoL (d=0.39; P=.002) and a decreased likelihood of high utilization of outpatient medical care (odds ratio=0.49; P<.001). The active group did not significantly outperform the CAU group in anxiety reduction or QoL improvement (d=0.20; P=.07). However, intent-to-treat analysis showed that the active group had a significantly lower likelihood of high utilization of outpatient medical care than the enhanced CAU group (P<.0001; odds ratio=0.09). CONCLUSIONS:A coach-facilitated digital cognitive behavioral program prescribed in primary care is feasible and acceptable. Primary care patients prescribed a digital cognitive behavioral program for anxiety experienced significant improvements in anxiety symptoms, QoL, and reduced medical utilization. This effect was observed even among patients with chronic medical conditions and behavioral health comorbidities. Although the primary outcomes in the active group did not improve significantly more than the CAU group, health care utilization declined, and some secondary outcomes improved in participants who engaged in the program compared to the CAU group. TRIAL REGISTRATION:ClinicalTrials.gov NCT03186872; https://clinicaltrials.gov/ct2/show/NCT03186872.
Project description:Significant part of Southeastern Europe (with a population of 76 million) has newborn screening (NBS) programs non-harmonized with developed European countries. Initial survey was conducted in 2013/2014 among 11 countries from the region (Albania, Bulgaria, Bosnia and Herzegovina (BIH), Croatia, Kosovo, Macedonia, Moldova, Montenegro, Romania, Serbia, and Slovenia) to assess the main characteristics of their NBS programs and their future plans. Their cumulative population at that time was ~52,5 million. At that time, none of the countries had an expanded NBS program, while phenylketonuria screening was not introduced in four and congenital hypothyroidism in three of 11 countries. We repeated the survey in 2020 inviting the same 11 countries, adding Cyprus, Greece, Hungary, and Malta (due to their geographical position in the wider region). The aims were to assess the current state, to evaluate the change in the period, and to identify the main obstacles impacting the implementation of expanded NBS and/or reaching a wider population. Responses were collected from 12 countries (BIH-Federation of BIH, BIH-Republic of Srpska, Bulgaria, Croatia, Greece, Hungary, Kosovo, North Macedonia, Malta, Montenegro, Romania, Serbia, Slovenia) with a population of 68.5 million. The results of the survey showed that the regional situation regarding NBS only modestly improved in this period. All of the surveyed countries except Kosovo screened for at least congenital hypothyroidism, while phenylketonuria was not screened in four of 12 countries. Croatia and Slovenia implemented an expanded NBS program using tandem mass spectrometry from the time of last survey. In conclusion, the current status of NBS programs in Southeastern Europe is very variable and is still underdeveloped (or even non-existent) in some of the countries. We suggest establishing an international task-force to assist with implementation and harmonization of basic NBS services where needed.
Project description:<h4>Background</h4>Sand flies (Diptera: Psychodidae) are medically important vectors of human and veterinary disease-causing agents. Among these, the genus Leishmania (Kinetoplastida: Trypanosomatidae), and phleboviruses are of utmost importance. Despite such significance, updated information about sand fly fauna is missing for Balkan countries where both sand flies and autochtonous leishmaniases are historically present and recently re-emerging. Therefore, a review of historical data on sand fly species composition and distribution in the region was followed by a large-scale entomological survey in eight Balkan countries to provide a recent update on local sand fly fauna.<h4>Methods</h4>The literature search involved the period 1910-2019. The entomological survey was conducted at 1189 sampling stations in eight countries (Bulgaria, Bosnia and Herzegovina, Croatia, Kosovo, Montenegro, North Macedonia, Serbia and Slovenia), covering 49 settlements and 358 sampling sites between June and October in the years 2014 and 2016, accumulating 130 sampling days. We performed a total of 1189 trapping nights at these stations using two types of traps (light and CO<sub>2</sub> attraction traps) in each location. Sampling was performed with a minimal duration of 6 (Montenegro) and a maximal of 47 days (Serbia) between 0-1000 m.a.s.l. Collected sand flies were morphologically identified.<h4>Results</h4>In total, 8490 sand fly specimens were collected. Morphological identification showed presence of 14 species belonging to genera Phlebotomus and Sergentomyia. Historical data were critically reviewed and updated with our recent findings. Six species were identified in Bosnia and Herzegovina (2 new records), 5 in Montenegro (2 new records), 5 in Croatia (2 new records), 9 in Bulgaria (5 new records), 11 in North Macedonia (1 new record), 10 in Serbia (no new records), 9 in Kosovo (3 new records) and 4 in Slovenia (no new records).<h4>Conclusions</h4>This study presents results of the first integrated sand fly fauna survey of such scale for the Balkan region, providing first data on sand fly populations for four countries in the study area and presenting new species records for six countries and updated species lists for all surveyed countries. Our findings demonstrate presence of proven and suspected vectors of several Leishmania species.
Project description:The genital anatomy of Orcula jetschini (Romania), Orcula zilchi (Bulgaria), and Orcula wagneri (Albania) is described. Based on anatomical features (morphology of the penial caecum) shell characters (sculpture and shape) and unpublished molecular data the genus Orcula is subdivided into three subgenera. Orcula zilchi was classified within the monotypic subgenus Orcula (Hausdorfia) subgen. n.; Orcula jetschini, Orcula wagneri, and Orcula schmidtii were classified to Orcula (Illyriobanatica) subgen. n. (type species: Pupa schmidtii) whereas the other Orcula species remain in the nominotypical subgenus. Orcula (Hausdorfia) is known from South-Eastern Bulgaria and North-Western Turkey, Orcula (Illyriobanatica) inhabits Western Romania, North-Western Greece, Albania, Macedonia, Kosovo, and Montenegro. The nine species of Orcula (Orcula) are known mainly from the Alps and the Western Carpathians (from Eastern France to Eastern Hungary and Slovakia). The occurrence of only one Orcula species namely Orcula jetschini is verified from Romania. Available information suggests that data on the Romanian occurrence of Orcula dolium and Orcula gularis were based on wrongly identified specimens. Sphyradium dobrogicum (=Orcula dobrogica) is considered as a synonym of Sphyradium doliolum.
Project description:<h4>Background</h4>Accidents and the resulting injuries are among the world's biggest health care issues, often causing long-term effects on psychological and physical health. With regard to psychological consequences, accidents can cause a wide range of burdens including adjustment problems. Although adjustment problems are among the most frequent mental health problems, there are few specific interventions available. The newly developed program SelFIT (German acronym: Selber wieder fit nach einem Unfall; "fit again after an accident") aims to remedy this situation by offering a low-threshold, web-based self-help intervention for psychological distress after an accident.<h4>Objective</h4>The overall aim is to evaluate the efficacy and cost-effectiveness of the SelFIT program plus care as usual (CAU) compared to only CAU. Furthermore, the program's user-friendliness, acceptance, and adherence are assessed. We expect that the use of SelFIT will be associated with a greater reduction in psychological distress, greater improvement in mental and physical well-being, and greater cost-effectiveness compared to CAU.<h4>Methods</h4>Adults (n=240) experiencing adjustment problems due to an accident they had between 2 weeks and 2 years before entering the study will be randomized into either the intervention or control group. Participants in the intervention group receive direct access to SelFIT. The control group receives access to the program after 12 weeks. There are 6 measurement points for both groups (baseline as well as after 4, 8, 12, 24, and 36 weeks). The main outcome is a reduction in anxiety, depression, and stress symptoms that indicate adjustment problems. Secondary outcomes include well-being, optimism, embitterment, self-esteem, self-efficacy, emotion regulation, pain, costs of health care consumption, and productivity loss, as well as the program's adherence, acceptance, and user-friendliness.<h4>Results</h4>Recruitment began in December 2019 and will continue at least until January 2021, with the option to extend this for another 6 months until July 2021. As of July 2020, 324 people have shown interest in participating, and 48 people have given their informed consent.<h4>Conclusions</h4>To the best of our knowledge, this is the first study examining a web-based self-help program designed to treat adjustment problems resulting from an accident. If effective, the program could complement the still limited offerings for secondary and tertiary prevention of psychological distress after an accident.<h4>Trial registration</h4>ClinicalTrials.gov NCT03785912; https://clinicaltrials.gov/ct2/show/NCT03785912.<h4>International registered report identifier (irrid)</h4>DERR1-10.2196/21200.
Project description:<h4>Introduction</h4>After the acute treatment phase, breast cancer patients often experience low quality of life and impaired mental health, which could potentially be improved by offering cognitive behavioural therapy (CBT) and addressing exercise and dietary habits. However, CBT and other behavioural interventions are rarely available beyond the acute treatment phase. Internet-based interventions could bridge such treatment gaps, given their flexibility and scalability. In this randomized controlled trial (RCT), we investigated the effects of such an intervention ("Optimune") over three months.<h4>Methods</h4>This RCT included 363 female breast cancer survivors (age range = 30-70), recruited from the community, who had completed the active treatment phase. Inclusion criteria were: breast cancer diagnosis less than 5 years ago and acute treatment completion at least 1 month ago. Participants were randomly assigned to (1) an intervention group (n = 181), in which they received care as usual (CAU) plus 12-month access to Optimune immediately after randomization, or (2) a control group (n = 182), in which they received CAU and Optimune after a delay of 3 months. Primary endpoints were quality of life (QoL), physical activity, and dietary habits at three months. We hypothesized that intervention group participants would report better QoL, more physical activity, and improved dietary habits after 3 months.<h4>Results</h4>Intention-to-treat (ITT) analyses revealed significant effects on QoL (d = 0.27, 95% CI: 0.07-0.48) and dietary habits (d = 0.36, 95% CI: 0.15-0.56), but the effect on physical exercise was not significant (d = 0.30; 95% CI: 0.10-0.51).<h4>Discussion</h4>These findings suggest the effectiveness of Optimune, a new CBT-based Internet intervention for breast cancer survivors, in facilitating improvements in quality of life and dietary habits. Efforts to disseminate this intervention more broadly may be warranted.<h4>Trial registration</h4>ClinicalTrials.gov, NCT03643640. Registered August 23rd 2018, https://clinicaltrials.gov/ct2/show/NCT03643640.