Istraživački radovi

  1. Jovanović N, Russo M, Pemovska T, Francis JJ, Arenliu A, Bajraktarov S, Kulenović AD, Stevović LI, Novotni A, Petrović SA, Radojičić T. Improving treatment of patients with psychosis in low-and-middle-income countries in Southeast Europe: results from a hybrid effectiveness-implementation, pragmatic, cluster-randomised clinical trial (IMPULSE). European Psychiatry. 2022 Aug 10:1-37.

    Ceo članak Prikaži apstrakt

    BackgroundIn Southeast Europe (SEE) standard treatment of patients with psychosis is largely based on pharmacotherapy with psychosocial interventions rarely available. DIALOG+ is a digital psychosocial intervention designed to make routine care therapeutically effective. This trial simultaneously examined effectiveness of DIALOG+ versus standard care on clinical and social outcomes (Aim 1) and explored intervention fidelity (Aim 2).

    MethodsA hybrid type II effectiveness–implementation, cluster-randomized trial was conducted in five SEE countries: Bosnia and Herzegovina, Kosovo*, Montenegro, North Macedonia, and Serbia. The intervention was offered to patients six times across 12 months instead of routine care. The outcomes were subjective quality of life (primary), clinical symptoms, satisfaction with services, and economic costs. Intervention fidelity was operationalized as adherence to the protocol in terms of frequency, duration, content, and coverage. Data were analyzed using multilevel regression.

    ResultsA total of 81 clinicians and 468 patients with psychosis were randomized to DIALOG+ or standard care. The intervention was delivered with high fidelity. The average number of delivered sessions was 5.5 (SD = 2.3) across 12 months. Patients in the intervention arm had better quality of life (MANSA) at 6 months (p = 0.03). No difference was found for other outcomes at 6 months. Due to disruptions caused by the COVID-19 pandemic, 12-month data were not interpretable.

    ConclusionsDIALOG+ improved subjective quality of life of individuals with psychosis at 6 months (after four sessions), albeit with small effect size. The intervention has the potential to contribute to holistic care of patients with psychosis.

  2. Marić N, Andrić Petrović S*, Russo M, Jerotić S, Ristić I, Savić B, Pemovska T, Milutinović M, Ribić E, Markovska-Simoska S, Dzubur Kulenovic A and Jovanovic N. Maintenance therapy of psychosis spectrum disorders in a real world setting: antipsychotics prescription patterns and long-term benzodiazepine use. Frontiers in Psychiatry. In Press

    Ceo članak Prikaži apstrakt

    Background: Maintenance therapy of patients with primary psychosis spectrum disorders (PSD) in the Western Balkans has received limited interest so far. The present study aimed to investigate long-term prescription patterns among outpatients with PSD.
    Methods: Information about prescription of antipsychotics (AP), benzodiazepines (BZD) and other psychotropic medication over a 6-month period was collected from outpatients (n=134; ICD-10 diagnosis F20-29) recruited by a larger multi-site study, to find mean daily number of psychotropic drugs, AP prescription patterns (including AP daily dose, route of administration, monotherapy vs. polypharmacy) and BZD utilisation (long-term add-on BZD therapy). Additionally, sex-differences in the aforementioned variables were explored.
    Results: Clinically stable outpatients (age 41.7±11.0; male 62.7%) were prescribed 2.8±1.1 psychotropic medications daily. The mean 6-month AP dose was 14.2±7.8 mg olanzapine equivalents. Long acting injectable AP was prescribed to 25.2% of the patients. Long-term AP monotherapy was found in 52.7%patients and the majority of them were prescribed second generation AP (65.2%). Long-term AP polypharmacy (42.7%) was more common in males (p=0.015). The most frequent co-prescription patterns were first generation AP plus clozapine. The highest rate of long-term AP co-prescription was found for BZD (in 42.7% cases, average 6-months daily dose of 2.8±2.7 mg lorazepam equivalents) and anticholinergics (33.6%).
    Conclusion: Existing appropriately designed interventions aiming to safely switch the inappropriate therapeutic regimens – very high prevalence of long-term AP polypharmacy and non-rational BZD co-prescription, should be implemented in the region of Western Balkans.

  3. Marić NP, Andrić Petrović S, Jerotić S, Ristić I, Savić B, Zebić M, Vuković V, Britvić D, Golubović O, Jakšić M, Jevđić K. Maintenance phase treatment of psychotic disorders in outpatients from Serbia–focus on long-term benzodiazepine use. International Journal of Psychiatry in Clinical Practice. 2020 Sep 1;24(3):315-21.

    Ceo članak Prikaži apstrakt

    Introduction: Prescribing trends in maintenance therapy of patients with primary psychotic disorders (PSD) may vary worldwide. Present study aimed to investigate prescription patterns in a sample of outpatients with PSD from Serbia.

    Methods: In a sample of 73 PSD outpatients we analysed the rate of antipsychotic polypharmacy and psychotropic polypharmacy, concomitant continual benzodiazepine use, and associations between therapy, psychotic symptoms and quality of life.

    Results: Maintenance therapy (median daily dose 321 mg of chlorpromazine equivalents) predominantly consisted of monotherapy with second generation antipsychotics (45.2%), followed by antipsychotic polypharmacy based on first and second generation combination (25.0%). The median number of psychotropic drugs was 3. Benzodiazepines were continually prescribed to more than 60% of patients (mean daily dose 2.9 ± 2.0 mg lorazepam equivalents). Patients with benzodiazepine use had significantly more psychotropic medications and more antipsychotic polypharmacy, poorer quality of life and more severe psychopathology in comparison to another group.

    Conclusion: The present study demonstrated new information regarding the prescription patterns of psychotropic drugs in outpatients with PSD in Serbia, amplified with clinically relevant information. This study also revealed distinct prescription patterns concerning antipsychotic/benzodiazepine polypharmacy. Overall, such findings are likely to contribute to improving clinical practice and care for patients with PSD in general.

  4. Savić B, Jerotić S, Ristić I, Zebić M, Jovanović N, Russo M, Marić NP. Long-Term Benzodiazepine Prescription During Maintenance Therapy of Individuals With Psychosis Spectrum Disorders—Associations With Cognition and Global Functioning. Clinical Neuropharmacology. 2021 May;44(3):89.

    Ceo članak Prikaži apstrakt

    Background: Cognitive difficulties have a significant impact on life functioning and overall well-being in patients with psychosis spectrum disorders (PSDs). There are indications that continuous use of benzodiazepines (BZDs) in various patient groups has a detrimental effect on cognition. Our aim was to explore the association between long-term BZD prescription, global functioning, and cognitive functioning in persons with PSD.

    Methods: This exploratory study included 55 PSD patients, recruited from 2 outpatient services in Serbia. Patients were grouped into BZD long-term prescription group and BZD-other group. Brief Psychiatric Rating Scale was used for symptom assessment, functioning was measured by Global Assessment and Functioning Scale, and cognition was assessed by the Global Assessment of Functioning-Cognition in Schizophrenia Scale.

    Results: The sample comprised 52.7% patients who were prescribed with BZD for 6 months or more continually (29/55), with a mean daily dose of 3.16 ± 0.66 mg lorazepam equivalents. There were no differences between study groups in any of the sociodemographic characteristics, duration of illness, or antipsychotic daily dosages. The BZD long-term prescription group had lower global (P < 0.01) and cognitive functioning (P < 0.01), higher Brief Psychiatric Rating Scale scores (1.86 vs 1.58, respectively, P < 0.01), and more psychotropic drugs prescribed on a daily basis than the other group (median: 4 vs 2, respectively, P < 0.01).

    Conclusions: The study explored a topic that continues to be underresearched, especially in the Balkans. Prospective studies and comprehensive cognitive batteries are needed to further elucidate the associations between polypharmacy, long-term BZD use, cognitive functioning, and global functioning during maintenance therapy of individuals with PSD.

  5. Ristić I, Andrić-Petrović S, Jerotić S, Zebić M, Jovanović N, Marić NP. Duration of psychiatric appointments for patients with Psychosis spectrum disorders in Serbia: Is it significantly prolonged by DIALOG+ psychosocial intervention?. Psihijatrija Danas. 2020;52(1-2):13-24.

    Ceo članak Prikaži apstrakt

    Despite national and international guidelines recommending inclusion of psychotherapy and psychosocial interventions as regular part of treatment for patients with psychosis spectrum disorders (PSD), outpatient psychiatric care in Southeastern Europe (SEE) is mostly limited to medication prescription. DIALOG+ is a recently developed technology-based, patient centered psychosocial intervention that provides an
    conomically viable intervention for treatment and comprehensive evaluation of multiple life domains. Its effectiveness in a range of
    psychiatric disorders has been shown in several studies conducted in high-income countries. Before an ongoing study evaluating DIALOG+ implementation and effectiveness in developing SEE countries is completed, we aimed to explore general impressions of mental health clinicians towards such an intervention and to compare the duration of treatment as usual (TAU) with DIALOG+ enriched appointments of PSD outpatients. The attendees of the national professional educational symposium were presented with DIALOG+, after which they completed a short survey on their general impressions towards the intervention. To obtain the information regarding duration of psychiatric appointments for patients with PSD in Serbia, we used data from a currently ongoing randomized clinical trial where DIALOG+ is being tested for effectiveness. The impressions of the survey (n=110) from mostly psychiatrists and psychiatry residents towards the concept of this intervention were overwhelmingly positive. However, the question arose if TAU is being prolonged by DIALOG+ to the extent that might limit its implementation. Although significant difference in average session duration was observed between DIALOG+ and TAU (31.96±16.47 vs. 19.75±6.11 minutes, p<0.01), providing structured interventions and patient evaluation might be of additional benefit for long term care and quality of life of PSD patients. To the best of our knowledge, this was the first evaluation of the duration of psychiatric appointments for outpatients with PSD in Serbia. Present information could be useful for different stakeholders in education of MH workers and implementation of DIALOG+ in the local settings.

  6. Ristić I, Jerotić S, Zebić M, Savić B, Vuković V, Russo M, Voskresenski T, Jovanović N, Marić NP. Factorial Structure of the Serbian Version of the Clinical Assessment Interview for Negative Symptoms–Evidence for Three Factors of Negative Symptoms. Frontiers in psychology. 2020 Oct 26;11:2852.

    Ceo članak Prikaži apstrakt

    Introduction: Negative symptoms are a common occurrence in patients with psychosis spectrum disorders. Previous analysis of the latent structure of the Clinical Assessment Interview for Negative Symptoms (CAINS) – which was developed to advance the assessment of negative symptomatology – showed two underlying sub-domains (Motivation and Pleasure; Expression). Recent findings indicate that a more complex structure might be more applicable.

    Aim: To evaluate the psychometric properties of the Serbian version of the CAINS in a sample of outpatients (N = 67) with psychosis spectrum disorders.

    Materials and Methods: Negative symptoms and general level of psychopathology were assessed with Serbian translations of the CAINS, the 53-item version of the Brief Symptom Inventory (BSI), and the 24-item version of the Brief Psychiatric Rating Scale (BPRS). Principal component analysis (PCA) was carried out on the CAINS items, and correlation analyses were done to assess its convergent and discriminant validity.

    Results: Our results showed an excellent internal consistency (Cronbach’s alpha = 0.92). PCA revealed a three-component solution consisting of Expressiveness and Motivation for Social and Family Relationships (Factor 1), Motivation for Vocational Activities (Factor 2), and Motivation for Recreation (Factor 3). Convergent validity was supported by significant correlations with the Negative symptoms domain of the BPRS (Factor 1, 0.695, p < 0.01; Factor 2, 0.352, p < 0.05; Factor 3, 0.452, p < 0.01). When assessing discriminant validity, weak correlations were found with BPRS and BSI scores.

    Conclusion: The Serbian version of CAINS is a valid, reliable and useful tool for the assessment of negative symptomatology. Our findings support a three-factor structure of CAINS, which indicates that the construct is more complex than envisaged by the original conceptualization of two distinct factors.

  7. Hunter J, McCabe R, Francis JJ, Pemovska T, Ribić E, Smajić Mešević E, Konjufca J, Markovska Simoska S, Blazevska Stoilkovska B, Radojičić T, Repišti S, Jerotić S, Ristić I, Zebić M, Injac-Stevović L, Arenliu A, Dzubur-Kulenović A, Berxulli D, Barjaktarov S, Jovanović N. Implementing a mental health intervention in low-and-middle-income countries in Europe: is it all about resources?. Global Psychiatry. 2020 Nov 11;4:31-54.

    Ceo članak Prikaži apstrakt

    Background: There are limited resources for improving mental health care across Europe, especially in Low-and-Middle- Income Countries (LMICs) in South-eastern Europe with fewer specialist staff and less funding. Scaling up psychosocial interventions that utilise available time and resources more effectively could improve care for people with psychosis in these settings. One intervention is DIALOG+, delivered via an app on a tablet computer: patients identify life areas to improve and clinicians use a solution-focussed process to help improve these areas. This intervention was piloted across mental healthcare systems in European LMICs, and focus groups were conducted to explore whether such interventions could use available resources effectively to improve care for psychosis in these settings.
    Methods: Eleven focus groups were conducted with clinicians and patients with psychosis who used the intervention over three months during the pilot study, in Bosnia and Herzegovina, Kosovo United Nations Resolution, Montenegro, North Macedonia and Serbia. The Theoretical Domains Framework (TDF), which describes factors affecting engagement with healthcare interventions, structured topic guides and guided analysis. Codes from the data were mapped onto the TDF, analysed to identify barriers and facilitators, translated into English and checked for inter-rater reliability.

    Results: 25 clinicians and 23 patients participated in focus groups. Clinicians’ barriers included limited time for sessions and difficulties working with acutely psychotic patients. Patients’ barriers were burden of greater concentration when engaging with DIALOG+ and feeling tense or disturbed during the sessions. Facilitators included motivation to use DIALOG+, positive opinions shared by others, perceived benefits for practice and improving clinician-patient conversations, relationships and care.

    Barriers to using psychosocial interventions could be overcome even if resources cannot be increased. Despite limited time and other barriers to using DIALOG+, perceived benefits to practice and clinician-patient relationships suggest that psychosocial interventions can use available resources effectively to improve care for psychosis.

    Apstrakti i saopštenja

    1. Marić N, Jovanović N: Strukturisana psihosocijalna intervencija – iskustva sa digitalnom aplikacijom DIALOG+ u tretmanu osoba sa psihotičnim simptomima. Drugi Internacionalni Kongres Dječje i Adolescentne Psihoterapije, Sarajevo, 2020

      Ceo članak Prikaži apstrakt

      DIALOG+ je jednostavna generička intervencija namenjena proceni zadovoljstva pacijenta sopstvenim životom i pruženim lečenjem, kao i bržem prepoznavanju problema i njihovih potreba. Na početku DIALOG+ intervencije je potrebno proceniti zadovoljstvo pacijenta u osam oblasti života i u tri domena koja se odnose na primenjenu terapiju, te utvrditi u kojim domenima pacijenti žele da im se više pomogne. Opisani strukturisani pristup koristi principe Terapije usmerene na rešenja i Kognitivno-bihejvioralne terapije. DIALOG+ podržava softver ‘DIALOG 2.0’na iPad tabletu sa ciljem da se pomogne pacijentu i kliničaru da razumeju pacijentove brige (’Razumevanje’), identifikuju scenario za poboljšanje (‘Očekivanja’), istraže mogućnosti delovanja (‘Istraživanje’), i na kraju da se dogovore oko aktivnosti koje će preduzeti kako bi se poboljšali stanje pacijenta i njegova društvena situacija situacija (‘Dogovaranje aktivnosti’). U okviru međunarodnog projekta IMPULSE (779334 — IMPULSE — H2020-SC1-2016-2017/H2020-SC1-2017) u pet Balkanskih zemalja urađeno je istraživanje kvaliteta zivota kod vanbolničkih pacijenata koji se leče zbog psihotičnih poremećaja sa ili bez stukturisane psihosocijalne intervencije DIALOG + tokom 12 meseci trajanja ovog randomizovanog dvostruko-slepog protokola. U Srbiji je bilo uključeno ukupno 80 pacijenata i 16 kliničara, a 71 pacijent je završio studiju praćenja. Osim kvantirtativnog ishoda – promene u kvalitetu života pacijenata sa ili bez DIALOG+ psihosocijalne intervencije, cilj je bio analizirati kvalitativne podatke, dobijene na osnovu opšteg utiska glavnih učesnika u studiji – pacijenata i kliničara i ispitati koliko ova intervencija produžava trajanje uobičajenih dospanzerskih poseta. U izlaganju će biti prikazani preliminarni rezultati na delu uzorka iz Srbije (n-71), biće predstavljeni utisci i iskustva kliničara i pacijenata i mogućnosti koje postoje za primenu DIALOG+ intervencije u drugim populacijama, prvenstveno u cilju očuvanja mentanog zdravlja mladih.

    2. Marić N, Jovanović N: Kada longitudinalno randomizovano intervencijsko istraživanje „zakači koronu“ – šta dalje? Okrugli sto – Ljubav prema istraživanjima u doba korone (voditelj Oliver Tošković). 68. Kongres psihologa Srbije, Beograd, 2020

    3. Šetić R, Majstorović T, Aleksić M, Zebić M. Model uspješnog uključivanja korisnika usluga u mentalnom zdravlju i njihovih porodica u proces oporavka: Preliminarni rezultati studije IMPULSE. SARAJEVSKI DANI PSIHOLOGIJE ZBORNIK RADOVA God. 6, br. 6 (2020), 277-293

      Ceo članak Prikaži apstrakt

      Studija IMPULSE Univerziteta Queen Mary iz Londona nudi jedinstvenu priliku radikalnog poboljšanja brige o osobama s psihotičnim poremećajima u zemljama s niskim i srednjim dohotkom u jugoistočnoj Europi. Jedan od ciljeva studije je uključivanje korisnika usluga u mentalnom zdravlju i njihovih porodica u proces oporavka. Uključivanje se temelji na formiranju savjetodavnih tijela korisnika i porodica koji prate i koriguju rad u toku projekta, te razvoja modela korisničkih udruženja, u kojim profesionalci i korisnici zajedno upravljaju udruženjem i razvijaju ga. U Bosni i Hercegovini Udruženje Menssana uključeno je u studiju kao model korisičkog udruženja, a studija se provodi još u Srbiji, Crnoj Gori, Sjevernoj Makedoniji i Kosovu.Cilj ovog rada je prikazati preliminarne rezultate IMPULSE studije po pitanju uključivanja korisnika u zemljama regije, u periodu od tri godine a koji se odnose na: aktivno uključivanje korisnika i članova porodice; iniciranje osnivanja korisničkih udruženja u regiji; razvijanje modela za uključivanje i osnaživanje korisnika i porodica. Također ćemo prikazati model funkcionisanja dnevno-rekreativnog centra Menssana koji se razvija paralelno sa studijom IMPULSE i koji je primjer dobre prakse u razvoju korisničkog udruženja.Rezultati projekta su potvrdili ispravnost temeljne ideje da su ljudi koji žive s problemima mentalnog zdravlja najbolji izvor informacija i najbolji zagovornici svojih prava u društvu uz adekvatnu pomoć profesionalaca u tome. Dobili smo značajan uvid u funkcionisanje korisničkih udruženja u regiji. Formirali smo i aktivno održali rad savjetodavnih tijela korisnika usluga u mentalnom zdravlju i članova porodica. Na osnovu njihovih potreba i iskustava doprinjeli smo kreiranju svih programa IMPULSE studije, posebno u dijelu zagovaranja osnivanja korisničkih udruženja u regiji i kreiranju aktivnosti u samim udruženjima.

    4. Jerotic S, Milutinovic M, Radojicic T, Pemovska T, Ristic I, Novotni L, Repisti S, Stevovic LI, Novotni A, Maric NP, Jovanovic N. Attitudes of professionals from South Eastern Europe toward dialog plus psychosocial intervention for patients with psychosis-short survey. In EUROPEAN PSYCHIATRY 2019 Apr 1 (Vol. 56, pp. S102-S103).

      Ceo članak Prikaži apstrakt

      Background and aims – Technology-assisted and patient-centered communication based methods could improve routine meetings between clinicians and patients. DIALOG+, a new intervention which effectively structures routine meetings, made them comprehensive and solution-focused and improved quality of life in persons with psychotic disorders from the UK. Psychotic disorders are one of the major health burdens in low- and middle-income countries (LMICs), which struggle to overcome funding difficulties and lack of qualified staff. However, it is still unknown how local factors in LMICs could influence the implementation and efficacy of methods such as DIALOG+. The objective of our survey was to explore a priori assumptions about DIALOG+ of mental health professionals from FYR of Macedonia, Montenegro and Serbia.

      Methods – During the professional meetings with large audience (National Congress/Symposium), the intervention has been described to the audience by local experts in local language. After the presentation which lasted for 20–30 minutes, professionals(with no experience in Dialog+) were invited to answer 8-questions survey anonymously, addressing their interest towards Dialog+, an opinion about its applicability and also about the possible obstacles for the implementation in the local mental health facilities.

      Results – On the basis of 182 replies (20 + 46 + 116, respectively),the first impression about Dialog+ was positive. Dialog+ was different in comparison to common practice of participating clinicians. Most of them have shown interest to implement it and found this innovation being primarily in favor of patients. As the major obstacles clinicians mentioned lack of their time and equipment acquisition limitations.

      Conclusions– This survey could provide meaningful directions for DIALOG+ implementation in LIMCs.

    5. Ristic I, Milutinovic M, Radojicic T, Pemovska T, Jerotic S, Novotni Lj, Repisti S, Injac-Stevovic L, Novotni A, Maric N, Jovanovic N. Initial impressions of professionals from South Eastern Europe towards a psychosocial intervention for patients with psychosis DIALOG+. Schizophrenia 360 °, Zagreb, Croatia, 6th-7th June, 2019.

      Prikaži apstrakt

      Background and Aims: DIALOG+ is a new technology-assisted, patient-centered intervention which effectively structures routine meetings and makes them comprehensive and solution-focused, resulting in improved quality of life in persons with psychotic disorders. It is unknown how local factors in LMICs could influence implementation and efficacy of methods such as DIALOG+. We sought to explore through a survey a priori assumptions of mental health professionals from Northern Macedonia, Montenegro and Serbia towards DIALOG+.

      Methods: During professional meetings with large audiences (National Congress/Symposium), the intervention has been described to the audience by local experts in local languages. After a 20-30-minute presentation, professionals were invited to answer an 8-question survey anonymously, rating their interest and first impressions towards DIALOG+, and marking possible obstacles for its implementation in local mental health facilities.

      Results: On the basis of 182 replies (20+46+116, respectively), first impressions about DIALOG+ were positive. DIALOG+ was different compared to common practice of participating clinicians. Most of them have shown interest for the intervention and found that it primarily helps the patients. The clinicians identified lack of time during visits and equipment acquisition as major obstacles for DIALOG + implementation.

      Conclusions: This survey could provide meaningful directions for DIALOG+ implementation in LMICs.


    1. Jovanovic N, Francis J, Maric NP, Arenliu A, Barjaktarov S, Kulenovic AD, Injac L, Feng Y, Novotni A. Implementing a psychosocial intervention DIALOG+ for patients with psychotic disorders in low and middle income countries in South Eastern Europe: protocol for a hybrid effectiveness-implementation cluster randomized clinical trial (IMPULSE). Global Psychiatry. 2020 May 21;3(1):83-96.

      Ceo članak Prikaži apstrakt

      Objectives: Psychotic disorders have large treatment gap in low- and middle-income countries (LMICs) in South-Eastern Europe, where up to 45% of affected people do not receive care for their condition. This study will assess the implementation of a generic psychosocial intervention called DIALOG+ in mental health care services and its effectiveness at improving patients’ clinical and social outcomes.

      Methods: This is a protocol for a multi-country, pragmatic, hybrid effectiveness–implementation, cluster-randomised, clinical trial. The trial aims to recruit 80 clinicians and 400 patients across 5 South-Eastern European LMICs: Bosnia and Herzegovina, Kosovo*, Montenegro, Republic of North Macedonia and Serbia. Clusters are clinicians working with patients with psychosis, and each clinician will deliver the intervention to five patients. After patient baseline assessments, clinicians will be randomly assigned to either the DIALOG+ intervention or treatment as usual, with an allocation ratio of 1:1. The intervention will be delivered six times over 12 months during routine clinical meetings. TThe primary outcome measure is the quality of life at 12 months [Manchester Short Assessment of Quality of Life (MANSA)]; the secondary outcomes include mental health symptoms [Brief Psychiatric Rating Scale (BPRS), Clinical Assessment Interview for Negative Symptoms (CAINS), Brief Symptom Inventory (BSI)], satisfaction with services [Client Satisfaction Questionnaire (CSQ-8)] and economic costs at 12 months [based on Client Service Receipt Inventory (CSRI), EQ-5D-5L and Recovering Quality of Life (ReQOL-10)]. The study will assess the intervention fidelity and the experience of clinicians and patients’ about implementing DIALOG+ in real-life mental health care settings. In the health economic assessment, the incremental cost-effectiveness ratio is calculated with effectiveness measured by quality-adjusted life year. Data will also be collected on sustainability and reach to inform guidelines for potentially scaling up and implementing the intervention widely. Conclusion: The study is expected to generate new scientific knowledge on the treatment of people with psychosis in health care systems with limited resources. The learning from LMICs could potentially help other countries to expand the access to care and alleviate the suffering of patients with psychosis and their families.

    2. Pemovska T, Jovanović N, Radojičić T, Arënliu A, Džubur-Kulenović A, Novotni A, Injac-Stevović L, Marić NP, Barjaktarov S, Francis JJ. Protocol for a process evaluation of a cluster randomised controlled trial to improve psychosocial treatment of patients with psychotic spectrum disorders: the IMPULSE trial. GLOBAL PSYCHIATRY, 2021; 4(1): 20-30. doi: 10.52095/gp.2020.1407

      Ceo članak Prikaži apstrakt

      Objective: This paper describes the protocol of a process evaluation of a cluster randomised controlled trial designed to evaluate the effectiveness, cost-effectiveness and implementation of a digital mental health intervention, called DIALOG+, in five low- and middle-income countries in Southeast Europe (Bosnia and Herzegovina, Kosovo1, Montenegro, North Macedonia and Serbia). The objectives of the process evaluation are: a) to explore attributes of context that might impact on the implementation of the DIALOG+ intervention; b) to assess intervention fidelity and c) to explore patients’ and clinicians’ retrospective (i.e. experienced) acceptability of the intervention.

      Materials and methods: This is a mixed-method process evaluation nested within the cluster randomised controlled trial. We adopted the guidance on process evaluations of complex interventions published by the United Kingdom Medical Research Council. Data collected during and after the trial, but prior to awareness of trial outcomes, include transcripts, questionnaire responses, routinely collected monitoring data and audio-recordings of intervention and control sessions. Data analysis is descriptive and involves triangulation methods to compare findings across countries, stakeholder groups (healthcare provider, patient) and data type (qualitative, quantitative).

      Results: This work is part of a larger study entitled ‘Implementation of an effective and cost-effective intervention for patients with psychotic disorders in low and middle-income countries in Southeast Europe’ (IMPULSE). The study is funded by the European Union’s Horizon 2020 research and innovation programme. The IMPULSE trial recruited 81 clinicians and 458 patients. The clinician clusters were randomised to the intervention (six sessions of DIALOG+ over 12 months) o r treatment-as-usual arm. Process data collection began in parallel with the trial, starting in April 2019. Data collection and analysis will be completed before the main trial findings are known. Process evaluation findings will be used to interpret the trial results including assessing the effect of context on outcomes.

      Conclusion: This process evaluation will explore the context, intervention fidelity and acceptability to contextualise the trial results, help in optimising sustainability of the intervention and inform its future dissemination. Th e methods described here may also inform the development and implementation of other complex psychosocial interventions in low-resource settings.