{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,5]],"date-time":"2026-02-05T07:27:58Z","timestamp":1770276478790,"version":"3.49.0"},"reference-count":27,"publisher":"Public Library of Science (PLoS)","issue":"2","license":[{"start":{"date-parts":[[2026,2,4]],"date-time":"2026-02-04T00:00:00Z","timestamp":1770163200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"European Union\u2019s Horizon 2020 research and innovation programme","award":["779334"],"award-info":[{"award-number":["779334"]}]},{"name":"the \u201cGlobal Alliance for Chronic Diseases (GACD) prevention and management of mental disorders\u201d","award":["SCI-HCO-07-2017"],"award-info":[{"award-number":["SCI-HCO-07-2017"]}]}],"content-domain":{"domain":["www.plosone.org"],"crossmark-restriction":false},"short-container-title":["PLoS One"],"abstract":"\n Background<\/jats:title>\n The IMPULSE trial investigated the effectiveness and implementation of a digital psychosocial intervention (DIALOG+) for people with psychosis in five Southeast European countries. DIALOG+ significantly improved patients\u2019 quality of life after four treatment sessions. The process evaluation reported here aimed to assess contextual influences on intervention delivery during the trial, to explain the trial findings and generate hypotheses about mechanisms of action by exploring acceptability from the perspectives of clinicians who delivered it and trial participants who received it, and fidelity (was the intervention delivered and received as planned?).<\/jats:p>\n <\/jats:sec>\n \n Method<\/jats:title>\n A mixed-methods process evaluation was conducted in accordance with the published protocol, guided by theoretical frameworks and the Medical Research Council\u2019s guidance for complex interventions. To explore the role of context, data were analysed about the participating services, policy documents, and from focus groups with key stakeholders. Semi-structured interviews with clinicians and patients were conducted to explore acceptability. Process data (format and content of sessions) were analysed to assess intervention fidelity. Data analysis included descriptive methods, framework and content analysis, and triangulation.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n Several attributes of context related to health services, including resource limitations, funding priorities, reliance on paper records and lack of community support, potentially negatively impacted DIALOG+ acceptability, fidelity and outcomes. Contextual enablers were also identified, including an appetite for change among key stakeholders that can help overcome contextual barriers. Acceptability of the psychosocial intervention was moderate to high and fidelity was high.<\/jats:p>\n <\/jats:sec>\n \n Conclusions<\/jats:title>\n Intervention acceptability is likely to have played a key role in ensuring high fidelity, which in turn likely contributed to the intervention\u2019s positive impact on patients\u2019 quality of life. The high fidelity confirms that the IMPULSE trial findings provide a valid assessment of the intervention as designed. While the identified contextual barriers appear not to have impaired intervention fidelity, acceptability and outcomes, they could pose challenges to the long-term sustainability of the intervention.<\/jats:p>\n <\/jats:sec>\n \n Trial registration<\/jats:title>\n Retrospectively registered on 29 March 2021, ISRCTN11913964<\/jats:p>\n <\/jats:sec>","DOI":"10.1371\/journal.pone.0338408","type":"journal-article","created":{"date-parts":[[2026,2,4]],"date-time":"2026-02-04T18:34:51Z","timestamp":1770230091000},"page":"e0338408","update-policy":"https:\/\/doi.org\/10.1371\/journal.pone.corrections_policy","source":"Crossref","is-referenced-by-count":0,"title":["Process evaluation of a hybrid effectiveness-implementation, pragmatic, cluster randomised controlled trial (IMPULSE) to improve psychosocial treatment of patients with psychotic-spectrum disorders in Southeast Europe"],"prefix":"10.1371","volume":"21","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4362-0165","authenticated-orcid":true,"given":"Tamara","family":"Pemovska","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7554-9837","authenticated-orcid":true,"given":"Nikolina","family":"Jovanovi\u0107","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tamara","family":"Radoji\u010di\u0107","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Silvana","family":"Markovska Simoska","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Fjolla","family":"Ramadani","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sanja","family":"Andri\u0107 Petrovi\u0107","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Emina","family":"Karamehi\u0107","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8905-5301","authenticated-orcid":true,"given":"Biljana","family":"Blazhevska Stoilkovska","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jon","family":"Konjufca","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Stefan","family":"Jeroti\u0107","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alma","family":"D\u017eubur Kulenovi\u0107","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lidija","family":"Injac Stevovi\u0107","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5784-8895","authenticated-orcid":true,"given":"Jill J.","family":"Francis","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"340","published-online":{"date-parts":[[2026,2,4]]},"reference":[{"key":"pone.0338408.ref001","volume-title":"Mental health atlas 2014","author":"World Health Organization","year":"2015"},{"key":"pone.0338408.ref002","volume-title":"Mental Health Action Plan 2013-2020","author":"World Health Organization","year":"2013"},{"issue":"1","key":"pone.0338408.ref003","doi-asserted-by":"crossref","first-page":"83","DOI":"10.2478\/gp-2019-0020","article-title":"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)","volume":"3","author":"N Jovanovic","year":"2020","journal-title":"Global Psychiatry"},{"issue":"5","key":"pone.0338408.ref004","doi-asserted-by":"crossref","first-page":"304","DOI":"10.1159\/000430991","article-title":"The Effectiveness of a Patient-Centred Assessment with a Solution-Focused Approach (DIALOG+) for Patients with Psychosis: A Pragmatic Cluster-Randomised Controlled Trial in Community Care","volume":"84","author":"S Priebe","year":"2015","journal-title":"Psychother Psychosom"},{"issue":"2","key":"pone.0338408.ref005","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pone.0148415","article-title":"Exploring the Mechanisms of a Patient-Centred Assessment with a Solution Focused Approach (DIALOG+) in the Community Treatment of Patients with Psychosis: A Process Evaluation within a Cluster-Randomised Controlled Trial","volume":"11","author":"S Omer","year":"2016","journal-title":"PLoS One"},{"issue":"1","key":"pone.0338408.ref006","doi-asserted-by":"crossref","DOI":"10.1192\/j.eurpsy.2022.2302","article-title":"Improving treatment of patients with psychosis in low-and-middle-income countries in Southeast Europe: Results from a hybrid effectiveness-implementation, pragmatic, cluster-randomized clinical trial (IMPULSE)","volume":"65","author":"N Jovanovi\u0107","year":"2022","journal-title":"Eur Psychiatry"},{"issue":"1","key":"pone.0338408.ref007","doi-asserted-by":"crossref","DOI":"10.1192\/j.eurpsy.2022.2310","article-title":"Cost-effectiveness of implementing a digital psychosocial intervention for patients with psychotic spectrum disorders in low- and middle-income countries in Southeast Europe: Economic evaluation alongside a cluster randomised trial","volume":"65","author":"Y Feng","year":"2022","journal-title":"Eur Psychiatry"},{"key":"pone.0338408.ref008","doi-asserted-by":"crossref","DOI":"10.1136\/bmj.h1258","article-title":"Process evaluation of complex interventions: Medical Research Council guidance","volume":"350","author":"GF Moore","year":"2015","journal-title":"BMJ"},{"issue":"1","key":"pone.0338408.ref009","doi-asserted-by":"crossref","first-page":"20","DOI":"10.52095\/gp.2020.1407","article-title":"Protocol for a process evaluation of a cluster randomised controlled trial to improve psychosocial treatment of patients with psychotic spectrum disorders: the IMPULSE trial","volume":"4","author":"T Pemovska","year":"2021","journal-title":"GPA"},{"issue":"6","key":"pone.0338408.ref010","doi-asserted-by":"crossref","first-page":"1","DOI":"10.3310\/pgfar05060","article-title":"Effective patient\u2013clinician interaction to improve treatment outcomes for patients with psychosis: a mixed-methods design","volume":"5","author":"S Priebe","year":"2017","journal-title":"Programme Grants Appl Res"},{"issue":"1","key":"pone.0338408.ref011","doi-asserted-by":"crossref","first-page":"31","DOI":"10.52095\/gp.2020.1409","article-title":"Implementing a mental health intervention in low-and-middle-income countries in Europe: is it all about resources?","volume":"4","author":"J Hunter","year":"2021","journal-title":"GPA"},{"key":"pone.0338408.ref012","author":"J Hunter","year":"2019"},{"key":"pone.0338408.ref013","year":"2019"},{"key":"pone.0338408.ref014","author":"L Injac Stevovi\u0107","year":"2018"},{"key":"pone.0338408.ref015","author":"A Ar\u00ebnliu","year":"2018"},{"issue":"1","key":"pone.0338408.ref016","doi-asserted-by":"crossref","first-page":"468","DOI":"10.1186\/s12888-021-03466-x","article-title":"Implementing a digital mental health intervention for individuals with psychosis - a multi-country qualitative study","volume":"21","author":"T Pemovska","year":"2021","journal-title":"BMC Psychiatry"},{"issue":"5","key":"pone.0338408.ref017","doi-asserted-by":"crossref","DOI":"10.1192\/bjo.2022.539","article-title":"Perceived sustainability of psychosocial treatment in low- and middle-income countries in South-Eastern Europe","volume":"8","author":"E Ribic","year":"2022","journal-title":"BJPsych Open"},{"issue":"5","key":"pone.0338408.ref018","doi-asserted-by":"crossref","first-page":"443","DOI":"10.1037\/0278-6133.23.5.443","article-title":"Enhancing treatment fidelity in health behavior change studies: best practices and recommendations from the NIH Behavior Change Consortium","volume":"23","author":"AJ Bellg","year":"2004","journal-title":"Health Psychol"},{"key":"pone.0338408.ref019","doi-asserted-by":"crossref","first-page":"40","DOI":"10.1186\/1748-5908-2-40","article-title":"A conceptual framework for implementation fidelity","volume":"2","author":"C Carroll","year":"2007","journal-title":"Implement Sci"},{"key":"pone.0338408.ref020"},{"issue":"1","key":"pone.0338408.ref021","doi-asserted-by":"crossref","first-page":"52","DOI":"10.1186\/s13012-019-0900-8","article-title":"Attributes of context relevant to healthcare professionals\u2019 use of research evidence in clinical practice: a multi-study analysis","volume":"14","author":"JE Squires","year":"2019","journal-title":"Implement Sci"},{"issue":"3","key":"pone.0338408.ref022","doi-asserted-by":"crossref","first-page":"377","DOI":"10.1177\/1049732305285708","article-title":"Developing and implementing a triangulation protocol for qualitative health research","volume":"16","author":"T Farmer","year":"2006","journal-title":"Qual Health Res"},{"issue":"1","key":"pone.0338408.ref023","doi-asserted-by":"crossref","first-page":"88","DOI":"10.1186\/s12913-017-2031-8","article-title":"Acceptability of healthcare interventions: an overview of reviews and development of a theoretical framework","volume":"17","author":"M Sekhon","year":"2017","journal-title":"BMC Health Serv Res"},{"key":"pone.0338408.ref024","doi-asserted-by":"crossref","first-page":"173","DOI":"10.4324\/9780203413081_chapter_9","article-title":"Qualitative data analysis for applied policy research.","volume-title":"Analyzing Qualitative Data","author":"J Ritchie","year":"1994","edition":"1"},{"issue":"9","key":"pone.0338408.ref025","doi-asserted-by":"crossref","first-page":"1277","DOI":"10.1177\/1049732305276687","article-title":"Three approaches to qualitative content analysis","volume":"15","author":"H-F Hsieh","year":"2005","journal-title":"Qual Health Res"},{"issue":"8","key":"pone.0338408.ref026","doi-asserted-by":"crossref","first-page":"675","DOI":"10.1016\/S2215-0366(19)30132-4","article-title":"The Lancet Psychiatry Commission: a blueprint for protecting physical health in people with mental illness","volume":"6","author":"J Firth","year":"2019","journal-title":"Lancet Psychiatry"},{"issue":"8","key":"pone.0338408.ref027","doi-asserted-by":"crossref","first-page":"634","DOI":"10.1016\/S2215-0366(17)30135-9","article-title":"A blind spot on the global mental health map: a scoping review of 25 years\u2019 development of mental health care for people with severe mental illnesses in central and eastern Europe","volume":"4","author":"P Winkler","year":"2017","journal-title":"Lancet Psychiatry"}],"container-title":["PLOS One"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pone.0338408","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,2,4]],"date-time":"2026-02-04T18:34:57Z","timestamp":1770230097000},"score":1,"resource":{"primary":{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pone.0338408"}},"subtitle":[],"editor":[{"given":"Cheong","family":"Kim","sequence":"first","affiliation":[],"role":[{"role":"editor","vocabulary":"crossref"}]}],"short-title":[],"issued":{"date-parts":[[2026,2,4]]},"references-count":27,"journal-issue":{"issue":"2","published-online":{"date-parts":[[2026,2,4]]}},"URL":"https:\/\/doi.org\/10.1371\/journal.pone.0338408","relation":{},"ISSN":["1932-6203"],"issn-type":[{"value":"1932-6203","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,2,4]]}}}