{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,8,15]],"date-time":"2025-08-15T01:29:41Z","timestamp":1755221381010,"version":"3.43.0"},"reference-count":44,"publisher":"Public Library of Science (PLoS)","issue":"8","license":[{"start":{"date-parts":[[2025,8,8]],"date-time":"2025-08-08T00:00:00Z","timestamp":1754611200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["www.plosone.org"],"crossmark-restriction":false},"short-container-title":["PLoS One"],"abstract":"<jats:sec id=\"sec001\">\n<jats:title>Background<\/jats:title>\n<jats:p>Considered a leading contributor to the global health burden, depression is characterized by its multifaceted nature. Recognizing the limitations of pharmacological treatments, non-pharmacological alternatives have been suggested to enhance full remission and increase quality of life.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec002\">\n<jats:title>Aim<\/jats:title>\n<jats:p>To contribute to this field, we aim to develop and investigate the efficacy of a short psychoeducational program as an adjunctive treatment for depression.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec003\">\n<jats:title>Methods\/design<\/jats:title>\n<jats:p>We propose a single-center, prospective, crossover, single blind, randomized controlled trial, with 190 patients diagnosed with Major Depressive Disorder-MDD (DSM-5-TR), and moderate or intense severity by Hamilton Depression Rating Scale -HAMD-17. Participants will be randomly assigned to one of two arms, Treatment as usual (TAU) + Psychoeducation (n\u2009=\u200996) or TAU (n\u2009=\u200996). The psychoeducational program will consist of six weekly group sessions (6\u201310 participants) with each session lasting 90 minutes, covering information and techniques for identifying and coping with depression. Reduction in depressive levels, measured by the Beck Depression Inventory-BDI-II, and an increase in their level of knowledge on depression will be considered our primary outcome. Secondary outcomes, such as improvement in functionality and quality of life, will be measured by the Global Functioning Rating Scale (GAF), Clinical Global Impression Scale, and cognitive and behavioral factors by the Cognitive and Behavioral Avoidance Scale-CBAS, and Thoughts Scale Depressants-DTS (EPD).<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec004\">\n<jats:title>Discussion<\/jats:title>\n<jats:p>Developing and validating a structured psychoeducational program for depression is crucial for understanding the contribution of psychoeducation for depression and to facilitate the replication of findings, if positive. If our program demonstrates efficacy-superiority compared to TAU treatment, it might present as an interesting, cost-effective alternative as an adjunctive treatment. An expansion to other modalities, including open groups, euthymic patients, and online formats, might be considered, depending on our results.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec005\">\n<jats:title>Trial registration<\/jats:title>\n<jats:p>NCT06467474<\/jats:p>\n<\/jats:sec>","DOI":"10.1371\/journal.pone.0329006","type":"journal-article","created":{"date-parts":[[2025,8,8]],"date-time":"2025-08-08T17:29:07Z","timestamp":1754674147000},"page":"e0329006","update-policy":"https:\/\/doi.org\/10.1371\/journal.pone.corrections_policy","source":"Crossref","is-referenced-by-count":0,"title":["Psychoeducation Group for Depression (PEG-D): Study protocol for a prospective, randomized, single-blind, crossover trial"],"prefix":"10.1371","volume":"20","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2064-9953","authenticated-orcid":true,"given":"Adriana Munhoz","family":"Carneiro","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sara Lisboa Teodoro","family":"Silva","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Fernando dos Santos","family":"Fernandes","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jainan Rodrigues","family":"Barretto","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tatiane Rodrigues","family":"de Brito","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lilian Hupfeld","family":"Moreno","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Fernando Cordeiro","family":"Pimentel","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bruna Alcaire","family":"Jorge","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Leonardo Afonso","family":"dos Santos","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Matheus Rassi","family":"Fernandes Ramos","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ricardo Alberto","family":"Moreno","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"340","published-online":{"date-parts":[[2025,8,8]]},"reference":[{"issue":"6","key":"pone.0329006.ref001","doi-asserted-by":"crossref","first-page":"657","DOI":"10.1590\/1516-4446-2020-0650","article-title":"Prevalence and correlates of major depressive disorder: a systematic review","volume":"42","author":"L Guti\u00e9rrez-Rojas","year":"2020","journal-title":"Braz J Psychiatry"},{"issue":"9","key":"pone.0329006.ref002","doi-asserted-by":"crossref","first-page":"641","DOI":"10.1177\/07067437241245384","article-title":"Canadian Network for Mood and Anxiety Treatments (CANMAT) 2023 Update on Clinical Guidelines for Management of Major Depressive Disorder in Adults: R\u00e9seau canadien pour les traitements de l\u2019humeur et de l\u2019anxi\u00e9t\u00e9 (CANMAT) 2023\u00a0: Mise \u00e0 jour des lignes directrices cliniques pour la prise en charge du trouble d\u00e9pressif majeur chez les adultes","volume":"69","author":"RW Lam","year":"2024","journal-title":"Can J Psychiatry"},{"key":"pone.0329006.ref003","article-title":"Clinical practice guidelines for the management of depression","volume":"59","author":"S Gautam","year":"2017","journal-title":"Indian J Psychiatry"},{"key":"pone.0329006.ref004","doi-asserted-by":"crossref","first-page":"38","DOI":"10.1186\/1471-244X-9-38","article-title":"Persistence and compliance to antidepressant treatment in patients with depression: a chart review","volume":"9","author":"N Sawada","year":"2009","journal-title":"BMC Psychiatry"},{"issue":"7","key":"pone.0329006.ref005","doi-asserted-by":"crossref","first-page":"493","DOI":"10.1177\/070674370304800711","article-title":"Patient attitudes regarding causes of depression: implications for psychoeducation","volume":"48","author":"J Srinivasan","year":"2003","journal-title":"Can J Psychiatry"},{"key":"pone.0329006.ref006","doi-asserted-by":"crossref","DOI":"10.4103\/psychiatry.IndianJPsychiatry_780_19","article-title":"Clinical practice guidelines for psychoeducation in psychiatric disorders general principles of psychoeducation","volume":"62","author":"S Sarkhel","year":"2020","journal-title":"Indian J Psychiatry"},{"issue":"3","key":"pone.0329006.ref007","doi-asserted-by":"crossref","first-page":"205","DOI":"10.1093\/brief-treatment\/mhh019","article-title":"Psychoeducation as evidence-based practice: considerations for practice, research, and policy","volume":"4","author":"EP Lukens","year":"2004","journal-title":"Brief Treat Crisis Interven"},{"issue":"1","key":"pone.0329006.ref008","doi-asserted-by":"crossref","first-page":"4","DOI":"10.1002\/wps.20083","article-title":"Advantages and limitations of Internet-based interventions for common mental disorders","volume":"13","author":"G Andersson","year":"2014","journal-title":"World Psychiatry"},{"issue":"4","key":"pone.0329006.ref009","doi-asserted-by":"crossref","first-page":"309","DOI":"10.1016\/0005-7916(84)90094-6","article-title":"An exploratory study: the psychoeducational group treatment of drug-refractory unipolar depression","volume":"15","author":"DO Antonuccio","year":"1984","journal-title":"J Behav Ther Exp Psychiatry"},{"issue":"5","key":"pone.0329006.ref010","doi-asserted-by":"crossref","first-page":"449","DOI":"10.1016\/j.cpr.2009.04.005","article-title":"Psychoeducational treatment and prevention of depression: the \u201cCoping with Depression\u201d course thirty years later","volume":"29","author":"P Cuijpers","year":"2009","journal-title":"Clin Psychol Rev"},{"issue":"11","key":"pone.0329006.ref011","doi-asserted-by":"crossref","first-page":"1019","DOI":"10.1177\/0004867413491154","article-title":"Effectiveness of psychoeducation for depression: a systematic review","volume":"47","author":"MFS de Tursi","year":"2013","journal-title":"Aust N Z J Psychiatry"},{"key":"pone.0329006.ref012","article-title":"How can psychoeducation help in the treatment of mental disorders?","volume":"40","author":"CTD Oliveira","year":"2023","journal-title":"Estud Psicol (Campinas)"},{"key":"pone.0329006.ref013","article-title":"SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials","volume":"346","author":"A-W Chan","year":"2013","journal-title":"BMJ"},{"key":"pone.0329006.ref014","volume-title":"Diagnostic and Statistical Manual of Mental Disorders: DSM-IV","author":"American Psychiatric Association","year":"1994","edition":"4"},{"key":"pone.0329006.ref015","volume-title":"Entrevista cl\u00ednica estruturada para os transtornos do DSM-5: SCID-5-CV vers\u00e3o cl\u00ednica","author":"MB First","year":"2017"},{"issue":"1","key":"pone.0329006.ref016","doi-asserted-by":"crossref","first-page":"56","DOI":"10.1136\/jnnp.23.1.56","article-title":"A rating scale for depression","volume":"23","author":"M Hamilton","year":"1960","journal-title":"J Neurol Neurosurg Psychiatry"},{"issue":"5","key":"pone.0329006.ref017","first-page":"255","article-title":"Tradu\u00e7\u00e3o do ingl\u00eas para o portugu\u00eas do question\u00e1rio de auto-avalia\u00e7\u00e3o da escala de Hamilton para a depress\u00e3o","volume":"42","author":"TRF Carvalho","year":"1993","journal-title":"J Brasileiro de Psiquiatria"},{"issue":"3","key":"pone.0329006.ref018","doi-asserted-by":"crossref","first-page":"291","DOI":"10.1016\/S0165-0327(02)00168-4","article-title":"Clinical impact of a 2-week psychotropic medication washout in unipolar depressed inpatients","volume":"75","author":"MF Grunebaum","year":"2003","journal-title":"J Affect Disord"},{"issue":"1","key":"pone.0329006.ref019","doi-asserted-by":"crossref","first-page":"51","DOI":"10.1007\/BF01064682","article-title":"Clinical profile of clozapine: adverse reactions and agranulocytosis","volume":"63","author":"JA Lieberman","year":"1992","journal-title":"Psychiatr Q"},{"key":"pone.0329006.ref020","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1111\/j.1600-0447.1987.tb10566.x","article-title":"The UKU side effect rating scale. A new comprehensive rating scale for psychotropic drugs and a cross-sectional study of side effects in neuroleptic-treated patients","volume":"334","author":"O Lingjaerde","year":"1987","journal-title":"Acta Psychiatr Scand Suppl"},{"key":"pone.0329006.ref021","unstructured":"Carneiro A, Lisboa S, Souto P, Oliveira P, Moreno R. Psychoeducation for Major Depressive Disorder: protocol for a systematic review [Internet]. PROSPERO. 2024 [cited 2025 Apr 8]. Available from: https:\/\/www.crd.york.ac.uk\/PROSPERO\/view\/CRD42023412082."},{"key":"pone.0329006.ref022","volume-title":"Estudo da confiabilidade e validade de uma vers\u00e3o modificada da Young Mania Rating Scale","author":"JAA Vilela","year":"2000"},{"key":"pone.0329006.ref023","volume-title":"Manual for the Beck Depression Inventory-II","author":"AT Beck","year":"1996"},{"key":"pone.0329006.ref024","volume-title":"Invent\u00e1rio Beck de Depress\u00e3o-II","author":"C Gorenstein","year":"2011"},{"issue":"3","key":"pone.0329006.ref025","doi-asserted-by":"crossref","first-page":"293","DOI":"10.1016\/S0005-7967(03)00140-2","article-title":"Avoidance and depression: the construction of the cognitive-behavioral avoidance scale","volume":"42","author":"ND Ottenbreit","year":"2004","journal-title":"Behav Res Ther"},{"key":"pone.0329006.ref026","volume-title":"Escala de Pensamentos Depressivos-EPD","author":"AM Carneiro","year":"2016"},{"issue":"2","key":"pone.0329006.ref027","doi-asserted-by":"crossref","first-page":"502","DOI":"10.1111\/j.1365-2753.2010.01614.x","article-title":"Reliability and validity of the Global Assessment of Functioning Scale in clinical outpatients with depressive disorders","volume":"18","author":"EMV Grootenboer","year":"2012","journal-title":"J Eval Clin Pract"},{"key":"pone.0329006.ref028","first-page":"28","article-title":"The clinical global impressions scale: applying a research tool in clinical practice","volume":"7","author":"J Busner","year":"2007","journal-title":"Psychiatry (Edgmont)"},{"key":"pone.0329006.ref029","doi-asserted-by":"crossref","first-page":"382","DOI":"10.1192\/bjp.134.4.382","article-title":"A new depression scale designed to be sensitive to change","volume":"134","author":"SA Montgomery","year":"1979","journal-title":"Br J Psychiatry"},{"key":"pone.0329006.ref030","doi-asserted-by":"crossref","first-page":"797","DOI":"10.1192\/bjp.150.6.797","article-title":"Depression assessment in Brazil. The first application of the Montgomery-Asberg Depression Rating Scale","volume":"150","author":"L Dratcu","year":"1987","journal-title":"Br J Psychiatry"},{"key":"pone.0329006.ref031","doi-asserted-by":"crossref","first-page":"42","DOI":"10.1186\/s12955-015-0235-3","article-title":"Hamilton depression rating scale and montgomery-asberg depression rating scale in depressed and bipolar I patients: psychometric properties in a Brazilian sample","volume":"13","author":"AM Carneiro","year":"2015","journal-title":"Health Qual Life Outcomes"},{"issue":"3","key":"pone.0329006.ref032","doi-asserted-by":"crossref","first-page":"318","DOI":"10.1097\/00004714-200206000-00013","article-title":"Effects of interrater reliability of psychopathologic assessment on power and sample size calculations in clinical trials","volume":"22","author":"MJ M\u00fcller","year":"2002","journal-title":"J Clin Psychopharmacol"},{"issue":"2","key":"pone.0329006.ref033","first-page":"137","article-title":"Moderate and severe depression. Gradations for the Montgomery-Asberg Depression Rating Scale","volume":"60","author":"MJ M\u00fcller","year":"2000","journal-title":"J Affect Disord"},{"key":"pone.0329006.ref034","doi-asserted-by":"crossref","first-page":"429","DOI":"10.1192\/bjp.133.5.429","article-title":"A rating scale for mania: reliability, validity and sensitivity","volume":"133","author":"RC Young","year":"1978","journal-title":"Br J Psychiatry"},{"issue":"2","key":"pone.0329006.ref035","doi-asserted-by":"crossref","first-page":"175","DOI":"10.3758\/BF03193146","article-title":"G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences","volume":"39","author":"F Faul","year":"2007","journal-title":"Behav Res Methods"},{"issue":"2","key":"pone.0329006.ref036","doi-asserted-by":"crossref","first-page":"377","DOI":"10.1016\/j.jbi.2008.08.010","article-title":"Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support","volume":"42","author":"PA Harris","year":"2009","journal-title":"J Biomed Inform"},{"key":"pone.0329006.ref037","volume-title":"Stata Statistical Software: Release 18","author":"StataCorp","year":"2023"},{"key":"pone.0329006.ref038","volume-title":"RStudio: Integrated Development for R","author":"RStudio Team","year":"2020"},{"key":"pone.0329006.ref039","doi-asserted-by":"crossref","first-page":"18","DOI":"10.1186\/1741-7015-8-18","article-title":"CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials","volume":"8","author":"CONSORT Group","year":"2010","journal-title":"BMC Med"},{"key":"pone.0329006.ref040","doi-asserted-by":"crossref","first-page":"83","DOI":"10.1186\/1471-244X-11-83","article-title":"The Clinical Global Impression Scale and the influence of patient or staff perspective on outcome","volume":"11","author":"T Forkmann","year":"2011","journal-title":"BMC Psychiatry"},{"key":"pone.0329006.ref041","first-page":"2811","article-title":"The low level of understanding of depression among patients treated with antidepressants: a survey of 424 outpatients in Japan","volume":"11","author":"S Kudo","year":"2015","journal-title":"Neuropsychiatr Dis Treat"},{"key":"pone.0329006.ref042","first-page":"33","article-title":"Psychoeducation: a measure to strengthen psychiatric treatment","volume":"14","author":"D Bhattacharjee","year":"2011","journal-title":"Ind Psychiatry J"},{"key":"pone.0329006.ref043","doi-asserted-by":"crossref","first-page":"79","DOI":"10.1186\/1741-7015-7-79","article-title":"Psychoeducation for depression, anxiety and psychological distress: a meta-analysis","volume":"7","author":"T Donker","year":"2009","journal-title":"BMC Med"},{"key":"pone.0329006.ref044","doi-asserted-by":"crossref","first-page":"15","DOI":"10.1186\/1745-0179-2-15","article-title":"A randomized controlled trial of a psychoeducational group program for unipolar depression in adults in Norway (NCT00319540)","volume":"2","author":"OS Dalgard","year":"2006","journal-title":"Clin Pract Epidemiol Ment Health"}],"container-title":["PLOS One"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pone.0329006","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,8,8]],"date-time":"2025-08-08T17:29:13Z","timestamp":1754674153000},"score":1,"resource":{"primary":{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pone.0329006"}},"subtitle":[],"editor":[{"given":"Dauda","family":"Salihu","sequence":"first","affiliation":[],"role":[{"role":"editor","vocabulary":"crossref"}]}],"short-title":[],"issued":{"date-parts":[[2025,8,8]]},"references-count":44,"journal-issue":{"issue":"8","published-online":{"date-parts":[[2025,8,8]]}},"URL":"https:\/\/doi.org\/10.1371\/journal.pone.0329006","relation":{},"ISSN":["1932-6203"],"issn-type":[{"value":"1932-6203","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,8,8]]}}}