{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,21]],"date-time":"2026-10-21T17:58:23Z","timestamp":1792605503880,"version":"4.5.0"},"reference-count":72,"publisher":"JMIR Publications Inc.","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JMIR Res Protoc"],"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Pregnancy is a complex period involving significant physical, mental, and social changes in a woman\u2019s life, affecting her psychological well-being. According to the literature, anxiety, stress, and depression are common symptoms among pregnant women. Promoting a healthy lifestyle with a focus on mental health is essential. In this context, digital solutions such as coaches on smartphones are emerging as valuable tools to support the psychological well-being of pregnant women without existing disorders.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>This study aims to present the research protocol of a pilot study designed as a proof-of-concept investigation. The study evaluates the feasibility, acceptability, and utility of an acceptance and commitment therapy\u2013based stress management mobile app. The primary objective is to explore the feasibility of using a coach, ALBA (A Well-Being Assistant), developed within the TreC Ricerca app, to promote women\u2019s psychological well-being during pregnancy through 5 sessions based on acceptance and commitment therapy. The pre- and postintervention effects on psychological well-being will also be explored as a secondary objective, serving as a proxy for the potential impact of the intervention.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>The study serves as a proof-of-concept investigation, where a small sample size (N=50) is deemed adequate to fulfill the study\u2019s objectives. Participant recruitment will be conducted among pregnant women affiliated with the pregnancy care services of the Azienda Provinciale per i Servizi Sanitari di Trento, using a convenience sampling approach. ALBA will interact with the participating women for 6 weeks, between the 14th and 26th weeks of gestation. Specifically, there will be 1 session per week, which the woman can choose, to allow more flexibility regarding her needs, supplemented by ALBA-supported exercises to be performed between sessions. This study adopts a mixed methods approach, combining quantitative and qualitative data collection and analysis. Usability and engagement are assessed using the System Usability Scale, Chatbot Usability Questionnaire, User Engagement Scale-Short Form, and the User Mobile Rating Scale. Moreover, other quantitative outcome measures include levels of stress, anxiety, depression, emotional regulation, psychological flexibility, coping strategies, self-efficacy, and overall well-being, along with qualitative data from semistructured interviews. Finally, the analysis of the data gathered in this study will primarily adopt descriptive statistics and a text mining approach, focused on evaluating the attainment of the study objectives and changes over experimental time.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>The psychoeducational approach aims to yield notable outcomes regarding the usability and engagement of women with ALBA. Furthermore, an anticipated enhancement in psychological well-being and quality of life is expected.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Existing literature indicates a preference among women in the perinatal period for online support, highlighting the potential of digital interventions to address barriers related to social stigma and seeking assistance. In this context, ALBA emerges as a valuable resource, providing consistent psychoeducational support for women throughout pregnancy.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>International Registered Report Identifier (IRRID)<\/jats:title>\n                    <jats:p>PRR1-10.2196\/53891<\/jats:p>\n                  <\/jats:sec>","DOI":"10.2196\/53891","type":"journal-article","created":{"date-parts":[[2025,5,28]],"date-time":"2025-05-28T17:20:06Z","timestamp":1748452806000},"page":"e53891","source":"Crossref","is-referenced-by-count":5,"title":["A Chatbot-Based Version of a World Health Organization\u2013Validated Intervention (Self-Help Plus) for Stress Management in Pregnant Women: Protocol for a Usability Study"],"prefix":"10.2196","volume":"14","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8610-2432","authenticated-orcid":false,"given":"Silvia","family":"Rizzi","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8524-8432","authenticated-orcid":false,"given":"Valentina","family":"Fietta","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2981-0851","authenticated-orcid":false,"given":"Lorenzo","family":"Gios","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6271-6037","authenticated-orcid":false,"given":"Stefania","family":"Poggianella","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0002-1240-8508","authenticated-orcid":false,"given":"Maria Chiara","family":"Pavesi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0007-5689-7987","authenticated-orcid":false,"given":"Chiara","family":"De Luca","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0001-3756-4518","authenticated-orcid":false,"given":"Debora","family":"Marroni","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0003-9668-5234","authenticated-orcid":false,"given":"Claudia","family":"Paoli","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0006-2747-5745","authenticated-orcid":false,"given":"Anna","family":"Gianatti","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0005-4402-8675","authenticated-orcid":false,"given":"Barbara","family":"Burlon","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0005-7620-9200","authenticated-orcid":false,"given":"Vanda","family":"Chiodega","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0002-5922-2647","authenticated-orcid":false,"given":"Barbara","family":"Endrizzi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0002-5582-0287","authenticated-orcid":false,"given":"Angela","family":"Giordano","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0009-5139-3784","authenticated-orcid":false,"given":"Francesca","family":"Biagioli","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0009-8720-691X","authenticated-orcid":false,"given":"Veronica","family":"Albertini","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3783-8195","authenticated-orcid":false,"given":"Marianna","family":"Purgato","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1073-9282","authenticated-orcid":false,"given":"Corrado","family":"Barbui","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0008-8788-1504","authenticated-orcid":false,"given":"Chiara","family":"Guella","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0003-1506-4728","authenticated-orcid":false,"given":"Erik","family":"Gadotti","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3471-2033","authenticated-orcid":false,"given":"Stefano","family":"Forti","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0002-0279-6594","authenticated-orcid":false,"given":"Fabrizio","family":"Taddei","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1010","published-online":{"date-parts":[[2025,8,1]]},"reference":[{"key":"ref1","doi-asserted-by":"publisher","DOI":"10.1192\/bjp.bp.115.179556"},{"key":"ref2","doi-asserted-by":"publisher","DOI":"10.32872\/cpe.6847"},{"key":"ref3","doi-asserted-by":"publisher","DOI":"10.1037\/tra0000703"},{"key":"ref4","unstructured":"World mental health report: transforming mental health for allWorld Health Organization202206162025-07-12https:\/\/www.who.int\/publications\/i\/item\/9789240049338"},{"key":"ref5","doi-asserted-by":"publisher","DOI":"10.1007\/s00737-013-0402-7"},{"key":"ref6","doi-asserted-by":"publisher","DOI":"10.1002\/brb3.1561"},{"key":"ref7","doi-asserted-by":"publisher","DOI":"10.1097\/01.aoa.0000389617.09252.47"},{"key":"ref8","doi-asserted-by":"publisher","DOI":"10.1016\/j.midw.2015.09.002"},{"key":"ref9","doi-asserted-by":"publisher","DOI":"10.1186\/s12884-021-04021-y"},{"key":"ref10","doi-asserted-by":"publisher","DOI":"10.1007\/s00737-023-01327-y"},{"key":"ref11","doi-asserted-by":"publisher","DOI":"10.1089\/jicm.2023.0114"},{"key":"ref12","doi-asserted-by":"publisher","DOI":"10.1016\/j.jad.2015.06.029"},{"key":"ref13","doi-asserted-by":"publisher","DOI":"10.1016\/j.midw.2024.103973"},{"key":"ref14","unstructured":"Mental well-being: resources for the publicWorld Health Organization20212025-04-22https:\/\/www.who.int\/news-room\/feature-stories\/mental-well-being-resources-for-the-public"},{"key":"ref15","unstructured":"Mental Health Gap Action Programme (\u200emhGAP)\u200e guideline for mental, neurological and substance use disorders: executive summaryWorld Health Organization20252025-07-12https:\/\/iris.who.int\/handle\/10665\/381088"},{"key":"ref16","doi-asserted-by":"publisher","DOI":"10.3389\/fdgth.2025.1560580"},{"key":"ref17","doi-asserted-by":"publisher","DOI":"10.1016\/j.invent.2015.06.002"},{"key":"ref18","doi-asserted-by":"publisher","DOI":"10.1159\/000517504"},{"key":"ref19","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2019-030259"},{"key":"ref20","doi-asserted-by":"publisher","DOI":"10.1007\/s10608-022-10338-5"},{"key":"ref21","doi-asserted-by":"publisher","DOI":"10.1177\/20552076221129084"},{"key":"ref22","doi-asserted-by":"crossref","DOI":"10.1037\/17335-000","author":"Hayes, SC","year":"2012","journal-title":"Acceptance and Commitment Therapy: The Process and Practice of Mindful Change"},{"key":"ref23","doi-asserted-by":"publisher","DOI":"10.1016\/j.brat.2005.06.006"},{"key":"ref24","doi-asserted-by":"publisher","DOI":"10.1186\/s12913-017-2031-8"},{"key":"ref25","doi-asserted-by":"publisher","DOI":"10.1007\/s10488-010-0319-7"},{"key":"ref26","doi-asserted-by":"publisher","DOI":"10.1037\/hea0000161"},{"key":"ref27","doi-asserted-by":"publisher","DOI":"10.1080\/17437199.2012.654964"},{"key":"ref28","unstructured":"Self-help plus (SH+)World Health Organization202109232025-07-12https:\/\/www.who.int\/publications\/i\/item\/9789240035119"},{"key":"ref29","doi-asserted-by":"publisher","DOI":"10.2196\/64614"},{"key":"ref30","doi-asserted-by":"publisher","DOI":"10.1016\/j.jbi.2019.103359"},{"key":"ref31","unstructured":"RischioGAAborto spontaneo: dati statisticiAssociazione Georgia2025-04-22http:\/\/www.associazionegeorgia.it\/2017\/area\/gravidanza-a-rischio\/aborto-spontaneo\/"},{"key":"ref32","doi-asserted-by":"publisher","DOI":"10.1089\/jwh.2007.0505"},{"key":"ref33","doi-asserted-by":"publisher","DOI":"10.1080\/01621459.1987.10478478"},{"key":"ref34","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijhcs.2018.01.004"},{"key":"ref35","author":"Brooke, J","year":"1996","journal-title":"Usability Evaluation in Industry"},{"key":"ref36","doi-asserted-by":"publisher","DOI":"10.1007\/s00779-023-01731-2"},{"key":"ref37","doi-asserted-by":"publisher","DOI":"10.2196\/mhealth.5849"},{"key":"ref38","doi-asserted-by":"publisher","DOI":"10.1145\/2702613.2732511"},{"key":"ref39","doi-asserted-by":"publisher","DOI":"10.1002\/asi.20801"},{"issue":"2","key":"ref40","first-page":"29","volume":"8","author":"Brooke, J","year":"2013","journal-title":"J Usability Stud"},{"key":"ref41","doi-asserted-by":"publisher","DOI":"10.2196\/mhealth.3422"},{"key":"ref42","doi-asserted-by":"publisher","DOI":"10.1006\/ijhc.1996.0101"},{"key":"ref43","author":"O\u2019Brien, H","year":"2016","journal-title":"Why Engagement Matters: Cross-Disciplinary Perspectives of User Engagement in Digital Media"},{"key":"ref44","doi-asserted-by":"publisher","DOI":"10.1080\/10447318.2015.1064648"},{"key":"ref45","doi-asserted-by":"publisher","DOI":"10.1017\/s0033291702006074"},{"key":"ref46","unstructured":"Kessler 10Transcultural Mental Health Centre2024-04-17https:\/\/www.dhi.health.nsw.gov.au\/transcultural-mental-health-centre-tmhc\/resources\/multilingual-resources-by-title\/kessler-10"},{"key":"ref47","doi-asserted-by":"publisher","DOI":"10.1177\/1073191116645905"},{"key":"ref48","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcbs.2021.05.007"},{"key":"ref49","doi-asserted-by":"publisher","DOI":"10.2307\/2136404"},{"key":"ref50","unstructured":"LimeSurvey homepageLimeSurvey2025-04-22http:\/\/www.limesurvey.org"},{"key":"ref51","doi-asserted-by":"publisher","DOI":"10.1037\/0022-3514.56.2.267"},{"key":"ref52","doi-asserted-by":"publisher","DOI":"10.3280\/PDS2015-002007"},{"key":"ref53","doi-asserted-by":"publisher","DOI":"10.1037\/0022-3514.85.2.348"},{"key":"ref54","doi-asserted-by":"publisher","DOI":"10.1027\/1015-5759\/a000009"},{"key":"ref55","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.2.5707.439"},{"key":"ref56","doi-asserted-by":"publisher","DOI":"10.1017\/s0033291700023710"},{"key":"ref57","first-page":"35","author":"Schwarzer, R","year":"1995","journal-title":"Measures in Health Psychology: A User\u2019s Portfolio"},{"key":"ref58","doi-asserted-by":"publisher","DOI":"10.1027\/\/1015-5759.18.3.242"},{"key":"ref59","unstructured":"SibiliaLSchwarzerRJerusalemMItalian adaptation of the general self-efficacy scale: self-efficacy generalizzataFree University of Berlin19952024-04-17http:\/\/userpage.fu-berlin.de\/~health\/italian.htm"},{"key":"ref60","unstructured":"Laboratory for the study of stress, immunity, and diseaseCarnegie Mellon University2025-07-14https:\/\/www.cmu.edu\/dietrich\/psychology\/stress-immunity-disease-lab\/scales\/index.html"},{"key":"ref61","doi-asserted-by":"publisher","DOI":"10.1097\/00005650-199206000-00002"},{"key":"ref62","doi-asserted-by":"publisher","DOI":"10.1016\/s0895-4356(98)00094-8"},{"key":"ref63","doi-asserted-by":"publisher","DOI":"10.1177\/1541931213571043"},{"key":"ref64","unstructured":"Linee guida per i siti web delle PA: vademecumGruppo di Lavoro per l\u2019Usabilit\u00e0 (GLU)20162025-07-23https:\/\/www.formez.it\/docs\/default-source\/pubblicazioni\/protocollo_eglu_2_0-pdf.pdf?sfvrsn=baf8350d_2"},{"key":"ref65","doi-asserted-by":"publisher","DOI":"10.2196\/mhealth.5849"},{"key":"ref66","doi-asserted-by":"publisher","DOI":"10.15167\/2421-4248\/jpmh2021.62.1.1894"},{"key":"ref67","author":"Marshall, C","year":"2021","journal-title":"Designing Qualitative Research"},{"key":"ref68","author":"Sheskin, DJ","year":"2011","journal-title":"Handbook of Parametric and Nonparametric Statistical Procedures"},{"key":"ref69","doi-asserted-by":"publisher","DOI":"10.1093\/biomet\/37.3-4.256"},{"key":"ref70","author":"Jackson, K","year":"2019","journal-title":"Qualitative Data Analysis with NVivo"},{"key":"ref71","doi-asserted-by":"publisher","DOI":"10.1891\/1058-1243.25.1.29"},{"key":"ref72","doi-asserted-by":"publisher","DOI":"10.1071\/PY13039"}],"container-title":["JMIR Research Protocols"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.researchprotocols.org\/2025\/1\/e53891","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,6,30]],"date-time":"2026-06-30T17:40:00Z","timestamp":1782841200000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.researchprotocols.org\/2025\/1\/e53891"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,8,1]]},"references-count":72,"URL":"https:\/\/doi.org\/10.2196\/53891","relation":{"has-preprint":[{"id-type":"doi","id":"10.2196\/preprints.53891","asserted-by":"object"}]},"ISSN":["1929-0748"],"issn-type":[{"value":"1929-0748","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,8,1]]}}}