Effectiveness of a guided mobile app intervention for depression and anxiety in university students (PROMES-U study): protocol of a multicenter randomized controlled trial
Background: Symptoms of depression and anxiety are common among Spanish university students. Minimally guided online interventions have shown promise in reducing symptomatology and preventing increased mental distress. Here we describe the protocol of a controlled study which aims to evaluate the ef...
| Autores: | , , , , , , , , , , , , , , |
|---|---|
| Tipo de recurso: | artículo |
| Estado: | Versión publicada |
| Fecha de publicación: | 2025 |
| País: | España |
| Institución: | Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya) |
| Repositorio: | Recercat. Dipósit de la Recerca de Catalunya |
| OAI Identifier: | oai:recercat.cat:10230/72612 |
| Acceso en línea: | https://hdl.handle.net/10230/72612 http://dx.doi.org/10.1186/s12889-025-24752-3 |
| Access Level: | acceso abierto |
| Palabra clave: | Anxiety Cognitive behavioral therapy Depression Effectiveness Mhealth Prevention intervention RCT University University students |
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Effectiveness of a guided mobile app intervention for depression and anxiety in university students (PROMES-U study): protocol of a multicenter randomized controlled trial |
| title |
Effectiveness of a guided mobile app intervention for depression and anxiety in university students (PROMES-U study): protocol of a multicenter randomized controlled trial |
| spellingShingle |
Effectiveness of a guided mobile app intervention for depression and anxiety in university students (PROMES-U study): protocol of a multicenter randomized controlled trial Ballester, Laura Anxiety Cognitive behavioral therapy Depression Effectiveness Mhealth Prevention intervention RCT University University students |
| title_short |
Effectiveness of a guided mobile app intervention for depression and anxiety in university students (PROMES-U study): protocol of a multicenter randomized controlled trial |
| title_full |
Effectiveness of a guided mobile app intervention for depression and anxiety in university students (PROMES-U study): protocol of a multicenter randomized controlled trial |
| title_fullStr |
Effectiveness of a guided mobile app intervention for depression and anxiety in university students (PROMES-U study): protocol of a multicenter randomized controlled trial |
| title_full_unstemmed |
Effectiveness of a guided mobile app intervention for depression and anxiety in university students (PROMES-U study): protocol of a multicenter randomized controlled trial |
| title_sort |
Effectiveness of a guided mobile app intervention for depression and anxiety in university students (PROMES-U study): protocol of a multicenter randomized controlled trial |
| dc.creator.none.fl_str_mv |
Ballester, Laura Gili, Margalida Roca, Miquel Forteza-Rey, Inés Soto-Sanz, Victoria Vilagut Saiz, Gemma, 1975- Amigo, Franco Moreno-Kustner, Berta Mortier, Philippe Piqueras, José Antonio Portillo-Van Diest, Ana Rebagliato, Marisa Rodríguez-Jiménez, Tíscar Alonso Caballero, Jordi PROMES-U study group |
| author |
Ballester, Laura |
| author_facet |
Ballester, Laura Gili, Margalida Roca, Miquel Forteza-Rey, Inés Soto-Sanz, Victoria Vilagut Saiz, Gemma, 1975- Amigo, Franco Moreno-Kustner, Berta Mortier, Philippe Piqueras, José Antonio Portillo-Van Diest, Ana Rebagliato, Marisa Rodríguez-Jiménez, Tíscar Alonso Caballero, Jordi PROMES-U study group |
| author_role |
author |
| author2 |
Gili, Margalida Roca, Miquel Forteza-Rey, Inés Soto-Sanz, Victoria Vilagut Saiz, Gemma, 1975- Amigo, Franco Moreno-Kustner, Berta Mortier, Philippe Piqueras, José Antonio Portillo-Van Diest, Ana Rebagliato, Marisa Rodríguez-Jiménez, Tíscar Alonso Caballero, Jordi PROMES-U study group |
| author2_role |
author author author author author author author author author author author author author author |
| dc.subject.none.fl_str_mv |
Anxiety Cognitive behavioral therapy Depression Effectiveness Mhealth Prevention intervention RCT University University students |
| topic |
Anxiety Cognitive behavioral therapy Depression Effectiveness Mhealth Prevention intervention RCT University University students |
| description |
Background: Symptoms of depression and anxiety are common among Spanish university students. Minimally guided online interventions have shown promise in reducing symptomatology and preventing increased mental distress. Here we describe the protocol of a controlled study which aims to evaluate the effectiveness of a guided preventive mental health intervention for depression and anxiety in Spanish university students. Methods: Ongoing two-arm multicenter randomized controlled trial (RCT) targeting undergraduate students from 6 public universities with symptoms of depression and/or anxiety. Students are evaluated (between February and November 2024) through a web-based survey assessing mental health problems, use of mental health services, self-perceived health, childhood and adolescent adversities, recent stressful events, social networks, university experiences, as well as sociodemographic variables. A total of 428 students, fulfilling the inclusion criteria, are randomly assigned to: intervention group (minimally guided mhealth prevention intervention) or control group (treatment as usual plus self-monitoring including periodic evaluations on mood and stress). The intervention is based on cognitive behavioral therapy principles, such as relaxation and cognitive restructuring, and includes weekly asynchronous feedback from a psychologist based on content and participation, along with self-monitoring. Participants are assessed at baseline, and 3, 6 and 12 months after randomization. The primary outcome consists of the reduction of depressive and/or anxiety symptoms post-intervention, assessed with the Patient Health Questionnaire-9, the Generalized Anxiety Disorder-7 and the Patient Health Questionnaire-Anxiety and Depression Scale. Secondary outcomes of the RCT will be symptoms of other mental health conditions, psychological wellbeing, academic stress, acceptability and adherence. Primary analyses will be conducted on an intention-to-treat basis. Discussion: The results of the PROMES-U RCT will provide valuable information on the effectiveness of a minimally guided preventive mental health intervention to reduce symptoms of depression and anxiety among university students that could be delivered in the campus context. Results will also provide information on the potential impact of the intervention on other relevant factors involved in mental health among university students and on the acceptability and adherence of this intervention. Trial registration number: NCT06078007. |
| publishDate |
2025 |
| dc.date.none.fl_str_mv |
2025 2026 2026 2026 |
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info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion |
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article |
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publishedVersion |
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https://hdl.handle.net/10230/72612 http://dx.doi.org/10.1186/s12889-025-24752-3 https://hdl.handle.net/10230/72612 |
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https://hdl.handle.net/10230/72612 http://dx.doi.org/10.1186/s12889-025-24752-3 |
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Inglés |
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Inglés |
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BMC Public Health. 2025;25(1):3740 |
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http://creativecommons.org/licenses/by-nc-nd/4.0/ info:eu-repo/semantics/openAccess |
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http://creativecommons.org/licenses/by-nc-nd/4.0/ |
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openAccess |
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application/pdf application/pdf |
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BioMed Central |
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BioMed Central |
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reponame:Recercat. Dipósit de la Recerca de Catalunya instname:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya) |
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Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya) |
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Recercat. Dipósit de la Recerca de Catalunya |
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Recercat. Dipósit de la Recerca de Catalunya |
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Effectiveness of a guided mobile app intervention for depression and anxiety in university students (PROMES-U study): protocol of a multicenter randomized controlled trialBallester, LauraGili, MargalidaRoca, MiquelForteza-Rey, InésSoto-Sanz, VictoriaVilagut Saiz, Gemma, 1975-Amigo, FrancoMoreno-Kustner, BertaMortier, PhilippePiqueras, José AntonioPortillo-Van Diest, AnaRebagliato, MarisaRodríguez-Jiménez, TíscarAlonso Caballero, JordiPROMES-U study groupAnxietyCognitive behavioral therapyDepressionEffectivenessMhealthPrevention interventionRCTUniversityUniversity studentsBackground: Symptoms of depression and anxiety are common among Spanish university students. Minimally guided online interventions have shown promise in reducing symptomatology and preventing increased mental distress. Here we describe the protocol of a controlled study which aims to evaluate the effectiveness of a guided preventive mental health intervention for depression and anxiety in Spanish university students. Methods: Ongoing two-arm multicenter randomized controlled trial (RCT) targeting undergraduate students from 6 public universities with symptoms of depression and/or anxiety. Students are evaluated (between February and November 2024) through a web-based survey assessing mental health problems, use of mental health services, self-perceived health, childhood and adolescent adversities, recent stressful events, social networks, university experiences, as well as sociodemographic variables. A total of 428 students, fulfilling the inclusion criteria, are randomly assigned to: intervention group (minimally guided mhealth prevention intervention) or control group (treatment as usual plus self-monitoring including periodic evaluations on mood and stress). The intervention is based on cognitive behavioral therapy principles, such as relaxation and cognitive restructuring, and includes weekly asynchronous feedback from a psychologist based on content and participation, along with self-monitoring. Participants are assessed at baseline, and 3, 6 and 12 months after randomization. The primary outcome consists of the reduction of depressive and/or anxiety symptoms post-intervention, assessed with the Patient Health Questionnaire-9, the Generalized Anxiety Disorder-7 and the Patient Health Questionnaire-Anxiety and Depression Scale. Secondary outcomes of the RCT will be symptoms of other mental health conditions, psychological wellbeing, academic stress, acceptability and adherence. Primary analyses will be conducted on an intention-to-treat basis. Discussion: The results of the PROMES-U RCT will provide valuable information on the effectiveness of a minimally guided preventive mental health intervention to reduce symptoms of depression and anxiety among university students that could be delivered in the campus context. Results will also provide information on the potential impact of the intervention on other relevant factors involved in mental health among university students and on the acceptability and adherence of this intervention. Trial registration number: NCT06078007.BioMed Central2026202620252026info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfapplication/pdfhttps://hdl.handle.net/10230/72612http://dx.doi.org/10.1186/s12889-025-24752-3https://hdl.handle.net/10230/72612reponame:Recercat. Dipósit de la Recerca de Catalunyainstname:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)InglésBMC Public Health. 2025;25(1):3740© The Author(s) 2025. Open Access This article is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License, which permits any non-commercial use, sharing, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if you modified the licensed material. You do not have permission under this licence to share adapted material derived from this article or parts of it. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc-nd/4.0/.http://creativecommons.org/licenses/by-nc-nd/4.0/info:eu-repo/semantics/openAccessoai:recercat.cat:10230/726122026-05-29T05:05:01Z |
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