Study protocol for pragmatic trials of Internet-delivered guided and unguided cognitive behavior therapy for treating depression and anxiety in university students of two Latin American countries: the Yo Puedo Sentirme Bien study

Antecedentes: el trastorno depresivo mayor (TDM) y el trastorno de ansiedad generalizada (TAG) son muy prevalentes entre los estudiantes universitarios y predicen un deterioro del rendimiento universitario y del funcionamiento posterior de la vida. Sin embargo, la mayoría de los estudiantes no recib...

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Autores:
UCC
Benjet, Corina
Carrasco , Nayib
Kessler, Ronald
Alan , Kazdin
Pim , Cuijpers
Yesica , Albor
Carlos , Contreras-Ibáñez
Ma Socorro , Durán González
Sarah , Gildea
Noé , González
José Benjamín , Guerrero López
Alex , Luedtke
Maria Elena, Medina-Mora5
Jorge , Palacios
Derek , Richards
Alicia , Salamanca-Sanabria
Nancy , Sampson
Tipo de recurso:
Article of investigation
Fecha de publicación:
2022
Institución:
Universidad Cooperativa de Colombia
Repositorio:
Repositorio UCC
Idioma:
OAI Identifier:
oai:repository.ucc.edu.co:20.500.12494/52855
Acceso en línea:
https://doi.org/10.1186/s13063-022-06255-3
https://hdl.handle.net/20.500.12494/52855
Palabra clave:
Depresión
Ansiedad
Terapia Cognitivo Conductual
Estudiantes Universitarios
Depression
Anxiety
Cognitive Behavioral Therapy
University Students
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openAccess
License
http://purl.org/coar/access_right/c_abf2
id COOPER2_f483e05fdfcf01e436a8eb2cfabf568e
oai_identifier_str oai:repository.ucc.edu.co:20.500.12494/52855
network_acronym_str COOPER2
network_name_str Repositorio UCC
repository_id_str
dc.title.none.fl_str_mv Study protocol for pragmatic trials of Internet-delivered guided and unguided cognitive behavior therapy for treating depression and anxiety in university students of two Latin American countries: the Yo Puedo Sentirme Bien study
title Study protocol for pragmatic trials of Internet-delivered guided and unguided cognitive behavior therapy for treating depression and anxiety in university students of two Latin American countries: the Yo Puedo Sentirme Bien study
spellingShingle Study protocol for pragmatic trials of Internet-delivered guided and unguided cognitive behavior therapy for treating depression and anxiety in university students of two Latin American countries: the Yo Puedo Sentirme Bien study
Depresión
Ansiedad
Terapia Cognitivo Conductual
Estudiantes Universitarios
Depression
Anxiety
Cognitive Behavioral Therapy
University Students
title_short Study protocol for pragmatic trials of Internet-delivered guided and unguided cognitive behavior therapy for treating depression and anxiety in university students of two Latin American countries: the Yo Puedo Sentirme Bien study
title_full Study protocol for pragmatic trials of Internet-delivered guided and unguided cognitive behavior therapy for treating depression and anxiety in university students of two Latin American countries: the Yo Puedo Sentirme Bien study
title_fullStr Study protocol for pragmatic trials of Internet-delivered guided and unguided cognitive behavior therapy for treating depression and anxiety in university students of two Latin American countries: the Yo Puedo Sentirme Bien study
title_full_unstemmed Study protocol for pragmatic trials of Internet-delivered guided and unguided cognitive behavior therapy for treating depression and anxiety in university students of two Latin American countries: the Yo Puedo Sentirme Bien study
title_sort Study protocol for pragmatic trials of Internet-delivered guided and unguided cognitive behavior therapy for treating depression and anxiety in university students of two Latin American countries: the Yo Puedo Sentirme Bien study
dc.creator.fl_str_mv UCC
Benjet, Corina
Carrasco , Nayib
Kessler, Ronald
Alan , Kazdin
Pim , Cuijpers
Yesica , Albor
Carlos , Contreras-Ibáñez
Ma Socorro , Durán González
Sarah , Gildea
Noé , González
José Benjamín , Guerrero López
Alex , Luedtke
Maria Elena, Medina-Mora5
Jorge , Palacios
Derek , Richards
Alicia , Salamanca-Sanabria
Nancy , Sampson
dc.contributor.author.none.fl_str_mv UCC
Benjet, Corina
Carrasco , Nayib
Kessler, Ronald
Alan , Kazdin
Pim , Cuijpers
Yesica , Albor
Carlos , Contreras-Ibáñez
Ma Socorro , Durán González
Sarah , Gildea
Noé , González
José Benjamín , Guerrero López
Alex , Luedtke
Maria Elena, Medina-Mora5
Jorge , Palacios
Derek , Richards
Alicia , Salamanca-Sanabria
Nancy , Sampson
dc.subject.none.fl_str_mv Depresión
Ansiedad
Terapia Cognitivo Conductual
Estudiantes Universitarios
topic Depresión
Ansiedad
Terapia Cognitivo Conductual
Estudiantes Universitarios
Depression
Anxiety
Cognitive Behavioral Therapy
University Students
dc.subject.other.none.fl_str_mv Depression
Anxiety
Cognitive Behavioral Therapy
University Students
description Antecedentes: el trastorno depresivo mayor (TDM) y el trastorno de ansiedad generalizada (TAG) son muy prevalentes entre los estudiantes universitarios y predicen un deterioro del rendimiento universitario y del funcionamiento posterior de la vida. Sin embargo, la mayoría de los estudiantes no reciben tratamiento, especialmente en los países de ingresos medianos bajos (PIBM). Nuestro objetivo es evaluar los efectos de ampliar el tratamiento utilizando terapia cognitivo-conductual transdiagnóstico (iCBT) escalable y económica a través de Internet entre estudiantes universitarios con síntomas de TDM y/o TAG en dos países de ingresos bajos y medios de América Latina (Colombia y México) e investigar la viabilidad. de crear una regla de tratamiento de precisión (PTR) para predecir para quién iCBT es más efectiva. Métodos: Primero llevaremos a cabo un ensayo clínico pragmático aleatorio en múltiples sitios (N = 1500) de estudiantes que buscan tratamiento en clínicas de salud mental para estudiantes en universidades participantes o respondiendo a un correo electrónico ofreciendo servicios. Los estudiantes en listas de espera para servicios clínicos serán asignados al azar a iCBT no guiada (33%), iCBT guiada (33%) y tratamiento habitual (TAU) (33%). iCBT se proporcionará inmediatamente, mientras que TAU se proporcionará siempre que haya una cita clínica disponible. Los efectos agregados a corto plazo se evaluarán a los 90 días y los efectos a más largo plazo a los 12 meses después de la aleatorización. Usaremos el aprendizaje automático conjunto para predecir la heterogeneidad de los efectos del tratamiento de iCBT guiada versus no guiada versus TAU y desarrollaremos una regla de tratamiento de precisión (PTR) para optimizar el resultado individual del estudiante. Luego realizaremos un segundo y un tercer ensayo con muestras separadas (n = 500 por brazo), pero con una asignación desigual entre dos brazos: el 25 % se asignará al tratamiento que se determine que produzca resultados óptimos según el PTR desarrollado en el primer ensayo. (PTR para resultados óptimos a corto plazo para el ensayo 2 y resultados a 12 meses para el ensayo 3), mientras que al 75 % restante se le asignará la misma asignación en los tres brazos de tratamiento. Discusión: Al recopilar características de referencia integrales para evaluar la heterogeneidad de los efectos del tratamiento, proporcionaremos información valiosa e innovadora para optimizar los efectos del tratamiento y guiar la planificación universitaria del tratamiento de salud mental. Un esfuerzo de este tipo podría tener enormes implicaciones para la salud pública de la región al aumentar el alcance del tratamiento, disminuir las necesidades insatisfechas y los tiempos de espera en las clínicas, y servir como modelo de planificación e implementación de intervenciones basadas en evidencia.
publishDate 2022
dc.date.issued.none.fl_str_mv 2022-06-02
dc.date.accessioned.none.fl_str_mv 2023-10-07T19:22:31Z
dc.date.available.none.fl_str_mv 2023-10-07T19:22:31Z
dc.type.none.fl_str_mv Artículos Científicos
dc.type.coar.none.fl_str_mv http://purl.org/coar/resource_type/c_2df8fbb1
dc.type.coarversion.none.fl_str_mv http://purl.org/coar/version/c_970fb48d4fbd8a85
dc.type.driver.none.fl_str_mv info:eu-repo/semantics/article
dc.type.version.none.fl_str_mv info:eu-repo/semantics/publishedVersion
format http://purl.org/coar/resource_type/c_2df8fbb1
status_str publishedVersion
dc.identifier.issn.none.fl_str_mv 1745-6215
dc.identifier.uri.none.fl_str_mv https://doi.org/10.1186/s13063-022-06255-3
https://hdl.handle.net/20.500.12494/52855
dc.identifier.bibliographicCitation.none.fl_str_mv Benjet, C., et. al. (2022). Study protocol for pragmatic trials of Internet-delivered guided and unguided cognitive behavior therapy for treating depression and anxiety in university students of two Latin American countries: the Yo Puedo Sentirme Bien study. Trials, 23 (450), 2-19.
identifier_str_mv 1745-6215
Benjet, C., et. al. (2022). Study protocol for pragmatic trials of Internet-delivered guided and unguided cognitive behavior therapy for treating depression and anxiety in university students of two Latin American countries: the Yo Puedo Sentirme Bien study. Trials, 23 (450), 2-19.
url https://doi.org/10.1186/s13063-022-06255-3
https://hdl.handle.net/20.500.12494/52855
dc.relation.isversionof.none.fl_str_mv https://pubmed.ncbi.nlm.nih.gov/35658942/
dc.relation.ispartofjournal.none.fl_str_mv TRIALS
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spelling UCCBenjet, CorinaCarrasco , NayibKessler, RonaldAlan , KazdinPim , CuijpersYesica , AlborCarlos , Contreras-IbáñezMa Socorro , Durán GonzálezSarah , GildeaNoé , GonzálezJosé Benjamín , Guerrero LópezAlex , LuedtkeMaria Elena, Medina-Mora5Jorge , PalaciosDerek , RichardsAlicia , Salamanca-SanabriaNancy , Sampson232023-10-07T19:22:31Z2023-10-07T19:22:31Z2022-06-021745-6215https://doi.org/10.1186/s13063-022-06255-3https://hdl.handle.net/20.500.12494/52855Benjet, C., et. al. (2022). Study protocol for pragmatic trials of Internet-delivered guided and unguided cognitive behavior therapy for treating depression and anxiety in university students of two Latin American countries: the Yo Puedo Sentirme Bien study. Trials, 23 (450), 2-19.Antecedentes: el trastorno depresivo mayor (TDM) y el trastorno de ansiedad generalizada (TAG) son muy prevalentes entre los estudiantes universitarios y predicen un deterioro del rendimiento universitario y del funcionamiento posterior de la vida. Sin embargo, la mayoría de los estudiantes no reciben tratamiento, especialmente en los países de ingresos medianos bajos (PIBM). Nuestro objetivo es evaluar los efectos de ampliar el tratamiento utilizando terapia cognitivo-conductual transdiagnóstico (iCBT) escalable y económica a través de Internet entre estudiantes universitarios con síntomas de TDM y/o TAG en dos países de ingresos bajos y medios de América Latina (Colombia y México) e investigar la viabilidad. de crear una regla de tratamiento de precisión (PTR) para predecir para quién iCBT es más efectiva. Métodos: Primero llevaremos a cabo un ensayo clínico pragmático aleatorio en múltiples sitios (N = 1500) de estudiantes que buscan tratamiento en clínicas de salud mental para estudiantes en universidades participantes o respondiendo a un correo electrónico ofreciendo servicios. Los estudiantes en listas de espera para servicios clínicos serán asignados al azar a iCBT no guiada (33%), iCBT guiada (33%) y tratamiento habitual (TAU) (33%). iCBT se proporcionará inmediatamente, mientras que TAU se proporcionará siempre que haya una cita clínica disponible. Los efectos agregados a corto plazo se evaluarán a los 90 días y los efectos a más largo plazo a los 12 meses después de la aleatorización. Usaremos el aprendizaje automático conjunto para predecir la heterogeneidad de los efectos del tratamiento de iCBT guiada versus no guiada versus TAU y desarrollaremos una regla de tratamiento de precisión (PTR) para optimizar el resultado individual del estudiante. Luego realizaremos un segundo y un tercer ensayo con muestras separadas (n = 500 por brazo), pero con una asignación desigual entre dos brazos: el 25 % se asignará al tratamiento que se determine que produzca resultados óptimos según el PTR desarrollado en el primer ensayo. (PTR para resultados óptimos a corto plazo para el ensayo 2 y resultados a 12 meses para el ensayo 3), mientras que al 75 % restante se le asignará la misma asignación en los tres brazos de tratamiento. Discusión: Al recopilar características de referencia integrales para evaluar la heterogeneidad de los efectos del tratamiento, proporcionaremos información valiosa e innovadora para optimizar los efectos del tratamiento y guiar la planificación universitaria del tratamiento de salud mental. Un esfuerzo de este tipo podría tener enormes implicaciones para la salud pública de la región al aumentar el alcance del tratamiento, disminuir las necesidades insatisfechas y los tiempos de espera en las clínicas, y servir como modelo de planificación e implementación de intervenciones basadas en evidencia.Background: Major depressive disorder (MDD) and generalized anxiety disorder (GAD) are highly prevalent among university students and predict impaired college performance and later life role functioning. Yet most students do not receive treatment, especially in low-middle-income countries (LMICs). We aim to evaluate the effects of expanding treatment using scalable and inexpensive Internet-delivered transdiagnostic cognitive behavioral therapy (iCBT) among college students with symptoms of MDD and/or GAD in two LMICs in Latin America (Colombia and Mexico) and to investigate the feasibility of creating a precision treatment rule (PTR) to predict for whom iCBT is most effective. Methods: We will first carry out a multi-site randomized pragmatic clinical trial (N = 1500) of students seeking treatment at student mental health clinics in participating universities or responding to an email offering services. Students on wait lists for clinic services will be randomized to unguided iCBT (33%), guided iCBT (33%), and treatment as usual (TAU) (33%). iCBT will be provided immediately whereas TAU will be whenever a clinic appointment is available. Short-term aggregate effects will be assessed at 90days and longer-term effects 12months after randomization. We will use ensemble machine learning to predict heterogeneity of treatment effects of unguided versus guided iCBT versus TAU and develop a precision treatment rule (PTR) to optimize individual student outcome. We will then conduct a second and third trial with separate samples (n = 500 per arm), but with unequal allocation across two arms: 25% will be assigned to the treatment determined to yield optimal outcomes based on the PTR developed in the first trial (PTR for optimal short-term outcomes for Trial 2 and 12-month outcomes for Trial 3), whereas the remaining 75% will be assigned with equal allocation across all three treatment arms. Discussion: By collecting comprehensive baseline characteristics to evaluate heterogeneity of treatment effects, we will provide valuable and innovative information to optimize treatment effects and guide university mental health treatment planning. Such an effort could have enormous public-health implications for the region by increasing the reach of treatment, decreasing unmet need and clinic wait times, and serving as a model of evidence-based intervention planning and implementation.https://scienti.minciencias.gov.co/cvlac/visualizador/generarCurriculoCv.do?cod_rh=0000342033https://orcid.org/0000-0002-1613-9790https://scienti.minciencias.gov.co/gruplac/jsp/visualiza/visualizagr.jsp?nro=00000000006790nayib.carrasco@ucc.edu.cohttps://scholar.google.com/citations?user=0Jjq1EgAAAAJ&hl=es1-19Peter JüniUniversidad Cooperativa de ColombiaPsicologíaMedellínhttps://pubmed.ncbi.nlm.nih.gov/35658942/TRIALSAuerbach RP, Alonso J, Axinn WG, Cuijpers P, Ebert DD, Green JG, et al. Mental disorders among college students in the World Health Organization World Mental Health Surveys. Psychol Med. 2016;46(14):2955–70. https://doi. org/10.1017/S0033291716001665.Cuijpers P, Auerbach RP, Benjet C, Bruffaerts R, Ebert D, Karyotaki E, et al. 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Internet Interv. 2021;100400:100400. https://doi. org/10.1016/j.invent.2021.100400.Simon N,McGillivray L, Roberts NP, BarawiK,Lewis CE, BissonJI.Acceptability ofinternet-basedcognitive behaviouraltherapy(i-CBT) for post-traumatic stressdisorder (PTSD): a systematic review.Eur J Psychotraumatol. 2019;10(1): 1646092.https://doi.org/10.1080/20008198.2019.1646092.DepresiónAnsiedadTerapia Cognitivo ConductualEstudiantes UniversitariosDepressionAnxietyCognitive Behavioral TherapyUniversity StudentsStudy protocol for pragmatic trials of Internet-delivered guided and unguided cognitive behavior therapy for treating depression and anxiety in university students of two Latin American countries: the Yo Puedo Sentirme Bien studyArtículos Científicoshttp://purl.org/coar/resource_type/c_2df8fbb1http://purl.org/coar/version/c_970fb48d4fbd8a85info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/openAccesshttp://purl.org/coar/access_right/c_abf2PublicationLICENSElicense.txtlicense.txttext/plain; charset=utf-84334https://repository.ucc.edu.co/bitstreams/5a5e0206-999f-4b67-b9dc-80881aa67e15/download3bce4f7ab09dfc588f126e1e36e98a45MD5220.500.12494/52855oai:repository.ucc.edu.co:20.500.12494/528552024-08-10 22:49:49.825metadata.onlyhttps://repository.ucc.edu.coRepositorio Institucional Universidad Cooperativa de 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