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Importance: Guided internet-delivered cognitive behavioral therapy (i-CBT) is a low-cost way to address high unmet need for anxiety and depression treatment. Scalability could be increased if some patients were helped as much by self-guided i-CBT as guided i-CBT. Objective: To develop an individualized treatment rule using machine learning methods for guided i-CBT vs self-guided i-CBT based on a rich set of baseline predictors. Design, Setting, and Participants: This prespecified secondary analysis of an assessor-blinded, multisite randomized clinical trial of guided i-CBT, self-guided i-CBT, and treatment as usual included students in Colombia and Mexico who were seeking treatment for anxiety (defined as a 7-item Generalized Anxiety Disorder [GAD-7] score of ≥10) and/or depression (defined as a 9-item Patient Health Questionnaire [PHQ-9] score of ≥10). Study recruitment was from March 1 to October 26, 2021. Initial data analysis was conducted from May 23 to October 26, 2022. Interventions: Participants were randomized to a culturally adapted transdiagnostic i-CBT that was guided (n = 445), self-guided (n = 439), or treatment as usual (n = 435). Main Outcomes and Measures: Remission of anxiety (GAD-7 scores of ≤4) and depression (PHQ-9 scores of ≤4) 3 months after baseline. Results: The study included 1319 participants (mean [SD] age, 21.4 [3.2] years; 1038 women [78.7%]; 725 participants [55.0%] came from Mexico). A total of 1210 participants (91.7%) had significantly higher mean (SE) probabilities of joint remission of anxiety and depression with guided i-CBT (51.8% [3.0%]) than with self-guided i-CBT (37.8% [3.0%]; P = .003) or treatment as usual (40.0% [2.7%]; P = .001). The remaining 109 participants (8.3%) had low mean (SE) probabilities of joint remission of anxiety and depression across all groups (guided i-CBT: 24.5% [9.1%]; P = .007; self-guided i-CBT: 25.4% [8.8%]; P = .004; treatment as usual: 31.0% [9.4%]; P = .001). All participants with baseline anxiety had nonsignificantly higher mean (SE) probabilities of anxiety remission with guided i-CBT (62.7% [5.9%]) than the other 2 groups (self-guided i-CBT: 50.2% [6.2%]; P = .14; treatment as usual: 53.0% [6.0%]; P = .25). A total of 841 of 1177 participants (71.5%) with baseline depression had significantly higher mean (SE) probabilities of depression remission with guided i-CBT (61.5% [3.6%]) than the other 2 groups (self-guided i-CBT: 44.3% [3.7%]; P = .001; treatment as usual: 41.8% [3.2%]; P < .001). The other 336 participants (28.5%) with baseline depression had nonsignificantly higher mean (SE) probabilities of depression remission with self-guided i-CBT (54.4% [6.0%]) than guided i-CBT (39.8% [5.4%]; P = .07). Conclusions and Relevance: Guided i-CBT yielded the highest probabilities of remission of anxiety and depression for most participants; however, these differences were nonsignificant for anxiety. Some participants had the highest probabilities of remission of depression with self-guided i-CBT. Information about this variation could be used to optimize allocation of guided and self-guided i-CBT in resource-constrained settings. Trial Registration: ClinicalTrials.gov Identifier: NCT04780542.
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Terapia Cognitivo-Conductual , Depresión , Humanos , Femenino , Adulto Joven , Adulto , Depresión/terapia , Universidades , Ansiedad/terapia , Trastornos de Ansiedad/terapia , Trastornos de Ansiedad/psicología , Terapia Cognitivo-Conductual/métodos , Resultado del Tratamiento , InternetRESUMEN
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 90 days and longer-term effects 12 months 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. TRIAL STATUS: IRB Approval of Protocol Version 1.0; June 3, 2020. Recruitment began on March 1, 2021. Recruitment is tentatively scheduled to be completed on May 30, 2024. TRIAL REGISTRATION: ClinicalTrials.gov NCT04780542 . First submission date: February 28, 2021.
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Terapia Cognitivo-Conductual , Trastorno Depresivo Mayor , Ansiedad/terapia , Trastornos de Ansiedad/terapia , Terapia Cognitivo-Conductual/métodos , Depresión/terapia , Humanos , Internet , América Latina , Ensayos Clínicos Pragmáticos como Asunto , Ensayos Clínicos Controlados Aleatorios como Asunto , Estudiantes/psicología , Resultado del Tratamiento , UniversidadesRESUMEN
Resumen Introducción: El distanciamiento social y la cuarentena han probado tener efectos negativos en la salud mental de las poblaciones, a saber: miedo, ansiedad, depresión y sintomatología de estrés postraumático. La resiliencia emerge como variable amortiguadora del impacto. El objetivo del estudio fue comparar el impacto psicológico del COVID-19 en varios países latinoamericanos. Método: se obtuvo una muestra de 1184 participantes de México, Cuba, Chile, Colombia y Guatemala; cuya edad osciló entre 18 y 83 años (M = 38.78, DT = 13.81). Se aplicó una encuesta sobre síntomas médicos asociados al COVID-19 con tres instrumentos para evaluar: (1) síntomas de depresión, ansiedad y estrés, (2) impacto del evento y (3) resiliencia. Resultados: Las personas más jóvenes, con mayor cantidad de síntomas médicos y con mayores puntajes de impacto del evento tienden a presentar mayor sintomatología depresiva, ansiosa y estrés, siendo el impacto del evento el predictor más determinante. La resiliencia fue el predictor protector contra la depresión, ansiedad y estrés. Conclusiones: Los resultados muestran las diferencias en la respuesta psicológica ante la pandemia del COVID-19 en cada país, y sugieren la necesidad del desarrollo de políticas públicas enfocadas en la prevención y la promoción de la salud integral ante emergencias sanitarias.
Abstract Introduction: Social distancing and quarantine have proven to have negative effects on the mental health of populations, namely fear, anxiety, depression and post-traumatic stress symptoms. Resilience emerges as a buffering variable for such impact. The objective of this study was to compare the psychological impact of COVID-19 in several Latin American countries. Method: A sample of 1184 participants from Mexico, Cuba, Chile, Colombia and Guatemala was obtained; whose age ranged from 18 to 83 years old (M = 38.78, SD = 13.81). A survey on medical symptoms associated with COVID-19 and three instruments to evaluate: (1) depression, anxiety and stress, (2) impact of the event and (3) resilience were administered. Results: Younger people, with more symptoms associated with COVID-19 and those who reported higher scores of impact of event tended to present greater depressive, anxious and stress symptomatology. The impact of the event was the most determinant predictor. Resilience was protective against the impact of event, depression, anxiety and stress. Conclusions: The results show the differences in the psychological response to COVID-19 in each country and suggesting the need to develop public policies focused on prevention and promotion of integral health when facing sanitary emergencies.
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The population's behavioral responses to containment and precautionary measures during the COVID-19 pandemic have played a fundamental role in controlling the contagion. A comparative analysis of precautionary behaviors in the region was carried out. A total of 1184 people from Mexico, Colombia, Chile, Cuba, and Guatemala participated through an online survey containing a questionnaire on sociodemographic factors, precautionary behaviors, information about COVID-19, concerns, maintenance of confinement, and medical symptoms associated with COVID-19. Cubans reported the highest scores for information about COVID-19. Colombians reported less frequent usage of precautionary measures (e.g., use of masks), but greater adherence to confinement recommendations in general, in contrast to the low levels of these behaviors in Guatemalans. Chileans reported greater pandemic-related concerns and the highest number of medical symptoms associated with COVID-19. These findings allow a partial characterization of the Latin American population's responses during the second and third phases of the COVID-19 pandemic and highlight the importance of designing and managing public health policies according to the circumstances of each population when facing pandemics.
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COVID-19 , Pandemias , Chile/epidemiología , Colombia , Guatemala/epidemiología , Humanos , América Latina/epidemiología , México , SARS-CoV-2RESUMEN
Resumen El conflicto armado Colombiano ha afectado la salud mental de las víctimas. La evaluación de la salud mental se realiza a partir del bienestar psicológico, la calidad de vida y el apoyo social percibido. Se indican resultados del Apoyo Social en 1139 víctimas de los municipios de Barrancabermeja, Trujillo, Bello, Montería y Santa Marta, mediante el cuestionario MOS de Apoyo Social, el cual se encuentra en un nivel alto influido por la dimensión de apoyo emocional. No se encontró una relación significativa con la calidad de vida y el bienestar psicológico, excepto en uno de los municipios de la muestra.
Abstract The Colombian armed conflict has affected victims' mental health. Mental health assessment is done from the psychological well-being, life quality and the perceived social support. Results of Social support are indicated in 1,139 victims of the municipalities of Barrancabermeja, Trujillo, Bello, Montería, and Santa Marta, by using the MOS questionnaire of social support, which is at a high level, which is influenced by the emotional support dimension. No significant relationship with the life quality and psychological well-being was found, except in one of the municipalities of the sample.