The CONSORT-EHEALTH checklist is intended for authors of randomized trials evaluating webbased and Internet-based applications/interventions, including mobile interventions, electronic games (incl multiplayer games), social media, certain telehealth applications, and other interactive and/or networked electronic applications. Some of the items (e.g. all subitems under item 5description of the intervention) may also be applicable for other study designs.The goal of the CONSORT EHEALTH checklist and guideline is to be a) a guide for reporting for authors of RCTs, b) to form a basis for appraisal of an ehealth trial (in terms of validity)CONSORT-EHEALTH items/subitems are MANDATORY reporting items for studies published in the Journal of Medical Internet Research and other journals / scienti c societies endorsing the checklist.Items numbered 1., 2., 3., 4a., 4b etc are original CONSORT or CONSORT-NPT (non-pharmacologic treatment) items. Items with Roman numerals (i., ii, iii, iv etc.) are CONSORT-EHEALTH extensions/clari cations.As the CONSORT-EHEALTH checklist is still considered in a formative stage, we would ask that you also RATE ON A SCALE OF 1-5 how important/useful you feel each item is FOR THE PURPOSE OF THE CHECKLIST and reporting guideline (optional).

BackgroundDepression is the principal cause of disability in the world. High prevalence rates of depression in general populations and college students have been found worldwide and in various cultural groups. Low-intensity cognitive behavioural internet-delivered treatment has demonstrated efficacy in high-income-countries (HICs). However little is known of their potential for adaptation and efficacy in low and middle-income countries.MethodsStudy (1) involves the cultural adaptation of the Space from Depression cognitive-behaviour internet-delivered programme with an asynchronous support for depressive symptoms. This includes initial researcher/clinician adaptation and the integration of cultural assessment feedback of the programme by a panel of experts and users through the theoretically-based Cultural Relevance Questionnaire (CRQ). Study (2) describes the implementation of the culturally adapted intervention using a randomised controlled trial methodology. The efficacy trial will include an active treatment group and a waiting-list control group of participants meeting eligibility criteria (mild to moderate depression symptoms). The active condition will consist of 7 weekly modules of internet-delivered cognitive behavioural therapy (iCBT) Space from Depression, with post-session feedback support. The primary outcome will be the Patient Health Questionnaire (PHQ-9). The study also involves collection of client reported significant events and client satisfaction with the internet-delivered treatment. Data will be collected at baseline and at post-treatment (week 7), and at follow-up (week 20/3 months). Analysis will be conducted on the intention-to-treat basis.DiscussionThe study seeks to establish a theoretically robust methodology for culturally adapting internet-delivered interventions for mental health disorders and to evaluate the efficacy of a culturally adapted internet-delivered treatment for depression in Colombia, with support. The study will be a first contribution to a method for culturally adapting internet-delivered interventions and also a first to examine the efficacy of such an adapted intervention in Latin America.Trial registrationClinical trials NCT03062215. Retrospectively registered 14th February 2017.

Introducción. En los últimos años, los problemas de salud mental durante el período prenatal se han convertido en un tema prioritario para el campo de la salud pública. A los efectos adversos que un estado de salud mental alterado representa para el bienestar de la madre y su descendencia se suma una debilidad de los sistemas de salud para dar respuesta a esta situación. En Colombia son aún inciertas las cifras de prevalencia de cualquier problema de salud mental durante la gestación, lo que dificulta la posibilidad de ofrecer una atención que considere las particularidades del contexto. El objetivo es diseñar un protocolo de tamización de depresión y ansiedad prenatal y factores de riesgo psicosocial asociados dirigido a usuarias del servicio de control prenatal de una institución hospitalaria del oriente colombiano. Metodología. La construcción del protocolo corresponde a un método formal de acuerdo a la clasificación realizada por el Ministerio de Protección Social de Colombia para las Guías de Práctica Clínica, incluye la revisión, síntesis y análisis de literatura sobre la ansiedad y la depresión prenatal (junto con los factores de riesgo psicosocial asociados) así como sobre las estrategias de detección y atención de las mismas. Esta revisión sirvió como base para la elaboración de una versión preliminar del protocolo que fue sometida a una revisión externa para verificar su validez, claridad y aplicabilidad, antes de proceder con el diseño de la versión final. Resultados. En concordancia con lo reportado en la literatura, el protocolo incluye la aplicación de instrumentos para la identificación de síntomas de ansiedad, depresión y factores de riesgo psicosocial asociados, tales como variables sociodemográficas (edad, nivel educativo, ocupación e ingresos económicos), el soporte social percibido y la calidad de la relación de pareja, antecedentes psicológicos y psiquiátricos personales y familiares, factores relacionados con el embarazo como complicaciones o experiencias negativas previas, características de personalidad y vivencia de eventos adversos y estresantes de la vida. Conclusiones. El protocolo da respuesta al vacío de identificación y atención a los problemas de salud mental de las gestantes.

BACKGROUND Internet-delivered treatments for depressive symptoms have proved to be successful in high-income Western countries. There may be potential for implementing such treatments in low- and middle-income countries such as Colombia, where access to mental health services is limited. OBJECTIVE The objective of this study was to assess the efficacy of a culturally adapted cognitive behavioral internet-delivered treatment for college students with depressive symptoms in Colombia. METHODS This was a randomized controlled trial with a 3-month follow-up. The program comprised seven modules. A total of 214 Colombian college students were recruited. They were assessed and randomly assigned to either the treatment group (n=107) or a waiting list (WL) control group (n=107). Participants received weekly support from a trained supporter. The primary outcome was symptoms of depression, as measured by the Patient Health Questionnaire - 9, and the secondary outcomes were anxiety symptoms assessed by the Generalized Anxiety Disorder questionnaire - 7. Other measures, including satisfaction with treatment, were evaluated after 7 weeks. RESULTS Research attrition and treatment dropouts were high in this study. On average, 7.6 sessions were completed per user. The mean time spent on the program was 3 hours and 18 min. The linear mixed model (LMM) showed significant effects after treatment (<i>t</i> _197.54=−5.189; <i>P</i>&lt;.001) for the treatment group, and these effects were maintained at the 3-month follow-up (<i>t</i> _39.62=4.668; <i>P</i>&lt;.001). Within-group results for the treatment group yielded a large effect size post treatment (<i>d</i>=1.44; <i>P</i>&lt;.001), and this was maintained at the 3-month follow-up (<i>d</i>=1.81; <i>P</i>&lt;.001). In addition, the LMM showed significant differences between the groups (<i>t</i> _197.54=−5.189; <i>P</i>&lt;.001). The results showed a large effect size between the groups (<i>d</i>=0.91; <i>P</i>&lt;.001). In the treatment group, 76.0% (16/107) achieved a reliable change, compared with 32.0% (17/107) in the WL control group. The difference between groups was statistically significant (X²₂=10.5; <i>P</i>=.001). CONCLUSIONS This study was the first contribution to investigating the potential impact of a culturally adapted internet-delivered treatment on depressive symptoms for college students as compared with a WL control group in South America. Future research should focus on identifying variables associated both with premature dropout and treatment withdrawal at follow-up. CLINICALTRIAL ClinicalTrials.gov NCT03062215; https://clinicaltrials.gov/ct2/show/NCT03062215