Effectiveness of an Internet-Based Self-Guided Program to Treat Depression in a Sample of Brazilian Users: Randomized Controlled Trial

Background Depression is undertreated in Brazil. Deprexis is a self-guided internet-based program used to treat depressive symptoms based on empirically supported integrative and cognitive behavioral therapy. Evidence from a meta-analysis supports Deprexis’ efficacy in German-speaking countries and the United States, but no study has been conducted using this program in countries with low literacy rates and large social disparities. Furthermore, few studies have investigated whether internet-based interventions ameliorate the psychological processes that might underlie depressive symptomatology, such as low perceived self-efficacy. Objective The main objective of this study was to replicate in Brazil previously reported effects of Deprexis on depressive symptom reduction. Therefore, the main research question was whether Deprexis is effective in reducing depressive symptoms and the general psychological state in Brazilian users with moderate and severe depression in comparison with a control group that does not receive access to Deprexis. A secondary research question was whether the use of Deprexis affects perceptions of self-efficacy. Methods We interviewed 312 participants recruited over the internet and randomized 189 participants with moderate to severe depression (according to the Patient Health Questionnaire–9 and a semistructured interview) to an intervention condition (treatment as usual plus immediate access to Deprexis for 90 days, n=94) or to a control condition (treatment as usual and delayed access to Deprexis, after 8 weeks, n=95). Results Participants from the immediate access group logged in at Deprexis an average of 14.81 (SD 12.16) times. The intention-to-treat analysis using a linear mixed model showed that participants who received Deprexis improved significantly more than participants assigned to the delayed access control group on the primary depression self-assessment measure (Patient Health Questionnaire–9; Cohen d=0.80; P<.001) and secondary outcomes, such as general psychological state measure (Clinical Outcome in Routine Evaluation–Outcome Measurement; Cohen d=0.82; P<.001) and the perceived self-efficacy measure (Cohen d=0.63; P<.001). The intention-to-treat analyses showed that 21% (20/94) of the participants achieved remission compared with 7% (7/95) in the control group (P<.001). The deterioration rates were lower in the immediate access control group. The dropout rate was high, but no differences in demographic and clinical variables were found. Participants reported a medium to high level of satisfaction with Deprexis. Conclusions These results replicate previous findings by showing that Deprexis can facilitate symptomatic improvement over 3 months in depressed samples of Brazilian users. From a public health perspective, this is important information to expand the reach of internet-based interventions for those who really need them, especially in countries with less access to mental health care. This extends previous research by showing significant effects on perceived self-efficacy. Trial Registration Registro Brasileiro de Ensaios Clíncos (ReBec) RBR-6kk3bx UTN U1111-1212-8998; https://ensaiosclinicos.gov.br/rg/RBR-6kk3bx/ International Registered Report Identifier (IRRID) RR2-10.1590/1516-4446-2019-0582

Is this a full powered effectiveness trial or a pilot/feasibility trial? * Manuscript tracking number * If this is a JMIR submission, please provide the manuscript tracking number under "other" (The ms tracking number can be found in the submission acknowledgement email, or when you login as author in JMIR. If the paper is already published in JMIR, then the ms tracking number is the four-digit number at the end of the DOI, to be found at the bottom of each published article in JMIR) TITLE AND ABSTRACT 1a) TITLE: Identification as a randomized trial in the title yes Outro: subitem not at all important 1 2 3 4 5 essential 1a) Does your paper address CONSORT item 1a? * I.e does the title contain the phrase "Randomized Controlled Trial"? (if not, explain the reason under "other") 1a-i) Identify the mode of delivery in the title Identify the mode of delivery. Preferably use "web-based" and/or "mobile" and/or "electronic game" in the title. Avoid ambiguous terms like "online", "virtual", "interactive". Use "Internet-based" only if Intervention includes non-web-based Internet components (e.g. email), use "computer-based" or "electronic" only if o ine products are used. Use "virtual" only in the context of "virtual reality" (3-D worlds). Use "online" only in the context of "online support groups". Complement or substitute product names with broader terms for the class of products (such as "mobile" or "smart phone" instead of "iphone"), especially if the application runs on different platforms. Does your paper address subitem 1a-i? * Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study The title is "Effectiveness of an internet-based self-guided program to treat depression in a sample of Brazilian users: results of a randomized controlled trial", which addresses this topic. All the references to Deprexis (intro, Methods/Intervention) are consistent with an "internet-based self-guided program".

1a-ii) Non-web-based components or important co-interventions in title
Mention non-web-based components or important co-interventions in title, if any (e.g., "with telephone support").
L i m p a r s e l e ç ã o Does your paper address subitem 1a-ii?
Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study There were short feedback messages to enhance participants' motivation: "It is possible to use the program without any contact with therapists but, like in some previous trials [e.g., 27], trained psychology students kept minimal contact with the participants by email. The messages were short feedbacks on usage and motivation to use the program delivered every other week." subitem not at all important 1 2 3 4 5 essential 1b) ABSTRACT: Structured summary of trial design, methods, results, and conclusions NPT extension: Description of experimental treatment, comparator, care providers, centers, and blinding status.
1a-iii) Primary condition or target group in the title Mention primary condition or target group in the title, if any (e.g., "for children with Type I Diabetes") Example: A Web-based and Mobile Intervention with Telephone Support for Children with Type I Diabetes: Randomized Controlled Trial L i m p a r s e l e ç ã o Does your paper address subitem 1a-iii? * Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes, in the title it says that it is Brazilian depressed sample. We are consistent with that in the text ( Does your paper address subitem 1b-i? * Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study In the abstract: "Deprexis is a self-guided internet-based program to treat depressive symptoms based on empirically supported integrative and cognitive-behavioral therapy." Regarding the comparator, it is clearly mentioned in the abstract as well: "We randomized 189 moderately to severely depressed participants (according to the PHQ-9 and a semistructured interview) to an intervention condition (treatment as usual [TAU] plus immediate access to Deprexis for 90 days, n=94), or to a control condition (TAU and delayed access to Deprexis, after 8 weeks, n=95)" subitem not at all important 1 2 3 4 5 essential 1b-ii) Level of human involvement in the METHODS section of the ABSTRACT Clarify the level of human involvement in the abstract, e.g., use phrases like "fully automated" vs. "therapist/nurse/care provider/physician-assisted" (mention number and expertise of providers involved, if any). (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) L i m p a r s e l e ç ã o Does your paper address subitem 1b-ii?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study The human contact was little during treatment (interview and short feedback messages to enhance motivation), as explained above subitem not at all important 1 2 3 4 5 essential 1b-iii) Open vs. closed, web-based (self-assessment) vs. face-to-face assessments in the METHODS section of the ABSTRACT Mention how participants were recruited (online vs. o ine), e.g., from an open access website or from a clinic or a closed online user group (closed usergroup trial), and clarify if this was a purely web-based trial, or there were face-to-face components (as part of the intervention or for assessment). Clearly say if outcomes were self-assessed through questionnaires (as common in web-based trials). Note: In traditional o ine trials, an open trial (open-label trial) is a type of clinical trial in which both the researchers and participants know which treatment is being administered. To avoid confusion, use "blinded" or "unblinded" to indicated the level of blinding instead of "open", as "open" in web-based trials usually refers to "open access" (i.e. participants can self-enrol). (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) Does your paper address subitem 1b-iii?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "We randomized 189 moderately to severely depressed participants (according to the PHQ-9 and a semi-structured interview)...". We also say that they were recruited online and that PHQ-9 is self-assessed subitem not at all important 1 2 3 4 5 essential 1b-iv) RESULTS section in abstract must contain use data Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study The results indicate that the immediate access group had significantly higher outcomes than the delayed access access group in all measures. Eg., in the abstract "Participants from the immediate access group logged in at Deprexis on average 14.81 times (SD=12.16). Intention-to-treat analysis using a linear mixed model showed that participants who received Deprexis improved significantly more than participants assigned to the delayed access control group on the primary depression self-assessment measure (PHQ-9; Cohen's d=0.80), and secondary outcomes such as general psychological state measure (CORE-OM; d=0.82), and the perceived self-efficacy measure (d=0.63). ITT analyses show that 21.3% of the participants achieved remission against 7.4% in the control group (p < 0.001). Deterioration rates were lower in the immediate access control group. Dropout was high, but no differences in the demographical and clinical variables were found. Participants reported a medium to high level of satisfaction with Deprexis" Does your paper address subitem 2a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Depression is a main concern for public health and one of the main causes of functional impairment and is associated with immense personal suffering and increased suicide risk. Although depressive disorders are among the most common mental health problems for which help is sought [1,2], there is evidence suggesting that the ones who most need help (e.g., the people with more severe depressive symptoms) are the ones who least seek treatment [3]. General barriers to providing psychotherapy include high costs for clients, long commutes, time constraints, negative perceptions of psychotherapy, and limited availability of services [4,5]. Importantly, in many parts of the world, there is a shortage of qualified professionals, especially in rural or sparsely populated areas [6]. (4) they are more anonymous and private, which is attractive for individuals with fear of stigmatization [12] and, also important (5) they are easily translatable and adaptable to other cultures [13]. In Brazil, research on such interventions is still at an early stage and very few studies assessing online treatments' effectiveness have been carried out. We are not aware of any studies in Brazil that have evaluated the effectiveness of an internet-based intervention for psychological problems in a controlled trial. Thus, more studies on the results and processes of online psychotherapy treatments are necessary to better evaluate their impact on potential users in the Brazilian context [14]." Deprexis was offered as a standalone intervention (self-guided) with minimal guidance. Does your paper address subitem 2a-ii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Deprexis is an established self-guided internet-based intervention for adults with elevated depressive symptoms. It uses an integrative approach based primarily on cognitivebehavioral therapy [CBT;15]. A recent Deprexis-specific meta-analysis of twelve randomized controlled trials reported an average effect size of 0.51 (Hedges' g) after 8 to 12 weeks, and the effectiveness of this program was not significantly associated with level of clinician guidance, developer involvement, setting (community vs. clinical), and initial symptom severity [16]. Additional studies have also demonstrated that intervention effects generalize to routine care settings [17] and that the intervention is cost-effective [10]. Evidence for the efficacy of this program has been reported in German-speaking countries [3,10,15,[18][19][20][21][22][23][24][25][26]) as well as in the United States [27]. All previous studies were carried out in high-income countries (according to The World Bank, n.d.). Even though Deprexis has been translated into ten languages, including Brazilian Portuguese, no study has been conducted with Brazilians who suffer from depression." 2b) In INTRODUCTION: Specific objectives or hypotheses METHODS 3a) Description of trial design (such as parallel, factorial) including allocation ratio 3b) Important changes to methods after trial commencement (such as eligibility criteria), with reasons Does your paper address CONSORT subitem 2b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "The main objective of this study is to replicate in Brazil previously reported effects of Deprexis on depressive symptom reduction. Therefore, the main research question is whether Deprexis is effective in reducing depressive symptoms and general psychological state in Brazilian moderately and severely depressed users in comparison to a control group that does not receive access to Deprexis. A secondary research question was whether the use of Deprexis affects perceptions of self-efficacy. " Does your paper address CONSORT subitem 3a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes. "We used a randomized controlled trial (RCT) parallel-group design (trial registration at ReBec: RBR-6kk3bx, UTN U1111-1212-8998) [34]. Participants were randomly allocated into two conditions: (1) an experimental condition, in which they received treatment as usual (TAU) plus immediate access to Deprexis for 90 days or (2) a control group, in which they also received TAU and delayed access to Deprexis after 8 weeks. TAU (other psychological or psychopharmacological treatments) was assessed at pre-and post-treatment." Does your paper address CONSORT subitem 4a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes. "Inclusion and exclusion criteriaEligible participants (1) were at least 18 years of age; (2) had regular access to the internet; (3) were residents of Brazil; (4) presented clinically relevant depressive symptoms defined as a score of at least 10 on the Patient Health Questionnaire-9 [PHQ-9; 35,36] and (5) were diagnosed with a depressive disorder (MDD) and/or dysthymia following the definitions of DSM 5 [37]. Participants were allowed to be in other psychological or psychopharmacological TAU if treatments were stabilized (i.e., treatments lasted at least one month). Candidates were excluded from the study if the screening interview indicated that they (1) presented other severe psychiatric symptoms that should be the primary focus of clinical attention (i.e., severe psychotic symptoms, manic episodes, severe substance abuse, severe obsessive-compulsive disorder); (2) showed potential to harm themselves or others; (3) had severe suicidal ideation; and (4) were psychiatric patients in the process of adaptation to medication (taking medication for less than a month, or changed dosage within the past month, or intending to switch medications within the three months after the start of the trial)."

4a-i) Computer / Internet literacy
Computer / Internet literacy is often an implicit "de facto" eligibility criterion -this should be explicitly clari ed. Does your paper address subitem 4a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study We did not access specifically computer/internet literacy, but rather we selected participants only if they "had regular access to the internet" (p. 4, Methods).
4a-ii) Open vs. closed, web-based vs. face-to-face assessments: Open vs. closed, web-based vs. face-to-face assessments: Mention how participants were recruited (online vs. o ine), e.g., from an open access website or from a clinic, and clarify if this was a purely web-based trial, or there were face-to-face components (as part of the intervention or for assessment), i.e., to what degree got the study team to know the participant. In online-only trials, clarify if participants were quasi-anonymous and whether having multiple identities was possible or whether technical or logistical measures (e.g., cookies, email con rmation, phone calls) were used to detect/prevent these. Does your paper address subitem 4a-ii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Recruitment was only online and is described in the Methods, p. 4. "A website, a fan page on Facebook, an Instagram account, and a Twitter profile (all @p.ficabem) were set up to provide basic information about the research procedures, the online intervention, and to recruit participants. The link to the website was advertised through associations of mental health professionals in Brazil (via e-mail or WhatsApp). Also, members of the research team were interviewed on local and regional TV channels and radio stations. Recruitment of participants took place between August 2018 (first participant in) and September 2020 (last participant in). From around halfway through the period (October 2019), we sponsored the link of the website using Google Ads. With this tool, the links to our study appeared in YouTube videos of mental health content"It is mentioned several times that the treatment was through the internet and it was self-guided, eg, p. 6, Treatment section: "Deprexis is an internet-based self-guided intervention designed to help people cope with and overcome depressive symptoms [15]. No face-to-face contact took place during treatment."

4a-iii) Information giving during recruitment
Information given during recruitment. Specify how participants were briefed for recruitment and in the informed consent procedures (e.g., publish the informed consent documentation as appendix, see also item X26), as this information may have an effect on user self-selection, user expectation and may also bias results.
4b) Settings and locations where the data were collected Does your paper address subitem 4a-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study The recruitment sources "website, a fan page on Facebook, an Instagram account, and a Twitter profile (all @p.ficabem)" was only set to "provide basic information about the research procedures and the online intervention". We told them we are as a team, that it was free of charge, the host institution, some info about depression and very shortly about the Deprexis (including a short video). This can all be seen here https://sites.google.com/view/ficabem/o-projeto?authuser=4In the paper we say that "All selected clients who decide to be part of the research were informed and consented to participate by signing an Informed Consent Form, in which they were explained the aim of the research, that Deprexis has been previously researched, that minimal risks were expected and they could withdraw at any time." (p. 8, Ethics). The informed consent form was as follows: "You are being invited to participate in the research project "Effectiveness of a self-guided, internet-based program for treating depression in a sample of Brazilian users", under the responsibility of researchers Dr. Rodrigo Teixeira Lopes (Catholic University of Petrópolis), Dr. Björn Meyer (Gaia Group, City University of London) and Dr. Américo de Araujo Pastor Junior (Federal University Fluminense). This study is important to expand and make cheaper and more accessible options for psychological treatment of depression, which is considered a serious public health problem. Deprexis has already proven effective for most people facing problems similar to yours who have used the program minimally through rigorous research conducted in Germany and the United States. If you agree to participate in this research, our quid pro quo is your free and unrestricted use of the Deprexis platform for 90 days. Your contribution is to do the proposed program, fill out some forms, and be interviewed in order to tell us about your mood and your experience with this tool. You will be accompanied by psychologists and psychology students who will be available to help you. There is a minimal risk that the dialogs will cause some discomfort at some points. Overall, more than 80% of Deprexis users report that the program has helped (Meyer, 2009). About 50% of users actually improve their depressive symptoms (Meyer, 2009;Beevers, 2017). Your participation will not offer any harm to you, as the information you provide will have confidentiality preserved. Your answers may be used in the final research document, as well as in future scientific articles and publications, always in an anonymous form. Your participation is voluntary and this consent may be withdrawn at any time without prejudice to you or the continuity of the research.In case of doubts, please contact UCP by phone, (24)  Does your paper address CONSORT subitem 4b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study We informed participants about the host instituition on the website and the ICF, as show in the previous item.

4b-i) Report if outcomes were (self-)assessed through online questionnaires
Clearly report if outcomes were (self-)assessed through online questionnaires (as common in web-based trials) or otherwise.
Does your paper address subitem 4b-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study In the instruments section it is made explicit which ones (including the primary and secondary outcome measures) are self-reported Does your paper address subitem 4b-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study The study were carried out in a small (not prestigious) university in Brazil. Does your paper address subitem 5-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study It is declared one conflict of interest "The authors declare that they have no competing interests, with the following exception: B. Meyer is employed full-time as the research director at Gaia AG, the company that developed and owns the Deprexis program. B. Meyer has not been involved in the data collection, data organization, or analysis.", p. 12. subitem not at all important 1 2 3 4 5 essential 5-ii) Describe the history/development process Describe the history/development process of the application and previous formative evaluations (e.g., focus groups, usability testing), as these will have an impact on adoption/use rates and help with interpreting results.
Does your paper address subitem 5-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Deprexis is an established self-guided internet-based intervention for adults with elevated depressive symptoms. It uses an integrative approach based primarily on cognitivebehavioral therapy [CBT;15]. A recent Deprexis-specific meta-analysis of twelve randomized controlled trials reported an average effect size of 0.51 (Hedges' g) after 8 to 12 weeks, and the effectiveness of this program was not significantly associated with level of clinician guidance, developer involvement, setting (community vs. clinical), and initial symptom severity [16]. Additional studies have also demonstrated that intervention effects generalize to routine care settings [17] and that the intervention is cost-effective

5-iii) Revisions and updating
Revisions and updating. Clearly mention the date and/or version number of the application/intervention (and comparator, if applicable) evaluated, or describe whether the intervention underwent major changes during the evaluation process, or whether the development and/or content was "frozen" during the trial. Describe dynamic components such as news feeds or changing content which may have an impact on the replicability of the intervention (for unexpected events see item 3b).
Does your paper address subitem 5-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study The program is quite established and this is made clear while describing it. There was no update in the translated version of the program.

5-iv) Quality assurance methods
Provide information on quality assurance methods to ensure accuracy and quality of information provided [1], if applicable.
Does your paper address subitem 5-iv?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study The manuscript was reviewed by all authors. The results were done and reviewed by two of the authors, with supervision of a more senior author subitem not at all important 1 2 3 4 5 essential 5-v) Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing flowcharts of the algorithms used Ensure replicability by publishing the source code, and/or providing screenshots/screencapture video, and/or providing owcharts of the algorithms used. Replicability (i.e., other researchers should in principle be able to replicate the study) is a hallmark of scienti c reporting.
Does your paper address subitem 5-v?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study We did the analysis using the SPSS and did not save the scripts, but we are looking a way to publish the raw data

5-vi) Digital preservation
Digital preservation: Provide the URL of the application, but as the intervention is likely to change or disappear over the course of the years; also make sure the intervention is archived (Internet Archive, webcitation.org, and/or publishing the source code or screenshots/videos alongside the article). As pages behind login screens cannot be archived, consider creating demo pages which are accessible without login.
Does your paper address subitem 5-vi?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study We do not own the intervention and we have left the work of maintaining it online for the developers.

5-vii) Access
Access: Describe how participants accessed the application, in what setting/context, if they had to pay (or were paid) or not, whether they had to be a member of speci c group. If known, describe how participants obtained "access to the platform and Internet" [1]. To ensure access for editors/reviewers/readers, consider to provide a "backdoor" login account or demo mode for reviewers/readers to explore the application (also important for archiving purposes, see vi).
Does your paper address subitem 5-vii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study We now referred in the MS that "demos of the program can be seen online at https://de.deprexis.com/." We also mention that "Participants randomized to the immediate access group received a voucher to access the program for 90 days and were asked to fill out the outcome measures after this period. They were also asked to answer a short questionnaire that included questions on whether the program had been used alone or together with psychotherapy or psychopharmacology. Furthermore, participants were asked about major life events that might have occurred during the intervention period. Participants randomized to the control condition were asked, eight weeks from the randomization date, to fill the outcome measures once more and when done, they received a voucher to access Deprexis."

5-ix) Describe use parameters
Describe use parameters (e.g., intended "doses" and optimal timing for use). Clarify what instructions or recommendations were given to the user, e.g., regarding timing, frequency, heaviness of use, if any, or was the intervention used ad libitum.
Does your paper address subitem 5-ix?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study We added in the Treatment section that "The participants were instructed to work on Deprexis each week and they were informed that they would only have access to the program for 90 days."

5-x) Clarify the level of human involvement
Clarify the level of human involvement (care providers or health professionals, also technical assistance) in the e-intervention or as co-intervention (detail number and expertise of professionals involved, if any, as well as "type of assistance offered, the timing and frequency of the support, how it is initiated, and the medium by which the assistance is delivered". It may be necessary to distinguish between the level of human involvement required for the trial, and the level of human involvement required for a routine application outside of a RCT setting (discuss under item 21 -generalizability).
Does your paper address subitem 5-x?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study We have specified that "It is possible to use the program without any contact with therapists but, like in some previous trials [e.g., 27], trained psychology students kept minimal contact with the participants by email. The messages were short feedbacks on usage and motivation to use the program delivered every other week." (p. 7, Treatment) Does your paper address subitem 5-xi? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study It is described that "Deprexis sends automatic daily messages with therapeutic contents to help in everyday life (e.g., becoming aware of unhelpful automatic thoughts, organizing the day, breaking down large problems into small steps, interacting with people, etc.)." And this also occurs also in the offered in the routine version of the program Does your paper address CONSORT subitem 6a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Patient Health Questionnaire [35,36]. The PHQ-9 served as the primary outcome measure" (Instruments section), and it was consistent in other parts of the paper (eg, Sample Size section "The sample size calculation of this study was based on the expected difference in the primary outcome variable (PHQ-9, which measures the severity of depressive symptoms"; "we observe significantly higher main effects for the immediate access group for the primary outcome measure [PHQ-9; F (1, 173.5)=19.85, p < 0.001]"). Equally, the CORE-OM and GSES were explicitly the secondary measures (Instruments section; eg, in the Results, "for the secondary outcome measures, between-group effect sizes at posttreatment with estimated means (ITT samples) were medium to large, ranging from d=0.63 (self-efficacy measure) to d=0.82 (CORE-OM total score)" 6a-i) Online questionnaires: describe if they were validated for online use and apply CHERRIES items to describe how the questionnaires were designed/deployed Since we had a high dropout rate, we asked the dropouts the reason for not answering the post-treatment questionnaires. "We examined the messages exchanged by the staff and 32 dropouts who answered the reasons for dropping out. We found that 16 participants reported that they had lost interest, 8 feared that the data would not be secure enough, two had problems with the login-in procedure and gave up trying, two reported that they did not present depressive symptoms anymore, two stated that questionnaires were too long, and one feared that he would be charged for it in the end." 7a) How sample size was determined We also explain in the Results section why we collected more data than planned "Due to the high study dropout rate (i.e., participants not filling in the post-treatment assessments) and given that we had enough funding, we collected more data than the 128 initially planned [34]. We randomized 189 moderately and severely depressed participants" Does your paper address CONSORT subitem 7b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Again, we extended the data collection because of the high dropout rate and made that explicit in the Results section: "Due to the high study dropout rate (i.e., participants not filling in the post-treatment assessments) and given that we had enough funding, we collected more data than the 128 initially planned [34]. We randomized 189 moderately and severely depressed participants" 8b) Type of randomisation; details of any restriction (such as blocking and block size) 9) Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned Does your paper address CONSORT subitem 8a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "The selected participants were randomly assigned to either the immediate access condition or to the delayed access condition. A 50:50 randomization procedure was used. It was computer-generated using the random algorithm developed at http://www.randomization.com. The randomization scheme was concealed from the whole study team." Does your paper address CONSORT subitem 8b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "A 50:50 randomization procedure was used" Does your paper address CONSORT subitem 9? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "It was computer-generated using the random algorithm developed at http://www.randomization.com. The randomization scheme was concealed from the study team." 10) Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions 11a) If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how NPT: Whether or not administering co-interventions were blinded to group assignment subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 10? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study It is now added that "The list was generated prior to the data collection by the study leader and only one student could open the file." 11a-i) Specify who was blinded, and who wasn't Specify who was blinded, and who wasn't. Usually, in web-based trials it is not possible to blind the participants [1, 3] (this should be clearly acknowledged), but it may be possible to blind outcome assessors, those doing data analysis or those administering cointerventions (if any Does your paper address subitem 11a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Participants were not blinded to which condition they were randomized." Since we used a delayed intervention, participants were aware that they would only get the intervention later.
11a-ii) Discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator" Informed consent procedures (4a-ii) can create biases and certain expectations -discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator".
L i m p a r s e l e ç ã o

Does your paper address subitem 11a-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Participants were randomly allocated into two conditions: (1) an experimental condition, in which they received treatment as usual (TAU) plus immediate access to Deprexis for 90 days or (2) a control group, in which they also received TAU and delayed access to Deprexis after 8 weeks. Participants were not blinded to which condition they were randomized. " https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS64RdfIAFvmrTSkZQL2-3O8O9hrL5Sw/viewform?hl=en_US&formkey=dGlKd2Z2Q… 47/74 11b) If relevant, description of the similarity of interventions (this item is usually not relevant for ehealth trials as it refers to similarity of a placebo or sham intervention to a active medication/intervention) 12a) Statistical methods used to compare groups for primary and secondary outcomes NPT: When applicable, details of whether and how the clustering by care providers or centers was addressed Does your paper address CONSORT subitem 11b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Not aplicable, only one intervention was used Does your paper address CONSORT subitem 12a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "ITT analyses were conducted using linear mixed models, which are widely used in this field of research and have been recommended because of their ability to estimate the missing data accurately [54,55]. Analyses of those who adhere to the protocol (per Protocol, PP, or completer analysis) were conducted using a general linear model for repeated measures and taking into account the observed (actual) means and standard deviations. Pre-posttreatment effect sizes and between-groups effect sizes were evaluated using Cohen's d.The clinical significance of the changes observed at post-treatment and after the delayed period was evaluated using the Jacobson & Truax's method [56]. For participants with missing post-treatment or post-delayed period data, the Last Observation Carried Forward method [57] was used. Chi-square tests were used to compare the rates of clinical improvement, and recovery, as well as any clinically significant deterioration ratios between groups." And it was consistent with the study protocol (Lopes et al 2020 subitem not at all important 1 2 3 4 5 essential 12b) Methods for additional analyses, such as subgroup analyses and adjusted analyses 12a-i) Imputation techniques to deal with attrition / missing values Imputation techniques to deal with attrition / missing values: Not all participants will use the intervention/comparator as intended and attrition is typically high in ehealth trials. Specify how participants who did not use the application or dropped out from the trial were treated in the statistical analysis (a complete case analysis is strongly discouraged, and simple imputation techniques such as LOCF may also be problematic [4]).
Does your paper address subitem 12a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "ITT analyses were conducted using linear mixed models, which are widely used in this field of research and have been recommended because of their ability to estimate the missing data accurately [54,55]." "The clinical significance of the changes observed at post-treatment and after the delayed period was evaluated using the Jacobson & Truax's method [56]. For participants with missing post-treatment or post-delayed period data, the Last Observation Carried Forward method [57] was used."

X26) REB/IRB Approval and Ethical Considerations [recommended as subheading under "Methods"] (not a CONSORT item)
subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 12b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "The clinical significance of the changes observed at post-treatment and after the delayed period was evaluated using the Jacobson & Truax's method [56]. For participants with missing post-treatment or post-delayed period data, the Last Observation Carried Forward method [57] was used. Chi-square tests were used to compare the rates of clinical improvement, and recovery, as well as any clinically significant deterioration ratios between groups." Does your paper address subitem X26-i?

X26-i) Comment on ethics committee approval
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "This research protocol was approved by the Research Ethics Committee of the Catholic University of Petrópolis, which is recognized by the Brazilian Ministry of Health (CAAE # 68709517.1.0000.5281)."

x26-ii) Outline informed consent procedures
Outline informed consent procedures e.g., if consent was obtained o ine or online (how? Checkbox, etc.?), and what information was provided (see 4a-ii). See [6] for some items to be included in informed consent documents.
L i m p a r s e l e ç ã o Does your paper address subitem X26-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study All selected clients who decide to be part of the research were informed and consented to participate by clicking "yes" on the online Informed Consent Form, in which they were explained the aim of the research, that Deprexis has been previously researched, that minimal risks were expected and they could withdraw at any time.

RESULTS
13a) For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analysed for the primary outcome NPT: The number of care providers or centers performing the intervention in each group and the number of patients treated by each care provider in each center

X26-iii) Safety and security procedures
Safety and security procedures, incl. privacy considerations, and any steps taken to reduce the likelihood or detection of harm (e.g., education and training, availability of a hotline) Does your paper address subitem X26-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "The students kept an open channel so that the participants could report any eventual harming effects or if they had general questions about the program." (Methods/Intervention). We now added "No participant explicitly wrote the students about any harmful effects of the program" in the results section.
13b) For each group, losses and exclusions after randomisation, together with reasons Does your paper address CONSORT subitem 13a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "As shown in the flowchart (Figure 2), many interested individuals clicked on the website (n=39.192). Out of 2.896 participants who completed the first screening, 2305 were invited for the interview and 312 were interviewed. Due to the high study dropout rate (i.e., participants not filling in the post-treatment assessments) and given that we had enough funding, we collected more data than the 128 initially planned [34]. We randomized 189 moderately and severely depressed participants to the immediate access condition (TAU plus immediate access to Deprexis for 90 days, n=94), or to the delayed access control group (TAU and delayed access to Deprexis, after 8 weeks, n= 95)." Does your paper address CONSORT subitem 13b? (NOTE: Preferably, this is shown in a CONSORT flow diagram) * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Does your paper address subitem 13b-i?
Copy and paste relevant sections from the manuscript or cite the gure number if applicable (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study The number and the reasons for losses are presented in more detail in Fig 2 ( Does your paper address CONSORT subitem 14a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Recruitment of participants took place between August 2018 (first participant in) and September 2020 (last participant in)." No follow up data was collected until now.
14a-i) Indicate if critical "secular events" fell into the study period Indicate if critical "secular events" fell into the study period, e.g., signi cant changes in Internet resources available or "changes in computer hardware or Internet delivery resources" L i m p a r s e l e ç ã o Does your paper address subitem 14a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study The data collection started before the pandemic. We made an analysis of the pre-treatment characteristics of participants joining before and after the pandemic (Table 1) and also tested whether it influenced dropout rates "intake before and after the beginning of the pandemic [x2 (2) Does your paper address CONSORT subitem 14b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study NA. The trial was not ended or was stopped earlier than planned Does your paper address CONSORT subitem 15? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study subitem not at all important 1 2 3 4 5 essential 16-i) Report multiple "denominators" and provide definitions Report multiple "denominators" and provide de nitions: Report N's (and effect sizes) "across a range of study participation [and use] thresholds" [1], e.g., N exposed, N consented, N used more than x times, N used more than y weeks, N participants "used" the intervention/comparator at speci c pre-de ned time points of interest (in absolute and relative numbers per group). Always clearly de ne "use" of the intervention.
Does your paper address subitem 16-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Tables 2 and 3 are consistent in reporting the denominator n for each analysis Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study This is consistent in the paper Analysis section: "Following the intention-to-treat (ITT) principle, data from all randomized participants were analyzed. ITT analyses were conducted using linear mixed models, which are widely used in this field of research and have been recommended because of their ability to estimate the missing data accurately [54,55]. Analyses of those who adhere to the protocol (per Protocol, PP, or completer analysis) were conducted using a general linear model for repeated measures and taking into account the observed (actual) means and standard deviations. Pre-post-treatment effect sizes and between-groups effect sizes were evaluated using Cohen's d.The clinical significance of the changes observed at posttreatment and after the delayed period was evaluated using the Jacobson & Truax's method [56]. For participants with missing post-treatment or post-delayed period data, the Last Observation Carried Forward method [57] was used. Chi-square tests were used to compare the rates of clinical improvement, and recovery, as well as any clinically significant deterioration ratios between groups." And throughout the results section (see tables 2 and 3).
17a) For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval) subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 17a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Table 2 shows the mean scores and standard deviations at pre-treatment, post-treatment, and post-delayed access period and the effect sizes, including CI.

17a-i) Presentation of process outcomes such as metrics of use and intensity of use
In addition to primary/secondary (clinical) outcomes, the presentation of process outcomes such as metrics of use and intensity of use (dose, exposure) and their operational de nitions is critical. This does not only refer to metrics of attrition (13-b) (often a binary variable), but also to more continuous exposure metrics such as "average session length". These must be accompanied by a technical description how a metric like a "session" is de ned (e.g., timeout after idle time) [1] (report under item 6a). Does your paper address subitem 17a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study It was not our goal to analyse usage, but still we present a that "The participants from the immediate access group (n=44) used Deprexis on average 14.81 days (SD=12.16)." Does your paper address CONSORT subitem 17b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study We present the absolute and relative numbers for the clinical analysis (see table 3) subitem not at all important 1 2 3 4 5 essential

19) All important harms or unintended effects in each group
(for speci c guidance see CONSORT for harms)

18-i) Subgroup analysis of comparing only users
A subgroup analysis of comparing only users is not uncommon in ehealth trials, but if done, it must be stressed that this is a self-selected sample and no longer an unbiased sample from a randomized trial (see 16-iii Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study We show the completer analysis at all analysis, including the clinical analysis (Table 3) Does your paper address CONSORT subitem 19? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study No participant explicitly wrote the students about any harmful effects of the program. Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study We did not assess qualitatively the participants subitem not at all important 1 2 3 4 5 essential 22-i) Restate study questions and summarize the answers suggested by the data, starting with primary outcomes and process outcomes (use) Restate study questions and summarize the answers suggested by the data, starting with primary outcomes and process outcomes (use).
Does your paper address subitem 22-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "This study addressed a gap in the literature on the effectiveness of internet-based interventions for depression in countries with lower literacy rates, such as Brazil, and in another linguistic and cultural background. Analyses with both the completer and the intention to treat samples showed that participants who received Deprexis improved significantly more than the delayed access control group on the main (depressive symptoms) and the secondary outcome measure (general psychological state), with large effect sizes. Also, participants in the active group improved significantly more on a perceived self-efficacy measure, which yielded a medium effect size. Participants reported medium to high levels of satisfaction with Deprexis. These results replicate previous findings by showing that Deprexis can facilitate symptomatic improvement over 3 months. It also extends previous research by demonstrating that this intervention is effective in a Brazilian sample, which differs culturally and linguistically from the previously studied populations Germany, Switzerland, and the US." Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "More studies should address the problem of dropout from internet interventions with creative designs. The challenges are to have clear definitions of dropping out and to contact the dropout participants afterward." "Additional research is needed to examine whether improvements are maintained over longer periods of time and who is particularly likely to respond to or drop out from this form of treatment"

20-i) Typical limitations in ehealth trials
Typical limitations in ehealth trials: Participants in ehealth trials are rarely blinded. Ehealth trials often look at a multiplicity of outcomes, increasing risk for a Type I error. Discuss biases due to non-use of the intervention/usability issues, biases through informed consent procedures, unexpected events.
L i m p a r s e l e ç ã o Does your paper address subitem 20-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study It is addressed in the discussion issues with recruiting participants from the community over the internet Does your paper address subitem 21-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Deprexis has been studied for many years now and has been carefully translated and adapted to ten different languages, including the Brazilian Portuguese language and culture. These results show that this intervention is effective in different cultures, even with minimal adaptations. From a public health perspective, this is an important information to expand the reach of internet interventions for the ones who really needed, especially in countries with less access to mental health care. " Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "we consider a strength that almost half of the participants randomized to the delayed access control group were receiving other forms of treatment as usual (psychotherapy alone, pharmacotherapy alone, or both combined). This should be a more conservative control group, in contrast to the common practice of a typical waiting list control group in which participants are selected for not having any other form of treatment."

X27) Conflicts of Interest (not a CONSORT item)
subitem not at all important 1 2 3 4 5 essential About the CONSORT EHEALTH checklist X27-i) State the relation of the study team towards the system being evaluated In addition to the usual declaration of interests ( nancial or otherwise), also state the relation of the study team towards the system being evaluated, i.e., state if the authors/evaluators are distinct from or identical with the developers/sponsors of the intervention.
L i m p a r s e l e ç ã o Does your paper address subitem X27-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study As a result of using this checklist, did you make changes in your manuscript? * What were the most important changes you made as a result of using this checklist?
The abstract was expanded and information about possible harmful effects How much time did you spend on going through the checklist INCLUDING making changes in your manuscript * Around 6 hours (including one hour that I needed to re-do because the form became empty) As a result of using this checklist, do you think your manuscript has improved? * Outro: Your answer must have a minimum of 25 characters.

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