The Efficacy of Be a Mom, a Web-Based Intervention to Prevent Postpartum Depression: Examining Mechanisms of Change in a Randomized Controlled Trial

Background Postpartum depression (PPD) is treatable and preventable, but most women do not seek professional help for their perinatal depressive symptoms. One increasingly popular approach of improving access to care is the use of web-based intervention programs. Objective The objective of this study was 2-fold: first, to assess the efficacy of Be a Mom, a brief web-based selective or indicated preventive intervention, in reducing depressive and anxiety symptoms of women at high risk for PPD; and second, to examine mechanisms of change linking modifiable self-regulatory skills (ie, emotion regulation, self-compassion, and psychological flexibility) to improved perinatal mental health outcomes. Methods This 2-arm, open-label randomized controlled trial involved a sample of 1053 perinatal women presenting high risk for PPD who were allocated to the Be a Mom intervention group or a waitlist control group and completed self-report measures at baseline and postintervention assessments. Univariate latent change score models were computed to determine changes over time in adjustment processes and outcomes, with a multigroup-model approach to detect differences between the intervention and control groups and a 2-wave latent change score model to examine whether changes in processes were related to changes in outcomes. Results Be a Mom was found to be effective in reducing depressive (intervention group: µΔ=–3.35; P<.001 vs control group: µΔ=–1.48; P<.001) and anxiety symptoms (intervention group: µΔ=–2.24; P<.001 vs control group: µΔ=–0.43; P=.04) in comparison with the control group, where such changes were inexistent or much smaller. All 3 psychological processes under study improved statistically significantly in posttreatment assessments: emotion regulation ability (Δχ23=12.3; P=.007) and psychological flexibility (Δχ23=34.9; P<.001) improved only in the intervention group, and although self-compassion increased in both groups (Δχ23=65.6; P<.001), these improvements were considerably greater in the intervention group. Conclusions These results suggest that Be a Mom, a low-intensity cognitive behavioral therapy program, is a promising first-line intervention for helping perinatal women, particularly those with early-onset PPD symptoms. Trial Registration ClinicalTrials.gov NCT03024645; https://clinicaltrials.gov/ct2/show/NCT03024645

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)

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 Efficacy of "Be a Mom", a Web-based Intervention to Prevent Postpartum Depression: Examining Mechanisms of Change in a Randomized Controlled Trial"

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 Not applicable; there were no additional interventions to the web-based program. 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 "This two-arm, open-label randomized controlled trial (RCT) involved a sample of 1058 perinatal women presenting high-risk for PPD, who were allocated to "Be a Mom" intervention group or a waiting-list control group, and completed self-report measures at baseline and post-intervention assessments. Univariate Latent Change Score (LCS) models were computed to determine changes over time in adjustment processes and outcomes, with a multigroup model approach to detect differences between the intervention and the groups, and a two-wave LCS model to examine whether changes in processes were related to changes in outcomes." 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 10/02/23, 13:40 CONSORT-EHEALTH (V 1.6.1) - 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 "This two-arm, open-label randomized controlled trial (RCT) involved a sample of 1058 perinatal women presenting high-risk for PPD, who were allocated to "Be a Mom" intervention group or a waiting-list control group, and completed self-report measures at baseline and post-intervention assessments." subitem not at all important 1 2 3 4 5 essential 1b-iv) RESULTS section in abstract must contain use data Report number of participants enrolled/assessed in each group, the use/uptake of the intervention (e.g., attrition/adherence metrics, use over time, number of logins etc.), in addition to primary/secondary outcomes. (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-iv?
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 «"Be a Mom" was found to be effective in reducing depressive (...) and anxiety symptoms (...), in comparison to the control group where such changes were inexistent or much smaller. All the three psychological processes under study improved significantly in post-treatment assessments: emotion regulation ability (...) and psychological flexibility (...) improved only in the intervention group, and even if selfcompassion increased in both groups (...), those improvements were considerably greater in the intervention group.» Results section, "Participants": "Of the eligible women, 1058 (76.9%) completed baseline assessment and were randomized to the intervention (n = 545) or to the control (n = 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 "Conclusions: These results suggest that "Be a Mom", a low intensity cognitive behavior therapy program, is a promising first-line intervention for helping perinatal women, particularly those with early-onset PPD symptoms." subitem not at all important 1 2 3 4 5 essential 2a-i) Problem and the type of system/solution Describe the problem and the type of system/solution that is object of the study: intended as stand-alone intervention vs. incorporated in broader health care program? Intended for a particular patient population? Goals of the intervention, e.g., being more cost-effective to other interventions, replace or complement other solutions? (Note: Details about the intervention are provided in "Methods" under 5) 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 "Even though PPD is treatable and amenable to preventive efforts, most women do not seek professional help for their perinatal depression symptoms [4], with recent research showing that attitudinal (e.g., thinking that no one will be able to help), knowledge (e.g., not knowing if one's problems are a reason to ask for help) and structural barriers (e.g., not having time or not being able to afford treatment) are the most common help-seeking barriers of perinatal women [5]. One increasingly popular approach of improving access to treatment is the utilization of web-based intervention programs, particularly low intensity interventions. 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 "Preliminary evidence from a pilot RCT attested the feasibility of the program and its effectiveness in reducing depression and anxiety symptoms of women at high-risk for PPD [15]. Furthermore, a greater decrease in depressive symptoms was found to be associated with a greater decrease in emotion regulation difficulties and a greater increase in selfcompassion, while psychological flexibility was found to be unrelated to changes in depression levels [16]. (...) Despite being the core the establishment of evidence-based interventions [12], the examination of mechanisms of change within the context of web-based interventions for PPD has not been performed until recently [16]." 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 "Given the fact that interventions to prevent PPD are most effective when they target at-risk women [17], this randomized controlled trial focused on a large sample of women at highrisk for PDD to ascertain the mechanisms of change associated with the efficacy of "Be a Mom" in reducing postpartum depression and anxiety symptoms, as they often occur in comorbidity. Specifically, bearing in mind that depression and anxiety are distinct but highly concurrent clinical phenomena [3], the study sought to examine whether changes in psychological processes (i.e., emotion regulation, self-compassion and psychological flexibility) were associated with changes in depressive and anxiety symptoms, among women who participated in the "Be a Mom" program (see Figure 1)." 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 "This study was a two-arm, open-label randomized controlled trial to assess the efficacy of "Be a Mom" intervention, in comparison with a waiting-list control group receiving usual care, among women presenting high-risk for PPD. The trial is registered at ClinicalTrials.gov (NCT03024645). (...) Eligible women who consented to participate in the study were given baseline assessment (T0), using the online survey platform Limesurvey. After completing the baseline assessment, eligible participants were randomly assigned using a computerized random number generator (allocation rate: 1:1) to the intervention group ("Be a Mom" intervention) or to the control group (waiting-list group receiving usual care)." subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 3b? * 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 important changes to methods were made after trial commencement.

3b-i) Bug fixes, Downtimes, Content Changes
Bug xes, Downtimes, Content Changes: ehealth systems are often dynamic systems. A description of changes to methods therefore also includes important changes made on the intervention or comparator during the trial (e.g., major bug xes or changes in the functionality or content) (5-iii) and other "unexpected events" that may have in uenced study design such as staff changes, system failures/downtimes, etc. Does your paper address subitem 3b-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 Not applicable; there were no bug fixes, downtimes or content changes within this RCT. 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 Eligibility criteria to participate in the study were as follows: a) being an adult woman (≥18 years) in the early postpartum period (up to 3 months postpartum); b) presenting high-risk for PPD (a score of 5.5 or higher in the Postpartum Depression Predictors Inventory-Revised [PDPI-R; see "Measures"]; c) having a computer/tablet/smartphone and internet access at home; d) having the ability to read and speak Portuguese; and e) being a Portugal resident. Exclusion criteria were the presence of a severe medically diagnosed health condition in the infant or in the mother (e.g., cerebral palsy in the infant, or schizophrenia spectrum or other psychotic disorders in the mother), as self-reported by mothers. Those women who did not meet eligibility criteria were informed through email and were advised to seek professional help, if needed.

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 "Eligibility criteria to participate in the study were as follows: (...) c) having a computer/tablet/smartphone and internet access at home; d) having the ability to read and speak Portuguese; (...)" 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 occurred online between January 2019 and January 2021, both through unpaid cross-posting and paid advertisements on social media networks (Facebook and Instagram). Paid advertisements/campaigns targeted women aged 18-45 years old with interests in maternity topics, with the following tagline: "Did you have a baby in the last three months? We want to know if "Be a Mom" is effective in promoting postpartum women's mental health, and you can help us! To know if you are eligible to participate in the study fill out the following form and we will contact you." Before getting access to the eligibility form (including a set of questions to assess eligibility criteria and contact information), women were given information about the study goals and procedures (including voluntary participation and data protection issues), the participants' and researchers' roles were clarified, and women were asked their informed consent to participate in the study (by clicking the option "I understand and accept the conditions of the study")."

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 "Before getting access to the eligibility form (including a set of questions to assess eligibility criteria and contact information), women were given information about the study goals and procedures (including voluntary participation and data protection issues), the participants' and researchers' roles were clarified, and women were asked their informed consent to participate in the study (by clicking the option "I understand and accept the conditions of the study")." 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 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 "Eligible women who consented to participate in the study were given baseline assessment (T0), using the online survey platform Limesurvey. After completing the baseline assessment, eligible participants were randomly assigned using a computerized random number generator (allocation rate: 1:1) to the intervention group ("Be a Mom" intervention) or to the control group (waiting-list group receiving usual care). (...) Post-intervention (T1) assessment was also performed online (through LimeSurvey platform) both in the intervention and control groups (after the intervention or eight weeks after randomization)." 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 following information, quoted from the manuscript, was shared with the participants within their informed consent: "The study was approved by the Ethics Committee of the Faculty of Psychology and Educational Sciences, University of subitem not at all important 1 2 3 4 5 essential 5-i) Mention names, credential, affiliations of the developers, sponsors, and owners Mention names, credential, a liations of the developers, sponsors, and owners [6] (if authors/evaluators are owners or developer of the software, this needs to be declared in a "Con ict of interest" section or mentioned elsewhere in the manuscript).
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 «"Be a Mom" is a brief, self-guided, web-based selective/indicated preventive intervention that is primarily targeted at women who exhibit risk for PPD and/or present early-onset PPD symptoms. (...) The content of each module includes psychoeducational information combined with practical exercises and endorses the structured and goal-oriented nature of CBT sessions [14].»

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 «"Be a Mom" is a brief, self-guided, web-based selective/indicated preventive intervention that is primarily targeted at women who exhibit risk for PPD and/or present early-onset PPD symptoms. (...) The content of each module includes psychoeducational information combined with practical exercises and endorses the structured and goal-oriented nature of CBT sessions [14].» (...) «Preliminary evidence from a pilot RCT attested the feasibility of the program and its effectiveness in reducing depression and anxiety symptoms of women at high-risk for PPD [15]. Furthermore, a greater decrease in depressive symptoms was found to be associated with a greater decrease in emotion regulation difficulties and a greater increase in self-compassion, while psychological flexibility was found to be unrelated to changes in depression levels

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 Not applicable; no revisions or updating were performed during the RCT.

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 "Email reminders were sent automatically to the participants if they went 3, 7 and 13 days without accessing it. The periodicity of the reminders was defined according to the guidelines provided by the software company that developed the web-based program and based on previous feedback obtained from postpartum women during the pilot RCT [15]. Noteworthy, the sequence of periodical reminders restarted every time a woman returned to proceed with the program, i.e., they were unrelated to the amount of content that had been already completed. Asynchronous communication channels were provided for programrelated support only. Access to the program was free of cost, and no compensation was given to participants. Participants assigned to the control group were offered no intervention but were free to access usual care (as were all participants). At the end of the RCT (including 3-months and 12-months follow-up assessments), they were offered access to "Be a Mom" intervention. Given that the first three to four months postpartum seem to be a high-risk period for depression [21], women in the wait-list control group were initially informed about their risk for PPD and instructed to interrupt their participation in the RCT and to seek professional help within the usual care if they felt their health condition was worsening." 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

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 This is the original, permanente URL for the app: https://beamom.pt/; the English version is under progress.

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 "Women assigned to the intervention arm were invited by email to register in a password-protected website that contained the "Be a Mom" intervention (beamom.pt; access to the program was restricted to invitation). Approximately two weeks after registration, participants were contacted via telephone by the research team to assess if there were any difficulties in accessing the website and to clarify any questions concerning the program's flow and functioning. After registration, women have access to the 5 modules (the "Couple's Relationship" module is only presented to women in a relationship) and were instructed that they should complete one module per week following the module's order, although a slower pace is allowed. Each module has an approximate length of 45 minutes. Women were given the option of pausing the module and resuming the last page visited during subsequent access. Although it was generally recommended to complete one module per week, given the usual competing demands of the postpartum period, women were allowed to complete the program within a maximum period of 8 weeks. Email reminders were sent automatically to the participants if they went 3, 7 and 13 days without accessing it. The periodicity of the reminders was defined according to the guidelines provided by the software company that developed the web-based program and based on previous feedback obtained from postpartum women during the pilot RCT [15]. Noteworthy, the sequence of periodical reminders restarted every time a woman returned to proceed with the program, i.e., they were unrelated to the amount of content that had been already completed. Asynchronous communication channels were provided for program-related support only. Access to the program was free of cost, and no compensation was given to participants. Participants assigned to the control group were offered no intervention but were free to access usual care (as were all participants). At the end of the RCT (including 3-months and 12-months follow-up assessments), they were offered access Does your paper address subitem 5-viii? * 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 «"Be a Mom" is a brief, self-guided, web-based selective/indicated preventive intervention that is primarily targeted at women who exhibit risk for PPD and/or present early-onset PPD symptoms. Grounded in CBT principles, it combines the classic CBT approach (e.g., cognitive restructuring, activity scheduling) with more recent "third wave" CBT features (e.g., values clarification, self-compassion). "Be a Mom" is a structured program with a modular approach that encompasses five sequential modules on the following topics: (1)

5-ix) Describe use parameters
Describe use parameters (e.g., intended "doses" and optimal timing for use 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 "Each module has an approximate length of 45 minutes. Women were given the option of pausing the module and resuming the last page visited during subsequent access. Although it was generally recommended to complete one module per week, given the usual competing demands of the postpartum period, women were allowed to complete the program within a maximum period of 8 weeks. Email reminders were sent automatically to the participants if they went 3, 7 and 13 days without accessing it. The periodicity of the reminders was defined according to the guidelines provided by the software company that developed the web-based program and based on previous feedback obtained from postpartum women during the pilot RCT [15]. Noteworthy, the sequence of periodical reminders restarted every time a woman returned to proceed with the program, i.e., they were unrelated to the amount of content that had been already completed. Asynchronous communication channels were provided for program-related support only. Access to the program was free of cost, and no compensation was given to participants. Participants assigned to the control group were offered no intervention but were free to access usual care (as were all participants). At the end of the RCT (including 3-months and 12-months follow-up assessments), they were offered access to "Be a Mom" intervention."

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 "One of the researchers was responsible for randomization, while other two researchers were responsible for the participants' enrollment and groups assignment." 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 "After registration, women have access to the 5 modules (the "Couple's Relationship" module is only presented to women in a relationship) and were instructed that they should complete one module per week following the module's order, although a slower pace is allowed. Each module has an approximate length of 45 minutes. Women were given the option of pausing the module and resuming the last page visited during subsequent access.
Although it was generally recommended to complete one module per week, given the usual competing demands of the postpartum period, women were allowed to complete the program within a maximum period of 8 weeks. Email reminders were sent automatically to the participants if they went 3, 7 and 13 days without accessing it. The periodicity of the reminders was defined according to the guidelines provided by the software company that developed the web-based program and based on previous feedback obtained from postpartum women during the pilot RCT [15]. Noteworthy, the sequence of periodical reminders restarted every time a woman returned to proceed with the program, i.e., they were unrelated to the amount of content that had been already completed." Does your paper address subitem 5-xii? * 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 "Eligible women who consented to participate in the study were given baseline assessment (T0), using the online survey platform Limesurvey. After completing the baseline assessment, eligible participants were randomly assigned using a computerized random number generator (allocation rate: 1:1) to the intervention group ("Be a Mom" intervention) or to the control group (waiting-list group receiving usual care). According to the guidelines established by the Pregnancy Surveillance Program in Portugal [20], postpartum usual care encompasses at least one medical appointment with a designated obstetrician or the woman's family doctor, and weekly visits to nursing services in primary care to monitor mothers' and their infants' general health status during the first two months postpartum. (...) Participants were informed about their assigned group through email (no blinding to the assigned group) and instructed to seek no other intervention besides "Be a Mom" and/or the usual care while participating in the RCT. " 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 "Eligible women who consented to participate in the study were given baseline assessment (T0), using the online survey platform Limesurvey. 8...) Post-intervention (T1) assessment was also performed online (through LimeSurvey platform) both in the intervention and control groups (after the intervention or eight weeks after randomization). (...) To examine changes over time both in the adjustment outcomes (depressive and anxiety symptoms) and in the psychological processes (emotion regulation, self-compassion and psychological flexibility), univariate LCS models were computed [29]." 6a-i) Online questionnaires: describe if they were validated for online use and apply CHERRIES items to describe how the questionnaires were designed/deployed Does your paper address subitem 6a-i?

Copy and paste relevant sections from manuscript text
Although the questionnaires were not specifically validated for online use, it is implicit that they had been successfully used in previous studies with this app: " Preliminary evidence from a pilot RCT attested the feasibility of the program and its effectiveness in reducing depression and anxiety symptoms of women at high-risk for PPD [15]. Furthermore, a greater decrease in depressive symptoms was found to be associated with a greater decrease in emotion regulation difficulties and a greater increase in selfcompassion, while psychological flexibility was found to be unrelated to changes in depression levels [16]."

6a-ii) Describe whether and how "use" (including intensity of use/dosage) was defined/measured/monitored
Describe whether and how "use" (including intensity of use/dosage) was de ned/measured/monitored (logins, log le analysis, etc.). Use/adoption metrics are important process outcomes that should be reported in any ehealth trial. Does your paper address subitem 6a-ii?
Copy and paste relevant sections from manuscript text "After registration, women have access to the 5 modules (the "Couple's Relationship" module is only presented to women in a relationship) and were instructed that they should complete one module per week following the module's order, although a slower pace is allowed. Each module has an approximate length of 45 minutes. Women were given the option of pausing the module and resuming the last page visited during subsequent access.
Although it was generally recommended to complete one module per week, given the usual competing demands of the postpartum period, women were allowed to complete the program within a maximum period of 8 weeks. Email reminders were sent automatically to the participants if they went 3, 7 and 13 days without accessing it. The periodicity of the reminders was defined according to the guidelines provided by the software company that developed the web-based program and based on previous feedback obtained from postpartum women during the pilot RCT [15]. Noteworthy, the sequence of periodical reminders restarted every time a woman returned to proceed with the program, i.e., they were unrelated to the amount of content that had been already completed." 6a-iii) Describe whether, how, and when qualitative feedback from participants was obtained Describe whether, how, and when qualitative feedback from participants was obtained (e.g., through emails, feedback forms, interviews, focus groups Does your paper address CONSORT subitem 6b? * 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 applicable; there were no changes to trial outcomes after the trial had commenced. 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 "To reduce attrition, weekly reminders (email and text messages on an alternate basis) were sent during one month to women who failed to complete baseline and post-intervention assessments. (...) Of the 2367 women enrolled in the study between January 2019 and January 2021, 1980 were assessed concerning risk for PPD, and 1376 women who presented high-risk for PPD (69.5% of women) were given baseline assessment. Of the eligible women, 1058 (76.9%) completed baseline assessment and were randomized to the intervention (n = 545) or to the control (n = 513) conditions." 8a) Method used to generate the random allocation sequence NPT: When applicable, how care providers were allocated to each trial group 8b) Type of randomisation; details of any restriction (such as blocking and block size) 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 Not applicable; this RCT did not use stopping guidelines, nor encompassed any interim analyses of the accumulating data.
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 "After completing the baseline assessment, eligible participants were randomly assigned using a computerized random number generator (allocation rate: 1:1) to the intervention group ("Be a Mom" intervention) or to the control group (waiting-list group receiving usual care)." 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 10) Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions 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 "This study was a two-arm, open-label randomized controlled trial to assess the efficacy of "Be a Mom" intervention, in comparison with a waiting-list control group receiving usual care, among women presenting high-risk for PPD." "After completing the baseline assessment, eligible participants were randomly assigned using a computerized random number generator (allocation rate: 1:1) to the intervention group ("Be a Mom" intervention) or to the control group (waiting-list group receiving usual care)." 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 "After completing the baseline assessment, eligible participants were randomly assigned using a computerized random number generator (allocation rate: 1:1) to the intervention group ("Be a Mom" intervention) or to the control group (waiting-list group receiving usual care)." 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 "One of the researchers was responsible for randomization, while other two researchers were responsible for the participants' enrollment and groups assignment."

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 informed about their assigned group through email (no blinding to the assigned group) and instructed to seek no other intervention besides "Be a Mom" and/or the usual care while participating in the RCT." 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".

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 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 informed about their assigned group through email (no blinding to the assigned group) and instructed to seek no other intervention besides "Be a Mom" and/or the usual care while participating in the RCT. (...) Participants assigned to the control group were offered no intervention but were free to access usual care (as were all participants). At the end of the RCT (including 3-months and 12-months follow-up assessments), they were offered access to "Be a Mom" intervention." 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 The issue of similarity of interventions is not applicable to this RCT. 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 "To examine changes over time both in the adjustment outcomes (depressive and anxiety symptoms) and in the psychological processes (emotion regulation, self-compassion and psychological flexibility), univariate LCS models were computed [29].

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 "Missing data were handled using the Full Information Maximum Likelihood estimation [28] " 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 "A multigroup model approach was used to check for differences between the intervention and the control groups in LCS models (.. Does your paper address subitem X26-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 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 "Before getting access to the eligibility form (including a set of questions to assess eligibility criteria and contact information), women were given information about the study goals and procedures (including voluntary participation and data protection issues), the participants' and researchers' roles were clarified, and women were asked their informed consent to participate in the study (by clicking the option "I understand and accept the conditions of the study")."

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 "Asynchronous communication channels were provided for program-related support only.
Given that the first three to four months postpartum seem to be a high-risk period for depression [21], women in the wait-list control group were initially informed about their risk for PPD and instructed to interrupt their participation in the RCT and to seek 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 Table 2. Changes in adjustment outcomes and psychological processes over time in the intervention and control groups.
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 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 occurred online between January 2019 and January 2021 (...) At the end of the RCT (including 3-months and 12-months follow-up assessments), they were offered access to "Be a Mom" intervention." 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 There were no critical "secular events" fell into the study period.
14b) Why the trial ended or was stopped (early)

15) A table showing baseline demographic and clinical characteristics for each group
NPT: When applicable, a description of care providers (case volume, quali cation, expertise, etc.) and centers (volume) in each group 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 The trial did not end or 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. 17a) For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval)

16-ii) Primary analysis should be intent-to-treat
Primary analysis should be intent-to-treat, secondary analyses could include comparing only "users", with the appropriate caveats that this is no longer a randomized sample (see 18-i).
L i m p a r s e l e ç ã o Does your paper address subitem 16-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 "In addition to the main analyses, the same analyses were repeated in two subgroups of women: evaluative respondents (i.e., intention-to-treat analysis, by including women who completed both baseline and post-intervention assessments in the statistical analyses) and women presenting clinically relevant depressive symptoms, i.e., EPDS scores at baseline >9." 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 3. Two-wave latent change score models estimates: correlations at baseline, crosslagged effects, and change-to-change effects in the intervention group and in the control group.
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 17b) For binary outcomes, presentation of both absolute and relative effect sizes is recommended 18) Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory 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 Each module has an approximate length of 45 minutes. Women were given the option of pausing the module and resuming the last page visited during subsequent access. Although it was generally recommended to complete one module per week, given the usual competing demands of the postpartum period, women were allowed to complete the program within a maximum period of 8 weeks.
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 Not applicable; the adjustment outcomes in this study are continuous.
Does your paper address CONSORT subitem 18? * 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. Changes in adjustment outcomes and psychological processes over time in the intervention and control groups; Table 3. Two-wave latent change score models estimates.

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 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 "...women in the wait-list control group were initially informed about their risk for PPD and instructed to interrupt their participation in the RCT and to seek professional help within the usual care if they felt their health condition was worsening."

19-i) Include privacy breaches, technical problems
Include privacy breaches, technical problems. This does not only include physical "harm" to participants, but also incidents such as perceived or real privacy breaches 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).
L i m p a r s e l e ç ã o 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 «"Be a Mom" was found to be uniquely effective in reducing depressive and anxiety symptoms (...) in comparison to the control group where such changes were inexistent or much smaller. (...) All the three psychological processes under study improved significantly (...) in post-treatment assessments: (...) and even if self-compassion increased in both groups, those improvements were considerably greater in the intervention group. 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 Cf. Subsection "Conclusions and Future Directions", in the Discussion section.

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 cf. subsection "Limitations" in the Discussion section. 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 Limitations in the generalization of the observed findings are discussed in the subsection "Limitations" (cf. Discussion). 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 "Moreover, "Be a Mom" has been recently investigated as a universal preventive intervention, also with promising results in the promotion of positive mental health among postpartum women with low risk for PPD [38]." About the CONSORT EHEALTH checklist yes, major changes yes, minor changes no 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.
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 Right in the Introduction section, it stands clear that the authors were the developers of this software (e.g., reference 14). If required, please include the following Declaration of interest: "All the authors participated in the development of the intervention." 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?
Suggestion: «Declaration of interest: "All the authors participated in the development of the intervention."» How much time did you spend on going through the checklist INCLUDING making changes in your manuscript * Taken altogether, between 3-4 working hours.
As a result of using this checklist, do you think your manuscript has improved? * We have carefully adopted this checklist when preparing our manuscr Would you like to become involved in the CONSORT EHEALTH group?
This would involve for example becoming involved in participating in a workshop and writing an "Explanation and Elaboration" document L i m p a r s e l e ç ã o

Any other comments or questions on CONSORT EHEALTH
This initiative is very much appreciated towards zealous research.
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