Optional Web-Based Videoconferencing Added to Office-Based Care for Women Receiving Psychotherapy During the Postpartum Period: Pilot Randomized Controlled Trial

Background Depression and anxiety during the postpartum period are common, with psychotherapy often being the preferred method of treatment. However, psychological, physical, and social barriers prevent women from receiving appropriate and timely psychotherapy. The option of receiving psychotherapy through videoconferencing (VC) during the postpartum period presents an opportunity for more accessible and flexible care. Objective The aim of this study was to assess the feasibility, acceptability, and preliminary effectiveness of optional VC added to usual office-based psychotherapy, with a psychotherapist during the postpartum period. Methods We conducted a pilot randomized controlled trial with 1:1 randomization to office-based care (treatment as usual; TAU) or office-based care with the option of VC (treatment as usual plus videoconferencing; TAU-VC) for psychotherapy during the postpartum period. We assessed the ability to recruit and retain postpartum women into the study from an urban perinatal mental health program offering postpartum psychotherapy, and we evaluated the uptake, acceptability, and satisfaction with VC as an addition to in-person psychotherapy. We also compared therapy attendance using therapist logs and symptoms between treatment groups. Symptoms were assessed at baseline and 3 months postrandomization with the Edinburgh Postnatal Depression Scale, Generalized Anxiety Disorder 7-item, and Parental Stress Scale. Furthermore, 3-month scores were compared between groups with intention-to-treat linear mixed-effects models controlling for baseline score. Results We enrolled 38 participants into the study, with 19 participants in each treatment group. Attendance data were available for all participants, with follow-up symptom measures available for 25 out of 38 participants (66%). Among the 19 TAU-VC participants, 14 participants (74%) utilized VC at least once. Most participants were highly satisfied with the VC option, and they reported average savings of Can $26 and 2.5 hours in travel and childcare expenses and time per appointment. There were no significant differences between the 2 groups for psychotherapy attendance or symptoms. Conclusions The option of VC appears to be an acceptable method of receiving psychotherapy for postpartum women, with benefits described in costs and time savings. On the basis of this small pilot sample, there were no significant differences in outcomes between office-based care with or without the option of VC. This study has demonstrated the feasibility of such a program in an urban center, which suggests that a larger study would be beneficial to provide evidence that is more conclusive.

Approx. Percentage of Users (starters) still using the app as recommended after 3 months * 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 "Web-based videoconferencing" is in the title. 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").
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 "In addition to o ce-based care" is in the title.
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 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 "For women receiving psychotherapy during the postpartum period" is in the 1b-i) Key features/functionalities/components of the intervention and comparator in the METHODS section of the ABSTRACT Mention key features/functionalities/components of the intervention and comparator in the abstract. If possible, also mention theories and principles used for designing the site. Keep in mind the needs of systematic reviewers and indexers by including important synonyms. (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-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 "We conducted a pilot randomized controlled trial with 1:1 randomization to o cebased care (treatment as usual; TAU) or o ce-based care with the option of VC (TAU-VC) for psychotherapy during the postpartum period." 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 objective of the pilot RCT was to assess the feasibility, acceptability, and preliminary effectiveness of adding the option of VC in addition to usual o cebased psychotherapy with a psychotherapist during the postpartum period." 1b-iii) Open vs. closed, web-based (self-assessment) vs. face-toface 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 Since the intervention involves providing patients with access to videoconferencing psychotherapy with a psychotherapy, it was not possible to blind either the participants or psychotherapists. We mentioned the participants were recruited "from a specialized mental health clinic". "We also compared therapy attendance using therapist logs and symptoms between groups. Symptoms were assessed at baseline and 3-months post randomization with the Edinburgh Postnatal Depression Scale (EPDS), Generalized Anxiety Disorder 7-Item (GAD-7), and Parental Stress Scale (PSS)." 1b-iv) RESULTS section in abstract must contain use data Describe the problem and the type of system/solution that is object of the study: intended as standalone 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 "Up to 15% of women experience postpartum mood disorders, with most preferring psychotherapy over medication for the treatment of their mental illnesses. However, childcare responsibilities and physical recovery, particularly after a surgical birth, create barriers for regular therapy attendance. Barriers to care often lead to delayed care, treatment discontinuation, and the lack of follow-up on recommendations. Untreated symptoms of perinatal mental illness can last for months or years, leading to persistent mental health problems and decreased quality of life for both the woman and child." "By overcoming the barriers to care that can be present in varying ways across a course of treatment, the addition of VC to an o ce-based treatment program could provide a very patient-centred option to receive care. This could lead to improved therapy adherence and completion rates, and possibly better outcomes as a result" 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 "They (virtual care tools) can address many barriers associated with in-person care, such as travel distance and time, travel costs, and stigma." A study by Maloni and colleagues [6] found that among postpartum women with depression and "who experienced pregnancy complications, over 90% demonstrated interest in Internet-based interventions, with 40% indicating a speci c interest in chatting virtually with a provider with expertise in postpartum depression." Studies on VC-based psychotherapy have demonstrated similar treatment outcomes when directly compared to the face-to-face option" 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 "In this study, we assessed the acceptability, uptake and preliminary effectiveness of adding the option to receive psychotherapy delivered by VC to standard o ce-based psychotherapy for women experiencing mood and anxiety problems during their rst year postpartum." 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 pilot randomized controlled trial comparing usual o ce-based care (treatment as usual; TAU) to o ce-based care with the option of VC on a personal device (TAU-VC) for psychotherapy for mood or anxiety problems in the postpartum period." "Participants were randomized 1:1 into one of the two treatment arms…" 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 "Participation was initially just offered to only new referrals to the clinic, but was expanded to include patients already in treatment after trial commencement to increase recruitment rate." 3b-i) Bug xes, 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. [2].
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 There were not any changes made on the intervention or comparator, or any "unexpected events", that in uenced study design. 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 "The inclusion criteria for this study were patients in the program, 18 years of age or older, referred to psychotherapy for mood and/or anxiety symptoms, who had access to and ability to use a web-enabled personal device or computer with the required audiovisual communication capability, and had a functioning email address (a requirement for the VC platform). Patients could be approached when pregnant if they intended to continue or start psychotherapy postpartum, but the study protocol was not initiated until after the woman returned for therapy postpartum. For postpartum patients, only women less than 9 months post-partum were included, to allow a minimum of 3 months of treatment before they reached 1 year postpartum and were discharged from the program. Patients with acute mania or psychosis, or severe suicidal ideation with planning and intent were excluded." 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 "…who had access to and ability to use a web-enabled personal device or computer with the required audiovisual communication capability…" 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 "Participation was initially just offered to only new referrals to the clinic, but was expanded to include patients already in treatment after trial commencement to increase recruitment rate." "Psychotherapists introduced the study to newly referred patients during the initial call about treatment, and to existing patients during a therapy session." We believe it is clear that there is a face-to-face component from the following: "In the TAU-VC group, participants had access to TAU with the added option of having any of their treatment sessions over VC." 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.
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 Your answer 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 "Psychotherapists introduced the study to newly referred patients during the initial call about treatment, and to existing patients during a therapy session." "Therapists provided the contact information of interested patients to a Research Assistant. The Research Assistant contacted interested patients to introduce and explain the study. If the patient was still interested, the Research Assistant obtained and documented informed verbal consent over the phone, and emailed a copy of the completed consent form to the patient." 4b-i) Report if outcomes were (self-)assessed through online questionnaires Clearly report if outcomes were (self-)assessed through online questionnaires (as common in webbased trials) or otherwise. subitem not at all important 1 2 3 4 5 essential 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 "Participants were recruited from a specialized mental health program in an ambulatory hospital within an urban city in Ontario, Canada that provides publiclyfunded individual psychotherapy for mood, anxiety, obsessive-compulsive, or trauma or stressed-related disorders in pregnancy and up to one year postpartum delivered by highly trained psychotherapists with Master of Social Work quali cations. The program accepts referrals from primary care, midwifery, obstetricians and psychiatrists from across Ontario, although the vast majority of women who receive care reside in the greater Toronto region (population ~ 6.4 million)." "Baseline symptom and function measures were administered by web-based survey." "The psychotherapists completed a therapy log for each of their participants, which documented the length of time 5) The interventions for each group with su cient details to allow replication, including how and when they were actually administered subitem not at all important 1 2 3 4 5 essential 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 "Baseline symptom and function measures were administered by web-based survey. Participants provided an email address and were sent a link to a survey hosted on FluidSurveys™ [which was later transitioned to SurveyMonkey® after an institutional change in survey host]. All participants received another survey link by email to complete follow-up measures two weeks prior to reaching three months, and again at 3 months if it had not been completed."

5-i) Mention names, credential, a liations 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 Since the participants are all new or existing patients of the clinic within the hospital, they are aware of the a liation. The hospital logo is also on the consent form. 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 Not applicable.

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 None of the above occurred throughout the study.

5-iv) Quality assurance methods
Provide information on quality assurance methods to ensure accuracy and quality of information 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 Not applicable. 5-v) Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing owcharts of the algorithms used Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture 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 do not have this information as we were not involved with the development of the technology. Use the link provided in the next question to get in touch with someone who can provide this information. We cannot provide screenshots as it is a videoconferencing platform.

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 https://otnhub.ca/

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 "To access the web-based platform, participants had to download a plugin for their computer which required a webcam and microphone, or an application for their mobile phone or tablet. The therapists all had unique accounts to log into the portal on their o ce computers. Therapists were able to schedule a therapy session and invite the participant by emailing them a personal link that included the date and time. Participants could attend sessions from their desired location, but were encouraged to ensure the location was private enough that they could participate fully in the session. When the appointment time arrived, participants and therapists could enter the virtual session. In addition to video and audio sharing, therapists had the ability to share their screens which allowed them to show worksheets or other visual materials during the session." We do not have access to a demo account. Please contact otnhub.ca. subitem not at all important 1 2 3 4 5 essential 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 "In the TAU group, participants received the standard form of psychotherapy available in the clinic. In the program, psychotherapists provide rst-line evidencebased treatments for depression and anxiety, including cognitive behaviour therapy and interpersonal therapy, adapted for the postpartum context. This treatment is provided mostly in-person, although sessions are sometimes delivered by telephone on an ad-hoc basis if a patient is unable to attend in person due to medical or lastminute childcare problems. Patients may also receive psychiatric care, including medication management, from the program psychiatrist until approximately 1 year postpartum. At this point, patients are referred back to their primary care provider for ongoing management. " "In the TAU-VC group, participants had access to TAU with the added option of having any of their treatment sessions over VC." "Therapists were able to schedule a therapy session and invite the participant by emailing them a personal link that included the date and time. Participants could attend sessions from their desired location, but were encouraged to ensure the location was private enough that they could participate fully in the session. When the appointment time arrived, participants and therapists could enter the virtual session. In addition to video and audio sharing, therapists had the ability to share their screens which allowed them to show worksheets or other visual materials during the session." "During the study, participants in the TAU-VC group were encouraged, but not required, to use VC for their therapy sessions and were still able to access in-person therapy sessions and phone support as per standard care. Participants were also informed that therapists could, at their discretion, recommend an in-person visit if they felt it was warranted for clinical reasons."

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 "During the study, participants in the TAU-VC group were encouraged, but not required, to use VC for their therapy sessions and were still able to access in-person therapy sessions and phone support as per standard care. Participants were also informed that therapists could, at their discretion, recommend an in-person visit if they felt it was warranted for clinical reasons."

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 "All participants receiving access to VC received an instruction pamphlet by email and had a brief test call with the Research Assistant to ensure their device met the required technical speci cations, demonstrate the platform, and to troubleshoot any initial technical issues." "For technical support during the study, participants were provided with the Research Assistant's contact information." "In the TAU-VC group, participants had access to TAU with the added option of having any of their treatment sessions over VC." TAU is de ned as " rst-line evidence-based treatments for depression and anxiety, including cognitive behaviour therapy and interpersonal therapy, adapted for the postpartum context. This treatment is provided mostly in-person, although sessions are sometimes delivered by telephone on an ad-hoc basis if a patient is unable to attend in person due to medical or last-minute childcare problems." 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 "Baseline symptom and function measures were administered by web-based survey.
Participants provided an email address and were sent a link to a survey hosted on FluidSurveys™ [which was later transitioned to SurveyMonkey® after an institutional change in survey host]. All participants received another survey link by email to complete follow-up measures two weeks prior to reaching three months, and again at 3 months if it had not been completed. A follow-up phone call was made to any outstanding surveys at 2 weeks post the 3-month time point."

5-xii) Describe any co-interventions (incl. training/support)
Describe any co-interventions (incl. training/support): Clearly state any interventions that are provided in addition to the targeted eHealth intervention, as ehealth intervention may not be designed as standalone intervention. This includes training sessions and support [1]. It may be necessary to distinguish between the level of training required for the trial, and the level of training for a routine application outside of a RCT setting (discuss under item 21 -generalizability. 6a) Completely de ned pre-speci ed primary and secondary outcome measures, including how and when they were assessed 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 "In the TAU-VC group, participants had access to TAU with the added option of having any of their treatment sessions over VC." "All participants receiving access to VC received an instruction pamphlet by email and had a brief test call with the Research Assistant to ensure their device met the required technical speci cations, demonstrate the platform, and to troubleshoot any initial technical issues." https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS64RdfIAFvmrTSkZQL2-3O8O9hrL5Sw/viewform?hl=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1 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 "We documented the number and rate of referrals, and the proportion of participants who provided follow-up data at the outcome time points." "The psychotherapists completed a therapy log for each of their participants, which documented the length of time [in minutes] and format [in-person, VC, or telephone] of each session, along with cancellations and no-shows, and how often a child was present for the session." "Descriptive statistics were generated to examine uptake of the intervention as de ned as number and percentage of sessions attended." "Session attendance variables were summarized as group means or medians and compared between groups with unpaired t-tests or non-parametric tests where medians were reported." "Edinburgh Postnatal Depression Scale (EPDS). The EPDS is a self-report depression screening measure that has been validated for use in pregnancy [22]. EPDS scores > 12 are predictive of a diagnosis of major depressive disorder. The EPDS has better ability to detect women with depression in the perinatal period than traditional depression measures because of the increased weight given to anxiety symptoms that appear to be more common in perinatal than in non-perinatal depression [22]. Generalized Anxiety Disorder 7-Item (GAD-7). The GAD-7 assesses symptoms of general anxiety. It has 7 items rated on a 4-point scale from 'never' to 'nearly every day,' as well as one perceived impairment rating. A score of ≥ 10 is highly suggestive of a problem with anxiety. A reduction of 5 points corresponds to a clinically meaningful improvement with a reduction in score of 50% representing response [23]. Parental Stress Scale (PSS). The PSS is an 18-item questionnaire that was developed to measure the level of stress associated with raising children. All items are scored on a 5-point Likert scale from 'strongly disagree' to 'strongly agree.' The questionnaire has shown good reliability and internal consistency [24]. It has been used to study parenting stress in a variety of parent-child circumstances and is correlated with measures of depression [25]. A total score is obtained by summing all items. "Baseline symptom and function measures were administered by web-based survey." "All participants received another survey link by email to complete follow-up measures two weeks prior to reaching three months, and again at 3 months if it had not been completed. A follow-up phone call was made to any outstanding surveys at 2 k t th 3 th ti i t " subitem not at all important 1 2 3 4 5 essential 2 weeks post the 3-month time point." "At follow-up, participants in the TAU-VC group were asked additional questions about their use of and satisfaction with VC." Telemedicine Satisfaction Questionnaire (TSQ). The TSQ was originally developed and studied by Yip et al. [26] to assess satisfaction with telemedicine. It has 15 items rated on a 5-point Likert scale from 'strongly disagree' to 'strongly agree.' The authors reported good internal validity and consistency. A factor analysis yielded 3 components: quality of care provided [8 items], similarity to in-person face-to-face interaction (5 items), and perception of the interaction (1 item). This study uses the original TSQ with the term 'telemedicine' substituted with 'video visits.' An overall score can be created by summing all items, or subscale scores can be calculated for the component domains. Individual items may also be examined to assess the positive and negative aspects of the intervention [26]. In this study, 2 additional items were added: "I am going to miss the equipment when the project ends," and "I would be willing to pay for video visits privately." These latter questions were added to gather additional data regarding interest in the intervention. Patient Reported Costs Questionnaire (PRCQ). This questionnaire was developed by the research team to assess the participant costs and cost savings associated with access to PCVC. Respondents were asked to estimate the amount and source of time and money they saved when they attended a session of therapy with VC compared to in-person. "TSQ and PRCQ items were analyzed descriptively." 6a-i) Online questionnaires: describe if they were validated for online use and apply CHERRIES items to describe how the questionnaires were designed/deployed If outcomes were obtained through online questionnaires, describe if they were validated for online use and apply CHERRIES items to describe how the questionnaires were designed/deployed [9].
Does your paper address subitem 6a-i?

Copy and paste relevant sections from manuscript text
The questionnaires were not validated for online use. ) Any changes to trial outcomes after the trial commenced, with reasons 6a-ii) Describe whether and how "use" (including intensity of use/dosage) was de ned/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 Since participants in the intervention group were provided with the option of using VC but were not required, this is not applicable.
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 subitem 6a-iii?
Copy and paste relevant sections from manuscript text We conducted semi-structured qualitative interviews with the therapists and select participants. We are currently analyzing the data.

7b) When applicable, explanation of any interim analyses and stopping guidelines
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 There were no changes to trial outcomes after the trial commenced.
7a-i) Describe whether and how expected attrition was taken into account when calculating the sample size Describe whether and how expected attrition was taken into account when calculating the sample size.
Does your paper address subitem 7a-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 "We aimed to recruit 40 participants, as has been recommended for pilot studies of an intervention where the goal is to have su cient variability to examine processes in the implementation of the protocol." 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. 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) 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 "For randomization, 20 slips of paper labelled with "TAU" and 20 with "TAU-VC" were placed in opaque envelopes by a research staff member not involved with this study. Upon documentation of informed consent, the Research Assistant opened one of the envelopes, revealed the group allocation and communicated it to the participant and psychotherapist. If a participant withdrew prior to being informed of their allocation, the paper was returned to an envelope and put back in the pile." 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 "Participants were allocated 1:1 to the intervention and control groups using simple randomization" https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS64RdfIAFvmrTSkZQL2-3O8O9hrL5Sw/viewform?hl=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1 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 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 "Participants were allocated 1:1 to the intervention and control groups using simple randomization." 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 "For randomization, 20 slips of paper labelled with "TAU" and 20 with "TAU-VC" were placed in opaque envelopes by a research staff member not involved with this study. Upon documentation of informed consent, the Research Assistant opened one of the envelopes, revealed the group allocation and communicated it to the participant and psychotherapist. If a participant withdrew prior to being informed of their allocation, the paper was returned to an envelope and put back in the pile." 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 co-interventions (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 and therapists were unblinded; data analyses were blinded to group allocation." 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".
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 We did not inform participants about the arm that was the intervention of interests, but participants may have understood that TAU+VC was the intervention of interests as it included an additional component (i.e. access to VC) compared to TAU.
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 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 "Descriptive statistics were generated to examine uptake of the intervention as de ned as number and percentage of sessions attended." "TSQ and PRCQ items were analyzed descriptively." "Session attendance variables were summarized as group means or medians and compared between groups with unpaired t-tests or non-parametric tests where medians were reported. Endpoint EPDS, GAD-7 and PSS total scores at 3 months were separately compared between groups with intention-to-treat linear mixed effects models including the relevant baseline score as a covariate. We conducted the same analyses in the subgroup of participants with baseline EPDS scores >12 to examine those participants with baseline symptoms suggestive of a major depressive disorder." 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 It did not matter whether the participants randomized to TAU+VC used VC or not during the course of the study as it was optional. We used intention to treat linear mixed effects.
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 "We conducted the same analyses in the subgroup of participants with baseline EPDS scores >12 to examine those participants with baseline symptoms suggestive of a major depressive disorder."

X26-i) Comment on ethics committee approval
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 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 ""If the patient was still interested, the Research Assistant obtained and documented informed verbal consent over the phone, and emailed a copy of the completed consent form to the patient." The consent form was a standard consent form approved by the Women's College Hospital Research Ethics Board.

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 "Participants could attend sessions from their desired location, but were encouraged to ensure the location was private enough that they could participate fully in the session." https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS64RdfIAFvmrTSkZQL2-3O8O9hrL5Sw/viewform?hl=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1 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 13b) For each group, losses and exclusions after randomisation, together with reasons subitem not at all important 1 2 3 4 5 essential 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 "43 individuals were referred to the study and provided consent to participate, but 5 did not complete baseline measures and so were not allocated to a treatment condition. A total of 38 participants were therefore included in the study; 19 in each group. At 3 months post-randomization, therapy attendance data were available for all participants (n=38, 100%), and 25 out of 38 (65.8%) completed symptom scale scores, with a slightly higher completion rate in the TAU-VC (n=14, 77.8%) than the TAU (n=11, 61.1%) condition." Does your paper address CONSORT subitem 13b? (NOTE: Preferably, this is shown in a CONSORT ow 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 "This information is demonstrated in Figure 1, the CONSORT ow diagram."

13b-i) Attrition diagram
Strongly recommended: An attrition diagram (e.g., proportion of participants still logging in or using the intervention/comparator in each group plotted over time, similar to a survival curve) or other gures or tables demonstrating usage/dose/engagement. 14b) Why the trial ended or was stopped (early) 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 Not applicable.
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 took place from June 2016 to July 2017." "A follow-up phone call was made to any outstanding surveys at 2 weeks post the 3month time point." 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" 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 that fell into the study period. 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 Not applicable as the trial was not ended or stopped early.

15) A
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 This information is included in Table 1.

15-i) Report demographics associated with digital divide issues
In ehealth trials it is particularly important to report demographics associated with digital divide issues, such as age, education, gender, social-economic status, computer/Internet/ehealth literacy of the participants, if known.
16) For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 15-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 Data on SES or race/ethnicity was not collected as they are not consistently documented in our assessments or the hospital's electronic medical record. However, this specialized mental health program is available to all women across Ontario with no catchment area, with demographics that re ect the population of the province. Examining this in future studies would be important as SES may re ect ability to use the VC platform (access to equipment and internet), and there could be ethnicity factors affecting treatment seeking and utilization of VC.

16-i) Report multiple "denominators" and provide de nitions
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 This information is included in Figure 1, CONSORT Flow Diagram. Usage was not relevant in this study because we didn't require amount of VC use among participants in TAU-VC; it was optional. subitem not at all important 1 2 3 4 5 essential 17a) For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% con dence 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).
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 "We also compared therapy attendance using therapist logs and symptoms between groups. Symptoms were assessed at baseline and 3-months post randomization with the Edinburgh Postnatal Depression Scale (EPDS), Generalized Anxiety Disorder 7-Item (GAD-7), and Parental Stress Scale (PSS). Three-month scores were compared between groups with intention-to-treat linear mixed effects models controlling for baseline score." "Endpoint EPDS, GAD-7 and PSS total scores at 3 months were separately compared between groups with intention-to-treat linear mixed effects models including the relevant baseline score as a covariate. We conducted the same analyses in the subgroup of participants with baseline EPDS scores >12 to examine those participants with baseline symptoms suggestive of a major depressive disorder." https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS64RdfIAFvmrTSkZQL2-3O8O9hrL5Sw/viewform?hl=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1 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 "At 3 months post-randomization, therapy attendance data were available for all participants (n=38, 100%), and 25 out of 38 (65.8%) completed symptom scale scores, with a slightly higher completion rate in the TAU-VC (n=14, 77.8%) than the TAU (n=11, 61.1%) condition." "PCVC was used at least once by 14 (74%) of the participants in the TAU-VC group. On average, users attended 50% of their sessions with VC, with four participants using VC for 100% of their therapy sessions and four participants using it for none of their sessions." "Eleven of the 14 VC users completed the TSQ. Of them, nine (82%) agreed or strongly agreed that they felt it allowed them to attend therapy sessions more frequently. The average item score was 4.7 out of 5, with average scores of 4.7 (SD=.43), 4.7 (SD =.31) and 4.6 (SD=.67) in the domains of quality of care provided, similarity to in-person face-to-face interaction, and perception of the interaction, respectively." "All participants who used VC at least once reported saving money and time when attending therapy sessions with VC compared to in-person. Speci cally, the average cost savings was $26CAD (SD=19.7, range $7-70CAD) in travel, child care, and other expenses per session, and the average time savings was 2.5 hours (SD=1.6, range 1 -7 hours) in preparation and transportation per session." "There were no signi cant differences between the two groups for the total number of sessions attended, the average length of time per session, the number of noshows or cancellations, and the number of sessions with a child in attendance (Table 2)." "Similarly, there were no signi cant differences in 3-month EPDS, GAD-7, or PSS between groups (see Table 3). When analyses were restricted to those with baseline EPDS > 12 (n=10 in the TAU-VC group, and n=9 in the TAU group), there were again no signi cant differences between groups for 3-month EPDS (F(1,9) = .058, P = .81), 9)=.004, P = .95), or PSS (F(1,9)=.003, P = .96)." https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS64RdfIAFvmrTSkZQL2-3O8O9hrL5Sw/viewform?hl=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1 subitem not at all important 1 2 3 4 5 essential 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-speci ed from exploratory 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 Not applicable.
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 had no binary outcomes. 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 "Similarly, there were no signi cant differences in 3-month EPDS, GAD-7, or PSS between groups (see Table 3). When analyses were restricted to those with baseline EPDS > 12 (n=10 in the TAU-VC group, and n=9 in the TAU group), there were again no signi cant differences between groups for 3-month EPDS (F(1,9) = .058, P = .81), GAD-7 (F(1,9)=.004, P = .95), or PSS (F(1,9)=.003, P = .96)."

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 subitem 18-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 due to small sample size.
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 Not applicable, as there were no important harms or unintended effects in each group. Does your paper address subitem 19-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 We conducted semi-structured qualitative interviewed with the therapists and select participants. We are currently analyzing the data. 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 "In this pilot study, we demonstrated feasibility of recruitment and retention of participants from a program providing psychotherapy to postpartum women with mood and/or anxiety symptoms into a study offering VC as an adjunct to o cebased care. We also showed that participants used the intervention, and reported high satisfaction and substantial savings in time and money. We found no statistically signi cant differences in total number of sessions attended, and, while the number of participants was small, there was no evidence that symptom outcomes differed between those with the option of VC compared to those attending o ce-based appointments only." 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 would hypothesize that by overcoming barriers to care, VC would increase attendance. However, this nding was not observed statistically between groups. A larger study would be better able to determine if access to optional VC impacts therapy attendance overall, or for certain subgroups."

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. 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 "This pilot study used a sample of 38 participants recruited from an academic ambulatory hospital in an urban city, so its patients may have access to more resources than other parts of the province where access barriers are more pronounced. Our program is unique in that it offers specialized care in a hospital that provides access to free child care during appointments, which eliminates some of the barriers to care in the postpartum population. Additionally, we have access to a secure government-funded VC platform. In this setting, we evaluated the option of VC for treatment, which in some areas may not be feasible when there is no access to o ce-based treatment and VC is the only option. Over 80% of the participants in the study had had some therapy experience prior to being referred to our program, so results may not be as generalizable to a therapy-naïve cohort. That said, we have demonstrated the feasibility of recruiting and retaining postpartum women receiving psychotherapy for mood and anxiety di culties to receive the option of VC in addition to o ce-based care. Additionally, uptake and acceptability of the intervention were high and there were no indications of signi cant differences in outcomes, supporting that a larger study is warranted."

21-i) Generalizability to other populations
Generalizability to other populations: In particular, discuss generalizability to a general Internet population, outside of a RCT setting, and general patient population, including applicability of the study results for other organizations 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 pilot study used a sample of 38 participants recruited from an academic ambulatory hospital in an urban city, so its patients may have access to more resources than other parts of the province where access barriers are more pronounced. Our program is unique in that it offers specialized care in a hospital that provides access to free child care during appointments, which eliminates some of the barriers to care in the postpartum population. Additionally, we have access to a secure government-funded VC platform. In this setting, we evaluated the option of VC for treatment, which in some areas may not be feasible when there is no access to o ce-based treatment and VC is the only option. Over 80% of the participants in the study had had some therapy experience prior to being referred to our program, so results may not be as generalizable to a therapy-naïve cohort." 21-ii) Discuss if there were elements in the RCT that would be different in a routine application setting Discuss if there were elements in the RCT that would be different in a routine application setting (e.g., prompts/reminders, more human involvement, training sessions or other co-interventions) and what impact the omission of these elements could have on use, adoption, or outcomes if the intervention is applied outside of a RCT setting.
Does your paper address subitem 21-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 Not applicable, there were no elements in the RCT that would be different in a routine application setting. The reminders from the Research Assistant were only for survey completion, not for engagement with the VC platform. Does your paper address CONSORT subitem 23? * 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 not registered as it is a pilot RCT with a very small sample size.
Does your paper address CONSORT subitem 24? * Cite a Multimedia Appendix, other reference, or 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 full trial protocol is not available.
Does your paper address CONSORT subitem 25? * 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 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 The study team has no relationship with the system being evaluated.
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? STOP -Save this form as PDF before you click submit To generate a record that you lled in this form, we recommend to generate a PDF of this page (on a Mac, simply select "print" and then select "print as PDF") before you submit it.
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