Complaint-Directed Mini-Interventions for Depressive Symptoms: A Health Economic Evaluation of Unguided Web-Based Self-Help Interventions Based on a Randomized Controlled Trial

Background Depression prevention and early intervention have become a top priority in the Netherlands, but with considerable room for improvement. To address this, Web-based complaint-directed mini-interventions (CDMIs) were developed. These brief and low-threshold interventions focus on psychological stress, sleep problems, and worry, because these complaints are highly prevalent, are demonstrably associated with depression, and have substantial economic impact. Objective The objective of this economic evaluation was to examine the added value of Web-based, unguided, self-help CDMIs compared with a wait-listed control group with unrestricted access to usual care from both a societal and a health care perspective. Methods This health economic evaluation was embedded in a randomized controlled trial. The study entailed 2 arms, in which 3 Web-based CDMIs were compared with a no-intervention waiting-list control group (which received the intervention after 3 months). We conducted measurements at baseline, and at 3 and 6 months. The primary outcome was the rate of responders to treatment on depressive symptoms as measured by the Inventory of Depressive Symptomatology Self-Report (IDS-SR). We estimated change in quality of life by calculating effect sizes (Cohen d) for individual pre- and posttreatment IDS-SR scores using a conversion factor to map a change in standardized effect size onto a corresponding change in utility. We calculated incremental cost-effectiveness ratios using bootstraps (5000 times) of seemingly unrelated regression equations and constructed cost-effectiveness acceptability curves for the costs per quality-adjusted life-year (QALY) gained. Results Of 329 study participants, we randomly assigned 165 to the CDMI group. At 3 months, the rate of responders to treatment was 13.9% (23/165) in the CDMI group and 7.3% (12/164) in the control group. At 3 months, participants in the CDMI group gained 0.15 QALYs compared with baseline, whereas participants in the control group gained 0.03 QALYs. Average total costs per patient at 3 months were €2094 for the CDMI group and €2230 for the control group (excluding baseline costs). Bootstrapped seemingly unrelated regression equations models resulted in a dominant incremental cost-effectiveness ratio (ie, lower costs and a higher rate of responders to treatment) for the CDMI group compared with the control group at 3 months, with the same result for the costs per QALY gained. Various sensitivity analyses attested to the robustness of the findings of the main analysis. Conclusions Brief and low-threshold Web-based, unguided, self-help CDMIs have the potential to be a cost-effective addition to usual care for adults with mild to moderate depressive symptoms. The CDMIs improved health status, while reducing participant health care costs, and hence dominated the care-as-usual control condition. As intervention costs were relatively low, and the internet is readily available in the Western world, we believe CDMIs can be easily implemented on a large scale. Trial Registration Netherlands Trial Register NTR4612; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4612 (Archived by WebCite at http://www.webcitation.org/6n4PVYddM)

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 osine 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 briety explain why the item is not applicable/relevant for your study "Complaint-Directed Mini-Interventions for Depressive Symptoms: A Health-Economic Evaluation of Unguided Web-Based Self-Help Interventions based on a randomized-controlled trial" subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 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 briety explain why the item is not applicable/relevant for your study N/A 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 briety explain why the item is not applicable/relevant for your study "Complaint-Directed Mini-Interventions for Depressive Symptoms" 1b) ABSTRACT: Structured summary of trial design, methods, results, and conclusions NPT extension: Description of experimental treatment, comparator, care providers, centers, and blinding status.
subitem not at all important 1 2 3 4 5 essential 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 briety explain why the item is not applicable/relevant for your study ". These brief and low-threshold interventions focus on psychological stress, sleep problems, and worry, because these complaints are highly prevalent, are demonstrably associated with depression and have a substantial economic impact.
Objective Aim of the current economic evaluation is to examine the added value of webbased unguided self-help CDMIs as compared to a wait-listed control group with unrestricted access to usual care" subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 1b-ii) Level of human involvement in the METHODS section of the ABSTRACT Clarify the level of human involvement in the abstract, e.g., use phrases like "fully automated" vs. "therapist/nurse/care provider/physician-assisted" (mention number and expertise of providers involved, if any). (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) 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 briety explain why the item is not applicable/relevant for your study N/A 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. osine), 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 osine 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) subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 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 briety explain why the item is not applicable/relevant for your study Not mentioned 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 briety explain why the item is not applicable/relevant for your study "In total, 329 participants were included in the study of which 165 randomized to the CDMI group." 1b-v) CONCLUSIONS/DISCUSSION in abstract for negative trials Conclusions/Discussions in abstract for negative trials: Discuss the primary outcome -if the trial is negative (primary outcome not changed), and the intervention was not used, discuss whether negative results are attributable to lack of uptake and discuss reasons. 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 briety explain why the item is not applicable/relevant for your study "Given the high prevalence and the chronic character of the condition, prevention and early intervention is of importance. Especially as it has been shown that current psychological and pharmacological interventions only moderately reduce the burden of depression [2,8].
The past decades depression prevention and early intervention has become a top priority within the Netherlands. However, despite evidence that such programmes can be effective, there is still considerable room for improvement.
SpeciUcally, there is a need for novel interventions that are easily accessible, cheap, and importantly, suitable for high risk populations (e.g. people with a low socioeconomic status), as the reach of preventive or early mental health interventions is far from optimal among these populations. It also important that interventions are able to encourage self-management and can be implemented against limited costs. With this in mind the web-based complaint-directed miniinterventions (CDMIs) were developed [9]. The unique feature of the CDMIs as an approach for depression is that they were developed by taking into account that symptoms preceding or underlying depression may not be disorder-speciUc (e.g., worry) and may also vary by individual, which is in line with recent symptomnetwork and trans-diagnostic approaches to mental disorders [10][11][12]." METHODS 3a) Description of trial design (such as parallel, factorial) including allocation ratio 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 briety explain why the item is not applicable/relevant for your study "The aim of the current economic evaluation is to examine the added value of the web-based unguided self-help CDMIs as compared to a wait-listed control group with unrestricted access to usual care both from a societal and healthcare perspective. The HEE was conducted in a sample of adults with mild-tomoderate depressive symptomatology from a societal perspective. In addition, analysis will be conducted from an employers' perspective to determine the cost and effects associated with CDMIs speciUcally related to productivity losses in the subsample of people with a paid job." 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 briety explain why the item is not applicable/relevant for your study "This economic evaluation was embedded in a randomized controlled trial (see Lokman et al. [21]). The study entailed two-arms in which three web-based CMDIs were compared to a no-intervention waiting-list control group. StratiUed block randomization was used to ensure that participants were equally distributed over the three different CMDIs (i.e. "sleep better," "stress less," or "worry less") and two levels of education ("high" (higher vocational or and university level education) or "low" educated). Measurements were conducted at baseline, and at three-and six-months follow-up." 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 briety explain why the item is not applicable/relevant for your study N/A 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 briety explain why the item is not applicable/relevant for your study "Patients were included if they fulUlled the following criteria: 1) ≥18 years of age; 2) had access to a computer with an internet connection; 3) sujcient proUciency of the Dutch language; 4) adequate computer skills to participate in the training, and 5) mild-to-moderate depressive symptoms deUned as a score of 14 to 38 on the Inventory of Depressive Symptomatology Self-Report (IDS-SR) [22]. These IDS-SR cut-off scores imply that the CDMIs were used for indicated prevention in subclinical depression and early intervention in the mild depression. Participants were excluded if they had suicidal thoughts or plans as measured with item 18 of the IDS-SR."

4a-i) Computer / Internet literacy
Computer / Internet literacy is often an implicit "de facto" eligibility criterion -this should be explicitly clariUed.
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 briety explain why the item is not applicable/relevant for your study N/A Open vs. closed, web-based vs. face-to-face assessments: Mention how participants were recruited (online vs. osine), 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 conUrmation, 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 briety explain why the item is not applicable/relevant for your study "Participants were recruited from June 2014 to January 2015 via open recruitment (i.e. through relevant websites, messages on social media, and messages in digital newsletters of the Trimbos Institute)." 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 briety explain why the item is not applicable/relevant for your study "Next, people interested in participation were referred to a special study website where they were given more information about the study and could register to take part in the study by completing a written or an online informed consent form including their name and email address. Applicants were requested to complete the Urst part of the self-report online baseline questionnaire, which acted as a screening instrument and consisted of the IDS-SR and questions about age, Internet access, and computer skills. Eligible participants received the second part of the online baseline questionnaire." 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 briety explain why the item is not applicable/relevant for your study "Participants were recruited from June 2014 to January 2015 via open recruitment (i.e. through relevant websites, messages on social media, and messages in digital newsletters of the Trimbos Institute). Next, people interested in participation were referred to a special study website where they were given more information about the study and could register to take part in the study by completing a written or an online informed consent form including their name and email address." subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 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.
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 briety explain why the item is not applicable/relevant for your study "Applicants were requested to complete the Urst part of the self-report online baseline questionnaire, which acted as a screening instrument and consisted of the IDS-SR and questions about age, Internet access, and computer skills. Eligible participants received the second part of the online baseline questionnaire." 4b-ii) Report how institutional ajliations are displayed Report how institutional ajliations are displayed to potential participants [on ehealth media], as ajliations with prestigious hospitals or universities may affect volunteer rates, use, and reactions with regards to an intervention.(Not a required item -describe only if this may bias results) 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 briety explain why the item is not applicable/relevant for your study Not speciUcally 20-09-18 08(45 CONSORT-EHEALTH (V 1.6.1) -Submission/Publication Form 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 briety explain why the item is not applicable/relevant for your study "With this in mind the web-based complaint-directed mini-interventions (CDMIs) were developed [9]." "All CDMIs were developed by the Trimbos Institute (Netherlands Institute for Mental Health and Addiction)."

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 briety explain why the item is not applicable/relevant for your study N/A

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 briety explain why the item is not applicable/relevant for your study N/A

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 briety explain why the item is not applicable/relevant for your study "With this in mind the web-based complaint-directed mini-interventions (CDMIs) were developed [9]. The unique feature of the CDMIs as an approach for depression is that they were developed by taking into account that symptoms preceding or underlying depression may not be disorder-speciUc (e.g., worry) and may also vary by individual, which is in line with recent symptom-network and trans-diagnostic approaches to mental disorders [10][11][12]. These brief and lowthreshold interventions focus on psychological stress, sleep problems, and worry, because these complaints are highly prevalent, are demonstrably associated with depression, have a substantial economic impact, and are frequently presented to the GP [13][14][15]. Hence, they focus on tackling complaints (symptoms) rather than on disorders, which allows each individual to choose the complaint(s) they want to focus on according to their needs." 5-v) Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing towcharts of the algorithms used Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing towcharts of the algorithms used. Replicability (i.e., other researchers should in principle be able to replicate the study) is a hallmark of scientiUc reporting. 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 briety explain why the item is not applicable/relevant for your study "In total, 329 participants were included in the study of which 165 randomized to the CDMI condition and 164 to the (waiting list) control condition. Participants in the CDMI group were distributed among the three interventions as followed: sleep problems n= 59 (35.7%); stress n=45 (27.3%); and worry n=61 (37.0%)." "Loss to follow-up At three months, 68 participants were lost to follow-up in the CDMI group (41.2%) and 24 participants in the control group (14.6%), which was statistically signiUcant (χ21=28.8, P<.001). Hence, a sensitivity analyses using covariates signiUcantly associated with drop-out at three months was performed. At six months, 97 participants were lost to follow-up in the CDMI group (58.8%) and 82 in the control group (50%) cumulatively. This resulted in 68 participants with complete follow-up in the CDMI group and 82 in the control group."

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.

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 speciUc 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 briety explain why the item is not applicable/relevant for your study 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 briety explain why the item is not applicable/relevant for your study "The CDMIs are made up of three to four modules, each module consisting of four to six exercises. Some modules, such as relaxation, are relevant for all three complaints (sleep, stress, and worry) and are, therefore, part of all three CDMIs. Fixed elements in every CDMI are a home page, a diary, a list with the user's favorite exercises, an exercise book, a to-do list, and a library. Users were free to choose between the modules and exercises and could work independently through the CDMI, without supervision. Participants received a reminder if they did not login to the CDMI within one week after registration. Participants were advised to spend 2 to 3 hours a week on the CDMI for a period of at least 4 weeks." subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 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 briety explain why the item is not applicable/relevant for your study "Participants were advised to spend 2 to 3 hours a week on the CDMI for a period of at least 4 weeks."

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 21generalizability).
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 briety explain why the item is not applicable/relevant for your study "Users were free to choose between the modules and exercises and could work independently through the CDMI, without supervision." 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 briety explain why the item is not applicable/relevant for your study "Participants received a reminder if they did not login to the CDMI within one week after registration. "

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 stand-alone 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. 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 briety explain why the item is not applicable/relevant for your study N/A 20-09-18 08(45 CONSORT-EHEALTH (V 1.6.1) -Submission/Publication Form Pagina 30 van 58 https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oim…formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full#gid=0 6a) Completely deUned pre-speciUed primary and secondary outcome measures, including how and when they were assessed 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 briety explain why the item is not applicable/relevant for your study "Primary outcome of the study was depressive symptomatology as measured by the Inventory of Depressive Symptomatology Self-Report (IDS-SR) [22]. The IDS-SR consists of 30 items relating to the last 7 days that cover nine diagnostic symptom domains used to characterize a major depressive episode as well as items to deUne melancholic and atypical symptom features, commonly associated symptoms (e.g. irritability, anxiety), and features of endogenous symptoms. The IDS-SR was chosen as primary outcome as the study focused on adults with mild-to-moderate depressive symptomatology and we hypothesised a greater reduction in depressive complaints for the participants using the online CDMIs. Items are scored on a four-point Likert scale and can be summed to obtain a total score. Scores range from zero to 84, with higher scores indicating greater depressive symptom severity. For the cost-effectiveness analysis (CEA), we used rate of responders to treatment as the central clinical end-term, arbitrarily chosen to ease interpretation of the cost-effectiveness analysis (i.e. additional costs per responder instead of additional costs per percentage improvement on IDS-SR scores). Rate of responders to treatment was deUned as having a decrease on the IDS-SR scale by 50% (or more) compared to baseline." 20-09-18 08(45 CONSORT-EHEALTH (V 1.6.1) - Does your paper address subitem 6a-ii?
Copy and paste relevant sections from manuscript text "Users were free to choose between the modules and exercises and could work independently through the CDMI, without supervision. Participants received a reminder if they did not login to the CDMI within one week after registration. Participants were advised to spend 2 to 3 hours a week on the CDMI for a period of at least 4 weeks." 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 briety explain why the item is not applicable/relevant for your study "The required sample size for this study to achieve a power of 80%, was estimated to be 292 (146 per condition), based on achieving an effect size of 0.33 with a power of 0.80 and a two-tailed test with α=0.05." 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 briety explain why the item is not applicable/relevant for your study N/A 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 briety explain why the item is not applicable/relevant for your study "Eligible participants received the second part of the online baseline questionnaire. To be able to conduct the stratiUed block randomization, applicants were asked which CDMI they would want to take part in: "Sleep better," "Stress less," or "Worry less"." 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 briety explain why the item is not applicable/relevant for your study "Eligible participants received the second part of the online baseline questionnaire. To be able to conduct the stratiUed block randomization, applicants were asked which CDMI they would want to take part in: "Sleep better," "Stress less," or "Worry less"." 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 briety explain why the item is not applicable/relevant for your study "More details can be found in Lokman et al. 2017 [21]." 10) Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions 11a) If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how NPT: Whether or not administering co-interventions were blinded to group assignment subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 10? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briety explain why the item is not applicable/relevant for your study "More details can be found in Lokman et al. 2017 [21]." 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 briety explain why the item is not applicable/relevant for your study Not blinded 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 briety explain why the item is not applicable/relevant for your study "Third, given the nature of the intervention, participants could not be blinded.
This may have biased participants in one way or another (e.g. placebo effect)." 12a) Statistical methods used to compare groups for primary and secondary outcomes NPT: When applicable, details of whether and how the clustering by care providers or centers was addressed Does your paper address CONSORT subitem 11b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briety explain why the item is not applicable/relevant for your study "A recent systematic review looking speciUcally at Internet-and mobile-based interventions targeting depression highlights the potential of those interventions to be cost-effective, with similar cost-effectiveness ratios compared to those reported for face-to-face psychotherapy and antidepressant drug treatment [35].
In this review, of the 14 e-interventions six were deemed cost-effective, Uve were not cost-effective, and two were undecided.
A systematic review looking at economic evaluations of internet interventions for mental health concluded that guided internet interventions for, among others, depression and anxiety demonstrated higher probabilities of being cost-effective [36]. However, the evidence for unguided internet interventions for depression was less convincing. Moreover, a study examining the cost-effectiveness of an online self-help intervention aimed to enhance well-being by fostering positive emotions and stimulate positive functioning demonstrated reduced depressive symptoms, though at higher costs leading to unfavourable cost-effectiveness ratio's [37].
The authors emphasise the importance of adherence to maintain long-term effects and possibly increase the cost-effectiveness. In terms of feasibility, Grijths & Christensen (2007) evaluated two communitybased internet programs in the treatment of depression and concluded that these interventions programs can be delivered effectively by using the internet. Furthermore, they emphasize the importance of using the internet as a more accessible alternative compared to face-to-face mental health services, especially in rural areas [38]." 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 briety explain why the item is not applicable/relevant for your study "All analyses were carried out while adhering to the intent-to-treat (ITT) principle, i.e. all participants were analysed as randomized provided that their baseline data were complete. For the current analyses, missing values at the follow-up measurements were imputed using multiple imputation (5 times). Imputation for total costs and IDS-SR scores was based on age, gender, group, baseline IDS-SR score, baseline JSEQ score, baseline PSS score, baseline GAD-7 score, and baseline health care, patients & family and productivity costs (for cost data only). To account for non-normality of the data, predictive mean matching was used in which ''real'' observed values from similar cases are imputed instead of imputing regression estimates [29,30]. Rate of responders to treatment, as determined by at least a 50% decrease in IDS-SR scores, was used to calculate an incremental cost-effectiveness ratio (ICER) by dividing the difference in costs by the difference in rate of responders to treatment between both groups. This results in the additional costs per extra responder. In addition, QALY estimates were used to calculate the incremental cost-utility ratio (ICUR) by dividing the difference in costs by the difference in QALY between both groups. This way, the ICUR represents the additional costs per QALY gained. To investigate the uncertainty around the ICER and ICUR, nonparametric bootstrapping (5000 times) was used. Bootstrapping is a nonparametric way to repeatedly simulate an analysis by resampling, with replacement, from the observed data [31]. Seemingly unrelated regression equations (SURE) were bootstrapped (5000 times) to allow for correlated residuals of the cost and utility equations and to account for baseline differences in productivity costs. Next, cost-effectiveness acceptability curves (CEACs) were constructed for the costs per QALY gained in which the likelihood that the CDMI's are cost-effective is presented given several willingness-to-pay (WTP) ceilings. A report from the Dutch Council for Public Health and Health Care has provided guidance on the ceiling ratios for a QALY for diseases deUned by their disability weight. Based on this report, the ceiling ratio can be roughly estimated to be €20,000-80,000 per QALY depending on the severity of the disease or disorder [32] and since we are looking at subclinical and mild manifestations of depression this would put the WTP ceiling at €20.000 per QALY gained. Comparative results are presented for 3 months follow-up as the control group Comparative results are presented for 3 months follow-up as the control group received the CDMIs after 3 months follow-up which hampers interpretation at 6 months follow-up. Results at 6 months are only used to check whether effects at 3 months were sustained. All analyses were carried out using STATA 14." 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 briety explain why the item is not applicable/relevant for your study "For the current analyses, missing values at the follow-up measurements were imputed using multiple imputation (5 times). Imputation for total costs and IDS-SR scores was based on age, gender, group, baseline IDS-SR score, baseline JSEQ score, baseline PSS score, baseline GAD-7 score, and baseline health care,

RESULTS
13a) For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analysed for the primary outcome NPT: The number of care providers or centers performing the intervention in each group and the number of patients treated by each care provider in each center 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 briety explain why the item is not applicable/relevant for your study "Next, people interested in participation were referred to a special study website where they were given more information about the study and could register to take part in the study by completing a written or an online informed consent form including their name and email address."

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 briety explain why the item is not applicable/relevant for your study "Participants were excluded if they had suicidal thoughts or plans as measured with item 18 of the IDS-SR. These participants were referred to contact their GP or an anonymous online platform for people with suicidal thoughts." 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 briety explain why the item is not applicable/relevant for your study "In total, 329 participants were included in the study of which 165 randomized to the CDMI condition and 164 to the (waiting list) control condition." Does your paper address CONSORT subitem 13b? (NOTE: Preferably, this is shown in a CONSORT tow 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 briety explain why the item is not applicable/relevant for your study "Loss to follow-up At three months, 68 participants were lost to follow-up in the CDMI group (41.2%) and 24 participants in the control group (14.6%), which was statistically signiUcant (χ21=28.8, P<.001). Hence, a sensitivity analyses using covariates signiUcantly associated with drop-out at three months was performed. At six months, 97 participants were lost to follow-up in the CDMI group (58.8%) and 82 in the control group (50%) cumulatively. This resulted in 68 participants with complete follow-up in the CDMI group and 82 in the control group."

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 Ugures or tables demonstrating usage/dose/engagement. 1 2 3 4 5 essential Does your paper address subitem 13b-i?
Copy and paste relevant sections from the manuscript or cite the Ugure 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 briety explain why the item is not applicable/relevant for your study "Loss to follow-up At three months, 68 participants were lost to follow-up in the CDMI group (41.2%) and 24 participants in the control group (14.6%), which was statistically signiUcant (χ21=28.8, P<.001). Hence, a sensitivity analyses using covariates signiUcantly associated with drop-out at three months was performed. At six months, 97 participants were lost to follow-up in the CDMI group (58.8%) and 82 in the control group (50%) cumulatively. This resulted in 68 participants with complete follow-up in the CDMI group and 82 in the control group." 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 briety explain why the item is not applicable/relevant for your study "Participants were recruited from June 2014 to January 2015 via open recruitment" 14a-i) Indicate if critical "secular events" fell into the study period Indicate if critical "secular events" fell into the study period, e.g., signiUcant changes in Internet resources available or "changes in computer hardware or Internet delivery resources" 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, qualiUcation, expertise, etc.) and centers (volume) in each group subitem not at all important 1 2 3 4 5 essential 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 briety explain why the item is not applicable/relevant for your study N/A 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 briety explain why the item is not applicable/relevant for your study N/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 briety explain why the item is not applicable/relevant for your study see Table 1 15-i) Report demographics associated with digital divide issues

16-i) Report multiple "denominators" and provide deUnitions
Report multiple "denominators" and provide deUnitions: 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 speciUc pre-deUned time points of interest (in absolute and relative numbers per group). Always clearly deUne "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 briety explain why the item is not applicable/relevant for your study Yes in text and in tables 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).
17a) For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% conUdence interval) subitem not at all important 1 2 3 4 5 essential 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 briety explain why the item is not applicable/relevant for your study Yes intention to treat was used 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 briety explain why the item is not applicable/relevant for your study Yes conUdence intervals for ICERs are presented inFigure 1 & 2 and in table 3 & 4 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 deUnitions 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 deUned (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 briety explain why the item is not applicable/relevant for your study No, there was no obligatory dose 18) Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-speciUed from exploratory subitem not at all important 1 2 3 4 5 essential 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 briety explain why the item is not applicable/relevant for your study N/A 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 briety explain why the item is not applicable/relevant for your study Yes, they are mentioned under "Sensitivity analyses"

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 briety explain why the item is not applicable/relevant for your study N/A 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 briety explain why the item is not applicable/relevant for your study N/A 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).
subitem not at all important 1 2 3 4 5 essential 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 briety explain why the item is not applicable/relevant for your study "This study examined the cost-effectiveness of web-based complaint-directed mini-interventions (CDMIs) in adult patients with mild-to-moderate depressive symptoms in comparison to a waitlisted control group with unrestricted access to usual care in the Netherlands. The study had a follow-up at three months and in the experimental arm of the trial an extended follow-up at six months to see if effects were sustained over time. The CDMI consisted of three different interventions ("sleep better," "stress less," and "worry less"). Patients in the waiting list control group were given access to the CDMIs after three months follow-up. When looking at rate of responders to treatment (deUned as a 50% reduction in IDS-SR depressive symptoms), a dominant ICER was found at three months follow-up implying that the CDMIs provide lower costs for better rates of responders to treatment. Looking at costs per QALY gained a dominant ICER was found at three months follow-up implying lower costs and increased QALYs. For both outcomes results were sustainable over 6 months' time, particular given the steady increase in rate of responders to treatment in the CDMI group at 6 months and increase of this responder rate in the control group at 6 months (after giving them access to the intervention at three months follow-up. Sensitivity analyses showed that results were robust to different assumptions, perspectives, or the way missing data was handled. Hence, this study demonstrates that it is possible to use an easily accessible and economically affordable intervention to improve participants' health status in a cost-effective manner." 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 briety explain why the item is not applicable/relevant for your study "Regarding the latter, future research may also focus on the impact of reminder systems incorporated into the CDMIs."

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 briety explain why the item is not applicable/relevant for your study "This study is not without limitations. First, the follow-up of the trial was at three months post baseline, which does not provide hard evidence for the longer-term effects. However, in the extended follow-up of the experimental arm we could see that the effects (rate of responders to treatment and QALY gains) were maintained until six months follow-up. In addition, at the 6-month follow-up the costs were relatively lower as those at 3 months (for both groups), suggesting that reductions in health care resource use may have occurred. Second, relatively large drop-out rates were encountered which made imputation of missing values necessary. Although high dropout rates are a problem often encountered in eHealth trials [39], one should always carefully consider imputation techniques, especially in the context of substantial drop-out. However, different imputation techniques led to comparable results attesting to the robustness of the main analysis. Third, given the nature of the intervention, participants could not be blinded. This may have biased participants in one way or another (e.g. placebo effect). Fourth, due to the fact that recruitment was mainly done by means of Internet-based recruitment avenues it is possible that some potential participants were missed. For example, could be that we missed participants that are less likely to engage in social media. Fifth, although they were free to Und additional care themselves, the control condition was not provided any intervention. This may have caused an overestimation of the effects of the CDMIs. Sixth, given the focus of each CDMI, some of the content differed between the three CDMIs, although there was also overlap in content. The CDMIs can be seen as an overall intervention approach that aims to target depressive complaints, but one in which participants are able to choose the CDMI they want to use based on their personal needs and do not have to use CDMIs that are not relevant to their situation. As a result, each CDMI may target depressive complaints differently. This would be an interesting avenue to explore in future to gain insight into the mechanisms of change. Finally, the generalizability of the Undings with respect to males and other educational levels remains to be determined as mainly highly educated female participants were included in the trial, but this selected group of participants may well retect the composition of the target group that will be reached after implementation of the CDMIs." 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 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 briety explain why the item is not applicable/relevant for your study "Finally, the generalizability of the Undings with respect to males and other educational levels remains to be determined as mainly highly educated female participants were included in the trial, but this selected group of participants may well retect the composition of the target group that will be reached after implementation of the CDMIs." 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. 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 briety explain why the item is not applicable/relevant for your study N/A 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 briety explain why the item is not applicable/relevant for your study "Netherlands Trial Register (NTR): NTR4612; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4612 (Archived by WebCite at http://www.webcitation.org/6n4PVYddM)" 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 briety explain why the item is not applicable/relevant for your study "This economic evaluation was embedded in a randomized controlled trial (see Lokman et al. [21])." 20-09-18 08(45 CONSORT-EHEALTH (V 1.6.1) - About the CONSORT EHEALTH checklist 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 briety explain why the item is not applicable/relevant for your study "This study was made possible with Unancial support from the Ministry of Health, Welfare and Sport and the Trimbos Institute." X27-i) State the relation of the study team towards the system being evaluated In addition to the usual declaration of interests (Unancial 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 briety explain why the item is not applicable/relevant for your study "The interventions that were used in this study were developed by the Trimbos Institute, the Netherlands Institute of Mental Health and Addiction, a non-proUt organization, where SL, SL, FS, and BFMW are employed. All authors declare that there are no other conticts of interest." yes, major changes yes, minor changes no yes no Anders: 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 Ulled 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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