Adherence With Online Therapy vs Face-to-Face Therapy and With Online Therapy vs Care as Usual: Secondary Analysis of Two Randomized Controlled Trials

Background Adherence to internet-delivered interventions targeting mental health such as online psychotherapeutic aftercare is important for the intervention’s impact. High dropout rates limit the impact and generalizability of findings. Baseline differences may be putting patients at risk for dropping out, making comparisons between online with face-to-face (F2F) therapy and care as usual (CAU) necessary to examine. Objective This study investigated adherence to online, F2F, and CAU interventions as well as study dropout among these groups and the subjective evaluation of the therapeutic relationship. Sociodemographic, social-cognitive, and health-related variables were considered. Methods In a randomized controlled trial, 6023 patients were recruited, and 300 completed the baseline measures (T1), 144 completed T2 (retention 44%-52%), and 95 completed T3 (retention 24%-36%). Sociodemographic variables (eg, age, gender, marital status, educational level), social-cognitive determinants (eg, self-efficacy, social support), health-related variables (eg, depressiveness), and expectation towards the treatment for patients assigned to online or F2F were measured at T1. Results There were no significant differences between the groups regarding dropout rates (χ21=0.02-1.06, P≥.30). Regarding adherence to the treatment condition, the online group outperformed the F2F and CAU conditions (P≤.01), indicating that patients randomized into the F2F and CAU control groups were much more likely to show nonadherent behavior in comparison with the online therapy groups. Within study groups, gender differences were significant only in the CAU group at T2, with women being more likely to drop out. At T3, age and marital status were also only significant in the CAU group. Patients in the online therapy group were significantly more satisfied with their treatment than patients in the F2F group (P=.02; Eta²=.09). Relationship satisfaction and success satisfaction were equally high (P>.30; Eta²=.02). Combining all study groups, patients who reported lower depressiveness scores at T1 (T2: odds ratio [OR] 0.55, 95% CI 0.35-0.87; T3: OR 0.56, 95% CI 0.37-0.92) were more likely to be retained, and patients who had higher self-efficacy (T2: OR 0.57, 95% CI 0.37-0.89; T3: OR 0.52, 95% CI 0.32-0.85) were more likely to drop out at T2 and T3. Additionally, at T3, the lower social support that patients reported was related to a higher likelihood of remaining in the study (OR 0.68, 95% CI 0.48-0.96). Comparing the 3 intervention groups, positive expectation was significantly related with questionnaire completion at T2 and T3 after controlling for other variables (T2: OR 1.64, 95% CI 1.08-2.50; T3: OR 1.59, 95% CI 1.01-2.51). Conclusions While online interventions have many advantages over F2F variants such as saving time and effort to commute to F2F therapy, they also create difficulties for therapists and hinder their ability to adequately react to patients’ challenges. Accordingly, patient characteristics that might put them at risk for dropping out or not adhering to the treatment plan should be considered in future research and practice. Online aftercare, as described in this research, should be provided more often to medical rehabilitation patients. Trial Registration ClinicalTrials.gov NCT04989842; https://clinicaltrials.gov/ct2/show/NCT04989842

yes: all primary outcomes were significantly better in intervention group vs control partly: SOME primary outcomes were significantly better in intervention group vs control no statistically significant difference between control and intervention potentially harmful: control was significantly better than intervention in one or more outcomes 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 offline 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.

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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 briefly explain why the item is not applicable/relevant for your study online therapy vs. face-to-face therapy and online therapy vs. care-as-usual

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").

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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 briefly explain why the item is not applicable/relevant for your study "Adherence with online therapy vs. face-to-face therapy and online therapy vs. care-asusual: Secondary analysis of two randomized controlled trials" subitem not at all important 1 2 3 4 5 essential 1b) ABSTRACT: Structured summary of trial design, methods, results, and conclusions NPT extension: Description of experimental treatment, comparator, care providers, centers, and blinding status.
subitem not at all important 1 2 3 4 5 essential 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

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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 briefly explain why the item is not applicable/relevant for your study "...online psychotherapeutic aftercare..." --> more information is not needed here 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)

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subitem not at all important 1 2 3 4 5 essential 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 briefly explain why the item is not applicable/relevant for your study in this paper, we were focussing on retention and adherence in F2F vs. online vs. CAU 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)

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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 briefly explain why the item is not applicable/relevant for your study "comparison between online with face-to-face (F2F) and care as usual (CAU)" subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 1b-iii) Open vs. closed, web-based (self-assessment) vs. face-to-face assessments in the METHODS section of the ABSTRACT Mention how participants were recruited (online vs. offline), 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 offline 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)
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 briefly explain why the item is not applicable/relevant for your study "N = 6,023 patients were recruited at their psychosomatic rehabilitation clinic." 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)
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 briefly explain why the item is not applicable/relevant for your study "Results: There were no significant differences between the groups with regard to dropout rates over time (χ2=0.02-1.06, P≥.30). Regarding adherence to the treatment condition, the online group outperformed the F2F condition with 3-6% and the CAU condition with 14-32% (P≤.01). Within study arms gender differences were significant only in the CAU group at T2, with women being more likely to dropout (84% vs. 59% remaining in the study). At T3, age (dropouts were 8 years older) and marital status (80% of those who remained in the study were married whereas only 35% of the dropouts were married) were not significant in the online or F2F group (P>.06 Does your paper address subitem 1b-v? 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 briefly explain why the item is not applicable/relevant for your study "Conclusions: While online interventions have many advantages to F2F variants such as saving time and effort to commute to the therapy, they also creating difficulties for therapists and hindering their ability to adequately react to patients' challenges. Accordingly, patient characteristics which might put them at risk for dropping out or not adhering to the treatment plan should be considered in future research and practice."

2a-i) Problem and the type of system/solution
Describe the problem and the type of system/solution that is object of the study: intended as stand-alone intervention vs. incorporated in broader health care program? Intended for a particular patient population? Goals of the intervention, e.g., being more cost-effective to other interventions, replace or complement other solutions? (Note: Details about the intervention are provided in "Methods" under 5)

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subitem not at all important 1 2 3 4 5 essential 2b) In INTRODUCTION: Specific objectives or hypotheses 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 briefly explain why the item is not applicable/relevant for your study "However, few studies have compared a human-delivered online therapy group with a control group with the same therapeutic techniques delivered in a face-to-face (F2F) format, and a treatment/care as usual group (CAU). So far, one study out of the few pre-existing studies found an advantage of the online therapy treatment over the CAU, and about the same effects as the F2F format [9]. The current research aims to use the data from this previous study for a secondary data analysis to further investigate adherence to the treatment arm, dropout from the study within the German Pension Insurance's framework concept for rehabilitation therapy [10], and the subjective evaluation of relationship, success and satisfaction." 2a-ii) Scientific background, rationale: What is known about the (type of) system

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Does your paper address subitem 2a-ii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study see Introduction "Prior work on study dropout and adherence Expansive knowledge already exists on factors affecting study participants, the likelihood of questionnaire completion (eg, [6]), and adherence to the assigned METHODS 3a) Description of trial design (such as parallel, factorial) including allocation ratio 3b) Important changes to methods after trial commencement (such as eligibility criteria), with reasons Does your paper address CONSORT subitem 2b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Research questions: 1. What difference exists between the online therapy groups (ONL1, ONL2) and the control groups (F2F, CAU) regarding (a) patients who complete the questionnaires (retainers) and (b) patients who adhere to the assigned therapy? 2. What reasons do patients have to not adhere to the assigned therapy? 3. What factors are related to completing the different study arms at T2 and T3? 4. Does the improvement expectation differ between the online therapy groups (ONL1, ONL2) and the control groups (F2F, CAU) and does it relate to questionnaire completion at T2 and T3 after controlling for other variables? 5. Does the subjective evaluation of the online (ONL1, ONL2) and F2F therapy differ with regard to relationship satisfaction success satisfaction and satisfaction with therapy?" 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 briefly explain why the item is not applicable/relevant for your study "If they agreed to participate, the rehabilitants who had an (F2F) therapy offer within a 45 min radius of their place of residence were randomly assigned to either the F2F therapy or the online therapy within the equivalence study ( Fig. 1). Those without therapy offers in their vicinity were randomly assigned to online therapy or to no therapy offer within the so-called superiority study. 253 rehabilitants were assigned to one of the two study arms via the above-mentioned query. For the equivalence study, 142 rehabilitants were included in online therapy or F2F follow-up; and 111 rehabilitants were assigned to online therapy or the control group (care as usual) for the superiority study ( Fig. 1)." subitem not at all important 1 2 3 4 5 essential 4a) Eligibility criteria for participants 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 briefly explain why the item is not applicable/relevant for your study no such changes had to be applied 3b-i) Bug fixes, Downtimes, Content Changes Bug fixes, 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 fixes or changes in the functionality or content) (5-iii) and other "unexpected events" that may have influenced study design such as staff changes, system failures/downtimes, etc. [2].

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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 briefly explain why the item is not applicable/relevant for your study does not apply to this study as we focussed on retention and adherence subitem not at all important 1 2 3 4 5 essential 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 briefly explain why the item is not applicable/relevant for your study see figure 1 and "N = 6,023 patients were recruited at their psychosomatic rehabilitation clinic. After excluding non-eligible patients, n = 300 completed the baseline measures (T1). All rehabilitants who had participated in a psychotherapeutic rehabilitation treatment with Dr. Becker

4a-i) Computer / Internet literacy
Computer / Internet literacy is often an implicit "de facto" eligibility criterion -this should be explicitly clarified.

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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 briefly explain why the item is not applicable/relevant for your study this was checked by the clinic but not further included as not main focus subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 4a-ii) Open vs. closed, web-based vs. face-to-face assessments: Open vs. closed, web-based vs. face-to-face assessments: Mention how participants were recruited (online vs. offline), e.g., from an open access website or from a clinic, and clarify if this was a purely webbased 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 confirmation, phone calls) were used to detect/prevent these.

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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 briefly explain why the item is not applicable/relevant for your study "N = 6,023 patients were recruited at their psychosomatic rehabilitation clinic. After excluding non-eligible patients, n = 300 completed the baseline measures (T1). All rehabilitants who had participated in a psychotherapeutic rehabilitation treatment with Dr. Becker  Rehabilitants were questioned during their stay by a member of the social services staff and asked whether they wanted to take advantage of an aftercare therapy offer. If they said yes, they were informed about the option of participating in the study and about the study conditions."

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.
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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 briefly explain why the item is not applicable/relevant for your study "All participants were informed about the purpose of the study (including information on the length of the questionnaires and data storage procedures) via a participant information form and an informed consent form..." 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 briefly explain why the item is not applicable/relevant for your study "N = 6,023 patients were recruited at their psychosomatic rehabilitation clinic. After excluding non-eligible patients, n = 300 completed the baseline measures (T1). All rehabilitants who had participated in a psychotherapeutic rehabilitation treatment with Dr. Becker  4b-i) Report if outcomes were (self-)assessed through online questionnaires Clearly report if outcomes were (self-)assessed through online questionnaires (as common in web-based trials) or otherwise.

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subitem not at all important 1 2 3 4 5 essential 5) The interventions for each group with sufficient details to allow replication, including how and when they were actually administered 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 briefly explain why the item is not applicable/relevant for your study "The survey was conducted during the rehabilitation by means of questionnaire measures at baseline (T1), 9 (superiority study) or 12 (equivalence study) months after the end of rehabilitation (after completion of the therapy intervention), and 15 (superiority study) or 18 (equivalence study) months after the end of rehabilitation. The reason for the postponed survey in the equivalence study was the waiting time for an aftercare place in the F2F therapy. The study participants were asked to fill out the T2 and T3 questionnaires by email and were reminded 2 and 4 weeks later, respectively. The questionnaires were filled out digitally via the platform soscisurvey.de. At T2 and T3, the rehabilitates were asked whether they really followed the study protocol in terms of adhering to the study arm and its therapy as they were assigned to " 4b-ii) Report how institutional affiliations are displayed

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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 briefly explain why the item is not applicable/relevant for your study the whole study took place within the Dr. Becker clinic group and with the described hospitals.
subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 5-i) Mention names, credential, affiliations of the developers, sponsors, and owners Mention names, credential, affiliations of the developers, sponsors, and owners [6] (if authors/evaluators are owners or developer of the software, this needs to be declared in a "Conflict of interest" section or mentioned elsewhere in the manuscript).

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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 briefly explain why the item is not applicable/relevant for your study Dr. Becker Clinic Group to which the recruiting hospitals belong

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.
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 briefly explain why the item is not applicable/relevant for your study the therapeutic method was Curriculum Hannover "comparison of the same aftercare delivered via the internet (content and procedure of the therapy; Curriculum Hannover [21,22]) compared to F2F and care-as-usual in terms of study dropout and intervention withdrawal. Thus, this will be the main aim of the current study, since the usefulness of Curriculum Hannover was tested before and clearly revealed its superiority to care-asusual, as well as parity between the internet and F2F delivery methods [9]."

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).
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 briefly explain why the item is not applicable/relevant for your study "Implementation of therapy The therapy in the usual F2F contact was based on the concept from the Curriculum Hanover [21,22], an aftercare treatment following the medical rehabilitation. Apart from the admission and final interviews, which were each a 50-minute individual interview, therapy took place over 25 weekly 90-minute group sessions with 8-10 participants. The online aftercare was carried out according to the same concept, but had technical peculiarities due to the digital format: the participants were instructed in advance on how to use the video platform by means of a learning video; this included, among other things, the rules for communication in the "virtual group room" as well as instructions for regularly checking the digital line. The psychotherapists prepared for the special features of the new format through training courses geared to equip them to build a therapeutic relationship in a targeted manner and to teach them how to use the video platform. Apart from group discussions, psychoeducation within the aftercare was conveyed by the therapists using PowerPoint presentations or a whiteboard. Handouts or homework could also be distributed.
Under study conditions, care-as-usual therapy meant that no standardized therapy measures were initiated. Whether the participants of this study arm independently took th ff d l "

5-iv) Quality assurance methods
Provide information on quality assurance methods to ensure accuracy and quality of information provided [1], if applicable.
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 briefly explain why the item is not applicable/relevant for your study not applicable as not main focus of this study subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 5-v) Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing flowcharts of the algorithms used Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing flowcharts of the algorithms used. Replicability (i.e., other researchers should in principle be able to replicate the study) is a hallmark of scientific reporting.

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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 briefly explain why the item is not applicable/relevant for your study not applicable as not main focus of this study

5-vi) Digital preservation
Digital preservation: Provide the URL of the application, but as the intervention is likely to change or disappear over the course of the years; also make sure the intervention is archived (Internet Archive, webcitation.org, and/or publishing the source code or screenshots/videos alongside the article). As pages behind login screens cannot be archived, consider creating demo pages which are accessible without login.
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 briefly explain why the item is not applicable/relevant for your study not applicable as not main focus of this study

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 specific 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).

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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 briefly explain why the item is not applicable/relevant for your study "Data Exclusion Inclusion criteria included indication for psychosomatic therapy (indication is determined by the procedure described in the German Pension Insurance's framework concept for rehabilitation therapy [10]) and access to a standard PC, tablet or smartphone with Internet access (DSL or LTE). The exclusion criteria were also based on the framework concept for rehabilitation therapy of the German Pension Insurance and included employability <3 hours/day on the general labor market, drawing or applying for an old-age pension of at least two-thirds of the fulltime pension, and drawing a benefit that is paid regularly until the start of a pension due to old age. Furthermore, patients with acute psychosomatic disorders are excluded." subitem not at all important

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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 briefly explain why the item is not applicable/relevant for your study Online vs. F2F and CAU, see above

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.
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 briefly explain why the item is not applicable/relevant for your study not applicable as not main focus of this study

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).

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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 briefly explain why the item is not applicable/relevant for your study all therapies were human delivered, just the mode varied

5-xi) Report any prompts/reminders used
Report any prompts/reminders used: Clarify if there were prompts (letters, emails, phone calls, SMS) to use the application, what triggered them, frequency etc. It may be necessary to distinguish between the level of prompts/reminders required for the trial, and the level of prompts/reminders for a routine application outside of a RCT setting (discuss under item 21 -generalizability).

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subitem not at all important 1 2 3 4 5 essential 6a) Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed 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 briefly explain why the item is not applicable/relevant for your study "The study participants were asked to fill out the T2 and T3 questionnaires by email and were reminded 2 and 4 weeks later, respectively."

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.

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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 briefly explain why the item is not applicable/relevant for your study "The online aftercare was carried out according to the same concept, but had technical peculiarities due to the digital format: the participants were instructed in advance on how to use the video platform by means of a learning video; this included, among other things, the rules for communication in the "virtual group room" as well as instructions for regularly checking the digital line. The psychotherapists prepared for the special features of the new format through training courses geared to equip them to build a therapeutic relationship in a targeted manner and to teach them how to use the video platform. Apart from group discussions, psychoeducation within the aftercare was conveyed by the therapists using PowerPoint presentations or a whiteboard. Handouts or homework could also be distributed " 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 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 briefly explain why the item is not applicable/relevant for your study in this study, we only evaluated retention/dropout, adherence and satisfaction 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].

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Does your paper address subitem 6a-i?

Copy and paste relevant sections from manuscript text
See section "Survey instruments The following items were analyzed in the current longitudinal study..."

6a-ii) Describe whether and how "use" (including intensity of use/dosage) was defined/measured/monitored
Describe whether and how "use" (including intensity of use/dosage) was defined/measured/monitored (logins, logfile analysis, etc.). Use/adoption metrics are important process outcomes that should be reported in any ehealth trial.

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subitem not at all important 1 2 3 4 5 essential 6b) Any changes to trial outcomes after the trial commenced, with reasons 7a) How sample size was determined NPT: When applicable, details of whether and how the clustering by care provides or centers was addressed Does your paper address subitem 6a-ii?
Copy and paste relevant sections from manuscript text not relevant for this study 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).

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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 briefly explain why the item is not applicable/relevant for your study "Power To determine the minimum required sample size through a priori analysis for obtaining a significant medium effect size, we used PADD 11 software and G*Power 3 software (Psychonomic Society, Inc) [23,24]. With regard to the superiority study and based on the assumption of an effect of the intervention of Cohen's d > .60 (> 8 points difference in primary end point), a total of 90 subjects (45 per study-arm) were needed to conduct the study at alpha < .05 and power > .80. Concerning the equivalence study and based on the assumption of an equivalence margin of Cohen's d < .29 (< 4 points difference in primary end point), a total of 410 subjects (205 per study arm) were planned for the study to test with at alpha < 05 and power > 80 [21 22] " 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 briefly explain why the item is not applicable/relevant for your study does not apply as we were explicitly interested in dropout prediction 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 10) Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions 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 briefly explain why the item is not applicable/relevant for your study "There were 300 participants randomized into two RCTs: equivalence study (n = 167, left hand side in Tab. 1) and superiority study (n = 133, right hand side in Tab. 1). " 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 briefly explain why the item is not applicable/relevant for your study does not apply in this study 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 briefly explain why the item is not applicable/relevant for your study does not apply in this study 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 briefly explain why the item is not applicable/relevant for your study not main focus of this study 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).

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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 briefly explain why the item is not applicable/relevant for your study blinding was not possible subitem not at all important 1 2 3 4 5 essential 11b) If relevant, description of the similarity of interventions (this item is usually not relevant for ehealth trials as it refers to similarity of a placebo or sham intervention to a active medication/intervention) 12a) Statistical methods used to compare groups for primary and secondary outcomes NPT: When applicable, details of whether and how the clustering by care providers or centers was addressed 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".

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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 briefly explain why the item is not applicable/relevant for your study study arm was obvious to patients 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 briefly explain why the item is not applicable/relevant for your study "The online aftercare was carried out according to the same concept, but had technical peculiarities due to the digital format" subitem not at all important 1 2 3 4 5 essential 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 briefly explain why the item is not applicable/relevant for your study "Statistical Analysis Differences between the intervention and control groups in terms of dropout and adherence (research question 1) were tested with frequency analyses (Chi²). Patients' reasons as to why they did not adhere (research question 2 and the sample description) were examined using descriptive analyses without calculating any statistics.
To test what factors were related to completing the different study arms (research question 3), t-tests, Chi²-tests, and logistic regression analyses (determining odd ratios, OR) were conducted. A MANOVA with post-hoc Bonferroni tests was performed testing whether the subjective evaluation of the online and F2F therapy would differ with regard to relationship satisfaction, success satisfaction, and satisfaction with therapy (research question 4). This was also followed up by logistic regression analyses.
To test whether the subjective evaluation of the online and F2F therapy differed with regard to relationship satisfaction, success satisfaction and satisfaction with therapy, a MANOVA was performed (research question 5) taking expectations into account. All analyses were run using SPSS 26 " 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]).

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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 briefly explain why the item is not applicable/relevant for your study was done in the primary paper but not in this study 12b) Methods for additional analyses, such as subgroup analyses and adjusted analyses

X26) REB/IRB Approval and Ethical Considerations [recommended as
subheading under "Methods"] (not a CONSORT item) subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 12b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study with some analyses, CAU was left out

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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 briefly explain why the item is not applicable/relevant for your study "The study protocol was approved by the Ethics Committee of the North Rhine Medical Association (Ärztekammer Nordrhein;No. 2015351 with Dec 4, 2015)." subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential x26-ii) Outline informed consent procedures Outline informed consent procedures e.g., if consent was obtained offline or online (how? Checkbox, etc.?), and what information was provided (see 4a-ii). See [6] for some items to be included in informed consent documents.

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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 briefly explain why the item is not applicable/relevant for your study "All participants were informed about the purpose of the study (including information on the length of the questionnaires and data storage procedures) via a participant information form and an informed consent form"

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)
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 briefly explain why the item is not applicable/relevant for your study was reported in primary paper

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 13b) For each group, losses and exclusions after randomisation, together with reasons Does your paper address CONSORT subitem 13a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study within the 2 studies, randomization was performed Does your paper address CONSORT subitem 13b? (NOTE: Preferably, this is shown in a CONSORT flow diagram) * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study yes, see Figure 1 and regarding text subitem not at all important 1 2 3 4 5 essential 14a) Dates defining the periods of recruitment and follow-up

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 figures or tables demonstrating usage/dose/engagement.

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Does your paper address subitem 13b-i?
Copy and paste relevant sections from the manuscript or cite the figure 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 briefly explain why the item is not applicable/relevant for your study main focus of this paper as we were explicitly interested in attrition i.e. retention 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 briefly explain why the item is not applicable/relevant for your study See 14a-i) Indicate if critical "secular events" fell into the study period Indicate if critical "secular events" fell into the study period, e.g., significant changes in Internet resources available or "changes in computer hardware or Internet delivery resources"

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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 briefly explain why the item is not applicable/relevant for your study did not apply to this study 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 briefly explain why the item is not applicable/relevant for your study no, this did not happen as patients could stay or drop out subitem not at all important 1 2 3 4 5 essential 16) For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups 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 briefly explain why the item is not applicable/relevant for your study see Table 3. The differences between patients who completed the study and who dropout at T2.

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.

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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 briefly explain why the item is not applicable/relevant for your study not focus of this study as we focussed on retention and adherence subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 16-i) Report multiple "denominators" and provide definitions Report multiple "denominators" and provide definitions: 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 specific pre-defined time points of interest (in absolute and relative numbers per group). Always clearly define "use" of the intervention.

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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 briefly explain why the item is not applicable/relevant for your study not focus of this study as we focussed on retention and adherence

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).

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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 briefly explain why the item is not applicable/relevant for your study not focus of this study as we focussed on retention and adherence 17a) For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval) subitem not at all important 1 2 3 4 5 essential 17b) For binary outcomes, presentation of both absolute and relative effect sizes is recommended 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 briefly explain why the item is not applicable/relevant for your study predicting retention, we did that 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 definitions 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 defined (e.g., timeout after idle time) [1] (report under item 6a).

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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 briefly explain why the item is not applicable/relevant for your study not focus of this study as we focussed on retention and adherence 18) Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified 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 briefly explain why the item is not applicable/relevant for your study effect sizes are reported in tables 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 briefly explain why the item is not applicable/relevant for your study not focus of this study as we focussed on retention and adherence

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).

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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 briefly explain why the item is not applicable/relevant for your study we focussed on retention as ran accoding analyses

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Does your paper address subitem 19-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 briefly explain why the item is not applicable/relevant for your study

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Does your paper address subitem 22-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 briefly explain why the item is not applicable/relevant for your study e.g., "However, these assumptions need to be researched further in the future and in more detail." "Thus, our study evaluated the intervention over a relatively long time frame and more studies like this are required in the future to replicate our findings with larger samples."

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.

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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 briefly explain why the item is not applicable/relevant for your study "The present study was designed to investigate online therapies with F2F therapy and care as usual in terms of symptom improvement. One main limitation was that the care as usual group was not assessed regarding their expectations due to practical and ethical considerations. Another limitation was the fact that dropouts were not specifically re-assessed because this was not planned with the study protocol [9]. However, further prospective and randomized studies are necessary to investigate the actual acceptance of online therapy opportunities and the prevention of dropout from (online) therapies and measurement points. Additionally, testing whether a tailoring to the expectations and resources of the patients would be worthwhile, specifically with regard to dropout and non-adherence "

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

23) Registration number and name of trial registry
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 briefly explain why the item is not applicable/relevant for your study this would go too far but of course would be an important topic.

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.

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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 briefly explain why the item is not applicable/relevant for your study CAU was explicitly use for this purpose