Transdiagnostic, Psychodynamic Web-Based Self-Help Intervention Following Inpatient Psychotherapy: Results of a Feasibility Study and Randomized Controlled Trial

Background Mental disorders have become a major health issue, and a substantial number of afflicted individuals do not get appropriate treatment. Web-based interventions are promising supplementary tools for improving health care for patients with mental disorders, as they can be delivered at low costs and used independently of time and location. Although psychodynamic treatments are used frequently in the face-to-face setting, there has been a paucity of studies on psychodynamic Web-based self-help interventions. Objective The objective of this study was to determine the feasibility and preliminary efficacy of a transdiagnostic affect-focused psychodynamic Web-based self-help intervention designed to increase emotional competence of patients with mental disorders. Methods A total of 82 psychotherapy inpatients with mixed diagnoses were randomized into two groups. Following discharge, the intervention group (IG) got access to a guided version of the intervention for 10 weeks. After a waiting period of 10 weeks, the wait-list control group (WLCG) got access to an unguided version of the intervention. We reported the assessments at the beginning (T0) and at the end of the intervention, resp. the waiting period (T1). The primary outcome was satisfaction with the treatment at T1. Secondary outcome measures included emotional competence, depression, anxiety, and quality of life. Statistical analyses were performed with descriptive statistics (primary outcome) and analysis of covariance; a repeated measurement analysis of variance was used for the secondary outcomes. Effect sizes were calculated using Cohen d and data were analyzed as per protocol, as well as intention-to-treat (ITT). Results Patients were chronically ill, diagnosed with multiple diagnoses, most frequently with depression (84%, 58/69), anxiety (68%, 47/69), personality disorder (38%, 26/69), and depersonalization-derealization disorder (22%, 15/69). A majority of the patients (86%, 36/42) logged into the program, of which 86% (31/36) completed the first unit. Satisfaction with the units mastered was rated as good (52%, 16/31) and very good (26%, 9/31). However, there was a steady decline of participation over the course of the program; only 36% of the participants (13/36) participated throughout the trial completing at least 50% of the sessions. According to the ITT analysis, participants improved statistically significantly and with moderate effect sizes (Cohen d) compared with the WLCG regarding depression (d=0.60), quality of life (d=0.53), and emotional competence (d=0.49). Effects were considerably stronger for the completers with respect to depression (d=1.33), quality of life (d=0.83), emotional competence (d=0.68), and general anxiety (d=0.62). Conclusions Although overall program satisfaction and benefit of the program were favorable with respect to the indicators of emotional disorders, the rate of completion was low. Our findings point to the need to target the intervention more specifically to the needs and capabilities of participants and to the context of the intervention. Trial Registration Clinicaltrials.gov NCT02671929; https://clinicaltrials.gov/ct2/show/NCT02671929 (Archived by WebCite at http://www.webcitation.org/6ntWg1yWb)


2 3 4 5 subitem not at all important essential
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 briepy explain why the item is not applicable/relevant for your study "Web-Based Self-Help Intervention Following Inpatient Psychotherapy" 1b) ABSTRACT: Structured summary of trial design, methods, results, and conclusions NPT extension: Description of experimental treatment, comparator, care providers, centers, and blinding status.

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) 1 2 3 4 5 subitem not at all important 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 briepy explain why the item is not applicable/relevant for your study "The objective of this study was to determine the feasibility and preliminary efficacy of a transdiagnostic affect-focused psychodynamic Web-based self-help intervention designed to increase emotional competence of patients with mental disorders." "A total of 82 psychotherapy inpatients with mixed diagnoses were randomized into two groups. Following discharge, the intervention group (IG) got access to a guided version of the intervention for 10 weeks. After a waiting period of 10 weeks, the wait-list control group (WLCG) got access to an unguided version of the intervention."

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) 1 2 3 4 5 subitem not at all important essential

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 briepy explain why the item is not applicable/relevant for your study "Following discharge, the intervention group (IG) got access to a guided version of the intervention for 10 weeks."

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. ooine), 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 ooine 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) 1 2 3 4 5 subitem not at all important 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 briepy explain why the item is not applicable/relevant for your study Patients were recruited offline during inpatient treatment and outcomes were self-assessed with Web-based questionnaires. "A total of 82 psychotherapy inpatients with mixed diagnoses were randomized into two groups."

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) 1 2 3 4 5 subitem not at all important essential 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 briepy explain why the item is not applicable/relevant for your study "A total of 82 psychotherapy inpatients with mixed diagnoses were randomized into two groups." "A majority of the patients (86%, 36/42) logged into the program, of which 86% (31/36) completed the first unit." "However, there was a steady decline of participation over the course of the program; only 36% participants (13/36) participated throughout the trial completing at least 50% of the sessions."

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. subitem not at all important essential 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 briepy explain why the item is not applicable/relevant for your study program guides participants to experience and express their emotions and thus to confront and overcome their maladaptive fears." "Johansson et al [9] recruited participants with depression or anxiety disorders over the Internet. They compared the intervention group (IG) with a control group that received basic support and clinical monitoring of symptoms but no treatment modules or any specific psychotherapeutic support. The betweengroup effect sizes in the randomized controlled trial (RCT) were moderate (d=0.48 for anxiety; d=0.77 for depression), and remission rates were significantly higher in the IG compared with the control group."

2b) In INTRODUCTION: SpeciUc objectives or hypotheses
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"Objectives
The primary goal of this study was to test the feasibility of a psychodynamic Internet-based self-help intervention for psychosomatic inpatients. For this purpose, we translated and adapted the self-help book Living Like You Mean It to the German language and health care system. Unlike Johansson et al [9], we did not recruit via Internet, through advertisement, but rather included participants of inpatient or day clinic treatment before discharge. As facilitation of emotional experience is one of the core processes in psychodynamic psychotherapy [31], we enlarged the scope of the transdiagnostic study to a broad range of mental disorders. Beyond that, we wanted to gather first hints of efficacy of the intervention regarding emotional competence, depression, and anxiety with an RCT. Hypotheses On the basis of a previous study [9], we hypothesized that at least 75% of the participants of the IG will be "very satisfied" or "mainly satisfied" with the intervention, and that at least 50% of them will complete all 8 units. Furthermore, we expected the participants of the IG to show significantly higher emotional competence, lower depression, and anxiety scores at the end of the intervention compared with the participants of the control group." METHODS 3a) Description of trial design (such as parallel, factorial) including allocation ratio 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 briepy explain why the item is not applicable/relevant for your study "Patients were informed about the study and its rationale in an information session during their inpatient or day clinic treatment. After giving written informed consent, eligible patients were coded and randomized by block randomization at a ratio of 1:1 with the help of the computer software Research Randomizer provided in the Web by Urbaniak and Plous [32]. Upon discharge, they received their log-in to the Web-based self-help intervention." 3b) Important changes to methods after trial commencement (such as eligibility criteria), with reasons 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 briepy explain why the item is not applicable/relevant for your study No changes to methods occurred.

3b-i) Bug Uxes, Downtimes, Content Changes
Bug Uxes, 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 Uxes or changes in the functionality or content) (5-iii) and other "unexpected events" that may have inpuenced study design such as staff changes, system failures/downtimes, etc. [2].

Does your paper address subitem 3b-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study 4a) Eligibility criteria for participants 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 briepy explain why the item is not applicable/relevant for your study "Becker et al [10] had described that inpatients and day clinic patients of the Department of Psychosomatic Medicine and Psychotherapy who were above the age of 18 years and had Internet access and an email address were eligible to participate. Patients with acute suicidality, psychosis, current alcohol or drug addiction, and a lifetime diagnosis of schizophrenia, schizoaffective, bipolar, or organic psychiatric disorder were excluded."

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 briepy explain why the item is not applicable/relevant for your study 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. ooine), 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.
1 2 3 4 5 subitem not at all important essential 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 briepy explain why the item is not applicable/relevant for your study "Patients were informed about the study and its rationale in an information session during their inpatient or day clinic treatment. After giving written informed consent, eligible patients were coded and randomized by block randomization at a ratio of 1:1 with the help of the computer software Research Randomizer provided in the Web by Urbaniak and Plous [32]. Upon discharge, they received their log-in to the Web-based self-help intervention."

4a-iii) Information giving during recruitment
Information given during recruitment. Specify how participants were briefed for recruitment and in the informed consent procedures (e.g., publish the informed consent documentation as appendix, see also item X26), as this information may have an effect on user self-selection, user expectation and may also bias results.

Does your paper address subitem 4a-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study 4b) Settings and locations where the data were collected 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 briepy explain why the item is not applicable/relevant for your study "Becker et al [10] had described that inpatients and day clinic patients of the Department of Psychosomatic Medicine and Psychotherapy who were above the age of 18 years and had Internet access and an email address were eligible to participate."
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 4b-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study "All questionnaires were given online. Assessments were performed at discharge from the clinic (T0), at the end of the intervention of the IG (T1), 2 months later for follow-up assessment (T2; only IG), and at the end of the intervention of the WLCG (T3; only WLCG)."

4b-ii) Report how institutional a.liations are displayed
Report how institutional atliations are displayed to potential participants [on ehealth media], as atliations 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) 1 2 3 4 5 subitem not at all important essential

Does your paper address subitem 4b-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study 5) The interventions for each group with sutcient details to allow replication, including how and when they were actually administered

5-i) Mention names, credential, a.liations of the developers, sponsors, and owners
Mention names, credential, atliations of the developers, sponsors, and owners [6] (if authors/evaluators are owners or developer of the software, this needs to be declared in a "Conpict of interest" section or mentioned elsewhere in the manuscript).

Does your paper address subitem 5-i?
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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.

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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).
1 2 3 4 5 subitem not at all important essential 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 briepy explain why the item is not applicable/relevant for your study

5-iv) Quality assurance methods
Provide information on quality assurance methods to ensure accuracy and quality of information provided [1], if applicable.

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5-v) Ensure replicability by publishing the source code, and/or providing screenshots/screencapture video, and/or providing ^owcharts of the algorithms used
Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing powcharts of the algorithms used. Replicability (i.e., other researchers should in principle be able to replicate the study) is a hallmark of scientiUc reporting.

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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.

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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).
1 2 3 4 5 subitem not at all important essential 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 briepy explain why the item is not applicable/relevant for your study was free of charge. To complete the intervention within 10 weeks, participants were asked to do one unit (Multimedia Appendix 2) per week. Only when participants had answered all questions in the unit´s tasks (Multimedia Appendix 3) and transmitted them to the Web-based therapist, a unit was considered to have been completed. Encouraging feedback was delivered within 2 weekdays after transmission of their replies by a trained psychologist who was supervised by 2 experienced psychotherapists, familiar with the intervention." Attending to bodily felt experience was regarded as a major venue for feeling and regulating emotions. Upon discharge from inpatient or day clinic treatment, the IG got access to the intervention for 10 weeks when they first logged onto the platform (Multimedia Appendix 1). Participation was free of charge. To complete the intervention within 10 weeks, participants were asked to do one unit (Multimedia Appendix 2) per week. Only when participants had answered all questions in the unit´s tasks (Multimedia Appendix 3) and transmitted them to the Web-based therapist, a unit was considered to have been completed. Encouraging feedback was delivered within 2 weekdays after transmission of their replies by a trained psychologist who was supervised by 2 experienced psychotherapists, familiar with the intervention."

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.

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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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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).
1 2 3 4 5 subitem not at all important essential 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 briepy explain why the item is not applicable/relevant for your study Intervention group: "Encouraging feedback was delivered within 2 weekdays after transmission of their replies by a trained psychologist who was supervised by 2 experienced psychotherapists, familiar with the intervention." Wait List Control Group "...the WLCG received an unguided version of the intervention and therefore did not receive feedback from a Web-based therapist (to be analyzed separately)."

5-xii) Describe any co-interventions (incl. training/support)
Describe any co-interventions (incl. training/support): Clearly state any interventions that are provided in addition to the targeted eHealth intervention, as ehealth intervention may not be designed as standalone intervention. This includes training sessions and support [1]. It may be necessary to distinguish between the level of training required for the trial, and the level of training for a routine application outside of a RCT setting (discuss under item 21 -generalizability.
1 2 3 4 5 subitem not at all important essential 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 briepy explain why the item is not applicable/relevant for your study "Encouraging feedback was delivered within 2 weekdays after transmission of their replies by a trained psychologist who was supervised by 2 experienced psychotherapists, familiar with the intervention." 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 briepy explain why the item is not applicable/relevant for your study of the Client Satisfaction Questionnaire  [33] at T1. The item "How satisfied are you with the Web-based self-help program overall?" was rated on a 4-point Likert scale ("very satisfied," "mostly satisfied," "slightly satisfied," "rather dissatisfied"). We used this item instead of the scale score because it was more appropriate to compare the results with the original Swedish study [9], which reported frequencies of overall satisfaction (82%) with the Web-based self-help intervention on which our program was based." Secondary Endpoints: "Emotional competence was assessed with the German version of the 27-item Emotion-Regulation Skills Questionnaire [34]. As items range from 0 to 4, they are summed up to a score from 0 to 108. Internal consistency is high (Cronbach alpha=.90).
The Patient Health Questionnaire-9 (PHQ-9) [35] was used to assess depressive symptoms. Adding the scores of the 9 items (from 0-3), the total score ranges from 0 to 27. Scores below 5 are labeled minimal, scores between 5 and 9 mild, from 10 to 14 as moderate, and above 14 as severe depressive symptoms. assessed the subjective prognosis of gainful employment with 3 items, resulting in a score between 0 and 3, so that a higher score indicates a higher risk for work disability or early retirement. The 8-item Somatic Symptom Scale [43] is a reliable and valid self-report measure covering gastrointestinal, pain, fatigue, cardiopulmonary, and general somatic symptoms burden over the past 7 days (0 = "not at all" to 4 = "very much"). Symptoms of depression and anxiety were measured after completing every unit with the PHQ-4 [44]. The PHQ-4 is a very short, reliable, and valid combination of items from the PHQ-9 and the GAD-7, consisting of four items, two for anxiety and depression each. Completion of units was determined objectively on the basis of entries in the database of the platform." 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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6a-ii) Describe whether and how "use" (including intensity of use/dosage) was deUned/measured/monitored
Describe whether and how "use" (including intensity of use/dosage) was deUned/measured/monitored (logins, logUle analysis, etc.). Use/adoption metrics are important process outcomes that should be reported in any ehealth trial.

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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). Copy and paste relevant sections from manuscript text 6b) Any changes to trial outcomes after the trial commenced, with reasons Does your paper address CONSORT subitem 6b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study No changes. 7a) How sample size was determined NPT: When applicable, details of whether and how the clustering by care provides or centers was addressed

7a-i) Describe whether and how expected attrition was taken into account when calculating the sample size
Describe whether and how expected attrition was taken into account when calculating the sample size. 1 2 3 4 5 subitem not at all important essential

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 briepy explain why the item is not applicable/relevant for your study 7b) When applicable, explanation of any interim analyses and stopping guidelines 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 briepy explain why the item is not applicable/relevant for your study Not applicable.
8a) Method used to generate the random allocation sequence NPT: When applicable, how care providers were allocated to each trial group 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 briepy explain why the item is not applicable/relevant for your study "After giving written informed consent, eligible patients were coded and randomized by block randomization at a ratio of 1:1 with the help of the computer software Research Randomizer provided in the Web by Urbaniak and Plous [32]." 8b) Type of randomisation; details of any restriction (such as blocking and block size) 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 briepy explain why the item is not applicable/relevant for your study "After giving written informed consent, eligible patients were coded and randomized by block randomization at a ratio of 1:1 with the help of the computer software Research Randomizer provided in the Web by Urbaniak and Plous [32]." 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 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 briepy explain why the item is not applicable/relevant for your study "After giving written informed consent, eligible patients were coded and randomized by block randomization at a ratio of 1:1 with the help of the computer software Research Randomizer provided in the Web by Urbaniak and Plous [32]." 10) Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions 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 briepy explain why the item is not applicable/relevant for your study "After giving written informed consent, eligible patients were coded and randomized by block randomization at a ratio of 1:1 with the help of the computer software Research Randomizer provided in the Web by Urbaniak and Plous [32]." 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 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).
1 2 3 4 5 subitem not at all important essential 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 briepy explain why the item is not applicable/relevant for your study The trial was unblinded.

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 briepy explain why the item is not applicable/relevant for your study 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)

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 briepy explain why the item is not applicable/relevant for your study Not relevant.
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 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 briepy explain why the item is not applicable/relevant for your study "The primary outcome was evaluated with descriptive statistics. Secondary outcomes were analyzed by analysis of covariance (ANCOVA) controlling outcome variables by their baseline scores and a repeated measurement analysis of variance (ANOVA) for the weekly assessment of the PHQ-4. With the participants' written consent, diagnoses were taken from the clinical documentation of the Department of Psychosomatic Medicine and Psychotherapy. Effect sizes were calculated transforming the eta-squared from ANCOVA into Cohen d to estimate treatment effects controlled for the baseline score."

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]).
1 2 3 4 5 subitem not at all important essential 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 briepy explain why the item is not applicable/relevant for your study "Multiple imputations resulted in implausible results by overestimating effects because of missing data, especially in participants with less completed units. Therefore, last observation carried forward (LOCF) was used as a conservative approach in an intention-to-treat analysis (ITT)."

12b) Methods for additional analyses, such as subgroup analyses and adjusted analyses
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 briepy explain why the item is not applicable/relevant for your study Not applicable.

X26-i) Comment on ethics committee approval
1 2 3 4 5 subitem not at all important essential

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 briepy explain why the item is not applicable/relevant for your study

x26-ii) Outline informed consent procedures
Outline informed consent procedures e.g., if consent was obtained ooine 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.

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 briepy explain why the item is not applicable/relevant for your study

X26-iii) Safety and security procedures
Safety and security procedures, incl. privacy considerations, and any steps taken to reduce the likelihood or detection of harm (e.g., education and training, availability of a hotline) 1 2 3 4 5 subitem not at all important essential

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 briepy explain why the item is not applicable/relevant for your study 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 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 briepy explain why the item is not applicable/relevant for your study "Out of 144 patients approached, 115 patients participated in the study information session. Of these, 26.9% (31/115) declined to participate. Two patients willing to participate had to be excluded because they had no private Internet access." 13b) For each group, losses and exclusions after randomisation, together with reasons Does your paper address CONSORT subitem 13b? (NOTE: Preferably, this is shown in a CONSORT ^ow diagram) * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study "A total of 82 participants were randomized to IG or WLCG. In addition, 86% (36/42) of the IG logged into the platform (values for WLCG were similar), and another 86% (31/36) completed the first unit. Nonstarters (IG: n=6; WLCG: n=7) were more often male than female (53.8% vs 46.2%) and more likely to be part-time employed than starters but not on a statistical significant level. Furthermore, 7 patients dropped out, 4 from the IG and 3 from the WLCG group; the reasons that they named were health problems (n=3), lack of time (n=2), and problems of dealing with the Web-based intervention (n=1), and one patient gave no response. Dropouts were older (mean 50.80, SD 7.92 vs mean 39.06, SD 14.36) than participants (t6,3=2.96, P=.02, d=1.37); otherwise, there were no differences. At the end of the treatment phase, waiting period (T1), 61% (50/82) of randomized participants completed the assessment."

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.

2 3 4 5
subitem not at all important 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 briepy explain why the item is not applicable/relevant for your study 14a) Dates deUning the periods of recruitment and follow-up 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 briepy explain why the item is not applicable/relevant for your study "Assessments were performed at discharge from the clinic (T0), at the end of the intervention of the IG (T1), 2 months later for follow-up assessment (T2; only IG), and at the end of the intervention of the WLCG (T3; only WLCG)."

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" 1 2 3 4 5 subitem not at all important 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 briepy explain why the item is not applicable/relevant for your study 13.10.17, 12)12 CONSORT-EHEALTH (V 1.6.1) -Submission/Publication Form Seite 29 von 40 https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oim…en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full 14b) Why the trial ended or was stopped (early) 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 briepy explain why the item is not applicable/relevant for your study Trial ended as planned.

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 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 briepy explain why the item is not applicable/relevant for your study A table showing baseline demographic and clinical characteristics for each group is included in the manuscript (table 1). " Table 1 shows the demographic and medical baseline data, separately for the IG and the WLCG. The majority of participants were female and unmarried; mean age was 40 years (IG: mean 38.92, SD 12.66; WLCG: mean 41.00, SD 16.00). Despite good education, only slightly over half of them were working or in training. Most frequent main diagnoses were affective, anxiety, and personality disorders, followed by depersonalization-derealization disorder and somatoform disorders. Substance abuse, eating disorders, and obsessive-compulsive disorders, etc, were classified as "others" in the table according to the International Statistical Classification of Diseases, Tenth Revision [47]. The majority (83%, 57/69) had more than one diagnosis."

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. 1 2 3 4 5 subitem not at all important essential Does your paper address subitem 15-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study Besides computer/internet/ehealth literacy all relevant information are within the paper.
16) For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups

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.
1 2 3 4 5 subitem not at all important essential 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 briepy explain why the item is not applicable/relevant for your study "A total of 82 participants were randomized to IG or WLCG. In addition, 86% (36/42) of the IG logged into the platform (values for WLCG were similar), and another 86% (31/36) completed the first unit. Nonstarters (IG: n=6; WLCG: n=7) were more often male than female (53.8% vs 46.2%) and more likely to be part-time employed than starters but not on a statistical significant level. Furthermore, 7 patients dropped out, 4 from the IG and 3 from the WLCG group; the reasons that they named were health problems (n=3), lack of time (n=2), and problems of dealing with the Web-based intervention (n=1), and one patient gave no response. Dropouts were older (mean 50.80, SD 7.92 vs mean 39.06, SD 14.36) than participants (t6,3=2.96, P=.02, d=1.37); otherwise, there were no differences. At the end of the treatment phase, waiting period (T1), 61% (50/82) of randomized participants completed the assessment. Participants who completed the T1 assessment did not differ from those participants who dropped out concerning sociodemographic characteristics and baseline mental symptoms. For all outcome analyses, patients were excluded when the baseline assessment (T0) was missing (n=13). A total of 69 participants were analyzed after substituting in the missing data based on LOCF.
In the IG, 13 participants completed the intervention, that is, logged into the intervention continuously for 10 weeks and finished at least 50% of the units."

16-ii) Primary analysis should be intent-to-treat
Primary analysis should be intent-to-treat, secondary analyses could include comparing only "users", with the appropriate caveats that this is no longer a randomized sample (see 18-i).

Does your paper address subitem 16-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study 17a) For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% conUdence interval) 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 briepy explain why the item is not applicable/relevant for your study Primary outcome: "The majority was mostly (57%, 12/21) or very satisfied (38%, 8/21); only one participant (5%, 1/21) was slightly dissatisfied (based on the one item of the CSQ-8). Asked whether they would do the Web-based self-help program once more if they needed help, more than half of the participants (57%, 12/21) said "definitely yes," about one third (29%, 6/21) said, "I believe so," and only few (14%, 3/21) answered, "I do not believe so."" Secondary outcomes: "Tables 2 and 3 show that the IG improved regarding the secondary outcome criteria, whereas the WLCG deteriorated. Compared with the WLCG, there were significant benefits in the IG regarding depressive symptoms, quality of life, and a trend to improvement regarding emotional competence in the ITT analyses (LOCF). Effect size differences were in the moderate range. Among completers of the intervention, there were significant improvements regarding emotional competence, depression, anxiety, and quality of life. Effect size differences were large (depression, quality of life) to moderate. Psychological complaints in the course of the intervention assessed with the PHQ-4 did not change over time in the IG using a repeated measurement ANOVA with LOCF (F7,210=0.66; P=.70)."

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 briepy explain why the item is not applicable/relevant for your study 17b) For binary outcomes, presentation of both absolute and relative effect sizes is recommended 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 briepy explain why the item is not applicable/relevant for your study Not applicable.
18) Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-speciUed from exploratory 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 briepy explain why the item is not applicable/relevant for your study Not applicable.

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 briepy explain why the item is not applicable/relevant for your study 19) All important harms or unintended effects in each group (for speciUc guidance see CONSORT for harms) Does your paper address CONSORT subitem 19? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study No harms or unintended effects were observed.

19-i) Include privacy breaches, technical problems
Include privacy breaches, technical problems. This does not only include physical "harm" to participants, but also incidents such as perceived or real privacy breaches [1], technical problems, and other unexpected/unintended incidents. "Unintended effects" also includes unintended positive effects [2].

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 briepy explain why the item is not applicable/relevant for your study

19-ii) Include qualitative feedback from participants or observations from staff/researchers
Include qualitative feedback from participants or observations from staff/researchers, if available, on strengths and shortcomings of the application, especially if they point to unintended/unexpected effects or uses. This includes (if available) reasons for why people did or did not use the application as intended by the developers.

Does your paper address subitem 19-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study DISCUSSION 22) Interpretation consistent with results, balancing beneUts and harms, and considering other relevant evidence NPT: In addition, take into account the choice of the comparator, lack of or partial blinding, and unequal expertise of care providers or centers in each group

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).
1 2 3 4 5 subitem not at all important 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 briepy explain why the item is not applicable/relevant for your study participation in the program. According to the conservative estimates of ITT analysis with LOCF, participants improved significantly and with moderate effect sizes compared with the WLCG with improvements in depression, quality of life, and emotional competence (trend). Effects of the small number of completers were considerably stronger. In line with previous findings [9], they reached strong effects regarding depression and anxiety and moderate effects regarding emotional processing."

22-ii) Highlight unanswered new questions, suggest future research
Highlight unanswered new questions, suggest future research.

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 briepy explain why the item is not applicable/relevant for your study 20) Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses

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.
1 2 3 4 5 subitem not at all important essential 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 briepy explain why the item is not applicable/relevant for your study "As this was a feasibility study, the sample was small, particularly in the completer group. Therefore, we cannot differentiate compliance and success between subgroups (eg, the presence or absence of personality disorder, the structure of work, or outpatient psychotherapy). Unfortunately, it is also not possible to compare the effects at the end of the intervention between the IG and the WLCG because participants of the WLCG only got access to the intervention after a waiting period of 10 weeks." 21) Generalisability (external validity, applicability) of the trial Undings NPT: External validity of the trial Undings according to the intervention, comparators, patients, and care providers or centers involved in the trial

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 1 2 3 4 5 subitem not at all important essential

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 briepy explain why the item is not applicable/relevant for your study

21-ii) Discuss if there were elements in the RCT that would be different in a routine application setting
Discuss if there were elements in the RCT that would be different in a routine application setting (e.g., prompts/reminders, more human involvement, training sessions or other co-interventions) and what impact the omission of these elements could have on use, adoption, or outcomes if the intervention is applied outside of a RCT setting.

Does your paper address subitem 21-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study OTHER INFORMATION 23) Registration number and name of trial registry 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 briepy explain why the item is not applicable/relevant for your study Clinicaltrials.gov NCT02671929; https://clinicaltrials.gov/ct2/show/NCT02671929 24) Where the full trial protocol can be accessed, if available 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 briepy explain why the item is not applicable/relevant for your study Becker J, Zwerenz R, Johansson R, Frederick RJ, Andersson G, Beutel ME. Using a transdiagnostic, psychodynamic online self-help intervention to maintain inpatient psychosomatic treatment effects: study protocol of a feasibility study. Internet Interv 2016 Sep;5:30-35.

25)
Sources of funding and other support (such as supply of drugs), role of funders 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 briepy explain why the item is not applicable/relevant for your study "The work group was funded by the Illa und Werner Zarnekow-Stiftung."

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 briepy explain why the item is not applicable/relevant for your study About the CONSORT EHEALTH checklist As a result of using this checklist, did you make changes in your manuscript? * yes, major changes yes, minor changes no What were the most important changes you made as a result of using this checklist?