A Mobile-Based Intervention to Increase Self-esteem in Students With Depressive Symptoms: Randomized Controlled Trial

Background Depressive symptoms are one of the most common and ever-increasing mental health problems among students worldwide. Conventional treatment options, particularly psychotherapy, do not reach all students in need of help. Internet- and mobile-based interventions are promising alternatives for narrowing the treatment gap. Objective In the framework of a randomized controlled trial, we aim to investigate the effectiveness, acceptance, and side effects of a self-help smartphone app (MCT & More) based on cognitive behavioral therapy, mindfulness, acceptance and commitment therapy, and metacognitive training in a sample of students with self-reported depressive symptoms. Furthermore, we were interested in examining the influence of treatment expectations and attitudes toward internet- and mobile-based interventions on treatment adherence and effectiveness. Methods A total of 400 students were recruited via open access websites and randomized to either the intervention group (n=200), who received access to the self-help smartphone app MCT & More for a period of 4 weeks, or to a wait-list control group (n=200). The Patient Health Questionnaire-9 (depression) served as the primary outcome parameter, and the Rosenberg Self-esteem Scale (self-esteem) and the global item of the World Health Organization Quality of Life-abbreviated version (quality of life) served as the secondary outcome parameters. The Attitudes Towards Psychological Online Interventions was used to measure attitudes toward internet- and mobile-based interventions. Outcome expectations were assessed using the Patient Questionnaire on Therapy Expectation and Evaluation, and side effects were assessed using the Inventory for Assessing Negative Effects of Psychotherapy. Results Per-protocol (PP), complete-case, and intention-to-treat analyses showed a significantly higher reduction in depressive symptoms (PP: F1,222=3.98; P=.047; d=0.26) and a significantly higher increase in self-esteem (PP: F1,220=8.79; P=.003; d=0.40) in the intervention group than in the wait-list control group. Most participants regularly used the self-help smartphone app (91/120, 75.8%, at least once a week). The more positive the attitude toward internet- and mobile-based interventions (r=0.260; P=.004) and the more positive the outcome expectation (r=0.236; P=.009), the more frequently the self-help smartphone app was used. Conclusions The effectiveness of the self-help smartphone app MCT & More was demonstrated among students with depressive symptoms compared with a wait-list control group. The app could be offered regularly as a low-threshold intervention to enhance students’ health. Trial Registration German Clinical Trials Register DRKS00020941; https://tinyurl.com/pr84w6er

Manuscript tracking number * If this is a JMIR submission, please provide the manuscript tracking number under "other" (The ms tracking number can be found in the submission acknowledgement email, or when you login as author in JMIR. If the paper is already published in JMIR, then the ms tracking number is the four-digit number at the end of the DOI, to be found at the bottom of each published article in JMIR) 26498 1a) Does your paper address CONSORT item 1a? * I.e does the title contain the phrase "Randomized Controlled Trial"? (if not, explain the reason under "other") CONSORT-EHEALTH (V 1.6.1) -Submission/Publication

1a-i) Identify the mode of delivery in the title
Identify the mode of delivery. Preferably use "web-based" and/or "mobile" and/or "electronic game" in the title. Avoid ambiguous terms like "online", "virtual", "interactive". Use "Internet-based" only if Intervention includes non-web-based Internet components (e.g. email), use "computer-based" or "electronic" only if 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.

Auswahl löschen
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 "mobile-based intervention" CONSORT-EHEALTH (V 1.6.1) -Submission/Publication

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").

Auswahl löschen
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 no non-web-based components or important co-interventions

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

Auswahl löschen
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 "students with depressive symptoms" CONSORT-EHEALTH (V 1.6.1) -Submission/Publication

1b-i) Key features/functionalities/components of the intervention and comparator in the METHODS section of the ABSTRACT
Mention key features/functionalities/components of the intervention and comparator in the abstract. If possible, also mention theories and principles used for designing the site. Keep in mind the needs of systematic reviewers and indexers by including important synonyms. (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) Does your paper address subitem 1b-i? * Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "techniques of cognitive behavioral therapy (CBT), mindfulness, acceptance and commitment therapy, and metacognitive training (MCT)" CONSORT-EHEALTH (V 1.6.1) -Submission/Publication Form https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS64RdfIAFvmrTSkZQL2... 16 von 90 22.12.20, 20:22 subitem not at all important 1 2 3 4 5 essential 1b-ii) Level of human involvement in the METHODS section of the ABSTRACT Clarify the level of human involvement in the abstract, e.g., use phrases like "fully automated" vs. "therapist/nurse/care provider/physician-assisted" (mention number and expertise of providers involved, if any). (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) Does your paper address subitem 1b-ii?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "self-help smartphone app" CONSORT-EHEALTH (V 1.6.1) -Submission/Publication Form https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS64RdfIAFvmrTSkZQL2... 17 von 90 22.12.20, 20:22 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) 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 briefly explain why the item is not applicable/relevant for your study "recruited via open access websites"; purely web-based trial; "self-assessment questionnaire" CONSORT-EHEALTH (V 1.6.1) -Submission/Publication 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 briefly explain why the item is not applicable/relevant for your study "A total of 400 students … randomized to either the intervention group (n = 200), … or to a wait list control group (n = 200)" "Most participants used the self-help smartphone app regularly (76 % at least once a week)." "Per-protocol (PP), complete-case (CC) and intention-to-treat (ITT) analyses showed a signiscantly higher reduction in depressive symptoms (PP: F(1,222) = 3.98, P = .047, d = .26) and a signiscantly higher increase in self-esteem (PP: 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 "The effectiveness of the self-help smartphone app "MCT & More" was demonstrated among students with depressive symptoms compared to a wait list control group." CONSORT-EHEALTH (V 1.6.1) -Submission/Publication

2a-i) Problem and the type of system/solution
Describe the problem and the type of system/solution that is object of the study: intended as stand-alone intervention vs. incorporated in broader health care program? Intended for a particular patient population? Goals of the intervention, e.g., being more cost-effective to other interventions, replace or complement other solutions? (Note: Details about the intervention are provided in "Methods" under 5) Does your paper address subitem 2a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Universities worldwide are confronted with increasing rates of mental health problems among students." "Despite their negative impact on functioning, mental disorders among students often remain undertreated." "Self-guided IBIs have the advantage, that they can be made available to a broad population requiring less resources (no psychotherapists required, can be used at any time without waiting time, lower costs for users)" "IBIs are not intended to replace traditional psychotherapy, but to expand conventional care prostably." CONSORT-EHEALTH (V 1.6.1) -Submission/Publication

2b) In INTRODUCTION: Specific objectives or hypotheses
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 "German students belong to the generation of digital natives (consdent in using computer technology) so it is assumed that students can easily handle internetbased interventions (IBIs)" "Smartphones are the most used technical devices among students on the campuses" "Self-guided IBIs have the advantage, that they can be made available to a broad population requiring less resources (no psychotherapists required, can be used at any time without waiting time, lower costs for users) making self-guided IBIs easier to implement at universities." "Mobile-based interventions have already proven to be an effective strategy for improving health-promoting behavior in the general population (e.g., physical activity, weight control)" "There is a need for high-quality apps, which are being investigated with regard to their benests and risks" METHODS 3a) Description of trial design (such as parallel, factorial) including allocation ratio Does your paper address CONSORT subitem 2b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "The aim of the study was to examine the acceptance and evcacy of the self-help smartphone app "MCT & More" among German students with depressive symptoms in comparison to a wait list control group." !It was expected that the use of the self-help smartphone app leads to a stronger reduction in depressive symptoms and to a higher increase in self-esteem and quality of life in the intervention group compared to a wait list control group after the intervention period. We aimed to investigate whether the effect of the app can be predicted by the attitudes towards IMIs and the expected outcome." 3b) Important changes to methods after trial commencement (such as eligibility criteria), with reasons 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 A randomized controlled trial (Intervention group and waitlist control group). The allocation rule was 1:1.
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 "The self-help smartphone app did not undergo major changes during the evaluation process of this study." CONSORT-EHEALTH (V 1.6.1) -Submission/Publication 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].
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 "The self-help smartphone app did not undergo major changes during the evaluation process of this study." CONSORT-EHEALTH (V 1.6.1) -Submission/Publication 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 "The following inclusion criteria had to be met: Student at a German university (checked by control questions about the structure of the study and the evaluation system), at least 18 years old, informed consent, having access to the internet and a smartphone, suffering from depressive symptoms (measured by PHQ-9, total score > 0), willingness to participate in two pseudonymous online assessments, willingness to use the self-help smartphone app for a period of four weeks on one' s own responsibility, willingness to leave an anonymous e-mail address, no acute suicidal tendencies (measured with item 9 of PHQ-9, cut-off > 1) and no current or past bipolar or psychotic disorder. Other psychiatric diagnoses were not a criterion for exclusion. Parallel treatments (e.g., psychotherapy or pharmacotherapy) could be continued during participation."

4a-i) Computer / Internet literacy
Computer / Internet literacy is often an implicit "de facto" eligibility criterion -this should be explicitly clarified.
Copy and paste relevant sections from the manuscript (include quotes in quotation 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 "having access to the internet and a smartphone" 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.
CONSORT-EHEALTH (V 1.6.1) -Submission/Publication 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 "Participants were recruited via online platforms and forums by posting an invitation to the study with a link to the online baseline assessment."

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.
CONSORT-EHEALTH (V 1.6.1) -Submission/Publication 4b) Settings and locations where the data were collected Does your paper address subitem 4a-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "At the beginning of the baseline assessment, participants received detailed information about the study's goals and procedure and were informed about the underlying data protection. An electronic informed consent form was obtained from each participant." 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 "Participants were recruited via online platforms and forums by posting an invitation to the study with a link to the online baseline assessment." CONSORT-EHEALTH (V 1.6.1) -Submission/Publication

4b-i) Report if outcomes were (self-)assessed through online questionnaires
Clearly report if outcomes were (self-)assessed through online questionnaires (as common in web-based trials) or otherwise.

Does your paper address subitem 4b-i? *
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "At both measurement points (t0, t1) data was collected online by the survey software Qualtrics®." via self-assessment questionnaires (see 2.6) CONSORT-EHEALTH (V 1.6.1) -Submission/Publication 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

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).

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 "The authors have developed the app "MCT & More"." CONSORT-EHEALTH (V 1.6.1) -Submission/Publication

5-ii) Describe the history/development process
Describe the history/development process of the application and previous formative evaluations (e.g., focus groups, usability testing), as these will have an impact on adoption/use rates and help with interpreting results.

Does your paper address subitem 5-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "The contents and exercised are based on metacognitive (group) training (MCT)

5-iii) Revisions and updating
Revisions and updating. Clearly mention the date and/or version number of the application/intervention (and comparator, if applicable) evaluated, or describe whether the intervention underwent major changes during the evaluation process, or whether the development and/or content was "frozen" during the trial.
Describe dynamic components such as news feeds or changing content which may have an impact on the replicability of the intervention (for unexpected events see item 3b).

Does your paper address subitem 5-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "The app has been continuously developed (e.g., gamiscation elements, design, program packages "gambling" and "metacognitive training", additional exercises within the other program packages, various language versions) since the last evaluation [35]. The self-help smartphone app did not undergo major changes during the evaluation process of this study." CONSORT-EHEALTH (V 1.6.1) -Submission/Publication

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

Does your paper address subitem 5-iv?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study

Meine Antwort
CONSORT-EHEALTH (V 1.6.1) -Submission/Publication -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.

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

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

Does your paper address subitem 5-vi?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your 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).
CONSORT-EHEALTH (V 1.6.1) -Submission/Publication 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 "During the four-week intervention period, the intervention group had free access to the self-help smartphone app "MCT & More" (see Table 1), which is primarily intended for individuals with depressive symptoms." In order to get access: "The following inclusion criteria had to be met: Student at a German university (checked by control questions about the structure of the study and the evaluation system), at least 18 years old, informed consent, having access to the internet and a smartphone, suffering from depressive symptoms (measured by PHQ-9, total score > 0), willingness to participate in two pseudonymous online assessments, willingness to use the self-help smartphone app for a period of four weeks on one' s own responsibility, willingness to leave an anonymous e-mail address, no acute suicidal tendencies (measured with item 9 of PHQ-9, cut-off > 1) and no current or past bipolar or psychotic disorder." CONSORT-EHEALTH (V 1.6.1) -Submission/Publication The app can be used as an ad on of (D-)MCT but can also be used stand-alone.
(D-)MCT focuses on the modiscation of cognitive biases and dysfunctional believes that are associated in the onset and maintenance of mental disorder such as psychosis and depression [47,52]. The training seeks to enable individuals to recognize and correct automatic and unconscious thought patterns. It also targets dysfunctional assumptions about thought processes as well as dysfunctional coping strategies (e.g., social withdrawal, thought suppression, rumination)." CONSORT-EHEALTH (V 1.6.1) -Submission/Publication

5-ix) Describe use parameters
Describe use parameters (e.g., intended "doses" and optimal timing for use). Clarify what instructions or recommendations were given to the user, e.g., regarding timing, frequency, heaviness of use, if any, or was the intervention used ad libitum.

Does your paper address subitem 5-ix?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Based on the principle that taking care of personal psychological well-being is a bit like brushing one's teeth, the exercises should be performed regularly so that they become routine. Therefore, the app sends daily reminders via push messages." CONSORT-EHEALTH (V 1.6.1) -Submission/Publication

5-x) Clarify the level of human involvement
Clarify the level of human involvement (care providers or health professionals, also technical assistance) in the e-intervention or as co-intervention (detail number and expertise of professionals involved, if any, as well as "type of assistance offered, the timing and frequency of the support, how it is initiated, and the medium by which the assistance is delivered". It may be necessary to distinguish between the level of human involvement required for the trial, and the level of human involvement required for a routine application outside of a RCT setting (discuss under item 21 -generalizability).

Does your paper address subitem 5-x?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "self-help"; no human involvement

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).
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 app sends daily reminders via push messages" CONSORT-EHEALTH (V 1.6.1) -Submission/Publication

5-xii) Describe any co-interventions (incl. training/support)
Describe any co-interventions (incl. training/support): Clearly state any interventions that are provided in addition to the targeted eHealth intervention, as ehealth intervention may not be designed as stand-alone intervention. This includes training sessions and support [1]. It may be necessary to distinguish between the level of training required for the trial, and the level of training for a routine application outside of a RCT setting (discuss under item 21 -generalizability. Does your paper address subitem 5-xii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "The app can be used as an ad on of (D-)MCT but can also be used stand-alone." "Parallel treatments (e.g., psychotherapy or pharmacotherapy) could be continued during participation." CONSORT-EHEALTH (V 1.6.1) -Submission/Publication Does your paper address subitem 6a-iii?
Copy and paste relevant sections from manuscript text "Within the intervention group, 119 participants slled out the questionnaire on patient satisfaction (ZUF-8). Table 6 shows the users subjective appraisal for each item." CONSORT-EHEALTH (V 1.6.1) -Submission/Publication 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 "The randomization took place automatically via the survey software Qualtrics® after the baseline assessment. The option "equal distribution" ensured that there was a balanced distribution between the two groups. The allocation rule was 1:1." 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 see Fig. 1 CONSORT-EHEALTH (V 1.6.1) -Submission/Publication 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 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 "The randomization took place automatically via the survey software Qualtrics® after the baseline assessment. The option "equal distribution" ensured that there was a balanced distribution between the two groups. The allocation rule was 1:1." 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 "The randomization took place automatically via the survey software Qualtrics®" 11a-i) Specify who was blinded, and who wasn't Specify who was blinded, and who wasn't. Usually, in web-based trials it is not possible to blind the participants [1, 3] (this should be clearly acknowledged), but it may be possible to blind outcome assessors, those doing data analysis or those administering co-interventions (if any).

Does your paper address subitem 11a-i? *
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "As usual in web-based trials, blinding the participants was not possible." CONSORT-EHEALTH (V 1.6.1) -Submission/Publication

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) 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 briefly explain why the item is not applicable/relevant for your study intervention group and waitlist control group (no intervention) 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 "For computing group differences in baseline characteristics, independent samples t-tests and Chi-square tests were performed. Between-group differences over time

12a-i) Imputation techniques to deal with attrition / missing values
Imputation techniques to deal with attrition / missing values: Not all participants will use the intervention/comparator as intended and attrition is typically high in ehealth trials. Specify how participants who did not use the application or dropped out from the trial were treated in the statistical analysis (a complete case analysis is strongly discouraged, and simple imputation techniques such as LOCF may also be problematic [4]).

Does your paper address subitem 12a-i? *
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Missing post-values were calculated using Expectation Maximization (EM)." CONSORT-EHEALTH (V 1.6.1) -Submission/Publication 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 "an explorative moderation analysis was carried out for the PP sample in order to identify possible moderators that affected differential symptom improvement (outcome measure: PHQ-9) using SPSS macro PROCESS by Hayes [57]." Copy and paste relevant sections from the manuscript (include quotes in quotation 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 "At the beginning of the baseline assessment, participants received detailed information about the study's goals and procedure and were informed about the underlying data protection. An electronic informed consent form was obtained from each participant."

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) CONSORT-EHEALTH (V 1.6.1) -Submission/Publication

RESULTS
13a) For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analysed for the primary outcome NPT: The number of care providers or centers performing the intervention in each group and the number of patients treated by each care provider in each center

Does your paper address subitem X26-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 briefly explain why the item is not applicable/relevant for your study "If the inclusion criteria were not met, the participants were automatically excluded from the online assessment. Then participants were informed about the reason for exclusion and received information about other help offers such as telephone numbers for acute crisis." "The collected data was anonymized and stored electronically on passwordprotected computers. By providing the codeword or the anonymized e-mail address, the data could be deleted at request of the participants." CONSORT-EHEALTH (V 1.6.1) -Submission/Publication 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 see Fig. 1 "A total of 400 participants (intervention group: 200, wait list control group: 200) were included in the analyses." 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 see Fig. 1 CONSORT-EHEALTH (V 1.6.1) -Submission/Publication Form https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS64RdfIAFvmrTSkZQL2...

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.

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 "246 participants had to be excluded because the inclusion criteria were not met.
The snal sample consisted of 400 individuals (see Fig. 1 "Flowchart")." CONSORT-EHEALTH (V 1.6.1) -Submission/Publication 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 "The data collection took place in Germany from 16.03.2020 (srst baseline assessment) to 06.07.2020 (last post assessment). During this period, Germany experienced the srst wave of the COVID-19 pandemic."

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" 14b) Why the trial ended or was stopped (early)

15) A table showing baseline demographic and clinical characteristics for each
group NPT: When applicable, a description of care providers (case volume, qualification, expertise, etc.) and centers (volume) in each group 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 "During this period, Germany experienced the srst wave of the COVID-19 pandemic." 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 Calculated sample size was achieved 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 2

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.

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 " Table 2 shows the demographic and psychopathological data of the sample at baseline." CONSORT-EHEALTH (V 1.6.1) -Submission/Publication

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.
CONSORT-EHEALTH (V 1.6.1) -Submission/Publication 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 "Within the intervention group, 120 participants (60 %) reported how often they used the self-help smartphone app during the intervention period (completed the daily exercise). The self-help smartphone app was used by 28 participants (23 %) daily, by 21 participants (18 %) 4 to 6 times a week, by 30 participants (25 %) 2 to 3 times a week, by 12 participants (10 %) once a week, by 23 participants (19 %) 1 to 3 times in total and by 6 participants (5 %) not at all."

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).
CONSORT-EHEALTH (V 1.6.1) -Submission/Publication 17a) For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval)

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 "To determine the evcacy of the self-help smartphone app, intention-to-treat (ITT), per-protocol (PP) and complete-case (CC) analyses were performed." 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 " 17b) For binary outcomes, presentation of both absolute and relative effect sizes is recommended 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).

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

Meine Antwort
CONSORT-EHEALTH (V 1.6.1) -Submission/Publication 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 see table 5; "The results for the interaction effect of the explorative moderation analysis are shown in Table 5. The analysis revealed that participants in the intervention group who had a higher expectation of treatment outcome (P = .02; PATHEV total score) and more hope (P = .049; PATHEV hope scale) showed a higher improved outcome on depressive symptoms (PHQ-9) compared to the wait list control group. In addition, participants of the intervention group who were more worried that the app will not help them (P = .03) and participants of the intervention group who stated a higher reduced or excessive need to eat (P = .02) showed a less improved outcome (PHQ-9) compared to the wait list control group."

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).
CONSORT-EHEALTH (V 1.6.1) -Submission/Publication 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 briefly explain why the item is not applicable/relevant for your study "Overall, 27 of 119 participants (23 %) reported a negative side effect. Fear of stigmatization was the most common negative side effect (n = 12, 10 %). In addition, 8 (7 %) reported, that they had longer phases in which they felt bad, 7 (6 %) that they had problems with insurances, 6 (5.0) that they suffer more from events from the past, 2 (2 %) that they felt worse, 2 (2 %) that they were more concerned about snancial issues, 1 (1 %) that trusting others is more divcult for them, 1 (1 %) that they were having a better relationship with their family and 1 (1 %) that they were having a better relationship with their friends. None of the participants stated that they had changed as a person to the negative, that they had suicidal thoughts or intentions for the srst time or that they experienced more con~icts in their partnership." "Of 119 participants (intervention group) who completed the questionnaire on side effects (INEP), 51 of the participants (43 %) reported at least one positive side effect. The most common reported positive side effect was that participants felt better when using the self-help smartphone app (n = 43, 36 %). Furthermore, 21 (18 %) stated that they suffered less from events from the past, 17 (14 %) that they experienced fewer con~icts in their partnership, 16 (14 %) that they were having a better relationship with their friends, 13 (11 %) that they were having a better relationship with their family and 10 (8 %) that trusting others was easier for them." CONSORT-EHEALTH (V 1.6.1) -Submission/Publication

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

Meine Antwort
CONSORT-EHEALTH (V 1.6.1) -Submission/Publication Restate study questions and summarize the answers suggested by the data, starting with primary outcomes and process outcomes (use).
CONSORT-EHEALTH (V 1.6.1) -Submission/Publication 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 briefly explain why the item is not applicable/relevant for your study "The study demonstrates the effectiveness of the self-help smartphone app "MCT & More" in students with depressive symptoms. As expected, the app led to a signiscant reduction in depressive symptoms and a signiscant increase in selfesteem within the intervention period of 4 weeks. In our study, a small effect size of d = .26 (PHQ-9; PP sample) in reducing depressive symptoms was found." "In addition, a medium to large effect size of d = .77 (RSE; PP sample) was found for the increase in self-esteem." "Contrary to our expectations, the use of the self-help smartphone app did not lead to a signiscant increase in quality of life (WHOQOL-BREF)." "Most participants used the self-help smartphone app regularly (76 % at least once a week; self-assessment) and completed the study (66 %)." CONSORT-EHEALTH (V 1.6.1) -Submission/Publication Copy and paste relevant sections from the manuscript (include quotes in quotation 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 "It should be considered that the assumption of a linear relationship between frequency of use and symptom reduction might be too simplistic and that further variables need to be evaluated to better understand the relationship." (between frequency of use and symptom reduction) "Future studies should investigate further variables (with respect to personal characteristics and app features) that positively in~uence the effectiveness to identify ways of increasing evcacy. In order to make self-help smartphone apps as target-group-specisc as possible, further subgroups should be identised for which a particularly high or low effectiveness is shown. In addition, follow-up studies are required to check for long-term effects. It should be investigated how attitudes towards IMIs and the expected treatment outcome can be improved in order to establish effective self-help smartphone apps as low threshold offers at universities and to promote treatment adherence. The self-help smartphone app could be used regularly at German universities as a low threshold offer to enhance students' health." CONSORT-EHEALTH (V 1.6.1) -Submission/Publication

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.
CONSORT-EHEALTH (V 1.6.1) -Submission/Publication 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 "To participate in the study, no psychiatric diagnosis was required, and participation was possible even with mild depressive symptoms, which led to a heterogeneity of depression levels. This has the advantage that a wider range of individuals with a desire for treatment was reached (regardless of whether they fulslled the criteria of a diagnosis). On the other hand, it has been shown that individuals with severe depressive symptoms benest more from low-threshold psychological interventions than mildly depressed individuals [70]." "Since the study was carried out online, the data collected was based on selfassessments of the participants. Therefore, it could not be eliminated that socially desirable or dishonest statements were made that could have distorted the results.
In addition, despite the integrated control questions on studying, it could not be completely prevented that individuals who were not enrolled at a German university also took part in the study." "Furthermore, the study showed baseline differences regarding some comorbid self-reported diagnoses and the evaluation of previous therapy experiences." CONSORT-EHEALTH (V 1.6.1) -Submission/Publication

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 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 "There was no structural equality between the sample and the general population (students in Germany) regarding gender and subject groups [13,71]." CONSORT-EHEALTH (V 1.6.1) -Submission/Publication 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 briefly explain why the item is not applicable/relevant for your study

Meine Antwort
CONSORT-EHEALTH (V 1.6.1) -Submission/Publication Form https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS64RdfIAFvmrTSkZQL2... Copy and paste relevant sections from the manuscript (include quotes in quotation 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 German Clinical trials Register (DRKS00020941) 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 briefly explain why the item is not applicable/relevant for your study not available

X27) Conflicts of Interest (not a CONSORT item)
subitem not at all important 1 2 3 4 5 essential 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 briefly explain why the item is not applicable/relevant for your study "This research did not receive any specisc grant from funding agencies in the public, commercial, or not-for-prost sectors."

X27-i) State the relation of the study team towards the system being evaluated
In addition to the usual declaration of interests (financial 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.
CONSORT-EHEALTH (V 1.6.1) -Submission/Publication Copy and paste relevant sections from the manuscript (include quotes in quotation 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 authors have developed the app "MCT & More"." As a result of using this checklist, did you make changes in your manuscript? * What were the most important changes you made as a result of using this checklist?
Meine Antwort How much time did you spend on going through the checklist INCLUDING making changes in your manuscript *

hours
As a result of using this checklist, do you think your manuscript has improved? * Would you like to become involved in the CONSORT EHEALTH group?
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