The Role of Emotion Regulation and Loss-Related Coping Self-efficacy in an Internet Intervention for Grief: Mediation Analysis

Background Internet interventions for mental disorders and psychological problems such as prolonged grief have established their efficacy. However, little is known about how internet interventions work and the mechanisms through which they are linked to the outcomes. Objective As a first step in identifying mechanisms of change, this study aimed to examine emotion regulation and loss-related coping self-efficacy as putative mediators in a randomized controlled trial of a guided internet intervention for prolonged grief symptoms after spousal bereavement or separation or divorce. Methods The sample comprised older adults who reported prolonged grief or adaptation problems after bereavement, separation, or divorce and sought help from a guided internet intervention. They were recruited mainly via newspaper articles. The outcome variables were grief symptoms assessed using the Texas Revised Inventory of Grief and psychopathology symptoms assessed using the Brief Symptom Inventory. A total of 6 module-related items assessed loss-focused emotion regulation and loss-related coping self-efficacy. In the first step, path models were used to examine emotion regulation and loss-related coping self-efficacy as single mediators for improvements in grief and psychopathology symptoms. Subsequently, exploratory path models with the simultaneous inclusion of emotion regulation and self-efficacy were used to investigate the specificity and relative strength of these variables as parallel mediators. Results A total of 100 participants took part in the guided internet intervention. The average age was 51.11 (SD 13.60) years; 80% (80/100) were separated or divorced, 69% (69/100) were female, and 76% (76/100) were of Swiss origin. The internet intervention increased emotion regulation skills (β=.33; P=.001) and loss-related coping self-efficacy (β=.30; P=.002), both of which correlated with improvements in grief and psychopathology symptoms. Path models suggested that emotion regulation and loss-related coping self-efficacy were mediators for improvement in grief. Emotion regulation showed a significant indirect effect (β=.13; P=.009), whereas coping self-efficacy showed a trend (β=.07; P=.06). Both were confirmed as mediators for psychopathology (β=.12, P=.02; β=.10; P=.02, respectively). The path from the intervention to the improvement in grief remained significant when including the mediators (β=.26, P=.004; β=.32, P≤.001, respectively) in contrast to the path from the intervention to improvements in psychopathology (β=.15, P=.13; β=.16, P=.10, respectively). Conclusions Emotion regulation and loss-related coping self-efficacy are promising therapeutic targets for optimizing internet interventions for grief. Both should be further examined as transdiagnostic or disorder-specific putative mediators in internet interventions for other disorders. Trial Registration ClinicalTrials.gov NCT02900534; https://clinicaltrials.gov/ct2/show/NCT02900534 International Registered Report Identifier (IRRID) RR2-10.1186/s13063-016-1759-5


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.

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Does your paper address subitem 1a-i? * Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study secondary mediation analysis of an RCT subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 1a-ii) Non-web-based components or important co-interventions in title Mention non-web-based components or important co-interventions in title, if any (e.g., "with telephone support").

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Does your paper address subitem 1a-ii?
Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study not applicable for this study 1a-iii) Primary condition or target group in the title Mention primary condition or target group in the title, if any (e.g., "for children with Type I Diabetes") Example: A Web-based and Mobile Intervention with Telephone Support for Children with Type I Diabetes: Randomized Controlled Trial

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Does your paper address subitem 1a-iii? * Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Internet Intervention for Grief 1b) ABSTRACT: Structured summary of trial design, methods, results, and conclusions NPT extension: Description of experimental treatment, comparator, care providers, centers, and blinding status.
subitem not at all important

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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 item not applicable for this study subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 1b-ii) Level of human involvement in the METHODS section of the ABSTRACT Clarify the level of human involvement in the abstract, e.g., use phrases like "fully automated" vs. "therapist/nurse/care provider/physician-assisted" (mention number and expertise of providers involved, if any). (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it)

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Does your paper address subitem 1b-ii?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Meine Antwort 1b-iii) Open vs. closed, web-based (self-assessment) vs. face-to-face assessments in the METHODS section of the ABSTRACT Mention how participants were recruited (online vs. offline), e.g., from an open access website or from a clinic or a closed online user group (closed usergroup trial), and clarify if this was a purely web-based trial, or there were face-to-face components (as part of the intervention or for assessment). Clearly say if outcomes were self-assessed through questionnaires (as common in web-based trials). Note: In traditional offline trials, an open trial (open-label trial) is a type of clinical trial in which both the researchers and participants know which treatment is being administered. To avoid confusion, use "blinded" or "unblinded" to indicated the level of blinding instead of "open", as "open" in web-based trials usually refers to "open access" (i.e. participants can self-enrol). (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it)
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "They were recruited mainly via newspaper articles." 1b-iv) RESULTS section in abstract must contain use data Report number of participants enrolled/assessed in each group, the use/uptake of the intervention (e.g., attrition/adherence metrics, use over time, number of logins etc.), in addition to primary/secondary outcomes. (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it)
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "A total of 100 participants took part in the guided internet intervention." subitem not at all important

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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 1 2 3 4 5 essential 2a-i) Problem and the type of system/solution Describe the problem and the type of system/solution that is object of the study: intended as stand-alone intervention vs. incorporated in broader health care program? Intended for a particular patient population? Goals of the intervention, e.g., being more cost-effective to other interventions, replace or complement other solutions? (Note: Details about the intervention are provided in "Methods" under 5)

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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 "The present study examines emotion regulation and loss-related coping self-efficacy as potential mechanisms of change in an internet intervention for prolonged grief symptoms after spousal bereavement or separation/divorce called LIVIA [32,33]. LIVIA addressed older adults who had experienced spousal bereavement or a separation/divorce and sought help for coping with prolonged grief symptoms, psychological distress or adaptation problems in daily life. Thus, LIVIA is the first intervention that focuses on grief after bereavement as well as grief after a separation or divorce. Both events require similar adaptation and mourning tasks identified by Worden i.e. accepting the reality of the loss, processing the pain of grief, adjusting to a life without the spouse, and remembering the lost spouse while reinvesting emotional energy into a new life [29]. We assume that the dual process model is also applicable for a separation or a divorce from a spouse insofar as these events imply breaking the bond and necessarily lead to a reorganization of one's life circumstances. Furthermore, we hypothesise that the effect of the intervention is based on the same mechanisms of change. " subitem not at all important 1 2 3 4 5 essential 2a-ii) Scientific background, rationale: What is known about the (type of) system "While considerable evidence has established the efficacy of cognitive-behavioural (internet) interventions for psychiatric disorders and several emotional problems including grief, little is known about how they lead to an improvement of symptoms or behaviour [10,11]. The identification of these mechanisms of change would be useful for tailoring interventions that specifically target these mechanisms and thus may be more potent or efficient [12]. It may also contribute to the development of more parsimonious interventions with fewer but equally effective components [13] which reduce the burden for clients as well as save time and cost [14].
Potential mechanisms of change can be specific factors posited in the theoretical background of the intervention (e.g. changes in maladaptive thinking or behaviour in cognitive behaviour therapy) or common factors, as the therapeutic alliance, empathy, expectations or a rationale that provides credibility to the intervention [15]. Self-efficacy is a central variable in social-cognitive theories [16]. Self-efficacy as belief in the ability to exercise control over events that affect one's life, to manage one's personal functioning and environmental demands plays an important role in stress reactions and adaptive coping in threatening situations [17]. Bereavement coping self-efficacy predicted lower emotional distress, higher psychological and spiritual well-being as well as better physical health in widows whose husbands had died of cancer [18]. Self-efficacy also predicted lower grief symptoms in students who lost a close person in a university campus shooting [19]. In addition, Benight and Bandura [17] concluded that coping self-efficacy was a mediator in the recovery from traumatic experiences. In line with this notion, change in coping self-efficacy predicted a decrease in post-traumatic stress symptoms in an e-health intervention for trauma survivors [20]. Moreover, self-efficacy was a mediator between psychopathology symptoms and disabilities in activities and participation [21].
Emotion regulation has been established as a transdiagnostic risk factor for different psychological disorders [22] and is a central intervention target in psychotherapy [23]. A review concluded that face-to-face emotion regulation interventions had positive short-and long-term effects for emotion process outcomes, affect and mood states, as well as medical and psychiatric disorders [24]. Improvements in the abilities to modify, accept, and tolerate negative emotions were consistent predictors of treatment outcomes in patients with various mental disorders [23]. Moreover, CBT enriched with an emotion-regulation training resulted in a greater reduction in depression, negative affect and increased wellbeing than routine CBT [25].
While some studies have examined emotion-regulation trainings as predictors or outcome of treatment, few studies have investigated emotion regulation as a mechanism of change. For example, modification of negative emotions was found to mediate the link between emotion-regulation skills and psychopathological symptoms assessed with the Brief Symptom Inventory [26]. Furthermore, emotion regulation was a mediator and putative mechanism of change in an internet intervention for stress management [27].
Emotion regulation and loss-related coping self-efficacy can be integrated as putative mechanisms of change in existing models of coping with grief. The dual process model of coping with bereavement posits that loss-oriented tasks, such as grief work, experiencing the pain of the loss, expressing emotions towards the deceased and transforming bonds with the lost person are necessary for a positive adaptation to the loss [28]. Similarly, the 2b) In INTRODUCTION: Specific objectives or hypotheses 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 "Building up on these results, the present post-hoc analyses aimed at investigating whether gains in emotion-regulation skills and loss-related coping self-efficacy mediated the intervention effects as a first step in elucidating mechanisms of change in an intervention for grief after spousal bereavement or separation/divorce. The present study is one of a few investigating mediators in internet interventions and the first that examined emotional and cognitive processes as mediators in a grief intervention. We hypothesised that both, gains in emotion-regulation skills and loss-related coping self-efficacy mediated the effect of the intervention on the improvements in grief and psychopathology symptoms." 3b) Important changes to methods after trial commencement (such as eligibility criteria), with reasons subitem not at all important 1 2 3 4 5 essential 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 "Therefore, the analysis sample consisted of 100 German-speaking participants who lost their spouse through bereavement (20%) or separation/divorce (80%) and who were randomly allocated to the intervention group or the wait-list control group. The wait-list control group received access to the treatment after 12-weeks. " 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 This was not the case in this study

3b-i) Bug fixes, Downtimes, Content Changes
Bug fixes, Downtimes, Content Changes: ehealth systems are often dynamic systems. A description of changes to methods therefore also includes important changes made on the intervention or comparator during the trial (e.g., major bug fixes or changes in the functionality or content) (5-iii) and other "unexpected events" that may have influenced study design such as staff changes, system failures/downtimes, etc. [2].

4a) Eligibility criteria for participants
subitem not at all important 1 2 3 4 5 essential 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

Meine Antwort
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 main inclusion criteria were the experience of spousal bereavement or a separation/divorce more than six months prior to enrolling in the study and seeking help for coping with prolonged grief symptoms, psychological distress or the psychosocial adaptation to a life without the partner. The main exclusion criteria were severe psychological or somatic disorders which needed immediate treatment and acute suicidality (BDI suicide item > 1 or suicidal ideation in the telephone interview) and a concomitant psychotherapy, and/or prescribed drugs against depression or anxiety if prescription or dosage has changed in the month prior or during the internet intervention."

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

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subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 4a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Meine Antwort 4a-ii) Open vs. closed, web-based vs. face-to-face assessments: Open vs. closed, web-based vs. face-to-face assessments: Mention how participants were recruited (online vs. offline), e.g., from an open access website or from a clinic, and clarify if this was a purely webbased trial, or there were face-to-face components (as part of the intervention or for assessment), i.e., to what degree got the study team to know the participant. In online-only trials, clarify if participants were quasi-anonymous and whether having multiple identities was possible or whether technical or logistical measures (e.g., cookies, email confirmation, phone calls) were used to detect/prevent these.

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Does your paper address subitem 4a-ii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Participants were mainly recruited by newspaper articles and online self-help forums." subitem not at all important 1 2 3 4 5 essential 4b) Settings and locations where the data were collected 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.
Copy and paste relevant sections from the manuscript (include quotes in quotation 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 received a written study information approved by the Ethics committee 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 "All self-report questionnaires were completed online using Qualtrics [37] at baseline, i.e. prior to the intervention and at post-measurement 12 weeks after receiving access to the programme. " subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 4b-i) Report if outcomes were (self-)assessed through online questionnaires Clearly report if outcomes were (self-)assessed through online questionnaires (as common in web-based trials) or otherwise.

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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 "All self-report questionnaires were completed online using Qualtrics [37] at baseline, i.e. prior to the intervention and at post-measurement 12 weeks after receiving access to the programme. "

4b-ii) Report how institutional affiliations are displayed
Report how institutional affiliations are displayed to potential participants [on ehealth media], as affiliations 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) 5) The interventions for each group with sufficient details to allow replication, including how and when they were actually administered subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 4b-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study The logo and the responsible organisation was included in the study information as required by the ethics committee

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

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Does your paper address subitem 5-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study not applicable for this study subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 5-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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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 not applicable for this study

5-iii) Revisions and updating
Revisions and updating. Clearly mention the date and/or version number of the application/intervention (and comparator, if applicable) evaluated, or describe whether the intervention underwent major changes during the evaluation process, or whether the development and/or content was "frozen" during the trial. Describe dynamic components such as news feeds or changing content which may have an impact on the replicability of the intervention (for unexpected events see item 3b).
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study not applicable for this study

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

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

5-vi) Digital preservation
Digital preservation: Provide the URL of the application, but as the intervention is likely to change or disappear over the course of the years; also make sure the intervention is archived (Internet Archive, webcitation.org, and/or publishing the source code or screenshots/videos alongside the article). As pages behind login screens cannot be archived, consider creating demo pages which are accessible without login.
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study not applicable for this study

5-vii) Access
Access: Describe how participants accessed the application, in what setting/context, if they had to pay (or were paid) or not, whether they had to be a member of specific group. If known, describe how participants obtained "access to the platform and Internet" [1]. To ensure access for editors/reviewers /readers, consider to provide a "backdoor" login account or demo mode for reviewers/readers to explore the application (also important for archiving purposes, see vi).

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

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Does your paper address subitem 5-viii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "The dual process model of coping with bereavement and the task model of mourning provided the theoretical background for the guided internet-based self-help intervention called LIVIA [32,33]. It consisted of ten text-based modules and a weekly email as guidance. The modules contained writing tasks for the exposure to the loss and assignments to practice in daily life. Several modules directly targeted emotion-regulation processes: Three modules focused on cognitive-behavioural techniques fostering positive emotions, self-care, and social relationships while two modules focused on exposure and loss-oriented interventions, i.e. writing tasks for accepting memories and pain as well as addressing unfinished business. Loss-related coping self-efficacy was a direct target in modules including information about grief or separation reactions, coping strategies and restorationoriented interventions for creating a life without the partner. "

5-ix) Describe use parameters
Describe use parameters (e.g., intended "doses" and optimal timing for use). Clarify what instructions or recommendations were given to the user, e.g., regarding timing, frequency, heaviness of use, if any, or was the intervention used ad libitum.
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Details are described in the efficacy paper

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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subitem not at all important 1 2 3 4 5 essential 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 "It consisted of ten text-based modules and a weekly email as guidance."

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

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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 not applicable in this study subitem not at all important 1 2 3 4 5 essential 6a) Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed 5-xii) Describe any co-interventions (incl. training/support) Describe any co-interventions (incl. training/support): Clearly state any interventions that are provided in addition to the targeted eHealth intervention, as ehealth intervention may not be designed as stand-alone intervention. This includes training sessions and support [1]. It may be necessary to distinguish between the level of training required for the trial, and the level of training for a routine application outside of a RCT setting (discuss under item 21 -generalizability.

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Does your paper address subitem 5-xii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study not applicable for this study Does your paper address CONSORT subitem 6a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "The severity of grief symptoms was assessed with the 16-item Texas Revised Inventory of Grief -German Version (TRIG) [34]. Answer categories were 1 = completely true to 5 = completely false. Cronbach alpha was .86 at pre-and .90 at post-measurement. The TRIG includes items which are applicable after divorce as well as bereavement and has proven a good factorial validity which was temporally invariant over one year [35].
Psychopathology symptoms were measured with the German version of the widely used Brief Symptom Inventory (BSI) [36]. The 53 items assessed a broad range of somatic and psychopathology symptoms within seven days prior to completing the questionnaire. Answer categories range from 0 = not at all to 4 = very much. Cronbach alpha was .90 at pre-and .96 at post-measurement.
Six module-related items assessed loss-focused emotion regulation and loss-related coping-self-efficacy. Response categories ranged from -3 = not at all to 3 = yes, exactly. A confirmatory factor analysis including the six items supported a two-factor model compared to a one factor model (1 factor model: CFI = .84, TLI = .74, RMSEA = .273; 2 factor model: CFI = .95, TLI = .91, RMSEA = .159). Details on the development of these measures and the results of the exploratory and confirmatory factor analyses are presented in supplement A. Loss-focused emotion regulation was assessed with the following module-related items ("I can cheer myself up"; "I can have a positive influence on my thoughts and feelings"; "I can take care of my own well-being".). Loss-focused coping self-efficacy contained three items ("I am convinced that I can cope with the loss of my spouse/with the separation/divorce"; "I am ready to do what is necessary to overcome my loss"; "I have a strong influence on the coping with my loss"). Cronbach alpha for emotion regulation was .90 at pre-and .91 at post-measurement and .76 at pre-and .85 at post-measurement for self-efficacy. To measure gains in emotion regulation and self-efficacy, we subtracted the pre sum score from the post sum scores. Thus, a positive value indicated a gain during the intervention. All self-report questionnaires were completed online using Qualtrics [37] at baseline, i.e. prior to the intervention and at post-measurement 12 weeks after receiving access to the programme.
In addition to the self-report questionnaires, the initial screening process included a telephone call, in which trained email-supporters assessed the criteria of the DSM-5 diagnosis of a Persistent Complex Bereavement Disorder. This required an adaptation of the criteria to the purpose of our study, i.e., we assessed the persistence of the symptoms already six months after the loss instead of 12 months and also employed the interview to individuals who lost their spouse through separation/divorce." subitem not at all important

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Does your paper address subitem 6a-i?
Copy and paste relevant sections from manuscript text not applicable for this study 6a-ii) Describe whether and how "use" (including intensity of use/dosage) was defined/measured/monitored Describe whether and how "use" (including intensity of use/dosage) was defined/measured/monitored (logins, logfile analysis, etc.). Use/adoption metrics are important process outcomes that should be reported in any ehealth trial.

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Does your paper address subitem 6a-ii?
Copy and paste relevant sections from manuscript text not applicable for this study subitem not at all important 1 2 3 4 5 essential 6b) Any changes to trial outcomes after the trial commenced, with reasons 7a) How sample size was determined NPT: When applicable, details of whether and how the clustering by care provides or centers was addressed 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 not applicable for this study 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 briefly explain why the item is not applicable/relevant for your study not applicable for this study subitem not at all important 1 2 3 4 5 essential 7b) When applicable, explanation of any interim analyses and stopping guidelines 8a) Method used to generate the random allocation sequence NPT: When applicable, how care providers were allocated to each trial group 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.

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Does your paper address subitem 7a-i?
Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study

Secondary analyses, not applicable for this study
Does your paper address CONSORT subitem 7b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study not applicable for this study 8b) Type of randomisation; details of any restriction (such as blocking and block size) 9) Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned 10) Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions Does your paper address CONSORT subitem 8a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Secondary analyses, not applicable for this study 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 We used random.org for this study Does your paper address CONSORT subitem 9? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study We used random.org for this study 11a) If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how NPT: Whether or not administering co-interventions were blinded to group assignment subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 10? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study We used random.org for this study 11a-i) Specify who was blinded, and who wasn't Specify who was blinded, and who wasn't. Usually, in web-based trials it is not possible to blind the participants [1, 3] (this should be clearly acknowledged), but it may be possible to blind outcome assessors, those doing data analysis or those administering co-interventions (if any).

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Does your paper address subitem 11a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Not applicable for this study subitem not at all important 1 2 3 4 5 essential 11b) If relevant, description of the similarity of interventions (this item is usually not relevant for ehealth trials as it refers to similarity of a placebo or sham intervention to a active medication/intervention) 12a) Statistical methods used to compare groups for primary and secondary outcomes NPT: When applicable, details of whether and how the clustering by care providers or centers was addressed 11a-ii) Discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator" Informed consent procedures (4a-ii) can create biases and certain expectations -discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator".

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Does your paper address subitem 11a-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Not applicable for this study, waitlist control group Does your paper address CONSORT subitem 11b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Not applicable for this study, waitlist control group subitem not at all important 1 2 3 4 5 essential 12b) Methods for additional analyses, such as subgroup analyses and adjusted analyses 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 Not applicable for this study, waitlist control group 12a-i) Imputation techniques to deal with attrition / missing values Imputation techniques to deal with attrition / missing values: Not all participants will use the intervention/comparator as intended and attrition is typically high in ehealth trials. Specify how participants who did not use the application or dropped out from the trial were treated in the statistical analysis (a complete case analysis is strongly discouraged, and simple imputation techniques such as LOCF may also be problematic [4]).

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Does your paper address subitem 12a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Not applicable for this study

X26) REB/IRB Approval and Ethical Considerations [recommended as subheading under "Methods"] (not a CONSORT item)
subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 12b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "In a second step, we computed mediation models for improvements in grief and psychopathology symptoms firstly with one single mediator and then with two parallel mediators in a path-analytic framework using Mplus v8.4 [38] using the original dataset. As mediator variables, we included gains in emotion regulation and gains in loss-related selfefficacy from pre-to post-measurement. We used observed difference scores for change in the mediators as well as in the outcome variables, i.e. grief and psychopathology symptoms. Positive change scores indicate improvements in grief and psychopathology symptoms. We used the "model indirect" command to specify and estimate the specific indirect effects for both mediators and the total indirect effect."

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Does your paper address subitem X26-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study

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Does your paper address subitem X26-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Participants first gave electronic and then oral informed consent in a telephone screening interview."

X26-iii) Safety and security procedures
Safety and security procedures, incl. privacy considerations, and any steps taken to reduce the likelihood or detection of harm (e.g., education and training, availability of a hotline)
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Secondary analyses, not applicable for this 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 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 "Out of the total sample (N = 110), nine individuals did not start the internet intervention (8.18%) and were excluded from the present analyses. One participant was excluded due to being a multivariate outlier which affected the mediation analyses. Therefore, the analysis sample consisted of 100 German-speaking participants who lost their spouse through bereavement (20%) or separation/divorce (80%) and who were randomly allocated to the intervention group or the wait-list control group. " 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 Secondary analyses, reported in the main outcome paper subitem not at all important 1 2 3 4 5 essential 14a) Dates defining the periods of recruitment and follow-up

13b-i) Attrition diagram
Strongly recommended: An attrition diagram (e.g., proportion of participants still logging in or using the intervention/comparator in each group plotted over time, similar to a survival curve) or other figures or tables demonstrating usage/dose/engagement.

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Does your paper address subitem 13b-i?
Copy and paste relevant sections from the manuscript or cite the figure number if applicable (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study

Secondary analyses, not applicable
Does your paper address CONSORT subitem 14a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study 14a-i) Indicate if critical "secular events" fell into the study period Indicate if critical "secular events" fell into the study period, e.g., significant changes in Internet resources available or "changes in computer hardware or Internet delivery resources"

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Does your paper address subitem 14a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study

Secondary analyses, not applicable
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 Not applicable for this study 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

15-i) Report demographics associated with digital divide issues
In ehealth trials it is particularly important to report demographics associated with digital divide issues, such as age, education, gender, social-economic status, computer/Internet/ehealth literacy of the participants, if known.

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Does your paper address subitem 15-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study

16-i) Report multiple "denominators" and provide definitions
Report multiple "denominators" and provide definitions: Report N's (and effect sizes) "across a range of study participation [and use] thresholds" [1], e.g., N exposed, N consented, N used more than x times, N used more than y weeks, N participants "used" the intervention/comparator at specific pre-defined time points of interest (in absolute and relative numbers per group). Always clearly define "use" of the intervention.

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subitem not at all important 1 2 3 4 5 essential 17a) For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval) 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 Secondary analyses, not applicable

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

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Does your paper address subitem 16-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Secondary mediation analyes, not applicable subitem not at all important 1 2 3 4 5 essential 17b) For binary outcomes, presentation of both absolute and relative effect sizes is recommended Does your paper address CONSORT subitem 17a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Secondary mediation analyes, not applicable 17a-i) Presentation of process outcomes such as metrics of use and intensity of use In addition to primary/secondary (clinical) outcomes, the presentation of process outcomes such as metrics of use and intensity of use (dose, exposure) and their operational definitions is critical. This does not only refer to metrics of attrition (13-b) (often a binary variable), but also to more continuous exposure metrics such as "average session length". These must be accompanied by a technical description how a metric like a "session" is defined (e.g., timeout after idle time) [1] (report under item 6a).

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Does your paper address subitem 17a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Secondary mediation analyes, not applicable 18) Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory Does your paper address CONSORT subitem 17b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Secondary mediation analyes, not applicable 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 "Mediation models with a single mediator: Improvement in grief was associated with gains in emotion regulation (β = .41; P = <.001) and gains in coping self-efficacy (β = .24; P = .016). Only emotion regulation showed a significant indirect path with a medium effect size (β = .13; P = .009). The indirect effect for coping self-efficacy showed a small to medium sized effect but did not reach the significance level (β = .07; P = .061). Improvement in psychopathology symptoms was related to gains in emotion regulation as well as loss-related self-efficacy (ER: β = .35; P = <.001; CSE: β = .35; P = <.001). Emotion regulation and loss-related self-efficacy functioned as mediators with medium effect sizes (indirect effects: ER: β = .12; P = .016; CSE: β = .10; P = .022).

Models with simultaneous parallel mediators:
Including emotion regulation and loss-related coping self-efficacy simultaneously in the analyses, the relative strength of both mediators was investigated in exploratory models. Improvement in grief was associated with gains in emotion regulation (β = .39; P = <.001), but not by gains in self-efficacy (β = .04; P = .734, see Figure 1a). Only emotion regulation mediated the association between taking part in the intervention and improvement in grief (indirect effect: β = .13; P = .008). The path from the intervention to the improvement in grief remained significant (β = .26; P = .005). The total indirect effect was significant and showed a medium effect size (β = .14; P = .016). Improvement in psychopathology symptoms was significantly predicted by gains in lossrelated coping self-efficacy (β = .23; P = .044, see Figure 1b). Emotion regulation showed a similar effect size but did not reach the significance level (β = .24; P = .054). The total indirect effect was significant (β = .15; P = .003), but not the specific indirect paths. However, post hoc Monte Carlo Power Analysis for Indirect Effects indicated that the models with two parallel mediators did not have enough power to detect specific indirect effects apart from the indirect path from emotion regulation on improvement of grief, see supplement A." subitem not at all important 1 2 3 4 5 essential

19) All important harms or unintended effects in each group
(for specific guidance see CONSORT for harms)

18-i) Subgroup analysis of comparing only users
A subgroup analysis of comparing only users is not uncommon in ehealth trials, but if done, it must be stressed that this is a self-selected sample and no longer an unbiased sample from a randomized trial (see 16-iii).

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Does your paper address subitem 18-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study

Seondary mediation analyses, not applicable
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 Copy and paste relevant sections from the manuscript (include quotes in quotation 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 Seondary mediation analyses, not applicable 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).

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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

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Does your paper address subitem 22-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "A fine-grained temporal design may also be able to detect more accurately the temporal sequence of change and the interplay of the mediators, and thus disentangle mechanisms of change. However, the speed and shape of change is not necessarily linear and sudden gains or losses may occur (for more details see [46]). Thus, the appropriate time point for assessing the mediators for capturing these changes may be difficult to determine and temporal associations between change in the mechanism and change in outcomes may be hard to disentangle [47]. " "Considering these limitations, the results of this study must be replicated and extended with larger samples and more measurement points. Further research should use validated measures for emotion regulation and loss-related coping selfefficacy and investigate whether the greater relative importance of emotion regulation compared to coping self-efficacy is specific to prolonged grief symptoms or whether it also generalises to distress-related disorders and other psychological disorders such as anxiety disorders. In addition, other potential mediators such as social support could be examined together with emotion regulation and coping self-efficacy." subitem not at all important

20-i) Typical limitations in ehealth trials
Typical limitations in ehealth trials: Participants in ehealth trials are rarely blinded. Ehealth trials often look at a multiplicity of outcomes, increasing risk for a Type I error. Discuss biases due to non-use of the intervention/usability issues, biases through informed consent procedures, unexpected events.

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Does your paper address subitem 20-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Secondary mediation analysis, not applicable

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

OTHER INFORMATION
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 "Moreover, the sample size of 100 participants limited the number of variables in the models, precluded more detailed analysis of the interplay of potential moderators and mediators, and lead to power issues for the models with two parallel mediators. Moreover, the sample included only 20 widowed individuals which precluded separate models for widowed participants. " 21-ii) Discuss if there were elements in the RCT that would be different in a routine application setting Discuss if there were elements in the RCT that would be different in a routine application setting (e.g., prompts/reminders, more human involvement, training sessions or other co-interventions) and what impact the omission of these elements could have on use, adoption, or outcomes if the intervention is applied outside of a RCT setting.

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Does your paper address subitem 21-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Secondary mediation analysis, not applicable 23) Registration number and name of trial registry 24) Where the full trial protocol can be accessed, if available 25) Sources of funding and other support (such as supply of drugs), role of funders 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 briefly explain why the item is not applicable/relevant for your study

Meine Antwort
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 "ClinicalTrials.gov NCT02900534; https://clinicaltrials.gov/ct2/show/NCT02900534." 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 work was supported by the Swiss National Science Foundation (SNSF) [grant 51NF40-160590] granted to Dario Spini. The SNSF had no role in the design of the study and collection, analysis, and interpretation of data and in writing the manuscript."

X27) Conflicts of Interest (not a CONSORT item)
subitem not at all important 1 2 3 4 5 essential About the CONSORT EHEALTH checklist yes, major changes yes, minor changes no 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.

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

Secondary mediation analyses, not applicable
As a result of using this checklist, did you make changes in your manuscript? * yes no Sonstiges: yes no Sonstiges: What were the most important changes you made as a result of using this checklist?
none, manuscript already accepted, this feels like a time-consuming useless task How much time did you spend on going through the checklist INCLUDING making changes in your manuscript * it took about three hours and it is useless to write this out for having enough caracters 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?
This would involve for example becoming involved in participating in a workshop and writing an "Explanation and Elaboration" document Auswahl löschen STOP -Save this form as PDF before you click submit To generate a record that you filled in this form, we recommend to generate a PDF of this page (on a Mac, simply select "print" and then select "print as PDF") before you submit it.
When you submit your (revised) paper to JMIR, please upload the PDF as supplementary file.
Don't worry if some text in the textboxes is cut off, as we still have the complete information in our database. Thank you! Any other comments or questions on CONSORT EHEALTH Filling out this form feels like a time-consuming useless task, the manuscript has already been submitted and/or accepted.