Internet-Based Cognitive Behavioral Therapy for Informal Caregivers: Randomized Controlled Pilot Trial

Background Caregiving for a family member can result in reduced well-being for the caregiver. Internet-delivered cognitive behavioral therapy (ICBT) may be one way to support this population. This is especially the case for caregivers in countries with limited resources, but high demand for psychological services. Objective In this study we evaluated the effects of a therapist-guided 8-week-long ICBT intervention for informal caregivers. Methods In total, 63 participants were recruited online and randomized either to the intervention or to the wait-list control group. The main study outcome was the Caregiver Burden Inventory (CBI). Secondary outcomes included measures of caregiver depression, anxiety, stress, and quality of life. Results Moderate between-group effect sizes were observed for the CBI measure, in favor of the intervention group, with a Cohen d=–0.70 for the intention-to-treat analysis. Analyses of the subscales of the CBI showed significant reductions on the subscales of Development and Physical Health. Moderate reductions were found for depression and anxiety scores as indicated by the Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder-7 (GAD-7) scores. Large between-group effects were observed for reduction in stress and increase in quality of life as indicated by the Perceived Stress Scale-14 (PSS-14), The Brunnsviken Brief Quality of Life Scale (BBQ), and The World Health Organization-Five Well-Being Index (WHO-5). In addition, participants experienced little to no difficulty in using the program and were mostly satisfied with the intervention’s platform and the choice of content. Conclusions This is the first internet intervention study for informal caregivers in Lithuania. The results suggest that therapist-guided ICBT can be effective in reducing caregiver burden, anxiety, depression, stress, and improving quality of life. Trial Registration ClinicalTrials.gov NCT04052724; https://clinicaltrials.gov/ct2/show/NCT04052724

yes: all primary outcomes were significantly better in intervention group vs control partly: SOME primary outcomes were significantly better in intervention group vs control no statistically significant difference between control and intervention potentially harmful: control was significantly better than intervention in one or more outcomes inconclusive: more research is needed Other: Approx. Percentage of Users (starters) still using the app as recommended after 3 months * Participants only had access to the treatment for the duration of the interventio Overall, was the app/intervention effective? * Is this a full powered effectiveness trial or a pilot/feasibility trial? * 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) 1a) Does your paper address CONSORT item 1a? * 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.
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 'Internet-based' is included in the title.

1a-ii) Non-web-based components or important co-interventions in title
Mention non-web-based components or important co-interventions in title, if any (e.g., "with telephone support").

Does your paper address subitem 1a-ii?
Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Your answer subitem not at all important 1 2 3 4 5 essential 1a-iii) Primary condition or target group in the title Mention primary condition or target group in the title, if any (e.g., "for children with Type I Diabetes") Example: A Web-based and Mobile Intervention with Telephone Support for Children with Type I Diabetes: Randomized Controlled Trial 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 We state: 'for informal caregivers'.

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) https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS64RdfIAFvmrTSkZQL2-3O8O9hrL5Sw/viewform?hl=en_US&formkey=dG… 10/53 subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 1b-i? * Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study We state: 'a therapist guided eight-week long ICBT intervention for informal caregivers' and 'participants were recruited online and randomized either to intervention or a wait-list control group'. Due to the limitations in scope, further details regarding the intervention are provided in the Method section.

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 Your answer 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 We state: ''Participant recruitment took place online.'.
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) INTRODUCTION 2a) In INTRODUCTION: Scientific background and explanation of rationale 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 We state: 'In total 63 participants were randomized either to intervention or a wait-list control group. Main study outcome was the Caregiver Burden Inventory (CBI). Secondary outcomes included measures of caregiver depression, anxiety, stress, and quality of life. Moderate between-group effect sizes were observed for the CBI measure, in favour of the intervention group, with a Cohen's d= -0.70 for intention to treat analysis and d= -0.73 for complete case analysis. Analyses of the subscales of the CBI showed significant reductions on the subscales of Development and Physical Health. Moderate reductions were found for depression and anxiety scores as indicated by Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder-7 (GAD-7). Large between-group effects were observed for reduction in stress and increase in quality of life as indicated by Perceived Stress Scale-14 (PSS-14), The Brunnsviken Brief Quality of Life Scale (BBQ) and The World Health Organisation-Five Well-being Index (WHO-5).'.

1b-v) CONCLUSIONS/DISCUSSION in abstract for negative trials
Conclusions/Discussions in abstract for negative trials: Discuss the primary outcome -if the trial is negative (primary outcome not changed), and the intervention was not used, discuss whether negative results are attributable to lack of uptake and discuss reasons. (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-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 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 We state: 'informal caregivers are becoming increasingly relied on for managing health care and societal costs for the elderly and chronically ill'; 'Yet, caregivers themselves are often faced with many challenges which puts them at risk for their own well-being'; 'One of ways in providing caregivers with support is to offer self-help programs delivered using modern information technology such as the internet'; 'Considering the need for further research studies, a growing number of caregivers and a need of accessible interventions the aim of this study was to develop and evaluate the effectiveness of an internet-based, therapist guided ICBT intervention in reducing caregiver burden'; 'The intervention was targeted for informal caregivers in Lithuania and was a set up as a pilot randomized controlled trial. What makes Lithuanian context of special interest is that over last couple of decades the country has experienced mass emigration of young and middle-aged persons'; 'the need for care provision in Lithuania is high'; 'results of this study will provide with knowledge about acceptability and effectiveness of such intervention in unique population where a demand of such services is high'. We state: 'Based on the current findings, there is some evidence that internet interventions for informal caregivers can be effective in improving their well-being'; 'At the same time, despite the emergence of internet intervention studies for informal caregivers, further highquality research is encouraged'.
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 We state: 'Decrease in the caregiver burden was defined as the primary goal with reduction in depression, anxiety, and stress as well as increase in quality of life, as secondary'; 'results of this study will provide with knowledge about acceptability and effectiveness of such intervention in unique population where a demand of such services is high'.
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 Like this: 'A two-armed randomized controlled trial was conducted online in Lithuania with participants recruited from the general population. Participants were randomly allocated to either to an eight-week internet treatment or to a wait-list control condition'; '63 participants were randomized to either intervention (n = 31) or wait-list control group (n = 32)'.
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 item is not applicable for our study as no important changes to methods occurred after trial commenced.

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 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

Not applicable
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 We state: 'To participate in the study, individuals had to have access to internet via computer or any other compatible device (e.g., smartphone or tablet) as well as an ability to use it throughout the duration of the intervention. Eligible participants had to have a score of 24 or more on the Caregiver Burden Inventory (CBI) [16], currently providing care for at least last couple of months or more from the start of the intervention, be 18 years old or over and be fluent in comprehending, writing and reading Lithuanian language. The intervention was not tailored to any specific group of caregivers (e.g., dementia). Individuals were not eligible to participate in the study if they were experiencing severe physical or mental health problems, alcohol addiction, experience of other severe traumatic events, suicide risk, severe interpersonal violence or their care receiver had a life expectancy below or approximately around six months.' We have made one exception regarding cut-off scores for CBI: one participant with a score of 21 was included in the study as individual expressed feeling burdened as well as wish for support during the phone interview.

4a-i) Computer / Internet literacy
Computer / Internet literacy is often an implicit "de facto" eligibility criterion -this should be explicitly clarified. 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 Your answer 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.
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 As stated in the Method section: 'Eligible participants were able to register from September 2019 to October 2019. Recruitment was conducted in various forms. The study was announced by the Vilnius University press release and posted on Vilnius University website, Facebook and other social media. Additionally, invitation to participate in the study was disseminated among the healthcare institutions, social services and patient organizations targeted to reach informal caregivers. The study publicity campaign reached national media, and the study was covered by national TV and Radio programs. In addition, information about the study was posted in national and regional press. After registration, individuals who filled in all the required measures online were contacted for a structured interview over telephone, after which eligibility to participate in the study was finalized'; 'A secure online platform iterapi was used for communication between therapists and participants, distribution of program materials and collection of assessments'; 'At the start of the intervention, all participants received an email containing their username as well as personalized link for creating their own password'. 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.
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 As stated: 'Upon opening the study website, participants were provided with information regarding inclusion and exclusion criteria as well as the registration process, management, and research team. After participants provided informed consent on a secure study website, they were asked to fill in the screening questionnaires'.

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 As stated in the Procedure section: 'A secure online platform iterapi [37] was used for communication between therapists and participants, distribution of program materials and collection of assessments. Participant personal information was anonymized by assigning each participant a code, which was then used for logging into the program. Included participants were also able to extend their data security by receiving code to their phone number, which had to be entered upon every logging in, after their self-generated password.' 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 All the outcomes were assessed via questionnaires online: 'After registration, individuals who filled in all the required measures online were contacted for a structured interview over telephone'. Phone interviews were used to further investigate if participants meet the inclusion criteria: 'Eligibility ... was assessed via phone interviews. Mini International Neuropsychiatric Interview Version 5 [17] ... was used in phone interviews for additional assessment of inclusion criteria.'.

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) 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 Your answer 5) The interventions for each group with sufficient details to allow replication, including how and when they were actually administered

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 Your answer

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 Your answer

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 Your answer

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 Your answer -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 Your answer

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 Your answer

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).
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 Participation in the program was completely voluntary and is described in the paper as: 'To participate in the study, individuals had to have access to internet via computer or any other compatible device (e.g., smartphone or tablet) as well as an ability to use it throughout the duration of the intervention. Eligible participants had to have a score of 24 or more on the Caregiver Burden Inventory (CBI) [16], currently providing care for at least last couple of months or more from the start of the intervention, be 18 years old or over and be fluent in comprehending, writing and reading Lithuanian language.'. Regarding the mode of delivery, we state: 'A secure online platform iterapi [37] was used for communication between therapists and participants, distribution of program materials and collection of assessments. Participant personal information was anonymized by assigning each participant a code, which participants then used for logging into the program. Included participants were also able to extend their data security by receiving code to their phone number, which had to be entered upon every logging in, after their self-generated password.'. 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 Complete overview of the intervention's content is presented in the Table 2. Few examples to evident information regarding mode of delivery, components of the intervention and theoretical framework is presented in selection of quotes: 'The intervention was an ICBT program consisting of eight modules, each dedicated to one theme. The themes were (chronologically): Introduction, Thoughts, Stress and relaxation, Problem Solving, Communication, Anxiety, Behavioural Activation and Maintenance'; 'Intervention content was partly adapted from materials previously used in other ICBT studies'; 'Choice of content, examples and exercises of the intervention were carefully selected and adopted for the target population grounded on the practices and guidelines in the field of informal caregiving'; 'Participants were provided access to one new module every week over the 8 weeks of intervention, starting from module 1'; 'The basic structure of the modules is very similar throughout the intervention: each module starts with psychoeducation, followed by one or few case examples which is then followed by several exercises. At the end of each module, participants were provided with suggestions about which exercises they should practice further that week'; 'Therapists were monitoring participants questions and providing with feedback on completed exercises daily via the intervention's platform'.

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 Your answer

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 Your answer 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 Weekly email reminders were sent to remind participants about viewing new materials and conducting exercises: 'Throughout duration of the program, every Thursday, participants received an email stating availability of the new material. Participants who did not view week's materials or have not conducted exercises were sent one weekly reminder. Reminder contained pre-defined short encouraging message and was sent on Mondays, by therapists to participants in own groups'.

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 This item is not applicable as no co-interventions or training/support were provided. 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 Outcomes were obtained via online-questionnaires at two points in time: 'Measures were collected online and administered at two points in time: at the start of the treatment (t1) and at the end of the treatment (t2). After four weeks since the start of the intervention, participants were contacted for a short phone interview. The main purpose of this conversation was to evaluate participant's experience of using the program as well as well as to give them an opportunity to ask questions'. 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 This item is not applicable as no changes to trial outcomes took place after the trial commenced.

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.

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 Your answer 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 8b) Type of randomisation; details of any restriction (such as blocking and block size) 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 This item is not applicable given the pilot nature of the study.
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 Participants were randomly allocated to either intervention or wait-list control group: 'Randomization was performed by independent researcher not involved in the trial. Website for generation of random numbers, www.random.org, was used. Randomization procedure was also used for randomly allocating therapists to participants.' 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 Randomization was performed according to 1:1 ratio for which 'Website for generation of random numbers, www.random.org, was used.'. No restrictions were applied.
https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS64RdfIAFvmrTSkZQL2-3O8O9hrL5Sw/viewform?hl=en_US&formkey=dG… 31/53 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 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 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 Participants were randomly allocated to either intervention or wait-list control group: 'Randomization was performed by independent researcher not involved in the trial. Website for generation of random numbers, www.random.org, was used.'. Randomization was performed according to 1:1 ratio.
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 Information regarding allocation sequence was provided either via email or a phone call by one of the therapists in the study. Regarding the randomization procedure: 'Randomization was performed by independent researcher not involved in the trial.'; 'After randomization, participants in the intervention and wait-list control groups were provided with information about the start of the intervention. Participants in the waiting-list control group were also explained that they will be able to receive access to the same treatment after the intervention group is finished.'. 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 In the procedure section we state: 'After randomization, participants in the intervention and wait-list control groups were provided with information about the start of the intervention. Participants in the waiting-list control group were also explained that they will be able to receive access to the same treatment after the intervention group is finished.'. Hence, all participants were aware that they will be able to use the intervention. The only difference between the intervention and wait-list control group participants was that, participants in the wait-list control group had to wait for approximately 8 weeks until they were able to use the treatment platform.
Regarding data collection we state: 'A secure online platform iterapi [37] was used for communication between therapists and participants, distribution of program materials and collection of assessments. Participant personal information was anonymized by assigning each participant a code, which participants then used for logging into the program.'. Hence, assessor blinding was irrelevant since no person was involved in data collection or processing.
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".

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 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

Your answer
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 This item is not applicable. 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 Complete information regarding statistical analysis is provided in the Method section, under Statistical Analysis subsection. Shorter version is provided further: 'Analysis was performed using IBM SPSS Statistics 25. The significance level was set at 0.05. Independent samples t-test and Fisher's exact test was used for investigating possible differences among participants in the two groups at baseline. Data collected at post-treatment was treated according to the intention-to-treat principle (ITT). That is, all the 63 randomized participants were included in the data analyses irrespectively of the fact that they did or did not fill in the post-assessment measures. For this, multiple imputation procedure was chosen considering that data was Missing at Random (MAR) [38].' and 'During the multiple imputation procedure, twenty simulations were imputed in a sequence. Since it is practically difficult to be fully confident that data is missing at random, complete case analyses were also performed. Results of both analyses were compared and reported. Descriptive statistics were used for evaluating attrition and overall satisfaction with the program. Regarding main outcomes, effect sizes and confidence intervals were calculated for within and between groups for both, complete cases, and ITT. Analysis of covariance (ANCOVA) was conducted to investigate treatment effects at post-treatment for primary and all secondary measures as recommended by Van Breukelen [40] with baseline scores entered as covariates. Jacobson and Truax method was used for calculating Reliable Change Index (RCI) and investigating clinical significance of change in primary outcome at post-treatment [41].'.

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 We state: 'Multiple imputation procedure was chosen considering that data was Missing at Random (MAR)' and 'Since it is practically difficult to be fully confident that data is missing at random, complete case analyses were also performed. Results of both analyses were compared and reported'.
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 We have decided not to perform sub-analysis due to modest sample size. Also, because the study is a pilot study. Does your paper address subitem X26-i?

X26-i) Comment on ethics committee approval
Copy and paste relevant sections from the manuscript (include quotes in quotation 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 Your answer

x26-ii) Outline informed consent procedures
Outline informed consent procedures e.g., if consent was obtained offline or online (how? Checkbox, etc.?), and what information was provided (see 4a-ii). See [6] for some items to be included in informed consent documents.

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 Your answer

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) https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS64RdfIAFvmrTSkZQL2-3O8O9hrL5Sw/viewform?hl=en_US&formkey=dG… 37/53 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 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

Your answer
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 For complete overview, please refer to Figure 1. We state: 'Participants were regarded as dropouts if post-treatment measures were missing. At post-treatment, out of 31 participants in the intervention group, 25 have had filled in the measures, yielding a dropout rate of approximately 19%. At the same time, 29 out of 32 participants have filled in the measures in the wait-list control group. Overall, post-treatment measures were collected from 54 participants, which indicated a dropout rate of 14%. Following the intervention, out of 32 participants in the wait-list control group, 23 had filled in the measures, showing a dropout rate of approximately 28%. In total, the overall dropout rate after intervention period ended for both groups combined was 24%.' https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS64RdfIAFvmrTSkZQL2-3O8O9hrL5Sw/viewform?hl=en_US&formkey=dG… 38/53 subitem not at all important 1 2 3 4 5 essential 14a) Dates defining the periods of recruitment and follow-up 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 Complete overview can be obtained from the RESULT section as well as the Figure 1. Shorter version is provided further: '63 participants were randomized to either intervention (n = 31) or wait-list control group (n = 32)'; 'Participants were regarded as dropouts if posttreatment measures were missing. At post-treatment, out of 31 participants in the intervention group, 25 have had filled in the measures, yielding a dropout rate of approximately 19%.'; 'Following the intervention, out of 32 participants in the wait-list control group, 23 had filled in the measures, showing a dropout rate of approximately 28%. In total, the overall dropout rate after intervention period ended for both groups combined was 24%.'; 'We were not able to reach all the participants who did not fill in the post-treatment measures. From participants that we did manage to reach, there were two main reasons for ceased participation: losing interest in participation (n=3) or death of care-receiver (n=3).'.

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 14b) Why the trial ended or was stopped (early) 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 Eligible participants were able to register from September 2019 to October 2019. Intervention group has started using the treatment on the 25th of October 2019 and until 19th of December of 2019. On the 19th of December 8-week treatment program was officially ended however, participants were given a couple of weeks (until 3rd of January 2020) to once again read through materials (if desired). However, during this time participants were not able to message or receive feedback from their therapists. Wait-list control group has started using the treatment platform on the 9th of January 2020 and until 5th of March. Wait-list control group was also given additional 2 weeks for reading through materials. Same as for the intervention group, during this time therapist support was no longer available. Consequently, from the 19th of March participants in the wait-list control group were no longer able access the treatment.

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" 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 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 Complete information regarding participant demographic characteristics is provided in Table 1. Shorter summary follows further: 'Most of the recruited participants were female (90%) caring for either their elderly mother or father (70%).'; 'Most of the participants had provided care for either one to four years (44%) or more than four years (40%). Most caregivers were spending five to seven to days per week (86%), and either three to seven (38%) or 12 and more hours (37%) per day providing care. In this respect, the sample could be described as consisting of high-intensity, long-term carers.'; 'No pre-treatment differences regarding demographic or outcome measures between participants randomized to treatment and wait-list control groups were detected.'.
Regarding care providers (therapists) in this study: 'Three graduate Master's in Clinical Psychology program students trained to deliver this intervention under supervision and three clinical psychologists were involved as therapists in the 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.
16) For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 15-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Information regarding digital divide or skills (other than the ability to use computer or compatible device) was not obtained.

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.
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 Information regarding denominators is provided in the Table 1 and Table 4. Complete information is also available from the Figure 1. As stated in the Statistical analysis section: 'Data collected at post-treatment was treated according to the intention-to-treat principle (ITT)' and 'Since it is practically difficult to be fully confident that data is missing at random, complete case analyses were also performed. Results of both analyses were compared and reported'.

16-ii) Primary analysis should be intent-to-treat
Primary analysis should be intent-to-treat, secondary analyses could include comparing only "users", with the appropriate caveats that this is no longer a randomized sample (see 18-i).
Does your paper address subitem 16-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study

Your answer
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 Effect sizes and CI for all the outcome measures are provided in the Table 3.

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).
https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS64RdfIAFvmrTSkZQL2-3O8O9hrL5Sw/viewform?hl=en_US&formkey=dG… 43/53 17b) For binary outcomes, presentation of both absolute and relative effect sizes is recommended 18) Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory 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

Your answer
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 For full information please refer to the Results section. Positive and Negative Reliable Change Index was calculated (as well as no change). Regarding this, complete information is provided in Table 4. Clinical significance for primary outcome measure was evaluated: 'Regarding clinical significance, both ITT and complete case analysis showed similar results. In the intervention group 2 (6.5% or 8% respectively) scored below cut-off score of 28.8. These participants were deemed as recovered since they achieved clinically significant change. In the control group, 1 (3.1% or 3.4% respectively) participant was found to achieve clinically significant change.'.
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 Detailed description of statistical analysis procedure is provided in the Method section. Exploratory analysis was not performed. No adjustments for baseline variables were made. Subgroup analysis was not performed.

18-i) Subgroup analysis of comparing only users
A subgroup analysis of comparing only users is not uncommon in ehealth trials, but if done, it must be stressed that this is a self-selected sample and no longer an unbiased sample from a randomized trial (see 16-iii).
Does your paper address subitem 18-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study

Your answer
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 Participants did not report any harmful experiences during the study period. As shown in Table 4, three participants in the complete sample (four based on ITT) have experienced Negative Reliable Change regarding their burden (measured by Caregiver Burden Inventory). Important to mention, that participants were able to contact therapists or researchers throughout the whole duration of the program: 'In cases of unclarity, participants were able to contact their assigned therapist via secure internal message function on the platform. Therapists were monitoring participants questions and providing with feedback on completed exercises daily via the intervention's platform.' subitem not at all important Restate study questions and summarize the answers suggested by the data, starting with primary outcomes and process outcomes (use).

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 Detailed information is provided in the Discussion section. For example: 'The aim of this study was to evaluate the effectiveness of an internet-based therapist guided program for reducing caregiver burden. Moderate between and within group effect sizes were found in reducing caregiver burden in the intervention group.'; 'Our results also revealed, that out of five caregiver burden components, significant post-treatment reductions were observed for subscales of Physical Health and Development.'; 'Moderate to high between and within group effect sizes were found on measures of anxiety, depression, and stress as well as increase in quality of life scores with only slight differences between ITT and complete case analysis'. Copy and paste relevant sections from the manuscript (include quotes in quotation 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 Your answer

20-i) Typical limitations in ehealth trials
Typical limitations in ehealth trials: Participants in ehealth trials are rarely blinded. Ehealth trials often look at a multiplicity of outcomes, increasing risk for a Type I error. Discuss biases due to non-use of the intervention/usability issues, biases through informed consent procedures, unexpected events. Does your paper address subitem 20-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study We state: 'One of the main limitations in this study is that we did not control for external help that caregivers were receiving. Even though all participants in the study identified themselves as primary caregivers, they could have been receiving various levels of support from other family members or professional workers such as nurses. In addition, all participants in the study were self-referred which limits the generalizability of our findings. There is also a concern regarding validation and reliability of the CBI measure. This was the first time this instrument was translated and used in Lithuanian language and the has not been tested in Lithuania previously. Even though positive changes in caregiver well-being were identified, at this point it is not possible to determine which components of the intervention were responsible for this improvement. We aim to further investigate this in the future.'; 'Informal caregivers supporting individuals with a range of support needs were included in this study. For example, there were individuals who were caring for a sibling with mental disorder as well as own underage children or elderly parents diagnosed with dementia. For this reason, it could be argued that intervention did not equally suit everyone need. However, our initial idea was to create an intervention that would be suitable to a wide group of caregivers. In that way, independently of the care-receiver's condition, everyone would find something that is applicable to own situation. The fact that we managed to detect improvement in caregiver well-being indicates, that such transdiagnostic interventions can be effective.'.

21-i) Generalizability to other populations
Generalizability to other populations: In particular, discuss generalizability to a general Internet population, outside of a RCT setting, and general patient population, including applicability of the study results for other organizations

23) Registration number and name of trial registry
Does your paper address subitem 21-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study We state: 'Due to close cultural and historical aspects, this experience could further extend to neighbouring Baltic countries in the region such as Latvia, where the need for psychological services for the informal caregivers is also high.'.

21-ii) Discuss if there were elements in the RCT that would be different in a routine application setting
Discuss if there were elements in the RCT that would be different in a routine application setting (e.g., prompts/reminders, more human involvement, training sessions or other co-interventions) and what impact the omission of these elements could have on use, adoption, or outcomes if the intervention is applied outside of a RCT setting.
Does your paper address subitem 21-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Your answer 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 X27) Conflicts of Interest (not a CONSORT item) 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 ClinicalTrials.gov NCT04052724, https://clinicaltrials.gov/ct2/show/NCT04052724 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 Trial protocol has not been published 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 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.
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

Your answer
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?
Your answer