Web-Based Self-Compassion Training to Improve the Well-Being of Youth With Chronic Medical Conditions: Randomized Controlled Trial

Background Up to one-third of young people live with chronic physical conditions (eg, diabetes, asthma, and autoimmune disease) that frequently involve recurrent pain, fatigue, activity limitations, stigma, and isolation. These issues may be exacerbated as young people transition through adolescence. Accordingly, young people with chronic illness are at a high risk of psychological distress. Accessible, evidence-based interventions for young people with chronic illnesses are urgently needed to improve well-being, support adaptation, and enhance daily functioning. Self-compassion, which is an adaptive means of relating to oneself during times of difficulty, is a promising intervention target for this population. Objective This study aims to test the efficacy of a 4-week, self-guided, web-based self-compassion training program for improving well-being among young Australians (aged 16-25 years) living with a chronic medical condition. The primary outcomes were self-compassion, emotion regulation difficulties, and coping; the secondary outcomes were well-being, distress, and quality of life. We also sought to test whether changes in primary outcomes mediated changes in secondary outcomes and gather feedback about the strengths and limitations of the program. Methods We conducted a single-blind, parallel-group, randomized controlled trial comparing a 4-week, fully automated, web-based self-compassion training program with a waitlist control. Participants were recruited via the internet, and outcomes were self-assessed at 4 (T1) and 12 weeks (T2) after the baseline time point via a web-based survey. A mixed methods approach was used to evaluate the program feedback. Results Overall, 151 patients (age: mean 21.15, SD 2.77 years; female patients: n=132, 87.4%) were randomized to the intervention (n=76, 50.3%) and control (n=75, 49.7%) groups. The loss–to–follow-up rate was 47.4%, and program use statistics indicated that only 29% (22/76) of young people in the experimental group completed 100% of the program. The main reported barrier to completion was a lack of time. As anticipated, treatment effects were observed for self-compassion (P=.01; partial η2=0.05; small effect); well-being (P≤.001; partial η2=0.07; medium effect); and distress (P=.003; partial η2=0.054; small-medium effect) at the posttest time point and maintained at follow-up. Contrary to our hypotheses, no intervention effects were observed for emotion regulation difficulties or maladaptive coping strategies. Improvements in adaptive coping were observed at the posttest time point but were not maintained at follow-up. Self-compassion, but not emotion regulation difficulties or coping, mediated the improvements in well-being. Conclusions Minimal-contact, web-based self-compassion training can confer mental health benefits on young people with chronic conditions. This group experiences substantial challenges to participation in mental health supports, and program engagement and retention in this trial were suboptimal. Future work should focus on refining the program content, engagement, and delivery to optimize engagement and treatment outcomes for the target group. Trial Registration Australian New Zealand Clinical Trials Registry 12619000572167; https://tinyurl.com/5n6hevt International Registered Report Identifier (IRRID) RR2-10.1186/s12889-020-8226-7

CONSORT-EHEALTH (V 1.6.1) -Submission/Publication Form The CONSORT-EHEALTH checklist is intended for authors of randomized trials evaluating web-based and Internet-based applications/interventions, including mobile interventions, electronic games (incl multiplayer games), social media, certain telehealth applications, and other interactive and/or networked electronic applications. Some of the items (e.g. all subitems under item 5 -description of the intervention) may also be applicable for other study designs.
The goal of the CONSORT EHEALTH checklist and guideline is to be a) a guide for reporting for authors of RCTs, b) to form a basis for appraisal of an ehealth trial (in terms of validity) CONSORT-EHEALTH items/subitems are MANDATORY reporting items for studies published in the Journal of Medical Internet Research and other journals / scienti c societies endorsing the checklist.
As the CONSORT-EHEALTH checklist is still considered in a formative stage, we would ask that you also RATE ON A SCALE OF 1-5 how important/useful you feel each item is FOR THE PURPOSE OF THE CHECKLIST and reporting guideline (optional).
Mandatory reporting items are marked with a red *. In the textboxes, either copy & paste the relevant sections from your manuscript into this form -please include any quotes from your manuscript in QUOTATION MARKS, or answer directly by providing additional information not in the manuscript, or elaborating on why the item was not relevant for this study. yes: all primary outcomes were signi cantly better in intervention group vs control partly: SOME primary outcomes were signi cantly better in intervention group vs control no statistically signi cant difference between control and intervention potentially harmful: control was signi cantly 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 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 o ine 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.
C l e a r s e l e c t i o n 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 brie y explain why the item is not applicable/relevant for your study "Web-based self-compassion training" https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS64RdfIAFvmrTSkZQL2-3O8O9hrL5Sw/viewform 10/79 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").
C l e a r s e l e c t i o n 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 brie y explain why the item is not applicable/relevant for your study This is not applicable -there are no non-web-based components 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 C l e a r s e l e c t i o n 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 brie y explain why the item is not applicable/relevant for your study "youth with chronic medical conditions" 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 brie y explain why the item is not applicable/relevant for your study Your answer 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 brie y explain why the item is not applicable/relevant for your study "We conducted a single-blind, parallel-groups, randomized controlled trial comparing a fourweek, fully-automated, web-based self-compassion training with waitlist control." 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 brie y explain why the item is not applicable/relevant for your study "Participants were recruited online and outcomes were self-assessed at four (T1) and twelve (T2) weeks via online survey" 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 brie y explain why the item is not applicable/relevant for your study This study demonstrates that minimal-contact online self-compassion training can confer benefits for self-compassion, wellbeing and distress among young people with chronic conditions. This group experiences substantial challenges to participation in mental health supports, and, although program engagement and retention in the current trial was suboptimal. 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 brie y explain why the item is not applicable/relevant for your study "Prior reviews consistently highlight the need for developmentally-appropriate interventions that promote better psychological functioning among chronically ill youth."; Following consultation with our target group, a priority was "strengths-based interventions designed for young people with chronic conditions, that they could access to support their mental health without needing to rely on access to a mental health professional. In addition to difficulties with accessing mental health support that are frequently reported by young people, having a chronic illness often involves unpredictable and activity-limiting symptoms which can restrict capacity to access face-to-face services. Accordingly, a strength-based digital intervention was recommended as a feasible means of promoting better wellbeing and mental health outcomes in this group." 2a-ii) Scientific background, rationale: What is known about the (type of) system Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "While there is substantial evidence demonstrating that digital mental health interventions are effective for improving mental health among children and young people, available digital interventions for young people with chronic conditions are largely limited to disease-specific approaches. Given that young people with different types of chronic conditions share many common experiences, and there are high levels of co-occurring diagnoses in this population, transdiagnostic approaches (i.e., those designed for a range of different conditions) have both practical and methodological benefits. However, there are no transdiagnostic digital interventions specifically designed for -or in partnership -with young people living with chronic conditions. of these young people, we sought to trial a digital program that was tailored to our population of interest." 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 brie y explain why the item is not applicable/relevant for your study "It was hypothesised that relative to waitlist control, the self-compassion intervention group would report: (1) significant pre-post improvements in self-compassion, coping, and emotion regulation; and (2) significant pre-post improvements in psychological distress, quality of life and wellbeing. We also hypothesised that changes in all outcomes would be maintained at 12-week follow up, and that changes in the secondary outcomes would be mediated by improvements in self-compassion, emotion regulation, and coping." 3a) Description of trial design (such as parallel, factorial) including allocation ratio 3b) Important changes to methods after trial commencement (such as eligibility criteria), with reasons Does your paper address CONSORT subitem 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 brie y explain why the item is not applicable/relevant for your study "We conducted a parallel-group single-blind randomized control trial comparing webbasedself-compassion training to waitlist control" 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 brie y explain why the item is not applicable/relevant for your study There were no changes after trial commencement. 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 brie y explain why the item is not applicable/relevant for your study "Eligibility criteria were as follows: (1) Australian resident; (2) aged between 16 and 25 years; (3) diagnosis of at least one chronic medical condition, defined as a physical condition lasting 6 months or longer and requiring medical follow-up for over a year; and (4) able access to a computer and sufficient internet literacy to access complete the online program."

4a-i) Computer / Internet literacy
Computer / Internet literacy is often an implicit "de facto" eligibility criterion -this should be explicitly clari ed. 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 brie y explain why the item is not applicable/relevant for your study "Eligibility criteria were as follows: (1) Australian resident; (2) aged between 16 and 25 years; (3) diagnosis of at least one chronic medical condition, defined as a physical condition lasting 6 months or longer and requiring medical follow-up for over a year; and (4) able access to a computer and sufficient internet literacy to access complete the online program." 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. o ine), e.g., from an open access website or from a clinic, and clarify if this was a purely web-based trial, or there were face-to-face components (as part of the intervention or for assessment), i.e., to what degree got the study team to know the participant. In online-only trials, clarify if participants were quasi-anonymous and whether having multiple identities was possible or whether technical or logistical measures (e.g., cookies, email con rmation, 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 brie y explain why the item is not applicable/relevant for your study "Participants were recruited online through the open-access websites of community organisations representing various chronic conditions including epilepsy, diabetes, asthma, cystic fibrosis, and myalgic encephalomyelitis/chronic fatigue syndrome." "Participants were screened and completed baseline measures online prior to randomization, preventing the possibility of multiple enrolments. Once randomized, participants received an phonecall from a research assistant to explain how and when they would be able to access the program. This prevented the possibility of multiple enrolments. Participants randomized to the intervention group were enrolled as a Teachable student and received access to the self-compassion program for 4 weeks, at which point they were asked to complete post-test measures. They were asked to complete follow-up measures at 12-weeks post-baseline. Participants in the waitlist group completed the same measures at baseline, 4 weeks and 12 weeks, and on completion of the follow-up measures received access to the intervention. All measures were self-assessed through online surveys administered via Qualtrics, and participants received a link to these via email. " https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS64RdfIAFvmrTSkZQL2-3O8O9hrL5Sw/viewform 25/79 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.
C l e a r s e l e c t i o n 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 brie y explain why the item is not applicable/relevant for your study 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 brie y explain why the item is not applicable/relevant for your study "All measures were self-assessed through online surveys administered via Qualtrics, and participants received a link to these via email." 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.
C l e a r s e l e c t i o n 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 brie y explain why the item is not applicable/relevant for your study "All measures were self-assessed through online surveys administered via Qualtrics, and participants received a link to these via email." 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.
C l e a r s e l e c t i o n 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 brie y explain why the item is not applicable/relevant for your study "Because SCO was initially developed for healthy adults, we engaged a co-design group of young people with chronic conditions to help us to tailor the program for this target group. The co-design process for the adapted program (named "Uplift" but referred to here as Self-Compassion Online -Chronic Medical Conditions; SCO-CMC) is outlined in Finlay-Jones et al. [50], which also reports the protocol for the current 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).
C l e a r s e l e c t i o n 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 brie y explain why the item is not applicable/relevant for your study "The intervention content did not change during the evaluation period. 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 brie y explain why the item is not applicable/relevant for your study It is unclear which information this item refers to. 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/screencapture video, and/or providing owcharts of the algorithms used. Replicability (i.e., other researchers should in principle be able to replicate the study) is a hallmark of scienti c reporting.
C l e a r s e l e c t i o n 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 brie y explain why the item is not applicable/relevant for your study The program is available on request for researchers who wish to replicate the study. Note that Teachable is a paid platform and any researcher who wish to replicate the study must incur the cost of this.

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.
C l e a r s e l e c t i o n 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 brie y explain why the item is not applicable/relevant for your study A screenshot is provided in the manuscript. Note that webcitation.org is no longer taking archive requests.

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 speci c 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).
C l e a r s e l e c t i o n 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 brie y explain why the item is not applicable/relevant for your study "For the purposes of the trial, once participants were randomized, they were contacted by a research assistant who provided them with login details to access the program for free. The program was not publicly available during the study period." 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 brie y explain why the item is not applicable/relevant for your study "The program involves psychoeducational components delivered in text and animated video format, online forms that participants use for reflection exercises, and meditation exercises delivered in audio and video format. There is one module per week, which participants are invited to work through at their own pace. All participants received a weekly email reminder to complete the content, regardless of their progress through the program. An overview of the program content is outlined in Finlay-Jones et al. [50] and reported in Supplementary File 2."

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 brie y explain why the item is not applicable/relevant for your study "There is one module per week, which participants are invited to work through at their own pace. All participants received a weekly email reminder to complete the content, regardless of their progress through the program"

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 brie y explain why the item is not applicable/relevant for your study "For the purposes of the trial, once participants were randomized, they were contacted by a research assistant who provided them with login details to access the program for free."

5-xi) Report any prompts/reminders used
Report any prompts/reminders used: Clarify if there were prompts (letters, emails, phone calls, SMS) to use the application, what triggered them, frequency etc. It may be necessary to distinguish between the level of prompts/reminders required for the trial, and the level of prompts/reminders for a routine application outside of a RCT setting (discuss under item 21 -generalizability).
Does your paper address subitem 5-xi? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "All participants received a weekly email reminder to complete the content, regardless of their progress through the program." 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 brie y explain why the item is not applicable/relevant for your study "Self-compassion, emotion regulation, and coping were selected as primary outcomes, and wellbeing, distress, and quality of life were selected as secondary outcomes." Psychometric information is provided for all measures used. "Consenting participants were screened and completed baseline measures online prior to randomization, which was conducted using the Qualtrics randomization module. Once randomized, participants received an phonecall from a research assistant to explain how and when they would be able to access the program. This prevented the possibility of multiple enrolments. Participants randomized to the intervention group were enrolled as a Teachable student and received an email link with access to the self-compassion program for 4 weeks. All participants were asked to complete post-test and follow-up measures at 4and 12-weeks post-baseline. On completion of the follow-up measures, participants in the waitlist group received access to the intervention. All measures were self-assessed through online surveys administered via Qualtrics, and participants received a link to these via email." Copy and paste relevant sections from manuscript text "Data on program engagement and feedback, including barriers to completion was gathered through two mechanisms. Data on program logins and completion of individual components of the program was gathered via the Teachable platform. There were two noted issues with these data: (1) participants who did not close their browser or sign out remained logged in and were recorded as a single login; (2) for individual component completion, participants had to select "mark as complete" in the Teachable platform for the completion to be recorded. We corroborated these data through self-report: all participants in the intervention group were asked to complete two items asking about the proportion of the program they completed, and reasons for non-completion. Additionally, interview invitations were sent to a sub-set of participants in the intervention group, eight weeks after program completion. Interviews focused on participants' experiences working through the program, when and how they used the program, what program elements they liked and disliked, and how the program could be improved. Participants were randomly selected at baseline to be invited to an interview, to ensure inclusion of those who may have disengaged from the program. Interviews were conducted with 7 participants who had varying levels of program completion." subitem not at all important 1 2 3 4 5 essential 6b) Any changes to trial outcomes after the trial commenced, with reasons 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).
C l e a r s e l e c t i o n Does your paper address subitem 6a-iii?
Copy and paste relevant sections from manuscript text "Additionally, interview invitations were sent to a sub-set of participants in the intervention group, eight weeks after program completion. Interviews focused on participants' experiences working through the program, when and how they used the program, what program elements they liked and disliked, and how the program could be improved. Participants were randomly selected at baseline to be invited to an interview, to ensure inclusion of those who may have disengaged from the program. Interviews were conducted with 7 participants who had varying levels of program completion." 7a) How sample size was determined NPT: When applicable, details of whether and how the clustering by care provides or centers was addressed subitem not at all important 1 2 3 4 5 essential 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 brie y explain why the item is not applicable/relevant for your study "there were no changes to trial outcomes once the trial had 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. 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 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 brie y explain why the item is not applicable/relevant for your study "An a priori power analysis determined that to conduct a test of intervention effects (power = 0.80 and α = .05) with a medium effect size, 40 participants per group would be required. Due to the complex challenges faced by young people with chronic conditions, we accounted for 45% attrition." 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 brie y explain why the item is not applicable/relevant for your study "We conducted intention-to-treat analyses of all participants (n = 151), and no interim analyses were conducted." https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS64RdfIAFvmrTSkZQL2-3O8O9hrL5Sw/viewform 46/79 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 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 brie y explain why the item is not applicable/relevant for your study "Consenting participants were screened and completed baseline measures online prior to randomization, which was simple randomization conducted using the Qualtrics randomization module." 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 brie y explain why the item is not applicable/relevant for your study "Consenting participants were screened and completed baseline measures online prior to randomization, which was simple randomization conducted using the Qualtrics randomization module." https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS64RdfIAFvmrTSkZQL2-3O8O9hrL5Sw/viewform 47/79 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 brie y explain why the item is not applicable/relevant for your study "Consenting participants were screened and completed baseline measures online prior to randomization, which was simple randomization conducted using the Qualtrics randomization module." 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 brie y explain why the item is not applicable/relevant for your study "Consenting participants were screened and completed baseline measures online prior to randomization, which was simple randomization conducted using the Qualtrics randomization module." "Once randomized, participants received an phonecall from a research assistant to explain their intervention allocation, including details of how and when they would be able to access the program. This prevented the possibility of multiple enrolments. Participants randomized to the intervention group were enrolled by the research assistant as a Teachable student and received an email link with access to the self-compassion program for 4 weeks. 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 cointerventions (if any).
C l e a r s e l e c t i o n 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 brie y explain why the item is not applicable/relevant for your study "We conducted a parallel-group single-blind randomized control trial comparing web-based self-compassion training to waitlist control." "Researchers completing the statistical analysis were blinded to participants' allocation." 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".
C l e a r s e l e c t i o n 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 brie y explain why the item is not applicable/relevant for your study This was a waitlist-controlled study; as such, it was clear to participants which intervention was the intervention of interest.
https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS64RdfIAFvmrTSkZQL2-3O8O9hrL5Sw/viewform 50/79 12a) Statistical methods used to compare groups for primary and secondary outcomes NPT: When applicable, details of whether and how the clustering by care providers or centers was addressed Does your paper address CONSORT subitem 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 brie y explain why the item is not applicable/relevant for your study Not relevant -this is a waitlist-controlled study.
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 brie y explain why the item is not applicable/relevant for your study subitem not at all important 1 2 3 4 5 essential 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]).
C l e a r s e l e c t i o n 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 brie y explain why the item is not applicable/relevant for your study "We conducted intention-to-treat analyses of all participants (n = 151), and no interim analyses were conducted. IBM SPSS was used to calculate demographics and mean scores on outcome measures, and to compare complete cases to cases lost, while R version 4.1.1 was used for all subsequent analysis. For the hypotheses regarding intervention effectiveness, linear mixed models (LMMs) were used to compare change in outcome measures across groups and time points, while controlling for age and gender. LMMs allow all participants to be retained regardless of attrition, and thus is appropriate for intention-totreat analysis (West et al., 2015). Furthermore, LMMs can account for the lack of independence between an individual's outcomes measured at different time points, and also allow the grouping of individuals at higher levels, i.e., into intervention and control groups (Heck et al., 2014). " Note that at the reviewer's request we have also included per-protocol analysis as a supplementary file. 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 brie y explain why the item is not applicable/relevant for your study "A LMM was tested for each primary and secondary outcome using the lme4 package for R (Bates et al., 2015), with restricted maximum likelihood for missing data. In each model, the participant was included as a random effect, with age included as a fixed effect. Time (Baseline, Post-Test, Follow-up), condition (intervention vs. wait-list control), and the interaction between time and condition were included as fixed effects. The time by condition interaction was calculated as a test of intervention effects, with partial η2 calculated as a between-groups effect size. For models with significant interaction effects, univariate F tests were used to determine the main effects of time within the intervention and control conditions and within-group effect sizes for time. Planned contrasts of estimated marginal means were used to determine significant changes in outcomes across specific time-points, with Cohen's d given as a measure of effect size. To account for multiple comparisons, the Tukey-adjustment was used for P value calculations. We also conducted causal mediation analysis in R using the mediation package developed by Dustin, Teppei [60] to test whether self-compassion, difficulties in emotion regulation, adaptive coping, or maladaptive coping would mediate the relationship between intervention effects and secondary outcomes of wellbeing, distress, and quality of life. For each model, the significance of the indirect effect was determined using 100000 simulations and 95% Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Participants read information sheets online (available here) and completed an online consent form by clicking a check box"

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

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) C l e a r s e l e c t i o n 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 brie y explain why the item is not applicable/relevant for your study As per the participant information forms, participants were provided with a list of support resources they could access if required. This included national mental health hotlines.
https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS64RdfIAFvmrTSkZQL2-3O8O9hrL5Sw/viewform 56/79 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 brie y explain why the item is not applicable/relevant for your study "A total of 527 entries were recorded for online screening survey to determine eligibility. After completing the baseline assessment, participants were randomised to either the intervention (n = 76) or the waitlist control group (n = 75)." 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 brie y explain why the item is not applicable/relevant for your study "Of the 76 participants in the intervention group, 39.5% (n = 30) completed both post-test and follow up measures, 22.4% (n = 17) provided only one of the two, and 38.2% (n = 29) did not complete either post-test or follow up. Of the 75 participants in the waitlist-control group, 77.3% (n = 58) completed both post-test and follow up measures, 16.0% (n = 12) completed only one of the two, and 6.7% (n = 5) did not complete either post-test or follow up." A CONSORT flow diagram is provided. Copy and paste relevant sections from the manuscript or cite the gure 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 brie y explain why the item is not applicable/relevant for your study We have reported attrition in text but have not provided an attrition diagram. subitem not at all important 1 2 3 4 5 essential 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 brie y explain why the item is not applicable/relevant for your study "Four weeks after allocation, participants were contacted to complete post-test measures. Twelve weeks after allocation and baseline assessment, all participants were contacted to complete the follow up measures, regardless of whether they completed post-test measures at four weeks."

14a-i) Indicate if critical "secular events" fell into the study period
Indicate if critical "secular events" fell into the study period, e.g., signi cant 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 brie y explain why the item is not applicable/relevant for your study This was not measured for this study.
Does your paper address CONSORT subitem 14b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study The trial concluded once the required sample of participants had been reached.
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 brie y explain why the item is not applicable/relevant for your study " 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 brie y explain why the item is not applicable/relevant for your study We have reported age and gender (and differences in these across groups) but have not reported SES or education. This is a noted limitation of the study. subitem not at all important 1 2 3 4 5 essential 16-i) Report multiple "denominators" and provide definitions Report multiple "denominators" and provide de nitions: 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 speci c pre-de ned time points of interest (in absolute and relative numbers per group). Always clearly de ne "use" of the intervention.
C l e a r s e l e c t i o n 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 brie y explain why the item is not applicable/relevant for your study We did not conduct subgroup analysis by usage groups, however we did conduct a per protocol analysis at request of a reviewer. This is reported in a Supplementary file. 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 brie y explain why the item is not applicable/relevant for your study Results for all primary and secondary outcomes are reported as group x time interactions, with confidence intervals, in Tables 3, 4 and 6.
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 de nitions 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 de ned (e.g., timeout after idle time) [1] (report under item 6a). Does your paper address subitem 17a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Based on components marked as completed, 19 (25%) completed all of the program" Percentage of participants marked as completing different percentage thresholds of the program is reported in Table 8.
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 brie y explain why the item is not applicable/relevant for your study

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).
C l e a r s e l e c t i o n 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 brie y explain why the item is not applicable/relevant for your study Per protocol analysis has been included as a supplementary file following a request from reviewers. Does your paper address subitem 19-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study 1 (4.3%) of participants reported issues accessing the program. Technical problems were experienced by researchers trying to utilise Teachable metrics of program engagement: "Due to technical problems with the Teachable platform, the percentage of videos viewed was not recorded. We therefore used completion of individual program components to quantity program completion, however these statistics represent a conservative estimate, as participants were required to manually mark components as completed and could move ahead through the program without doing this" Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Qualitative feedback from participants is presented in the section "Program Feedback" 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 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 brie y explain why the item is not applicable/relevant for your study "This study investigated the efficacy of a self-guided online self-compassion training program for improving self-compassion and related mental health outcomes in young people living with chronic conditions. Outcomes for participants in the self-compassion program were compared with outcomes for participants in a waitlist control group, with post-test assessments conducted at 4 weeks, and follow-up assessment at 12 weeks. While results overall demonstrated the benefit of the program on self-compassion and related wellbeing outcomes, not all outcomes were as expected. Nevertheless, the findings provide insights into the opportunities and challenges afforded by online programs for young people with chronic conditions, while the baseline profiles of the participants underscore the need for targeted interventions designed for this group." Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Accordingly, it may be that an extended or more explicit focus on addressing emotion regulation difficulties is warranted for this target group. Furthermore, as advancements in digital technology are enabling greater ecological validity in emotion regulation measurement (for example, the use of ecological momentary assessment via smartphones [73]), it is recommended that future iterations of self-compassion intervention research consider how digital technology can be leveraged to provide state-and context-sensitive measures of emotion regulation. This would allow researchers to more closely map changes in emotion regulation to self-compassion practice, as well as determine changes across contexts that are meaningful to young people with chronic conditions (for example, during difficult experiences in healthcare settings)."

22-ii) Highlight unanswered new questions, suggest future research
"We recommend that future work use intervention optimisation or dismantling designs to determine which components of the online program are associated with treatment gains in these outcomes, and whether the re-inclusion of components specifically focused on addressing emotion regulation difficulties improves treatment effects for emotion regulation and distress" "further research is required to optimise the program for young people with different accessibility requirements." "Future research should consider the additional barriers to engagement faced by such participants and work to co-develop strategies to ensure that these participants have equitable opportunities to engage in the intervention" "Based on these findings an interesting avenue for future research is to design interventions comprised of brief components that young people can engage with separately, or in combination, at time that suits them (e.g., a series of single-session interventions rather than a four-week consecutive program)" "In future, it is recommended that researchers use digital programs that collect program use data in a more nuanced way that that provided by the Teachable platform to allow for deeper understanding of program use and attrition patterns.

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.
C l e a r s e l e c t i o n 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 brie y explain why the item is not applicable/relevant for your study "Nevertheless, there were several limitations to the study, including the use of a waitlist control group and reliance on self-report data. While this was appropriate given the early stage of testing of the SCO-CMC program and the minimal-contact nature of the program, the use of a waitlist control group can artificially inflate estimates of treatment effects [84]. As noted, attrition from the study was higher than previously reported averages for children and young people, which can introduce attrition bias [22]. While we conducted intention-totreat analyses to account for this, these attrition rates compromise the generalizability of the findings." 21) Generalisability (external validity, applicability) of the trial findings Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "While we conducted intention-to-treat analyses to account for this, these attrition rates compromise the generalizability of the findings. 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 cointerventions) 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.
C l e a r s e l e c t i o n 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 brie y explain why the item is not applicable/relevant for your study "Finally, while the ecological validity of the study was generally high, the use of a research assistant to enrol participants in intervention or waitlist conditions does represent a threat to external validity." About the CONSORT EHEALTH checklist X27-i) State the relation of the study team towards the system being evaluated In addition to the usual declaration of interests ( nancial 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.
C l e a r s e l e c t i o n 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 brie y explain why the item is not applicable/relevant for your study "Dr Finlay-Jones developed the content for the SCO-CMC program. None of the authors have any involvement with the Teachable platform. There are no other conflicts of interest to report." yes, major changes yes, minor changes no yes no Other: 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?
Inclusion of more detail.
How much time did you spend on going through the checklist INCLUDING making changes in your manuscript

* Approximately seven hours
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Any other comments or questions on CONSORT EHEALTH
This took an extraordinarily long time to complete and is repetitive to CONSORT guidelines. It would be helpful to align JMIR templates with these guidelines and/or use AI to reduce the length of completing this process. Additionally, all weblinks provided for this form were broken and it took considerable effort to locate it.