Internet-Based Cognitive Behavioral Therapy for Symptoms of Depression and Anxiety Among Patients With a Recent Myocardial Infarction: The U-CARE Heart Randomized Controlled Trial

Background Symptoms of depression and anxiety are common after a myocardial infarction (MI). Internet-based cognitive behavioral therapy (iCBT) has shown good results in other patient groups. Objective The aim of this study was to evaluate the effectiveness of an iCBT treatment to reduce self-reported symptoms of depression and anxiety among patients with a recent MI. Methods In total, 3928 patients were screened for eligibility in 25 Swedish hospitals. Of these, 239 patients (33.5%, 80/239 women, mean age 60 years) with a recent MI and symptoms of depression or anxiety were randomly allocated to a therapist-guided, 14-week iCBT treatment (n=117), or treatment as usual (TAU; n=122). The iCBT treatment was designed for post-MI patients. The primary outcome was the total score of the Hospital Anxiety and Depression Scale (HADS) 14 weeks post baseline, assessed over the internet. Treatment effect was evaluated according to the intention-to-treat principle, with multiple imputations. For the main analysis, a pooled treatment effect was estimated, controlling for age, sex, and baseline HADS. Results There was a reduction in HADS scores over time in the total study sample (mean delta=−5.1, P<.001) but no difference between the study groups at follow-up (beta=−0.47, 95% CI −1.95 to 1.00, P=.53). Treatment adherence was low. A total of 46.2% (54/117) of the iCBT group did not complete the introductory module. Conclusions iCBT treatment for an MI population did not result in lower levels of symptoms of depression or anxiety compared with TAU. Low treatment adherence might have influenced the result. Trial Registration ClinicalTrials.gov NCT01504191; https://clinicaltrials.gov/ct2/show/NCT01504191 (Archived at Webcite at http://www.webcitation.org/6xWWSEQ22)

1b) ABSTRACT: Structured summary of trial design, methods, results, and conclusions NPT extension: Description of experimental treatment, comparator, care providers, centers, and blinding status.

1b-i) Key features/functionalities/components of the intervention and comparator in the METHODS section of the ABSTRACT
Mention key features/functionalities/components of the intervention and comparator in the abstract. If possible, also mention theories and principles used for designing the site. Keep in mind the needs of systematic reviewers and indexers by including important synonyms. (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) 1 2 3 4 5 subitem not at all important essential Does your paper address subitem 1b-i? * Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study

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: "among Patients with a Recent Myocardial Infarction" Of these, 239 patients (33% women, mean age 60 years) with a recent MI and symptoms of depression or anxiety were randomly allocated to "a therapist-guided, 14 week iCBT treatment" (n=117), or "treatment as usual" (n=122).
Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) 1 2 3 4 5 subitem not at all important essential

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

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-toface 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 webbased trials usually refers to "open access" (i.e. participants can self-enrol). (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) 1 2 3 4 5 subitem not at all important essential

Does your paper address subitem 1b-iii?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study 1b-iv) RESULTS section in abstract must contain use data Report number of participants enrolled/assessed in each group, the use/uptake of the intervention (e.g., attrition/adherence metrics, use over time, number of logins etc.), in addition to primary/secondary outcomes. (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) 1 2 3 4 5 subitem not at all important essential "a therapist-guided" In total, 3928 patients were "screened for eligibility in 25 Swedish hospitals". The primary outcome was the total score of the Hospital Anxiety and Depression Scale (HADS) 14 weeks post baseline, "assessed online".

2a-i) Problem and the type of system/solution
Describe the problem and the type of system/solution that is object of the study: intended as stand-alone intervention vs. incorporated in broader health care program? Intended for a particular patient population? Goals of the intervention, e.g., being more cost-effective to other interventions, replace or complement other solutions? (Note: Details about the intervention are provided in "Methods" under 5) 1 2 3 4 5 subitem not at all important essential Does your paper address subitem 2a-i? * "Treatment adherence was low. 46% of the iCBT group did not complete the introductory module." "Low treatment adherence might have influenced the result." Copy and paste relevant sections from the manuscript (include quotes in quotation 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 2a-ii) Scientific background, rationale: What is known about the (type of) system Scientific background, rationale: What is known about the (type of) system that is the object of the study ( "To improve access to effective support, increased engagement in e-health solutions within the cardiac community has been called upon [10], with internet-based CBT (iCBT) representing an e-health solution that may improve access to acceptable, effective and cost-effective psychological treatment [11] iCBT has been found to reduce symptoms of depression and anxiety among adults with common mental health difficulties [12]. " "Furthermore, preliminary evidence suggests iCBT may reduce symptoms of depression and anxiety for adults with high cardiovascular risk [14]. However, there is limited knowledge regarding the effectiveness and acceptability of iCBT for symptoms of depression and anxiety among MI patients recruited in a clinical setting. " "The aim of the present randomized controlled trial (RCT) was to evaluate the effectiveness therapist-guided iCBT versus usual care in patients with a recent MI and comorbid symptoms of depression and anxiety." including allocation ratio Does your paper address CONSORT subitem 3a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study 3b) Important changes to methods after trial commencement (such as eligibility criteria), with reasons Does your paper address CONSORT subitem 3b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study

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

Does your paper address subitem 3b-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study The U-CARE Heart study is a RCT comparing therapist-guided iCBT to treatment as usual (TAU). /---/ Patients were randomly assigned (stratified by clinical recruiting center) with a 1:1 allocation, using a computer generated code.
Three protocol design modifications were made during the ongoing trial. First, the inclusion criteria threshold was lowered from >10 to >7 on either of the two Hospital Anxiety and Depression Scale (HADS) [16] subscale scores (5th March 2014), in order to increase the recruitment rate (after having recruited only 7 patients).
Second, minor changes were made to the introduction module after completion of the internal pilot trial including the first 20 patients [15]. Third, a mobile device version of the treatment was launched after 63 patients had been randomized to iCBT, representing 54% of the total allocated to this trial arm (29th February 2016).

4a) Eligibility criteria for participants
Does your paper address CONSORT subitem 4a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study

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 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 web-based trial, or there were faceto-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.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 4a-ii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Exclusion criteria were /.../ "(2) unable to use computer/internet/email/mobile phone". /---/ "Patients were identified and screened for eligibility during a routine visit to a cardiac nurse at 1-8 weeks following their MI. Nurses provided brief trial information and logged all consecutive patients matching the inclusion criteria. U-CARE research staff at the coordinating center (Uppsala), called eligible patients to provide further study information. Written information and an informed consent form were sent to patients via postal service. Patients providing informed consent subsequently received an email with a username and password to access a secure internet-based portal to complete the online baseline assessments." Exclusion criteria were /.../ "(2) unable to use computer/internet/email/mobile phone".

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 4b) Settings and locations where the data were collected Does your paper address CONSORT subitem 4b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study

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.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 4b-i? * "Patients were identified and screened for eligibility during a routine visit to a cardiac nurse at 1-8 weeks following their MI. Nurses provided brief trial information and logged all consecutive patients matching the inclusion criteria. U-CARE research staff at the coordinating center (Uppsala), called eligible patients to provide further study information." "Written information and an informed consent form were sent to patients via postal service".
"Patients providing informed consent subsequently received an email with a username and password to access a secure internet-based portal to complete the online baseline assessments".
Copy and paste relevant sections from the manuscript (include quotes in quotation 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 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) 1 2 3 4 5 subitem not at all important essential

Does your paper address subitem 4b-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study 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 "Patients providing informed consent subsequently received an email with a username and password to access a secure internet-based portal to complete the online baseline assessments".
All letters to the participants and the written information mentioned that the study was hosted by Uppsala University.

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

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

5-iv) Quality assurance methods
Provide information on quality assurance methods to ensure accuracy and quality of information provided [1], if "The treatment consisted of a 14-week, therapist-guided tailored CBT intervention delivered via a secure internet-based portal (U-CARE-portal)".
"The treatment was developed by licensed psychologists, in consultation with patients with a history of depression and anxiety post-MI".
The development is described even further in a submitted parallel manuscript (Wallin et. al., under review)  "Second, minor changes were made to the introduction module after completion of the internal pilot trial including the first 20 patients [15]. Third, a mobile device version of the treatment was launched after 63 patients had been randomized to iCBT, representing 54% of the total allocated to this trial arm (29th February 2016)" 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

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

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

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

Does your paper address subitem 5-vi?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Patients that did not complete the online baseline or follow-up assessment were reminded by Short Message Service (SMS), with research staff blind to group allocation telephoning patients who did not complete the assessment within one week of receiving the SMS reminder". This is much elaborated in another manuscript submitted in paralell to the same journal (Wallin et.al.). That submission includes both screenshots and descriptions of the design of the platform.

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

5-viii) Mode of delivery, features/functionalities/components of the intervention and comparator, and the theoretical framework
The URL is www.u-care.se. To log in you will need a password and a username. We have not yet created demo pages.
"Patients providing informed consent subsequently received an email with a username and password to access a secure internet-based portal to complete the online baseline assessments".

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

5-x) Clarify the level of human involvement
Clarify the level of human involvement (care providers or health professionals, also technical assistance) in the eintervention 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 21generalizability).

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 "The treatment consisted of a 14-week, therapist-guided tailored CBT intervention delivered via a secure internet-based portal (U-CARE-portal). The treatment was developed by licensed psychologists, in consultation with patients with a history of depression and anxiety post-MI. The treatment included 10 modules with different themes, adapted to MI patients (Table 1). The introduction module was compulsory and thereafter patients were able to choose which modules to work with, as informed by previous research suggesting tailored iCBT provides patients with more control while maintaining treatment quality [18]. Each module contained 2-4 treatment steps, with each step including a PDF with text-based psychoeducation, and one-to-two homework assignments. Patients were recommended to work with one step per week during treatment period. Homework assignments consisted of self-monitoring, skills training, and engagement in exercises based on CBT-techniques (Table 1). Modules were considered complete when all homework assignments within a module were sent to the therapist for feedback. In addition, the iCBT treatment included a library with supplementary material and video clips of interviews conducted with post-MI patients concerning coping with common psychological reactions post-MI. Patients also had access to a discussion board where they could communicate with other patients randomized to the treatment arm." "Patients were recommended to work with one step per week during treatment period".
"Each patient was assigned one of three available therapists, all licensed psychologists specialized in CBT. Each therapist provided feedback on homework assignments via the portal. The purpose of feedback was to express empathy, encourage work with the treatment and reinforce treatment activity, all of which has been found to correlate with adherence and outcome [19]. Patients were able to contact their therapist at any time, with therapist responses provided within 48 hours. Patients inactive for more than one week were contacted by their therapist via telephone, with SMS reminders sent if were unable to be reached via telephone. Motivational interviewing techniques were used during telephone calls to resolve any identified barriers regarding treatment inactivity. Occasionally telephone calls included explanations regarding treatment module content, however calls were not therapeutic and focused on working directly with the material. Telephone call duration ranged between 5 and 30 minutes. Further, technical support, provided by research staff (blinded to allocation) was available via telephone and email".

5-xi) Report any prompts/reminders used
Report any prompts/reminders used: Clarify if there were prompts (letters, emails, phone calls, SMS) to use the application, what triggered them, frequency etc. It may be necessary to distinguish between the level of prompts/reminders required for the trial, and the level of prompts/reminders for a routine application outside of a RCT setting (discuss under item 21 -generalizability).
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 5-xi? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study

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 21generalizability.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 5-xii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study 6a) Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed Does your paper address CONSORT subitem 6a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Patients that did not complete the online baseline or follow-up assessment were reminded by Short Message Service (SMS), with research staff blind to group allocation telephoning patients who did not complete the assessment within one week of receiving the SMS reminder". /---/ "Patients inactive for more than one week were contacted by their therapist via telephone, with SMS reminders sent if were unable to be reached via telephone".
"[T]echnical support, provided by research staff (blinded to allocation) was available via telephone and email". 6a-i) Online questionnaires: describe if they were validated for online use and apply CHERRIES items to describe how the questionnaires were designed/deployed If outcomes were obtained through online questionnaires, describe if they were validated for online use and apply CHERRIES items to describe how the questionnaires were designed/deployed [9].

Does your paper address subitem 6a-i?
Copy and paste relevant sections from manuscript text

6a-ii) Describe whether and how "use" (including intensity of use/dosage) was defined/measured/monitored
Describe whether and how "use" (including intensity of use/dosage) was defined/measured/monitored (logins, logfile analysis, etc.). Use/adoption metrics are important process outcomes that should be reported in any ehealth trial.

Does your paper address subitem 6a-ii?
Copy and paste relevant sections from manuscript text 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).
1 2 3 4 5 subitem not at all important essential "HADS-total score (HADS-T) was the primary outcome measure of self-reported symptoms of depression and anxiety, consisting of 14 items divided equally on two subscales: anxiety (HADS-A) and depression (HADS-D). Each item is rated on a four point Likert scale, resulting in a total score of 42. Higher scores indicate more severe symptoms, with scores above seven on either subscale indicating mild symptoms [16]. The HADS is a reliable and valid measurement of symptom severity, and can detect cases of depression and anxiety in different populations [21]. Several studies support the validity of online administration of HADS [22]." "The HADS is a reliable and valid measurement of symptom severity, and can detect cases of depression and anxiety in different populations [21]. Several studies support the validity of online administration of HADS [22]".
"Adherence was defined as the proportion of treated patients completing the prescribed amount of content within the treatment period".
This issue is much expanded in the parallel submitted manuscript (Wallin et.al.) Does your paper address subitem 6a-iii?
Copy and paste relevant sections from manuscript text 6b) Any changes to trial outcomes after the trial commenced, with reasons Does your paper address CONSORT subitem 6b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study 7a) How sample size was determined NPT: When applicable, details of whether and how the clustering by care provides or centers was addressed

7a-i) Describe whether and how expected attrition was taken into account when calculating the sample size
Describe whether and how expected attrition was taken into account when calculating the sample size.

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 "Patients also had access to a discussion board". /---/ "Patients were able to contact their therapist at any time, with therapist responses provided within 48 hours".
No changes.
The study originally aimed for a higher number of participants which is desribed in st published Study Protocol (Norlund et.al, 2015). In this ms it is stated that "The study had enough patients (n>126) to detect a medium effect size (CohenŁs d = 0.5) with the power of 80 at alpha level 0.05." 7b) When applicable, explanation of any interim analyses and stopping guidelines Does your paper address CONSORT subitem 7b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study 8a) Method used to generate the random allocation sequence NPT: When applicable, how care providers were allocated to each trial group Does your paper address CONSORT subitem 8a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study 8b) Type of randomisation; details of any restriction (such as blocking and block size) Does your paper address CONSORT subitem 8b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study 9) Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until "A statistical analysis plan prepared in line with Consolidated Standards of Reporting Trial (CONSORT) 2010 statements, was completed before the trial database was locked, and treatment allocation was disclosed. No interim analysis was performed".
"Patients were randomly assigned (stratified by clinical recruiting center) with a 1:1 allocation, using a computer generated code. Randomization occurred automatically in the internet-based portal".
"Patients were randomly assigned (stratified by clinical recruiting center) with a 1:1 allocation, using a computer generated code. Randomization occurred automatically in the internet-based portal".
interventions were assigned Does your paper address CONSORT subitem 9? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study 10) Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions Does your paper address CONSORT subitem 10? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study 11a) If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how NPT: Whether or not administering co-interventions were blinded to group assignment

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).

2 3 4 5 subitem not at all important essential
Does your paper address subitem 11a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study The randomization was done totally automatically within the internet-portal without any involvement of the researchers.
"Patients were randomly assigned (stratified by clinical recruiting center) with a 1:1 allocation, using a computer generated code. Randomization occurred automatically in the internet-based portal, with patients receiving an email to inform them of condition assignment".
11a-ii) Discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator" Informed consent procedures (4a-ii) can create biases and certain expectations -discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator".

Does your paper address subitem 11a-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study 11b) If relevant, description of the similarity of interventions (this item is usually not relevant for ehealth trials as it refers to similarity of a placebo or sham intervention to a active medication/intervention) Does your paper address CONSORT subitem 11b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study 12a) Statistical methods used to compare groups for primary and secondary outcomes NPT: When applicable, details of whether and how the clustering by care providers or centers was addressed Does your paper address CONSORT subitem 12a? * It was not possible to have neither blind patients nor therapists. Research staff was blind to study group allocation. "Patients that did not complete the online baseline or follow-up assessment were reminded by Short Message Service (SMS), with research staff blind to group allocation telephoning patients who did not complete the assessment within one week of receiving the SMS reminder". /---/ "Further, technical support, provided by research staff (blinded to allocation) was available via telephone and email".
Yes they did. The study did only use one intervention arm. No.
CONSORT-EHEALTH (V 1. Copy and paste relevant sections from the manuscript (include quotes in quotation 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

12a-i) Imputation techniques to deal with attrition / missing values
Imputation techniques to deal with attrition / missing values: Not all participants will use the intervention/comparator as intended and attrition is typically high in ehealth trials. Specify how participants who did not use the application or dropped out from the trial were treated in the statistical analysis (a complete case analysis is strongly discouraged, and simple imputation techniques such as LOCF may also be problematic [4]).
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 12a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study 12b) Methods for additional analyses, such as subgroup analyses and adjusted analyses Does your paper address CONSORT subitem 12b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study X26) REB/IRB Approval and Ethical Considerations [recommended as subheading under "Methods"] (not a "ITT analyses were preceded by multiple imputation via chained equations and predictive mean matching".
"ITT analyses were preceded by multiple imputation via chained equations and predictive mean matching".
"Secondary outcomes were analyzed using ITT only. We report effect estimates as pooled adjusted point estimates (Ł) with 95% Confidence Intervals (CI). Paired t-tests were performed for all outcomes (baseline vs follow-up) to assess change over time. The relationship between number of completed homework assignments and changes in HADS-T over time was calculated with SpearmanŁs rank order correlation".

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

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

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

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

Does your paper address subitem X26-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "The study protocol was approved by the regional ethics committee in Uppsala (2011/217)".
"U-CARE research staff at the coordinating center (Uppsala), called eligible patients to provide further study information. Written information and an informed consent form were sent to patients via postal service. Patients providing informed consent subsequently received an email with a username and password to access a secure internet-based portal to complete the online baseline assessments".

RESULTS
13a) For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analysed for the primary outcome NPT: The number of care providers or centers performing the intervention in each group and the number of patients treated by each care provider in each center Does your paper address CONSORT subitem 13a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study 13b) For each group, losses and exclusions after randomisation, together with reasons Does your paper address CONSORT subitem 13b? (NOTE: Preferably, this is shown in a CONSORT 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

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.
Suicidal and highly depressed patients were excluded from the study. These were contacted and reffered elsewhere.
A CONSORT flow-chart is included.
A CONSORT flow-chart is included. subitem not at all important essential

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

14a-i) Indicate if critical "secular events" fell into the study period
Indicate if critical "secular events" fell into the study period, e.g., significant changes in Internet resources available or "changes in computer hardware or Internet delivery resources" 1 2 3 4 5 subitem not at all important essential

Does your paper address subitem 14a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study A figure describing the use of the intervention over time is included in the manuscript.
"Patients (n=239) were recruited from 25 cardiac clinics in Sweden from September 2013 to December 2016".
Smart phones and iPads became popular. This lead to: "Third, a mobile device version of the treatment was launched after 63 patients had been randomized to iCBT, representing 54% of the total allocated to this trial arm (29th February 2016)".
14b) Why the trial ended or was stopped (early) Does your paper address CONSORT subitem 14b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study 15) A table showing baseline demographic and clinical characteristics for each group NPT: When applicable, a description of care providers (case volume, qualification, expertise, etc.) and centers (volume) in each group Does your paper address CONSORT subitem 15? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study

15-i) Report demographics associated with digital divide issues
In ehealth trials it is particularly important to report demographics associated with digital divide issues, such as age, education, gender, social-economic status, computer/Internet/ehealth literacy of the participants, if known.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 15-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study

No.
A 16) For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups

16-i) Report multiple "denominators" and provide 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.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 16-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study

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 17a) For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval) This is reported throughout the manuscript.
"The main analyses were conducted according to the intention-to-treat (ITT) principle for all outcomes". 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

17a-i) Presentation of process outcomes such as metrics of use and intensity of use
In addition to primary/secondary (clinical) outcomes, the presentation of process outcomes such as metrics of use and intensity of use (dose, exposure) and their operational definitions is critical. This does not only refer to metrics of attrition (13-b) (often a binary variable), but also to more continuous exposure metrics such as "average session length". These must be accompanied by a technical description how a metric like a "session" is defined (e.g., timeout after idle time) [1] (report under item 6a).

Does your paper address subitem 17a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study 17b) For binary outcomes, presentation of both absolute and relative effect sizes is recommended Does your paper address CONSORT subitem 17b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study 18) Results of any other analyses performed, including Effect size and its precision are mentioned throughout the manuscript.
"The relationship between number of completed homework assignments and changes in HADS-T over time was calculated with SpearmanŁs rank order correlation".
Not applicable.
subgroup analyses and adjusted analyses, distinguishing prespecified from exploratory Does your paper address CONSORT subitem 18? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly 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).

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

Does your paper address CONSORT subitem 19? *
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study

19-i) Include privacy breaches, technical problems
"Sensitivity analyses of HADS-T were conducted on observed data. Supplementary analyses of HADS-T were performed based on per protocol (PP) data from all patients that had completed at least one homework assignment. Secondary outcomes were analyzed using ITT only".
"Sensitivity analyses of HADS-T were conducted on observed data. Supplementary analyses of HADS-T were performed based on per protocol (PP) data from all patients that had completed at least one homework assignment. Secondary outcomes were analyzed using ITT only".
"Adverse events Two patients in the iCBT group, and three patients in the control group reported severe depression (MADRS-S >34) or suicidal ideation (MADRS-S item 9>3) at follow-up".
Include privacy breaches, technical problems. This does not only include physical "harm" to participants, but also incidents such as perceived or real privacy breaches [1], technical problems, and other unexpected/unintended incidents. "Unintended effects" also includes unintended positive effects [2].

Does your paper address subitem 19-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study

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

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

22-i) Restate study questions and summarize the answers suggested by the data, starting with primary outcomes and process outcomes (use)
Restate study questions and summarize the answers suggested by the data, starting with primary outcomes and process outcomes (use).
A parallel manuscript (Wallin et.al.) is describing feedback from users in detail.
A parallel manuscript (Wallin et.al.) is describing feedback from users in detail.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 22-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study

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

Does your paper address subitem 22-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study 20) Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses

20-i) Typical limitations in ehealth trials
Typical limitations in ehealth trials: Participants in ehealth trials are rarely blinded. Ehealth trials often look at a multiplicity of outcomes, increasing risk for a Type I error. Discuss biases due to non-use of the intervention/usability issues, biases through informed consent procedures, unexpected events.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 20-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "In this RCT we evaluated the effectiveness of a therapist-guided tailored iCBT treatment compared to TAU to reduce symptoms of depression and anxiety among recent MI patients. Both groups reported a decreased level of symptoms of depression and/or anxiety over time to a similar extent, with no difference between groups at follow-up. Adherence was low compared to other tailored iCBT interventions for depression and anxiety [26], indicating most patients allocated to iCBT received only a small treatment dose." "Effective and accessible psychological treatments are important given symptoms of depression and anxiety are common post-MI. Despite the success of iCBT trials [13] utilizing self-referral recruitment methods for patients with a range of comorbid physical and mental conditions, alongside calls for the widespread implementation of e-health interventions for cardiac populations [10], the present study questions the promise of iCBT for MI patients recruited at cardiac clinics. As such, future research should examine the potential differences in terms of iCBT acceptability between populations recruited via self-referral versus clinical settings. Further, increased efforts are needed to better understand how to improve treatment adherence. Such efforts may include exploratory studies investigating factors related to treatment acceptability. Finally, our results support the notion that systematic development and feasibility testing, in close collaboration with potential end-users, should be undertaken to improve treatment relevance and acceptability [50]. Whilst, this study was preceded by both semi-structured feasibility testing and an internal pilot study this was apparently not sufficient". 21) Generalisability (external validity, applicability) of the trial findings NPT: External validity of the trial findings according to the intervention, comparators, patients, and care providers or centers involved in the trial

21-i) Generalizability to other populations
Generalizability to other populations: In particular, discuss generalizability to a general Internet population, outside of a RCT setting, and general patient population, including applicability of the study results for other organizations 1 2 3 4 5 subitem not at all important essential

Does your paper address subitem 21-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study

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

Does your paper address subitem 21-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "The present trial recruited patients from 25 hospitals in both rural and urban areas in Sweden. The content and design of the portal, and the treatment were developed in consultation with patients with personal experience of emotional distress post-MI to increase acceptability, relevance, and usability. We prepared a detailed statistical analysis plan and pre-specified adjustment by covariates to ensure a transparent analysis procedure [47]. We have provided detailed descriptions of the intervention and its delivery, in line with recent reporting guidelines [48], enabling comparison with other iCBT treatments targeting cardiac patients. Therapist support was provided by licensed psychologists, specialized in the CBT methodology. Despite all efforts to develop a user-friendly and relevant iCBT treatment, adherence to treatment was low. Given the obtained dose of treatment was low, the effect of the treatment might be difficult to evaluate. The PP analysis did not differ from the ITT analysis. However, our definition of PP may be criticized of being too liberal (completion of only one homework assignment). Moreover, HADS was developed as a screening measure and might not be sensitive enough to detect minor changes over time. However, none of the more sensitive secondary outcomes assessments indicated an effect. Diagnostic interviews might have been a more valid assessment of symptoms of depression and anxiety. Furthermore, the initial cut-of >10 in any of the HADS subscales was lowered early in the study to >7 in order to increase recruitment rate. Patients reporting a low level of depression and anxiety have less room for improvement, resulting in a reduced likelihood of detecting a treatment effect [49]. This might also have resulted in inclusion of patients experiencing a low level of emotional distress, and consequently low perceived need for psychological help".
"Most iCBT studies with positive results are efficacy studies based on self-referral by people seeking help online. In this study we recruited patients within a routine care setting using screening methods". /---/ "The present trial recruited patients from 25 hospitals in both rural and urban areas in Sweden".