Effects of Internet-Based Cognitive Behavioral Therapy for Harmful Alcohol Use and Alcohol Dependence as Self-help or With Therapist Guidance: Three-Armed Randomized Trial

Background Alcohol use is a major contributor to health loss. Many persons with harmful use or alcohol dependence do not obtain treatment because of limited availability or stigma. They may use internet-based interventions as an alternative way of obtaining support. Internet-based interventions have previously been shown to be effective in reducing alcohol consumption in studies that included hazardous use; however, few studies have been conducted with a specific focus on harmful use or alcohol dependence. The importance of therapist guidance in internet-based cognitive behavioral therapy (ICBT) programs is still unclear. Objective This trial aims to investigate the effects of a web-based alcohol program with or without therapist guidance among anonymous adult help-seekers. Methods A three-armed randomized controlled trial was conducted to compare therapist-guided ICBT and self-help ICBT with an information-only control condition. Swedish-speaking adult internet users with alcohol dependence (3 or more International Classification of Diseases, Tenth Revision criteria) or harmful alcohol use (alcohol use disorder identification test>15) were included in the study. Participants in the therapist-guided ICBT and self-help ICBT groups had 12-week access to a program consisting of 5 main modules, as well as a drinking calendar with automatic feedback. Guidance was given by experienced therapists trained in motivational interviewing. The primary outcome measure was weekly alcohol consumption in standard drinks (12 g of ethanol). Secondary outcomes were alcohol-related problems measured using the total alcohol use disorder identification test-score, diagnostic criteria for alcohol dependence and alcohol use disorder, depression, anxiety, health, readiness to change, and access to other treatments or support. Follow-up was conducted 3 (posttreatment) and 6 months after recruitment. Results During the recruitment period, from March 2015 to March 2017, 1169 participants were included. Participants had a mean age of 45 (SD 13) years, and 56.72% (663/1169) were women. At the 3-month follow-up, the therapist-guided ICBT and control groups differed significantly in weekly alcohol consumption (−3.84, 95% Cl −6.53 to −1.16; t417=2.81; P=.005; Cohen d=0.27). No significant differences were found in weekly alcohol consumption between the self-help ICBT group and the therapist-guided ICBT at 3 months, between the self-help ICBT and the control group at 3 months, or between any of the groups at the 6-month follow-up. A limitation of the study was the large number of participants who were completely lost to follow-up (477/1169, 40.8%). Conclusions In this study, a therapist-guided ICBT program was not found to be more effective than the same program in a self-help ICBT version for reducing alcohol consumption or other alcohol-related outcomes. In the short run, therapist-guided ICBT was more effective than information. Only some internet help-seekers may need a multisession program and therapist guidance to change their drinking when they use internet-based interventions. Trial Registration ClinicalTrials.gov NCT02377726; https://clinicaltrials.gov/ct2/show/NCT02377726


1a-i) Identify the mode of delivery in the title
Identify the mode of delivery. Preferably use "web-based" and/or "mobile" and/or "electronic game" in the title. Avoid ambiguous terms like "online", "virtual", "interactive". Use "Internet-based" only if Intervention includes non-web-based Internet components (e.g. email), use "computer-based" or "electronic" only if offline products are used. Use "virtual" only in the context of "virtual reality" (3-D worlds). Use "online" only in the context of "online support groups". Complement or substitute product names with broader terms for the class of products (such as "mobile" or "smart phone" instead of "iphone"), especially if the application runs on different platforms.

Rensa markering
Does your paper address subitem 1a-i? * Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Web-based treatment of harmful alcohol use and alcohol dependence: A randomized controlled trial" Ditt svar är för stort. Testa att förkorta en del av dina svar. Mention non-web-based components or important co-interventions in title, if any (e.g., "with telephone support").
Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Not applicable: no non-web-based components were used in the interventions 1a-iii) Primary condition or target group in the title Mention primary condition or target group in the title, if any (e.g., "for children with Type I Diabetes") Example: A Web-based and Mobile Intervention with Telephone Support for Children with Type I Diabetes: Randomized Controlled Trial

Rensa markering
Does your paper address subitem 1a-iii? * Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Web-based treatment of harmful alcohol use and alcohol dependence" Ditt svar är för stort. Testa att förkorta en del av dina svar.

Rensa markering
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 "comparing therapist-guided ICBT and self-help ICBT with an information only control condition" "Participants in the therapist-guided ICBT and self-help ICBT groups had 12-week access to a program consisting of five main and three extra modules as well as a drinking-calendar with automatic feedback." 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 1b-ii) Level of human involvement in the METHODS section of the ABSTRACT Clarify the level of human involvement in the abstract, e.g., use phrases like "fully automated" vs. "therapist/nurse/care provider/physician-assisted" (mention number and expertise of providers involved, if any). (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it)
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 "therapist-guided ICBT" "The guidance was given by experienced therapists trained in motivational interviewing" 1b-iii) Open vs. closed, web-based (self-assessment) vs. face-to-face assessments in the METHODS section of the ABSTRACT Mention how participants were recruited (online vs. offline), e.g., from an open access website or from a clinic or a closed online user group (closed usergroup trial), and clarify if this was a purely web-based trial, or there were face-to-face components (as part of the intervention or for assessment). Clearly say if outcomes were self-assessed through questionnaires (as common in web-based trials). Note: In traditional offline trials, an open trial (open-label trial) is a type of clinical trial in which both the researchers and participants know which treatment is being administered. To avoid confusion, use "blinded" or "unblinded" to indicated the level of blinding instead of "open", as "open" in web-based trials usually refers to "open access" (i.e. participants can self-enrol). (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it)

INTRODUCTION 2a) In INTRODUCTION: Scientific background and explanation of rationale
1b-v) CONCLUSIONS/DISCUSSION in abstract for negative trials Conclusions/Discussions in abstract for negative trials: Discuss the primary outcome -if the trial is negative (primary outcome not changed), and the intervention was not used, discuss whether negative results are attributable to lack of uptake and discuss reasons. (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it)
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "we did not find a therapist-guided ICBT program to be more effective than the same program as self-help ICBT in reducing alcohol consumption or other alcohol-related outcomes. In the short run therapist-guided ICBT seems be more effective than information." Ditt svar är för stort. Testa att förkorta en del av dina svar.
CONSORT-EHEALTH (V 1.6.1) -Submission/Publication Form https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS6... 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)

Rensa markering
Does your paper address subitem 2a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Internet interventions can help overcome some of the problems with implementation, limited accessibility and stigma" "More extended internet alcohol interventions are intended to be used over a number of weeks or sessions" "Therapist guided ICBT for alcohol were tested in five of the 14 previous studies and was found to be more effective than waiting-list" "need for studies on internet interventions aimed specifically at people with harmful use or alcohol dependence [19], since many of the participants in previous studies of ICBT programs for alcohol have had AUDIT-scores indicating a higher level of alcohol related problems." Does your paper address subitem 2a-ii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "the effects of ICBT programs as well as therapist guided ICBT for alcohol are still unclear. There is also a need for studies on internet interventions aimed specifically at people with harmful use or alcohol dependence" "In a Cochrane review on digital alcohol interventions, including internet interventions (in 37 of 57 studies), the effect compared to no or minimal interventions was 23 grams (95% CI 15 to 30) less alcohol consumed weekly. According to a recent individual patient data metaanalysis of internet alcohol interventions, the effect on alcohol consumption compared to various controls were -22 grams per week (95 % CI -8.7 to -34.6) [18]." METHODS 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 2b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "The hypothesis of the trial were that: 1) a therapist-guided ICBT program would lead to a greater reduction in alcohol consumption and in alcohol related problems than information alone.
2) a self-help ICBT program would lead to a greater reduction in alcohol consumption and in alcohol related problems than information alone.
3) a therapist-guided ICBT program would lead to a greater reduction in alcohol consumption and in alcohol related problems than a self-help ICBT program." 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 "In a 3-arm randomized controlled trial, with a parallel design, participants were randomly assigned to an Internet-delivered cognitive-behavioral therapy (ICBT) program as self-help, with therapist-guidance or to information control at a ratio of 1:1:1 and block size of 30." Ditt svar är för stort. Testa att förkorta en del av dina svar.

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].
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Not currently included in manuscript. There were no changes in content or downtimes, during the study. Only small bugfixes and security updates to the platform were made.
CONSORT-EHEALTH (V 1.6.1) -Submission/Publication Form https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS6... 1 2 3 4 5 essential 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 "Individuals were included if they had harmful use (defined as >15 total score on the AUDIT) or alcohol dependence (confirmed 3 or more ICD-10 criteria)."

4a-i) Computer / Internet literacy
Computer / Internet literacy is often an implicit "de facto" eligibility criterion -this should be explicitly clarified.
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "To be able to complete the registration the participant needed to understand written Swedish and be computer literate enough to access and navigate the website via a computer, tablet or smartphone." Ditt svar är för stort. Testa att förkorta en del av dina svar.
CONSORT-EHEALTH (V 1.6.1) -Submission/Publication Form https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS6... Open vs. closed, web-based vs. face-to-face assessments: Mention how participants were recruited (online vs. offline), e.g., from an open access website or from a clinic, and clarify if this was a purely webbased trial, or there were face-to-face components (as part of the intervention or for assessment), i.e., to what degree got the study team to know the participant. In online-only trials, clarify if participants were quasi-anonymous and whether having multiple identities was possible or whether technical or logistical measures (e.g., cookies, email confirmation, phone calls) were used to detect/prevent these.

Rensa markering
Does your paper address subitem 4a-ii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Participants were recruited at the Swedish internet site alkoholhjälpen.se" "Eligible participants were asked to complete online baseline questionnaires" 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.

4b) Settings and locations where the data were collected
Does your paper address subitem 4a-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Interested users were informed that they would answer a survey and be randomized to one of three different forms of support, but were not informed about the specifics. Adult individuals who gave their informed consent were instructed to create a personal account, with a unique username and password. They were then directed to a screening page where they were required to give informed consent for participation in the study" "Participants were blinded to what kind of support that participants in the other groups received." Does your paper address CONSORT subitem 4b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Participants were recruited at the Swedish internet site alkoholhjälpen.se, an open access website that provides information and a discussion forum to individuals seeking help online for alcohol consumption. The site has been publicly accessible since 2007. During the recruitment period for the current study, alkoholhjälpen.se had approximately 20 000 unique visitors every month and a mean of 100 new forum-posts every day." "All visitors on alkoholhjälpen.se from March 2015 to March 2017 were invited to participate in a study to develop and test different forms of internet-delivered support for changing alcohol habits" "Eligible participants were asked to complete online baseline questionnaires including primary and secondary measures (see Measures). All participants were treated as anonymous users. They were asked to provide an email-address and a mobile phone number for notifications and follow-up reminders. Email and phone numbers were not verified, nor used for identification or for any other purposes." Ditt svar är för stort. Testa att förkorta en del av dina svar.

Rensa markering
Does your paper address subitem 4b-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "At follow-up participants were e-mailed a link, or re-directed when logging in on the intervention website, to the follow-up questionnaires." 4b-ii) Report how institutional affiliations are displayed Report how institutional affiliations are displayed to potential participants [on ehealth media], as affiliations with prestigious hospitals or universities may affect volunteer rates, use, and reactions with regards to an intervention.(Not a required item -describe only if this may bias results)

5)
The interventions for each group with sufficient details to allow replication, including how and when they were actually administered subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 4b-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Not currently included in manuscript. alkoholhjalpen.se is run by Stockholm Center of Dependency disorders with funds from the Swedish public health authorites, which was stated in the footer of the site. The study was conducted by Karoliska Institute, which was stated in the informed consent. This was the same for all interventions groups.

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).
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Not currently included in manuscript. The first author (MJ) has configured the internet platform and co-authored the program used in the study. The program is licensed under creative commons and the internet platform Drupal is open-source. MJ, PL and MG are employed at the Addiction eClinic, both part of the Stockholm Center of Dependency disorders that offers face-to-face and internet-based treatments for alcohol use disorders, including alkoholhjalpen.se. Ditt svar är för stort. Testa att förkorta en del av dina svar.
CONSORT-EHEALTH (V 1.6.1) -Submission/Publication Form https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS6... 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.
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Not currently included in manuscript. The first version of the iCBT program at alkoholhjalpen.se was developed 2007 in co-operation with an advertising and communication agency. It was programed in Flash with integrated animations and videos. The development included focus-groups of potential users and the program was one of the interventions tested in a controlled trial (Sinadinovic et al. 2014). The second version moved the program into the content management system (CMS) Drupal (drupal.org). The third version (eChange) was a shorter program, inspired by the study by Blankers et al (Blankers, Koeter, and Schippers 2011), which was tested in a pilot (Sundstrom et al. 2016) and an observational study (Johansson, Sinadinovic, Hammarberg, Sundström, et al. 2017). The Fourth and current version (eChange alkoholhjälpen) is based on previous programs and updated based on the feedback from users and experience from previous studies.

5-iii) Revisions and updating
Revisions and updating. Clearly mention the date and/or version number of the application/intervention (and comparator, if applicable) evaluated, or describe whether the intervention underwent major changes during the evaluation process, or whether the development and/or content was "frozen" during the trial. Describe dynamic components such as news feeds or changing content which may have an impact on the replicability of the intervention (for unexpected events see item 3b).
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Not currently included in manuscript. Development of the service was frozen during the study. The only changes were new content posted by users in the discussion forum and a news feed. Minor technical updates were also made to keep the platform secure.

5-iv) Quality assurance methods
Provide information on quality assurance methods to ensure accuracy and quality of information provided [1], if applicable.
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "The three therapists involved had several years' experience from the Swedish alcohol helpline [47] and had all reached approved level in phone based motivational interviewing prior to entering the study. They had been trained in ICBT and received regular supervision from the first author, who is a trained therapist with several years' experience of work with CBT and ICBT programs. " 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.
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Screenshots included in manuscript. Snapshots and content of previous and current versions are available via the first author. The Swedish program content is licensed according to creative commons attribution share alike (creativecommons.org).

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

5-vii) Access
Access: Describe how participants accessed the application, in what setting/context, if they had to pay (or were paid) or not, whether they had to be a member of specific group. If known, describe how participants obtained "access to the platform and Internet" [1]. To ensure access for editors/reviewers /readers, consider to provide a "backdoor" login account or demo mode for reviewers/readers to explore the application (also important for archiving purposes, see vi).
CONSORT-EHEALTH (V 1.6.1) -Submission/Publication Form https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS6... 1 2 3 4 5 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 "Participants were recruited at the Swedish internet site alkoholhjälpen.se, an open access website that provides information and a discussion forum to individuals seeking help online for alcohol consumption. The site has been publicly accessible since 2007. During the recruitment period for the current study, alkoholhjälpen.se had approximately 20 000 unique visitors every month and a mean of 100 new forum-posts every day. All service use was free of charge and no advertising was allowed on the website. "

5-viii) Mode of delivery, features/functionalities/components of the intervention
and comparator, and the theoretical framework
CONSORT-EHEALTH (V 1.6.1) -Submission/Publication Form https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS6... 1 2 3 4 5 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 Also see 5-ii.
"The program was based on self-help material used in previous studies on the internet and in specialist care [24,34,39,40]. Content and exercises in the program was based on motivational interviewing [35,36], relapse-prevention [37,38] and behavioural-self-control [39,40]. The program was divided into five main modules, three extra problem-solving modules and 10 fact sheets (see list of modules in Table 5). The length of the program was approximately 17000 words in total, with 5500 words in the extra modules and 3000 words in the fact sheets. See Figure 1 for example pictures of the program. Automatic reminders with suggestions on what module to work on were sent at 1-4, 6 and 8 weeks. Users were also encouraged to register alcohol-consumption or craving, and details on the situation where they drank or experienced craving. This was done in a private drinking-calendar" "Participants in the therapist-guided ICBT group had the same access to the same program as the self-help ICBT described above. In addition to the program the therapist-guided ICBT group could communicate with a therapist, through asynchronous text-messages on the intervention website, during the 12 weeks of the program." The control group was given access to a text-only information on changing their alcohol habits based on the text Alcohol and you"

5-ix) Describe use parameters
Describe use parameters (e.g., intended "doses" and optimal timing for use). Clarify what instructions or recommendations were given to the user, e.g., regarding timing, frequency, heaviness of use, if any, or was the intervention used ad libitum.
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Automatic reminders with suggestions on what module to work on were sent at 1-4, 6 and 8 weeks. " "To allow participant to complete the modules at the pace recommended, with room for some delay, the participants had access to the program during 12 weeks after allocation." "Participants that completed 4 or more modules in the program was regarded as treatment completers. "

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). 1 2 3 4 5 essential Does your paper address subitem 5-x?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "In addition to the program the therapist-guided ICBT group could communicate with a therapist, through asynchronous text-messages on the intervention website, during the 12 weeks of the program. The support from the therapist was focused on motivating the user to continue to use the program and change their drinking. Each time the participant had completed any of the modules, the therapist wrote personal feedback and answered any questions about the program, via private comments on the web-platform. The feedback highlighted parts of what the participant had stated in the exercises included in each module, that were important from a MI or CBT perspective. Users that did not use or stopped using the program for several weeks were reminded by the therapist two times, with personal messages on the website (with notification on mail). " "All three groups also had access to the discussion forum at the website" "Participants who did not respond to this initial request received up to five automated e-mail reminders, a manual e-mail reminder and a mobile text message."

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).
CONSORT-EHEALTH (V 1.6.1) -Submission/Publication Form https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS6... 1 2 3 4 5 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 "Automatic reminders with suggestions on what module to work on were sent at 1-4, 6 and 8 weeks. " "Users that did not use or stopped using the program for several weeks were reminded by the therapist two times, with personal messages on the website (with notification on mail). " "Participants who did not respond to this initial request received up to five automated e-mail reminders, a manual e-mail reminder and a mobile text message."

5-xii) Describe any co-interventions (incl. training/support)
Describe any co-interventions (incl. training/support): Clearly state any interventions that are provided in addition to the targeted eHealth intervention, as ehealth intervention may not be designed as stand-alone intervention. This includes training sessions and support [1]. It may be necessary to distinguish between the level of training required for the trial, and the level of training for a routine application outside of a RCT setting (discuss under item 21 -generalizability. Does your paper address subitem 5-xii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "All three groups also had access to the discussion forum at the website as well as facts on alcohol and health and information about how to find additional support within the health care or social welfare system. Communication between the server hosting the intervention and the participant was encrypted and protected with an individual login name and a password." Ditt svar är för stort. Testa att förkorta en del av dina svar.
CONSORT-EHEALTH (V 1.6.1) -Submission/Publication Form https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS6... 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 "The primary outcome was the difference between groups in alcohol consumption, in mean weekly standard drinks. The number of standard drinks each of the seven days in the preceding week was self-reported using the Timeline Follow-back (TLFB) method [48]. One standard drink contains 12 grams of pure alcohol according to the Swedish definition." "Alcohol-related outcomes were assessed with a number of different instruments. The AUDIT [38] is a 10-item instrument, covering both alcohol-consumption and problems, that has been validated in Swedish and via computer [51,52]. The AUDIT total score was used as a continuous measure of alcohol related problems." "Alcohol dependence was assessed by the number of self-reported alcohol dependence criteria during the last year according to . Alcohol Use Disorder was assessed by the number of self-rated of alcohol use disorder criteria during the last year according to . " "Health related quality of life was assessed with EuroQol-5 dimension (EQ-5D-5L)... Symptoms of depression were measured by the total score of Montgomery Asberg Depression Rating Scale -Self Rated (MADRS-S) [51,52]. Symptoms of anxiety were measured by the total score of Generalized Anxiety Disorder Assessment-7 Items (GAD-7; [53,54])." "Follow-up was conducted 3 and 6 months after recruitment. " "The same questionnaires with all primary and secondary outcomes used at baseline were also used at follow-up, adjusted for the time since last assessment (3 months)." Ditt svar är för stort. Testa att förkorta en del av dina svar.
Copy and paste relevant sections from manuscript text "The TLFB has been shown to be a valid and reliable procedure to document recent drinking also when administered via internet" "The AUDIT [38] is a 10-item instrument, covering both alcohol-consumption and problems, that has been validated in Swedish and via computer [51,52]. " 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.
Copy and paste relevant sections from manuscript text "All use of the intervention was logged for each user. Participants that completed 4 or more modules in the program was regarded as treatment completers." 6a-iii) Describe whether, how, and when qualitative feedback from participants was obtained Describe whether, how, and when qualitative feedback from participants was obtained (e.g., through emails, feedback forms, interviews, focus groups).
Copy and paste relevant sections from manuscript text "Working alliance was measured 3 and 6 weeks after randomization... Session Rating Scale (SRS) [62] in regard to using the website and the intervention that they had received. After each module in the program users in the Therapist-guided ICBT and Selfhelp ICBT groups could rate how helpful they found the module" "The baseline questionnaires were followed by a survey on why participants choose to use web-based services and their preferences regarding such services." Ditt svar är för stort. Testa att förkorta en del av dina svar.

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 7b) When applicable, explanation of any interim analyses and stopping guidelines 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 No changes to trial outcomes were made after the trial started.

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.
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 "With α = 0.05 and 80 percent power, n=394 per group was required to the desired effect size, totaling n=1182. To allow analyses also on observed data only, assuming 50% missing data at follow-up, the enrollment goal was however increased to n=2400. " Ditt svar är för stort. Testa att förkorta en del av dina svar.

8a) Method used to generate the random allocation sequence
NPT: When applicable, how care providers were allocated to each trial group 8b) Type of randomisation; details of any restriction (such as blocking and block size) Does your paper address CONSORT subitem 7b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study We did not use any interim analyses or stopping guidelines. For funding reasons the maximum recruitment window was pre-specified to 24 months.

Does your paper address CONSORT subitem 8a? *
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Participants who completed the baseline measures were randomized according to a fully automated and concealed procedure in the online platform." 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 "ratio of 1:1:1 and block size of 30" Ditt svar är för stort. Testa att förkorta en del av dina svar.
CONSORT-EHEALTH (V 1.6.1) -Submission/Publication Form https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS6... 9) Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned 10) Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions 11a) If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how NPT: Whether or not administering co-interventions were blinded to group assignment Does your paper address CONSORT subitem 9? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Participants who completed the baseline measures were randomized according to a fully automated and concealed procedure in the online platform." Both the recruitment and the randomization and allocation were fully automated, preprogrammed and concealed within the platform. None of the researchers or therapists had any contact with the users before they were randomized. And no one had knowledge of at what user the program switched to the next block, e.g. the size of the initial block when the recruitment started.
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 Both the recruitment and the randomization and allocation were fully automated and preprogrammed by the firste author.
CONSORT-EHEALTH (V 1.6.1) -Submission/Publication Form https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS6... 11a-i) Specify who was blinded, and who wasn't Specify who was blinded, and who wasn't. Usually, in web-based trials it is not possible to blind the participants [1, 3] (this should be clearly acknowledged), but it may be possible to blind outcome assessors, those doing data analysis or those administering co-interventions (if any).

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Does your paper address subitem 11a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Participants were blinded to what kind of support that participants in the other groups received." 11a-ii) Discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator" Informed consent procedures (4a-ii) can create biases and certain expectations -discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator".

11b) If relevant, description of the similarity of interventions
(this item is usually not relevant for ehealth trials as it refers to similarity of a placebo or sham intervention to a active medication/intervention) 12a) Statistical methods used to compare groups for primary and secondary outcomes NPT: When applicable, details of whether and how the clustering by care providers or centers was addressed Does your paper address subitem 11a-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Participants were blinded to what kind of support that participants in the other groups received. " "Interested users were informed that they would answer a survey and be randomized to one of three different forms of support, but were not informed about the specifics." 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 "Participants in the therapist-guided ICBT group had the same access to the same program as the self-help ICBT described above." "All three groups also had access to the discussion forum at the website as well as facts on alcohol and health and information about how to find additional support within the health care or social welfare system. " 1 2 3 4 5 essential Does your paper address CONSORT subitem 12a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "All statistical analyses were two-sided tests and, unless specified otherwise, used a significance level of p < .05. Factorial ANOVAs were used to test differences in baseline measures between users who were retained and users who were lost to follow-up, including interactions between group and lost to follow-up (at either 3 month or 6 month)." "In accordance with the original protocol, differences in observed means at each follow-up were analyzed with t-tests, under the missing at random assumption; significant contrasts were however supplemented with tipping point sensitivity analyses that systematically imputed missing data at a group-level across a range of plausible mean values in the two non-respondent groups (with the same standard deviation) [65,66]."

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

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Does your paper address subitem 12a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "mixed effects modelling that would be fully compliant with the intention to treat principle, and better equipped to handle the presumed high degree of missing data" Ditt svar är för stort. Testa att förkorta en del av dina svar. 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 "Prior to analysing the data, the decision was made to supplement the original analytic protocol with mixed effects modelling that would be fully compliant with the intention to treat principle, and better equipped to handle the presumed high degree of missing data [63]. By modelling data at both group (fixed) and individual (random) levels, mixed models are well-suited for data from repeated observations (modeling clustering of data at an individual level) [67] and maximum likelihood estimation is used to handle missing data [68]. Analyzing outcomes with (generalized) mixed effects models also allowed the use of family functions more appropriate for the distribution of the outcome. "
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "This trial was approved by the Stockholm Regional Ethical Review Board (No. 2014/1758-31/2)."

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.
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "They were then directed to a screening page where they were required to give informed consent for participation in the study, answer demographic questions, the questions in the Alcohol Use Disorder Identification Test (AUDIT) [38] and questions about alcohol dependence (ICD-10) criteria." Obtained online with a Checkbox.

X26-iii) Safety and security procedures
Safety and security procedures, incl. privacy considerations, and any steps taken to reduce the likelihood or detection of harm (e.g., education and training, availability of a hotline)
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Communication between the server hosting the intervention and the participant was encrypted and protected with an individual login name and a password." "email-address and a mobile phone number for notifications and follow-up reminders. Email and phone numbers were not verified, nor used for identification or for any other purposes." Ditt svar är för stort. Testa att förkorta en del av dina svar.

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.
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 " Table 5 for detailed program use." Does your paper address CONSORT subitem 14a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "the recruitment period, from March 2015 to March 2017" "Follow-up was conducted 3 and 6 months after recruitment." "Additional follow-ups at 12 and 24 months after recruitment" Ditt svar är för stort. Testa att förkorta en del av dina svar.
CONSORT-EHEALTH (V 1.6.1) -Submission/Publication Form https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS6... 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"
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate 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 such event occured during the study period.
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 "This was lower than the target sample size required to adjust analyses on observed data only for estimated attrition at follow-up, but only negligibly smaller than in the raw power calculation with estimated missing data (n=1182). Recruitment nonetheless ceased after the pre-specified 24 months recruitment window, for funding reasons." Ditt svar är för stort. Testa att förkorta en del av dina svar.
CONSORT-EHEALTH (V 1.6.1) -Submission/Publication Form https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS6... 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 "Full demographic and clinical variables at baseline are presented in Table 1."

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.

Rensa markering
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 Age, education, gender, employment and housing are reported in table 1.
CONSORT-EHEALTH (V 1.6.1) -Submission/Publication Form https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS6... 16-i) Report multiple "denominators" and provide definitions Report multiple "denominators" and provide definitions: Report N's (and effect sizes) "across a range of study participation [and use] thresholds" [1], e.g., N exposed, N consented, N used more than x times, N used more than y weeks, N participants "used" the intervention/comparator at specific pre-defined time points of interest (in absolute and relative numbers per group). Always clearly define "use" of the intervention.

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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 In CONSORT flow, see 13b.

16-ii) Primary analysis should be intent-to-treat
17a) For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval) Does your paper address subitem 16-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "In accordance with the original protocol, differences in observed means at each follow-up were analyzed with t-tests, under the missing at random assumption; significant contrasts were however supplemented with tipping point sensitivity analyses that systematically imputed missing data at a group-level across a range of plausible mean values in the two non-respondent groups (with the same standard deviation) [65,66]." "Prior to analysing the data, the decision was made to supplement the original analytic protocol with mixed effects modelling that would be fully compliant with the intention to treat principle" Ditt svar är för stort. Testa att förkorta en del av dina svar.
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 "The therapist-guided ICBT group had significantly lower mean weekly alcohol consumption compared to the control group at 3 months (difference=-3.84, 95 CI=-6.53 to -1.16, d=0.27)." "No significant differences in weekly alcohol consumption were found between the self-help ICBT group and the control group  or between the therapist-guided ICBT group and the self-help ICBT group (difference =-1.43, 95 CI -4.26 to 1.40)" "At 3 months (post-treatment) there were significant differences between the therapistguided ICBT group and the control group in the secondary outcomes AUDIT d=0.39), d=0.26), d=0.25) and d=0.26). A difference was also found between the self-help ICBT and control group on the AUDIT (difference=-1.95, 95 CI=-3.44 to -.46, d=0.26) at 3 months. No significant differences in secondary outcomes between the therapist-guided ICBT and selfhelp ICBT were found at 3 months. " "There were no significant differences in weekly alcohol consumption between any of the groups at 6 months. The difference between the therapist-guided ICBT and control group was -0.60 (95 CI=-3.70 to 2.50), between self-help ICBT and control group -0.45 (95 CI=-3.87 to 2.96) and between the therapist-guided ICBT and the self-help ICBT -0.15 (95 CI=-3.70 to 3.41). No significant differences in secondary outcomes between any of the groups were found at 6 months. See Table 3 for details and supplementary materials Table S2 for tipping point analyses of secondary outcomes." Ditt svar är för stort. Testa att förkorta en del av dina svar.
CONSORT-EHEALTH (V 1.6.1) -Submission/Publication Form https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS6... 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).
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate 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 number of modules completed by the therapist-guided ICBT (M=3.3 (SD=3.5)) was significantly higher (t= 2.9, p=.004) compared to the self-help ICBT (M=2.6 (SD=3.2)) but there was no significant difference in number of calendar entries (therapist-guided ICBT: M=39 (SD=61) and self-help ICBT M=37 (SD=102); t=0.60, p=.58). In the therapist-guided ICBT 40% were treatment completers and in the self-help ICBT 30% (Chi2=6.46, p=.011). In the therapist-guided ICBT 58% sent at least one message to their therapists. They sent a mean of 4.7 (SD=4.7) messages and received a mean of 6.0 (SD=4.1) from their therapist. See Table 5 for detailed program use. The number of participants who used the discussion forum was higher in the control group compared to the therapist-guided ICBT group (n=107 (27%) vs n=71 (18%); Chi2=8.74, p=.003). But there were no significant differences between self-help ICBT (n=88, 22%) and the therapist-guided ICBT or the control group in forum usage. " Ditt svar är för stort. Testa att förkorta en del av dina svar.

18) Results of any other analyses performed, including subgroup analyses and
adjusted analyses, distinguishing pre-specified from exploratory Does your paper address CONSORT subitem 17b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Not relevant for the study.
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 "The mixed model ITT analysis showed a significant larger decrease in weekly alcohol consumption over time in the therapist-guided ICBT (time x therapist: t=-2.33, p=.02) compared to control, but not in the self-help ICBT (time x self-help: t=-1.68, p=.09) compared to control (see models in table 4). A model comparing only the participants in the therapistguided ICBT and self-help ICBT did not reveal any significant effect of group x time (t=-0.57, p=.57) There was a significant decrease in weekly alcohol consumption over time for participants in all three groups according to the estimate of time in the unconditional model (t=-11.98, p>.001)." "According to the mixed model analysis of secondary outcomes a significantly larger decrease in AUDIT over time was found for both the therapist-guided ICBT and self-help ICBT compared a to control as shown by therapist-guided ICBT x time (t=-3.55, p<.001) and self-help ICBT x time (-2.23, p=.026). There were also significant therapist-guided ICBT x time group effects in AUDIT-C (-2.71; p=.007), ICD (-1.89, p=.06) and DSM-5 (-2.10, p=.036). No other significant time x group effects were found in the mixed model analysis of secondary outcomes. Over time there was significant decrease among all participants on the AUDIT, AUDIT-C, ICD, DSM-5, MADRS-S, GAD-7, binge-drinking days and drinks on drinking days as well significant increase inEQ-5D-5L and non-drinking days. See supplementary material Table S3 for additional models." Ditt svar är för stort. Testa att förkorta en del av dina svar.

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).
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Not applicable in this study.
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 "There were no reported adverse events due to the intervention reported by participants. Among follow-up participants at 6 months 17 of 508 (3%) had changed their alcohol use to a more severe category according to AUDIT and 99 of 508 (19%) stayed within the highest AUDIT category." Ditt svar är för stort. Testa att förkorta en del av dina svar. Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Data from this survey will be presented elsewhere." 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).
CONSORT-EHEALTH (V 1.6.1) -Submission/Publication Form https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS6... 1 2 3 4 5 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 "The results only partly confirmed the first hypothesis. Participants randomized to therapistguided ICBT reduced their weekly alcohol consumption as well as alcohol related problems (measured with the AUDIT), and signs of Alcohol Use Disorder, significantly more than participants in the control group at 3-months follow-up; they also reduced their alcohol related problems more than participants in the control group at 6-months follow-up. " "The results did not confirm the second hypothesis. Self-help ICBT was not more effective than the control condition in changing alcohol consumption. This is in line with results from the first study of alkoholhjälpen.se [34] and two other large studies of publicly available services [26,31]. However, the self-help ICBT group did change their alcohol related problems significantly more compared to controls at 3 months. No support was found for the third hypothesis. There were no significant differences in changed drinking or other outcomes between therapist-guided ICBT and self-help ICBT. "

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

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Ditt svar är för stort. Testa att förkorta en del av dina svar. Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "These findings are in line with the results of previous studies on therapist-guided ICBT but with smaller differences between the groups. " "no significant differences in changed drinking or other outcomes between therapist-guided ICBT and self-help ICBT." There is still a need for more studies on multi-session internet intervention for harmful alcohol use and alcohol dependence, including studies with long-term follow-up. Low-risk drinking was reported by 43% of participants at both follow-ups, but without differences between groups. Only some internet help-seekers might need ICBT and therapist guidance in order to change their drinking when they use internet interventions. Others, who did not improve, might have benefited from more intensive support. A model of support-on-demand or accelerated care could be tested in future studies on the internet. One important challenge for future studies is to improve follow-up rates as well as adherence to interventions without reducing the willingness to use the interventions. Increased demands on users to identify themselves or have contact with a professional might make people, who wish to stay anonymous or feel ashamed or stigmatized, more reluctant to seek support [82]. Ditt svar är för stort. Testa att förkorta en del av dina svar.

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.

Rensa markering
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 "Despite great efforts in reminding and reinforcing participants for answering follow-up questions, attrition was high. Participants lost to follow-up showed some differences to those retained, a factor which limits the generalizability of the results. However, tipping point analyses and the fact that there were no significant arm × attrition interactions on outcomes, suggest that no sampling bias was introduced as result of the attrition. The attrition could be a consequence of allowing users to be relatively anonymous and having a fast and accessible way of signing up for the study, lowering the threshold for engagement. Loss to follow-up also entails that we were powered to detect a smaller than planned effect size. In the between-group comparison of the self-help and therapist-guided arms at the three-month follow-up, observed sample sizes would give 80% power to detect d>0.29, which is still to be considered a small difference. We can however not rule out that the true difference is smaller than this. Adherence to the program was relatively low, with only 30% completers in the self-help ICBT and 40% in the therapist-guided ICBT, which is consistent with previous studies on ICBT (see supplementary material Table S1). Higher adherence might improve the effects of the internet-based program. Due to the online setting the participants did not go through a clinical diagnostic interview and some participants may not have been diagnosed as having alcohol dependence had an interview been included in the study design. " Ditt svar är för stort. Testa att förkorta en del av dina svar.

OTHER INFORMATION
23) Registration number and name of trial registry 24) Where the full trial protocol can be accessed, if available 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 "In the current study we aimed to come as close as possible to the intended target group of the intervention when used in regular service at alkoholhjälpen.se. The trial was conducted in the same setting. Information on needed language skills and the limitations of the interventions in helping those with severe psychiatric problems were provided, but no other criteria was used to exclude participant that fulfilled the criteria set for harmful use or alcohol dependence." Does your paper address CONSORT subitem 23? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Trial registration: ClinicalTrials.gov, identifier: NCT02377726, https://clinicaltrials.gov /ct2/show/NCT02377726" Ditt svar är för stort. Testa att förkorta en del av dina svar.

25)
Sources of funding and other support (such as supply of drugs), role of funders X27) Conflicts of Interest (not a CONSORT item) Does your paper address CONSORT subitem 24? * Cite a Multimedia Appendix, other reference, or copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Translated original protocol is provided as appendix.
Does your paper address CONSORT subitem 25? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Grants: Sven Andreasson, Swedish Research Council https://forte.se/ Grant nr 2013-1798 Magnus Johansson, Doctoral School in Health Care Sciences, https://ki.se/en/nvs/doctoralprojects The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
CONSORT-EHEALTH (V 1.6.1) -Submission/Publication Form https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS6... About the CONSORT EHEALTH checklist yes, major changes yes, minor changes no X27-i) State the relation of the study team towards the system being evaluated In addition to the usual declaration of interests (financial or otherwise), also state the relation of the study team towards the system being evaluated, i.e., state if the authors/evaluators are distinct from or identical with the developers/sponsors of the intervention.
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate 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 first author (MJ) has configured the internet platform and co-authored the program used in the study. The program is licensed under creative commons and the internet platform Drupal is open-source. MJ, PL and MG are employed at the Addiction eClinic, both part of the Stockholm Center of Dependency disorders that offers face-to-face and internetbased treatments for alcohol use disorders, including alkoholhjalpen.se.
As a result of using this checklist, did you make changes in your manuscript? * Ditt svar är för stort. Testa att förkorta en del av dina svar.