CONSORT-EHEALTH Checklist V1.6.2 Report

1b-i) Key features/functionalities/components of the intervention and comparator in the METHODS section of the ABSTRACT Yes. "“Change Your Drinking” is a German-language diary-based, fully automated alcohol intervention. In 2010, a revised version of the program was developed. It is more strongly orientated to concepts of relapse prevention than the previous version, includes more feedback and offers more possibilities to interact with the program. Moreover, the program duration was extended from ten to fourteen days." 1b-ii) Level of human involvement in the METHODS section of the ABSTRACT "“Change Your Drinking” is a German-language diary-based, fully automated alcohol intervention." 1b-iii) Open vs. closed, web-based (self-assessment) vs. face-to-face assessments in the METHODS section of the ABSTRACT Yes. "The effectiveness of both program versions was compared in a purely web-based open randomized controlled trial with follow-up surveys after six weeks and three months." 1b-iv) RESULTS section in abstract must contain use data Yes, partly. "A total of 595 participants were included in the trial. Follow-up rates were 58 % after six weeks and 50 % after three months. No groupdifferences were found in any of the outcomes (P ≥ .44). However, the revised version was used by more participants (81 %) than the original version (56 %). A significant time-effect was detected in all outcomes." 1b-v) CONCLUSIONS/DISCUSSION in abstract for negative trials Yes. "The duration and complexity of the programme played a minor role in reducing alcohol consumption. However, differences in the program usage suggest a higher attractiveness of the revised version." INTRODUCTION 2a-i) Problem and the type of system/solution Yes. "Despite high levels of problematic alcohol use, only few young people seek professional help. The World Health Organization (WHO) estimates that globally, 78 % of those in need for treatment remain untreated [9]. Internet-based self-help programs are developed to reduce this gap. Among others, their advantages include easy accessibility and relative anonymity. Online programs provide an appealing alternative especially to those who would abstain from face-to-face treatment due to fear of exposure or embarrassment. Meta-analyses show that online self-help programs have a rather small effect size, but due to their scalability they are a cost-effective way to reduce alcohol consumption in the population [10,11]. The German Federal Centre for Health Education (BZgA) is offering its free online self-help program “Change Your Drinking” for young adults since 2009. Designed to help users to reduce their alcohol consumption, while keeping the threshold for participation low, the program aims to give adolescents and young adults easier access to professional help." 2a-ii) Scientific background, rationale: What is known about the (type of) system Yes. "Study results from the field of web-based tobacco interventions show that more frequent and intensive use of web content is related to higher levels of smoking cessation [12]. Therefore the program was revised and new modules designed to encourage reflection of one’s own alcohol use were added. The revised program is more complex and more strongly orientated to concepts of relapse prevention. In addition, it includes more feedback and further possibilities to interact with the program. The duration of the program was extended from ten to fourteen days." METHODS 3a) CONSORT: Description of trial design (such as parallel, factorial) including allocation ratio Yes. "This paper examines whether the revised version of “Change Your Drinking” is more effective in reducing alcohol consumption than the original version. Outcomes were the alcohol use days, the total intake in grams, the occurrence of binge drinking (yes/no) and binge drinking (yes/no) (all referring to the last seven days prior to each survey) as well as the number of alcohol-related problems." 3b) CONSORT: Important changes to methods after trial commencement (such as eligibility criteria), with reasons No changes were made during the trial. 3b-i) Bug fixes, Downtimes, Content Changes No substantial technical issues had to be fixed. No content changes have been made. 4a) CONSORT: Eligibility criteria for participants Yes. "In order to be invited for the study, participants had to be Internet literate, at least 18 years old, had to reach the cut-off of 8 points in AUDIT or had to consume more than 24/12 g (male/female) of pure alcohol per day on average in the past week." 4a-i) Computer / Internet literacy Yes. "In order to be invited for the study, participants had to be Internet literate, at least 18 years old, had to reach the cut-off of 8 points in AUDIT or had to consume more than 24/12 g (male/female) of pure alcohol per day on average in the past week." 4a-ii) Open vs. closed, web-based vs. face-to-face assessments: Yes. "The intervention and the study were conducted purely web based on the addiction prevention website www.drugcom.de and the alcohol prevention website www.kenn-dein-limit.de, both run by the BZgA (http://www.webcitation.org/6CstlbzBl). Recruitment of participants started in December 2010 and ended in March 2012. All users of the freely accessible “Check Your Drinking” self-assessment were invited for the study if they met the eligibility criteria described below." 4a-iii) Information giving during recruitment Yes. Information given during recruitment is attached in the appendix. 4b) CONSORT: Settings and locations where the data were collected