Abstract
BackgroundAlcohol dependence is a common disorder with a continuum regarding severity. Most alcohol-dependent persons have a moderate level of dependence and live under socially orderly conditions. Treatment-seeking in this group is low, mainly due to stigma and because treatment options are seen as unappealing.Alcohol is a relevant topic to discuss in many primary care (PC) consultations and PC is less stigmatizing to visit compared to addiction care units for people with alcohol problems. However, general practitioners (GPs) hesitate to engage in treating alcohol problems due to time constraints and lack of knowledge. Screening and brief interventions are effective for high consumers but there are few studies on dependence.MethodsThis is a two-group, parallel, randomized controlled trial (RCT). The aim is to study whether an Internet-based Cognitive Behavioral Treatment (iCBT) when added to treatment as usual (TAU) is more effective than TAU only for alcohol dependence in PC. Two hundred and sixty adults with alcohol dependence will be included. Participants are randomized to iCBT and TAU or TAU only. The primary study outcome is alcohol consumption in grams per week and heavy-drinking days. Secondary outcomes include alcohol-related problem severity, number of diagnostic criteria for alcohol dependence, depression and anxiety symptoms, health-related quality of life and biochemical markers for high consumption and liver pathology. Data will be analyzed using mixed-effect models.DiscussionInternet-based interventions are attractive to, and have been shown to reach, people with alcohol problems. Yet there are no studies investigating the efficacy of Internet treatment of alcohol dependence in PC. In this study we hypothesize that iCBT when added to TAU will improve treatment outcome for alcohol dependence in PC, compared to TAU only. If effective, iCBT can be distributed to the public to a low cost for a stakeholder and has the opportunity to reduce both short-term and long-term public health costs.Trial registrationISRCTN69957414. Retrospectively registered on 7 June 2018.
Highlights
Alcohol dependence is a common disorder with a continuum regarding severity
The burden of the Discussion This study protocol describes the first study on the efficacy of an Internet cognitive behavioral intervention for alcohol dependence in primary care (PC)
The intervention program evaluated in this randomized controlled superiority trial is designed to be accessible and easy to use. Another purpose when designing this intervention program has been to add as little workload as possible for the General practitioner (GP) to refer the patients to treatment
Summary
We adhered to the Standard Protocol Items Recommendations for Interventional Trials (SPIRIT) guidelines in the preparation of this protocol (see Fig. 1 and Additional file 1 for the SPIRIT Figure and Checklist, respectively). The GPs give all participants feedback on the assessment and biomarkers and design a treatment plan based on current routines at the PC clinic For those randomized to iCBT, the Internet program will be made available the following Monday after randomization. All GPs are offered a brief training in giving feedback on the assessment and biomarkers and the use of medication for treatment of alcohol dependence Together this serves as the base of TAU which is provided to the participants in both study arms. Patients will be contacted by automatically created messages in the web-based treatment platform and by the research nurse when necessary during weeks 13 and 52 in order to conduct the follow-up assessments and blood tests.
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
