1. Internet-Based Primary Prevention Intervention for Alcohol Use: A Randomized Trial Nicolas Bertholet, MD, MSc Alcohol Treatment Center, Lausanne University Hospital Switzerland AMERSA, San Francisco, October 2014

2. Study investigators Lausanne University Hospital, Lausanne, Switzerland: Alcohol treatment center, Department of community medicine and health: Nicolas Bertholet Jacques Gaume Mohamed Faouzi Jean-Bernard Daeppen Gerhard Gmel Clinical epidemiology center, Department of community medicine and health: Bernard Burnand Australian National University, Canberra, Australia, and CAMH, Toronto, Canada: John A. Cunningham

3. Introduction Preventing unhealthy alcohol use among young individuals is of great interest in regards of the risk for damaging consequences Over the past decade, there has been a large increase in the development of internet or computer-based interventions for unhealthy alcohol use –Internet could be used to deliver primary prevention interventions –Questions remain whether or not brief intervention including feedback delivered to low risk drinkers may be harmful (potential iatrogenic effect)

4. Introduction We proposed to test the impact of an internet-based alcohol brief intervention (IBI) in a general population sample of young men with low risk alcohol use. Low risk alcohol use was defined as: Drinking <=14 drinks per week AND Absence of binge drinking (defined as one or more episode of binge drinking (6 or more drinks/occasion) per month AND Alcohol Use Disorders Identification Test (AUDIT) score <=8

5. Methods Parallel-group randomized controlled trial Participants categorized as presenting low risk alcohol use at baseline were randomized (online) to receive the intervention or not. This took place immediately following completion of the baseline assessment and was unknown to the participants. Follow-up assessments at 1 and 6 months after randomization. Entire study was done electronically.

6. Sample The trial took advantage of the ongoing Cohort study on Substance Use Risk Factors (C-SURF). Switzerland has mandatory army conscription for all 19- year-old males. Because there is no pre-selection for army conscription, this offers a unique opportunity to access the entire Swiss population of this age group. C-SURF cohort members were recruited between August 2010 and July 2011 In 2012, C-SURF participants were invited to participate in the randomized trial (3mo after their last C-SURF assessment)

7. Primary Prevention Internet-based brief intervention (PPIBI) adapted from www.alcooquizz.ch -Normative feedback -Comparison of the participant’s alcohol consumption per week and per occasion to the consumption of individuals of the same age in the Swiss population) -Feedback on reported consequences (if any reported) -Calorific value of reported consumption (if the participant reported drinking) -Computed blood alcohol concentration -Based on maximum reported alcohol consumption (if any reported), and potential consequences -Indication of the absence of unhealthy alcohol use, with indication that the reported alcohol use (if any) is associated with no or limited risks for health. -Message that no change in their current use of alcohol is necessary and encouragement not to increase the current alcohol use

8. Outcomes Primary outcomes (at 1 and 6 months) were -prevalence of monthly binge drinking -weekly alcohol use (mean number of drinks per week) Secondary outcomes (at 6 months) were -AUDIT score (timeframe adapted for 6 months) -number of alcohol-related consequences (0 to 12)

9. Analyses The intervention impact was assessed with: –Chi-square test (binge drinking prevalence) –Random-effects negative binomial model (number of drinks/week)

10. Army recruitment centers attendees, Swiss young males (n=13,245) C-SURF participants (n=5,990) Individuals completing the baseline assessment (n=1633) 37.4% Low risk alcohol use (n=896) 54.9% Unhealthy alcohol use (n=737) 45.1% Did not access the website (n=2278) or declined participation (n=724) Intervention, 6 mo assessment (n=421) 93.3%Control, 6 mo assessment (n=414) 93.0% Intervention, 1 mo assessment (n=423) 93.8%Control, 1 mo assessment (n=421) 94.6% Intervention (n=451)Control (n=445) Individuals invited to participate (n=4,365)

11. Results 896 young men with low risk alcohol use were randomized. Follow-up rates were 94% at 1 month and 93% at 6 months.

12. Full sample (n=896) Age 21.0 (1.3) Linguistic region: French speaking 521 (58.2%) German speaking 375 (41.9%) Number of drinks/week, mean(SD) 2.3 (2.2) Binge drinking, n (%) 0 (0%)* AUDIT score, mean (SD) 3.5 (2.1) Number of alcohol consequences (0-12), mean (SD) 1.0 (1.1) Results: baseline characteristics * By definition (inclusion criteria)

13. Results: primary outcomes Prevalence of binge drinking Baseline1mo6mo Intervention0%14.4%13.3% Control0%19.0%13.0% Small protective intervention effect at 1mo (chi square=3.18, p=0.07)

14. Results: primary outcomes Number of drinks/week Baseline1mo6mo Intervention2.4 (2.2)2.3 (2.6)2.5 (3.0) Control2.4 (2.3)2.8 (3.7)2.7 (3.9)

15. Results: primary outcomes Number of drinks/week NUMBER OF DRINKS/WEEK* IRR95%CIzp Control group, 1 month 1.070.97; 1.171.390.1 Control group, 6 months 1.030.94; 1.130.710.5 Intervention group, 1 month 0.950.86; 1.04-1.160.2 Intervention group, 6 months 1.030.94; 1.130.640.5 Between group tests Chi2p Intervention 1mo vs. Control 1mo 3.600.06 Intervention 6mo vs. Control 6mo 0.001.0 Intervention 1mo vs. Intervention 6mo 2.790.09 Control 1mo vs. Control 6mo 0.400.5 * random-effects negative binomial regression model adjusted for age and linguistic region

16. Results: primary outcomes Number of drinks/week NUMBER OF DRINKS/WEEK* IRR95%CIzp Control group, 1 month 1.070.97; 1.171.390.1 Control group, 6 months 1.030.94; 1.130.710.5 Intervention group, 1 month 0.950.86; 1.04-1.160.2 Intervention group, 6 months 1.030.94; 1.130.640.5 Between group tests Chi2p Intervention 1mo vs. Control 1mo 3.600.06 Intervention 6mo vs. Control 6mo 0.001.0 Intervention 1mo vs. Intervention 6mo 2.790.09 Control 1mo vs. Control 6mo 0.400.5 * random-effects negative binomial regression model adjusted for age and linguistic region Intervention effect on the number of drinks/week at 1 month

17. Limitations and… strengths Limitations: –Self-report –Very short assessment (but extensive assessment in the cohort study) Strength: –Sample –High follow up rate

18. Conclusions There was no iatrogenic effect. Immediate effects following a PPIBI conducted among young men in the general population are plausible, but were not maintained at longer term.

19. Funding The randomized trial was funded by the Swiss National Science Foundation (grant 325130_135538/1, PI: N Bertholet) The study intervention (website) was developed in part with funds from a grant from the Department of community medicine and health (to N Bertholet) C-SURF funded by the Swiss National Science Foundation (33CSCO-122679, PI: G Gmel) Both studies were approved by the Ethics Committee for Clinical Research of the Lausanne University Medical School

20. Thank youcontact: Nicolas.Bertholet@chuv.ch Acknowledgments: N Sanchez: project manager J Stierli, S Huber, M Dubi: research assistants R Borloz: administrative assistant S & J Szabo, M Grand d’Hauteville, D Gartner: web-design & development M Rège-Walther C Eidenbenz: project manager C-SURF C-SURF team Participants