1. Internet-based brief intervention for young men with unhealthy alcohol use: a randomized trial in a general population sample 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 Most of the evidence of efficacy for internet-based interventions comes from studies conducted among College/University students (some conflicting evidence too…) More evidence is needed among young individuals outside of “student” settings

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 unhealthy alcohol use. Unhealthy alcohol use was defined as: Drinking >14 drinks per week OR At least one episode of binge drinking (6 or more drinks/occasion) per month OR Alcohol Use Disorders Identification Test (AUDIT) score >8

5. Methods Parallel-group randomized controlled trial Participants categorized as presenting unhealthy 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. Internet-based brief intervention (IBI) adapted from www.alcooquizz.ch -Normative feedback -indicating the percentage of people of the same age drinking as much as the participant and less than the participant -Feedback on four categories of consequences -“me, my body and my mind”; “me and the others”; “me and my professional activities”; and “me, violence and accidents” -Calorific value of reported consumption and equivalents depicted as hamburgers and chocolate bars -Computed blood alcohol concentration for reported maximum number of drinks per occasion -Indication of risk -according to the presence of weekly risky drinking, binge drinking and AUDIT -Information on alcohol and health -Recommendations indicating low-risk drinking limits

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) 1)was injured or injured someone else 2)had a hangover 3)missed a class or work 4)performed poorly at work 5)got into an argument or fight with friends 6)had unplanned sex 7)had unprotected sex 8)damaged property 9)had problems with the police 10)received medical treatment 11)observed negative impact on physical health 12)observed negative impact on mental health

9. 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% Unhealthy alcohol use (n=737) 45.1% No unhealthy alcohol use (n=896) Did not access the website (n=2278) or declined participation (n=724) Intervention, 6 mo assessment (n=338) 92.1%Control, 6 mo assessment (n=329) 88.9% Intervention, 1 mo assessment (n=340) 92.6%Control, 1 mo assessment (n=338) 91.4% Intervention (n=367)Control (n=370) Individuals invited to participate (n=4,365)

10. Results 737 young men with unhealthy alcohol use were randomized. Follow-up rates were 92% at 1 month and 91% at 6 months.

11. Full sample (n=737) Age20.8 (1.1) Linguistic region: French speaking409 (55.5%) German speaking328 (44.5%) Binge drinking, n (%)626 (84.9%) Number of drinks/week, mean(SD)9.8 (7.9) AUDIT score, mean (SD)10.6 (4.2) Number of alcohol consequences (0-12), mean (SD)2.8 (2.0) Results: baseline characteristics The most frequently reported consequences were: hangover (95%), observed a negative impact on physical health (29%), had unplanned sex (26%), damaged property (24%), missed a class or work (23%), and performed poorly at work (20%).

12. Results: primary outcomes Prevalence of binge drinking Baseline1mo6mo Intervention85.6%75.0%69.8% Control84.3%76.3%71.1%

13. Results: primary outcomes Prevalence of binge drinking BINGE DRINKING* OR95%CIzp Control group, 1 month0.420.28; 0.653.89<.0001 Control group, 6 months0.270.17; 0.416.01<.0001 Intervention group, 1 month0.370.24; 0.574.54<.0001 Intervention group, 6 months0.240.15; 0.366.56<.0001 Between group testsChi2p Intervention 1mo vs. Control 1mo0.280.6 Intervention 6mo vs. Control 6mo0.200.7 Intervention 1mo vs. Intervention 6mo3.990.05 Control 1mo vs. Control 6mo4.260.04 * random-effects logit model adjusted for age and linguistic region

14. Results: primary outcomes Prevalence of binge drinking No intervention effect (no difference between groups) BINGE DRINKING* OR95%CIzp Control group, 1 month0.420.28; 0.653.89<.0001 Control group, 6 months0.270.17; 0.416.01<.0001 Intervention group, 1 month0.370.24; 0.574.54<.0001 Intervention group, 6 months0.240.15; 0.366.56<.0001 Between group testsChi2p Intervention 1mo vs. Control 1mo0.280.6 Intervention 6mo vs. Control 6mo0.200.7 Intervention 1mo vs. Intervention 6mo3.990.05 Control 1mo vs. Control 6mo4.260.04

15. Results: primary outcomes Number of drinks/week Baseline1mo6mo Intervention10.1 (7.9)9.4 (11.0)8.5 (8.5) Control9.5 (7.8)9.2 (8.1)9.1 (8.9)

16. Results: primary outcomes Number of drinks/week NUMBER OF DRINKS/WEEK* IRR95%CIzp Control group, 1 month0.900.83; 0.97-2.700.007 Control group, 6 months0.900.83; 0.97-2.750.006 Intervention group, 1 month0.840.78; 0.91-4.28<.0001 Intervention group, 6 months0.800.74; 0.87-5.51<.0001 Between group testsChi2p Intervention 1mo vs. Control 1mo1.480.2 Intervention 6mo vs. Control 6mo4.600.03 Intervention 1mo vs. Intervention 6mo1.370.2 Control 1mo vs. Control 6mo0.001.0 * random-effects negative binomial regression model adjusted for age and linguistic region

17. Results: primary outcomes Number of drinks/week Intervention effect on the number of drinks/week at 6 months NUMBER OF DRINKS/WEEK* IRR95%CIzp Control group, 1 month0.900.83; 0.97-2.700.007 Control group, 6 months0.900.83; 0.97-2.750.006 Intervention group, 1 month0.840.78; 0.91-4.28<.0001 Intervention group, 6 months0.800.74; 0.87-5.51<.0001 Between group testsChi2p Intervention 1mo vs. Control 1mo1.480.2 Intervention 6mo vs. Control 6mo4.600.03 Intervention 1mo vs. Intervention 6mo1.370.2 Control 1mo vs. Control 6mo0.001.0

18. Results: secondary outcomes AUDIT score: –At 6 months, the mean (SD) AUDIT score was 8.8 (4.3) in the intervention group and 9.3 (4.5) in the control group. –An intervention effect was found for AUDIT scores. In the negative binomial regression model adjusted for baseline AUDIT score, the incidence rate ratio (IRR)(95%CI) in the intervention group compared to the control group was 0.92 (0.87; 0.98), p=0.01. Number of consequences: –At 6 months, the mean (SD) number of reported consequences was 2.2 (1.8) in the intervention group and 2.3 (1.7) in the control group. –There was no intervention effect for reported consequences [IRR(95%CI)=0.93 (0.84; 1.03)] in the model adjusted for number of consequences at baseline.

19. Conclusions There were significant reductions in alcohol use over time in the intervention and the control group –Consistent with regression to the mean, due to the selection operating at inclusion. The IBI had: –No impact on subsequent binge drinking prevalence –But was effective in reducing the mean number of drinks consumed per week at 6 months and in influencing the AUDIT scores at 6 months.

20. 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 Funding

21. 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