internet-based brief intervention for young men with unhealthy alcohol use: a randomized trial in a...

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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

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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 HospitalSwitzerland

AMERSA, San Francisco, October 2014

Study investigatorsLausanne 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

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

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

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.

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)

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

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 else2) had a hangover3) missed a class or work4) performed poorly at work5) got into an argument or fight with

friends6) had unplanned sex7) had unprotected sex8) damaged property

9) had problems with the police10) received medical treatment11) observed negative impact on physical

health12) observed negative impact on mental

health

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)

Results

• 737 young men with unhealthy alcohol use were randomized.

• Follow-up rates were 92% at 1 month and 91% at 6 months.

Full sample (n=737)

Age 20.8 (1.1)

Linguistic region:

French speaking 409 (55.5%)

German speaking 328 (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%).

Results: primary outcomes Prevalence of binge drinking

Baseline 1mo 6mo

Intervention 85.6% 75.0% 69.8%

Control 84.3% 76.3% 71.1%

Results: primary outcomes Prevalence of binge drinking

BINGE DRINKING*OR 95%CI z p

Control group, 1 month 0.42 0.28; 0.65 3.89 <.0001Control group, 6 months 0.27 0.17; 0.41 6.01 <.0001Intervention group, 1 month 0.37 0.24; 0.57 4.54 <.0001Intervention group, 6 months 0.24 0.15; 0.36 6.56 <.0001Between group tests Chi2 pIntervention 1mo vs. Control 1mo 0.28 0.6Intervention 6mo vs. Control 6mo 0.20 0.7Intervention 1mo vs. Intervention 6mo 3.99 0.05Control 1mo vs. Control 6mo 4.26 0.04

* random-effects logit model adjusted for age and linguistic region

Results: primary outcomes Prevalence of binge drinking

•No intervention effect (no difference between groups)

BINGE DRINKING*OR 95%CI z p

Control group, 1 month 0.42 0.28; 0.65 3.89 <.0001Control group, 6 months 0.27 0.17; 0.41 6.01 <.0001Intervention group, 1 month 0.37 0.24; 0.57 4.54 <.0001Intervention group, 6 months 0.24 0.15; 0.36 6.56 <.0001Between group tests Chi2 pIntervention 1mo vs. Control 1mo 0.28 0.6Intervention 6mo vs. Control 6mo 0.20 0.7Intervention 1mo vs. Intervention 6mo 3.99 0.05Control 1mo vs. Control 6mo 4.26 0.04

Results: primary outcomesNumber of drinks/week

Baseline 1mo 6mo

Intervention 10.1 (7.9) 9.4 (11.0) 8.5 (8.5)

Control 9.5 (7.8) 9.2 (8.1) 9.1 (8.9)

Results: primary outcomesNumber of drinks/week

NUMBER OF DRINKS/WEEK*IRR 95%CI z p

Control group, 1 month 0.90 0.83; 0.97 -2.70 0.007Control group, 6 months 0.90 0.83; 0.97 -2.75 0.006Intervention group, 1 month 0.84 0.78; 0.91 -4.28 <.0001Intervention group, 6 months 0.80 0.74; 0.87 -5.51 <.0001Between group tests Chi2 pIntervention 1mo vs. Control 1mo 1.48 0.2Intervention 6mo vs. Control 6mo 4.60 0.03Intervention 1mo vs. Intervention 6mo 1.37 0.2Control 1mo vs. Control 6mo 0.00 1.0

* random-effects negative binomial regression model adjusted for age and linguistic region

Results: primary outcomesNumber of drinks/week

•Intervention effect on the number of drinks/week at 6 months

NUMBER OF DRINKS/WEEK*IRR 95%CI z p

Control group, 1 month 0.90 0.83; 0.97 -2.70 0.007Control group, 6 months 0.90 0.83; 0.97 -2.75 0.006Intervention group, 1 month 0.84 0.78; 0.91 -4.28 <.0001Intervention group, 6 months 0.80 0.74; 0.87 -5.51 <.0001Between group tests Chi2 pIntervention 1mo vs. Control 1mo 1.48 0.2Intervention 6mo vs. Control 6mo 4.60 0.03Intervention 1mo vs. Intervention 6mo 1.37 0.2Control 1mo vs. Control 6mo 0.00 1.0

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.

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.

• 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

Thank you contact: [email protected]

Acknowledgments:N Sanchez: project managerJ Stierli, S Huber, M Dubi: research assistantsR Borloz: administrative assistantS & J Szabo, M Grand d’Hauteville, D Gartner: web-design & developmentM Rège-WaltherC Eidenbenz: project manager C-SURFC-SURF teamParticipants