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Trials
Published in: Trials 1/2020

Open Access 01-12-2020 | Study protocol

Smartphone-based secondary prevention intervention for university students with unhealthy alcohol use identified by screening: study protocol of a parallel group randomized controlled trial

Authors: Nicolas Bertholet, Elodie Schmutz, Véronique S. Grazioli, Mohamed Faouzi, Jennifer McNeely, Gerhard Gmel, Jean-Bernard Daeppen, John A. Cunningham

Published in: Trials | Issue 1/2020

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Abstract

Background

Unhealthy alcohol use is a leading cause of morbidity and mortality among young people, including university students. Delivering secondary prevention interventions against unhealthy alcohol use is challenging. Information technology has the potential to reach large parts of the general population. The present study is proposed to test a proactive secondary prevention smartphone-based intervention against unhealthy alcohol use.

Methods

This is a parallel-group, randomized controlled trial (1:1 allocation ratio) among 1696 university students with unhealthy alcohol use, identified by screening and followed up at 3, 6, and 12 months. Participants will be randomized to receive access to a smartphone-based intervention or to a no intervention control condition.
The primary outcome will be self-reported volume of alcohol drunk over the past 30 days, reported as the mean number of standard drinks per week over the past 30 days, measured at 6 months. Secondary outcomes will be number of heavy drinking days over the past 30 days, at 6 months. Additional outcomes will be maximum number of drinks on any day over the past 30 days, alcohol-related consequences (measured using the Short Inventory of Problems (SIP-2R), and academic performance.

Discussion

The aim of this trial is to close the evidence gap on the efficacy of smartphone-based secondary prevention interventions. If proven effective, smartphone-based interventions have the potential to reach a large portion of the population, completing what is available on the Internet.

Trial registration

ISRCTN, 10007691. Registered on 2 December 2019. Recruitment will start in April 2020.
Appendix
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Literature
1.
Bauer UE, Briss PA, Goodman RA, Bowman BA. Prevention of chronic disease in the 21st century: elimination of the leading preventable causes of premature death and disability in the USA. Lancet. 2014;384(9937):45–52.PubMedCrossRef
2.
Baumel A, Kane JM. Examining predictors of real-world user engagement with self-guided eHealth interventions: analysis of mobile apps and websites using a novel dataset. J Med Internet Res. 2018;20(12):e11491.PubMedPubMedCentralCrossRef
3.
Berkowitz AD. In: Lederman L, Stewart L, editors. An overview of the social norms approach. Changing the culture of college drinking: a socially situated health communication campaign. Creskill: Hampton Press; 2005.
4.
Berman AH, Gajecki M, Sinadinovic K, Andersson C. Mobile interventions targeting risky drinking among university students: a review. Curr Addict Rep. 2016;3:166–74.PubMedPubMedCentralCrossRef
5.
Bertholet N, Cunningham JA, Faouzi M, Gaume J, Gmel G, Burnand B, Daeppen JB. Internet-based brief intervention for young men with unhealthy alcohol use: a randomized controlled trial in a general population sample. Addiction. 2015;110(11):1735–43.PubMedCrossRef
6.
Bertholet N, Cunningham JA, Faouzi M, Gaume J, Gmel G, Burnand B, Daeppen JB. Internet-based brief intervention to prevent unhealthy alcohol use among young men: a randomized controlled trial. PLoS One. 2015;10(12):e0144146.PubMedPubMedCentralCrossRef
7.
Bertholet N, Daeppen JB, McNeely J, Kushnir V, Cunningham JA. Smartphone application for unhealthy alcohol use: a pilot study. Subst Abus. 2017;0.
8.
Bertholet N, Gaume J, Faouzi M, Daeppen JB, Gmel G. Perception of the amount of drinking by others in a sample of 20-year-old men: the more I think you drink, the more I drink. Alcohol Alcohol. 2011;46(1):83–7.PubMedCrossRef
9.
Bertholet N, Godinho A, Cunningham JA. Smartphone application for unhealthy alcohol use: pilot randomized controlled trial in the general population. Drug Alcohol Depend. 2018;195:101–5.PubMedCrossRef
10.
Bradley KA, DeBenedetti AF, Volk RJ, Williams EC, Frank D, Kivlahan DR. AUDIT-C as a brief screen for alcohol misuse in primary care. Alcohol Clin Exp Res. 2007;31(7):1208–17.PubMedCrossRef
11.
Bush K, Kivlahan DR, McDonell MB, Fihn SD, Bradley KA. The AUDIT alcohol consumption questions (AUDIT-C): an effective brief screening test for problem drinking. Ambulatory Care Quality Improvement Project (ACQUIP). Alcohol Use Disorders Identification Test. Arch Intern Med. 1998;158(16):1789–95.PubMedCrossRef
12.
Cohn AM, Hunter-Reel D, Hagman BT, Mitchell J. Promoting behavior change from alcohol use through mobile technology: the future of ecological momentary assessment. Alcohol Clin Exp Res. 2011;35(12):2209–15.PubMedPubMedCentralCrossRef
13.
Collaborators GBDA. Alcohol use and burden for 195 countries and territories, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet. 2018;392(10152):1015–35.CrossRef
14.
Crane D, Garnett C, Brown J, West R, Michie S. Behavior change techniques in popular alcohol reduction apps: content analysis. J Med Internet Res. 2015;17(5):e118.PubMedPubMedCentralCrossRef
15.
Crutzen R, Goritz AS. Social desirability and self-reported health risk behaviors in web-based research: three longitudinal studies. BMC Public Health. 2010;10:720.PubMedPubMedCentralCrossRef
16.
17.
Cunningham JA, Ansara D, Wild TC, Toneatto T, Koski-Jannes A. What is the price of perfection? The hidden costs of using detailed assessment instruments to measure alcohol consumption. J Stud Alcohol. 1999;60(6):756–8.PubMedCrossRef
18.
Cunningham JA, Breslin FC. Only one in three people with alcohol abuse or dependence ever seek treatment. Addict Behav. 2004;29:221–3.PubMedCrossRef
19.
Cunningham JA, Gulliver A, Farrer L, Bennett K, Carron-Arthur B. Internet interventions for mental health and addictions: current findings and future directions. Curr Psychiatry Rep. 2014;16(12):521.PubMedCrossRef
20.
Cunningham JA, Wild TC, Bondy SJ, Lin E. Impact of normative feedback on problem drinkers: a small-area population study. J Stud Alcohol. 2001;62(2):228–33.PubMedCrossRef
21.
Cunningham JA, Wild TC, Cordingley J, van Mierlo T, Humphreys K. A randomized controlled trial of an internet-based brief intervention for alcohol abusers. Addiction. 2009;12(104):2023–32.CrossRef
22.
23.
Foxcroft DR, Smith LA, Thomas H, Howcutt S. Accuracy of Alcohol Use Disorders Identification Test for detecting problem drinking in 18-35 year-olds in England: method comparison study. Alcohol Alcohol. 2015;50(2):244–50.PubMedCrossRef
24.
Gajecki M, Berman AH, Sinadinovic K, Rosendahl I, Andersson C. Mobile phone brief intervention applications for risky alcohol use among university students: a randomized controlled study. Addict Sci Clin Pract. 2014;9:11.PubMedPubMedCentralCrossRef
25.
Garnett C, Crane D, Brown J, Kaner E, Beyer F, Muirhead C, Hickman M, Redmore J, de Vocht F, Beard E, Michie S. Reported theory use by digital Interventions for hazardous and harmful alcohol consumption, and association with effectiveness: meta-regression. J Med Internet Res. 2018;20(2).PubMedPubMedCentralCrossRef
26.
Gonzalez VM, Dulin PL. Comparison of a smartphone app for alcohol use disorders with an Internet-based intervention plus bibliotherapy: a pilot study. J Consult Clin Psychol. 2015;83(2):335–45.PubMedPubMedCentralCrossRef
27.
Hingson RW, Zha W, Weitzman ER. Magnitude of and trends in alcohol-related mortality and morbidity among U.S. college students ages 18–24, 1998–2005. J Stud Alcohol Drugs Suppl. 2009;(Supplement 16):12–20.
28.
29.
Kaner EFS, Beyer FR, Garnett C, Crane D, Brown J, Muirhead C, Redmore J, O'Donnell A, Newham JJ, de Vocht F, Hickman M, Brown H, Maniatopoulos G, Michie S. Personalised digital interventions for reducing hazardous and harmful alcohol consumption in community-dwelling populations. Cochrane Database Syst Rev. 2017;9.
30.
Kazemi DM, Borsari B, Levine MJ, Li S, Lamberson KA, Matta LA. A systematic review of the mhealth interventions to prevent alcohol and substance abuse. J Health Commun. 2017;22(5):413–32.PubMedPubMedCentralCrossRef
31.
Khadjesari Z, Murray E, Hewitt C, Hartley S, Godfrey C. Can stand-alone computer-based interventions reduce alcohol consumption? A systematic review. Addiction. 2011;106(2):267–82.PubMedCrossRef
32.
Khadjesari Z, White IR, McCambridge J, Marston L, Wallace P, Godfrey C, Murray E. Validation of the AUDIT-C in adults seeking help with their drinking online. Addict Sci Clin Pract. 2017;12(1):2.PubMedPubMedCentralCrossRef
33.
Kiluk BD, Dreifuss JA, Weiss RD, Morgenstern J, Carroll KM. The Short Inventory of Problems - revised (SIP-R): psychometric properties within a large, diverse sample of substance use disorder treatment seekers. Psychol Addict Behav. 2013;27(1):307–14.PubMedCrossRef
34.
Kypri K, Langley JD. Perceived social norms and their relation to university student drinking. J Stud Alcohol. 2003;64:8.CrossRef
35.
Marmet S, Gmel G, Gmel G, Frick H, Rehm J. In: Addiction. Suisse A, editor. Alcohol-attributable mortality in Switzerland between 1997 and 2011. Lausanne; 2013.
36.
Marmet S, Rehm J, Gmel G, Frick H, Gmel G. Alcohol-attributable mortality in Switzerland in 2011 - age-specific causes of death and impact of heavy versus non-heavy drinking. Swiss Med Wkly. 2014;144:w13947.PubMed
37.
McAlaney J, McMahon J. Normative beliefs, misperceptions, and heavy episodic drinking in a British student sample. J Stud Alcohol Drugs. 2007;68(3):385–92.PubMedCrossRef
38.
McCambridge J, Kypri K. Can simply answering research questions change behaviour? Systematic review and meta analyses of brief alcohol intervention trials. PLoS One. 2011;6(10):e23748.PubMedPubMedCentralCrossRef
39.
McCambridge J, Wilson A, Attia J, Weaver N, Kypri K. Randomized trial seeking to induce the Hawthorne effect found no evidence for any effect on self-reported alcohol consumption online. J Clin Epidemiol. 2019;108:102–9.PubMedCrossRef
40.
Meredith SE, Alessi SM, Petry NM. Smartphone applications to reduce alcohol consumption and help patients with alcohol use disorder: a state-of-the-art review. Adv Health Care Technol. 2015;1:47–54.PubMedPubMedCentral
41.
42.
Noell J, Glasgow RE. Interactive technology applications for behavioral counseling: issues and opportunities for health care settings. Am J Prev Med. 1999;17(4):269–74.PubMedCrossRef
43.
Orji R, Lomotey R, Oyibo K, Orji F, Blustein J, Shahid S. Tracking feels oppressive and 'punishy': exploring the costs and benefits of self-monitoring for health and wellness. Digit Health. 2018;4:2055207618797554.PubMedPubMedCentral
44.
Orji R, Vassileva J, Mandryk R. Towards an effective health interventions design: an extension of the health belief model. Online J Public Health Inform. 2012;4(3).
45.
Perkins HW. Surveying the damage: a review of research on consequences of alcohol misuse in college populations. J Stud Alcohol Suppl. 2002;(Supplement 14):91–100.
46.
Perkins HW. Misperception of peer drinking norms in Canada: another look at the "reign of error" and its consequences among college students. Addict Behav. 2007;32(11):2645–56.PubMedCrossRef
47.
Perkins HW, Haines MP, Rice R. Misperceiving the college drinking norm and related problems: a nationwide study of exposure to prevention information, perceived norms and student alcohol misuse. J Stud Alcohol. 2005;4(66):470–8.PubMedCrossRef
48.
Rehm J. Measuring quantity, frequency, and volume of drinking. Alcohol Clin Exp Res. 1998;22(2 Suppl):4S–14S.PubMedCrossRef
49.
Riper H, Hoogendoorn A, Cuijpers P, Karyotaki E, Boumparis N, Mira A, Andersson G, Berman AH, Bertholet N, Bischof G, Blankers M, Boon B, Boss L, Brendryen H, Cunningham J, Ebert D, Hansen A, Hester R, Khadjesari Z, Kramer J, Murray E, Postel M, Schulz D, Sinadinovic K, Suffoletto B, Sundstrom C, de Vries H, Wallace P, Wiers RW, Smit JH. Effectiveness and treatment moderators of internet interventions for adult problem drinking: an individual patient data meta-analysis of 19 randomised controlled trials. PLoS Med. 2018;15(12):e1002714.PubMedPubMedCentralCrossRef
50.
Riper H, Spek V, Boon B, Conijn B, Kramer J, Martin-Abello K, Smit F. Effectiveness of E-self-help interventions for curbing adult problem drinking: a meta-analysis. J Med Internet Res. 2011;13(2):e42.PubMedPubMedCentralCrossRef
51.
Rogers RW. In: Cacioppo J, Petty R, editors. Cognitive and psychological processes in fear appeals and attitude change: a revised theory of protection and motivation. Social Psychophysiology. New York: Guilford; 1983. p. 153–76.
52.
Ronis DL. Conditional health threats: health beliefs, decisions, and behaviors among adults. Health Psychol. 1992;11(2):127–34.PubMedCrossRef
53.
Rosenstock IM, Strecher VJ, Becker MH. Social learning theory and the health belief model. Health Educ Q. 1988;15(2):175–83.PubMedCrossRef
54.
Sobell LC, Agrawal S, Sobell MB, Leo GI, Young LJ, Cunningham JA, Simco ER. Comparison of a quick drinking screen with the timeline followback for individuals with alcohol problems. J Stud Alcohol. 2003;64(6):858–61.PubMedCrossRef
55.
Song T, Qian S, Yu P. Mobile health interventions for self-control of unhealthy alcohol use: systematic review. JMIR Mhealth Uhealth. 2019;7(1):e10899.PubMedPubMedCentralCrossRef
56.
Tansil KA, Esser MB, Sandhu P, Reynolds JA, Elder RW, Williamson RS, Chattopadhyay SK, Bohm MK, Brewer RD, McKnight-Eily LR, Hungerford DW, Toomey TL, Hingson RW, Fielding JE, F. Community Preventive Services Task. Alcohol electronic screening and brief intervention: a community guide systematic review. Am J Prev Med. 2016;51(5):801–11.PubMedPubMedCentralCrossRef
57.
Vernon ML. A review of computer-based alcohol problem services designed for the general public. J Subst Abus Treat. 2010;38(3):203–11.CrossRef
Metadata
Title
Smartphone-based secondary prevention intervention for university students with unhealthy alcohol use identified by screening: study protocol of a parallel group randomized controlled trial
Authors
Nicolas Bertholet
Elodie Schmutz
Véronique S. Grazioli
Mohamed Faouzi
Jennifer McNeely
Gerhard Gmel
Jean-Bernard Daeppen
John A. Cunningham
Publication date
01-12-2020
Publisher
BioMed Central
Published in
Trials / Issue 1/2020
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-020-4145-2

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