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Brief Alcohol Interventions With Mobile Phone Applications for University Students: Interventions Targeting Differing Risk Levels in Two Consecutive Randomized Controlled Trials
Sponsor study identifier
Secondary identifiers
OTHER · Karolinska Institutet, Legal Dept.
interventional
2,166
1 country
1
Study Start
September 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2015
Actual (reported)Study Completion
March 2015
Actual (reported)The purpose of this study is to evaluate the efficacy of three mobile phone applications, Promillekoll, PartyPlanner and TeleCoach among university student union members with problematic drinking. Two trials are conducted, one a three-armed randomized controlled study, and the second a two-armed randomized control study. Outcomes are measured in terms of changes in problematic alcohol use at follow up 6,12 and 18 weeks after baseline data gathering. Both the Promillekoll and PartyPlanner apps feature real time registration of alcohol consumption and give feedback of estimated blood alcohol concentration levels. PartyPlanner also allows for planning an alcohol consumption event in advance and for later comparison of the plan with actual consumption. Study 1 compares these two apps with a control group. In Study 2, participants reporting alcohol consumption above the weekly recommended level are redirected to randomized assignment to an in-depth app, TeleCoach, which offers different exercises for reducing alcohol use. After 6 weeks the controls are offered the TeleCoach intervention for 6 weeks, and the first intervention group loses app access. In both studies, followup occurs 6, 12 and 18 weeks after baseline registration. Hypotheses: Study 1: 1. The groups receiving the Promillekoll and PartyPlanner interventions will reduce their alcohol use to a larger extent than the control group at follow-up compared to the baseline level. 2. The planning function in PartyPlanner will be associated with an increased decrease in alcohol consumption compared to only real-time use for Promillekoll. Study 2: The proportion of participants with risky use above recommended levels will decline faster in the group that receives the intervention first, in comparison to controls.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2015
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 14, 2014
Actual (reported)February 17, 2014
Actual (reported)September 2014
Date type not reportedThis date has not been verified as actual or estimated.
March 2015
Actual (reported)March 2015
Actual (reported)Change in estimated Blood Alcohol Concentration (eBAC)
Change in Blood Alcohol Concentration estimated using Widmark's formula for Blood Alcohol Concentration estimation.
6, 12 and 18 weeks
Alcohol Use Disorders Identification Test (AUDIT)
Change in total AUDIT score, as a summarized measure of alcohol use (including alcohol consumption and alcohol-related problems).
6, 12 and 18 weeks
Quantity
6, 12 and 18 weeks
Frequency
6, 12 and 18 weeks
Smartphone app monitoring alcohol use with feedback on eBAC level.
Smartphone-adapted web-based app for simulating an event with alcohol consumption in advance, real time monitoring of alcohol use with eBAC feedback during the event and later possibility of comparison between the plan and the event.
Waitlist control group that is given access to the Promillekoll and PartyPlanner apps after a 12-week wait.
Smartphone app monitoring alcohol use with feedback on eBAC level.
Smartphone-adapted web-based app for simulating an event with alcohol consumption in advance, real time monitoring of alcohol use with eBAC feedback during the event and later possibility of comparison between the plan and the event.
Contact the study team to confirm eligibility.
Karolinska institutet, Department of Clinical Neuroscience
Stockholm, 11364, Sweden
Gajecki M, Andersson C, Rosendahl I, Sinadinovic K, Fredriksson M, Berman AH. Skills Training via Smartphone App for University Students with Excessive Alcohol Consumption: a Randomized Controlled Trial. Int J Behav Med. 2017 Oct;24(5):778-788. doi: 10.1007/s12529-016-9629-9.
Berman AH, Gajecki M, Fredriksson M, Sinadinovic K, Andersson C. Mobile Phone Apps for University Students With Hazardous Alcohol Use: Study Protocol for Two Consecutive Randomized Controlled Trials. JMIR Res Protoc. 2015 Dec 22;4(4):e139. doi: 10.2196/resprot.4894.
Anne H Berman, PhD
Karolinska Institutet
2,166 participants (actual enrollment reported by the registry).
First Submitted
February 14, 2014
First Posted
February 17, 2014
Study Start
September 2014
Date type not reportedThis date has not been verified as actual or estimated.
Six-week access to the TeleCoach app, with exercises and vignettes for reducing or abstaining from alcohol consumption, followed by a 6-week period with no access to the app.
Initially a 6 week no-app control period, followed by 6-week access to the TeleCoach app, offering exercises and vignettes for reducing or abstaining from alcohol consumption.
Smartphone app providing exercises and vignettes for reducing or abstaining from alcohol consumption.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Primary Completion
March 2015
Actual (reported)Study Completion
March 2015
Actual (reported)Last Updated
September 1, 2015
Record last verified: 2015-08
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Source: ClinicalTrials.gov.
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