Two Consecutive Randomized Controlled Trials Using Mobile Phone Applications for Risky Alcohol Use
Brief Alcohol Interventions With Mobile Phone Applications for University Students: Interventions Targeting Differing Risk Levels in Two Consecutive Randomized Controlled Trials
2 other identifiers
interventional
2,166
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2014
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 14, 2014
CompletedFirst Posted
Study publicly available on registry
February 17, 2014
CompletedStudy Start
First participant enrolled
September 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedSeptember 1, 2015
August 1, 2015
6 months
February 14, 2014
August 31, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Secondary Outcomes (2)
Quantity
6, 12 and 18 weeks
Frequency
6, 12 and 18 weeks
Study Arms (5)
Promillekoll
EXPERIMENTALSmartphone app monitoring alcohol use with feedback on eBAC level.
PartyPlanner
EXPERIMENTALSmartphone-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.
Control Study 1
NO INTERVENTIONWaitlist control group that is given access to the Promillekoll and PartyPlanner apps after a 12-week wait.
Crossover group 1: TeleCoach - Control
EXPERIMENTALSix-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.
Crossover group 2: Control - TeleCoach
EXPERIMENTALInitially 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.
Interventions
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.
Smartphone app providing exercises and vignettes for reducing or abstaining from alcohol consumption.
Eligibility Criteria
You may qualify if:
- membership in the included student unions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Karolinska institutet, Department of Clinical Neuroscience
Stockholm, 11364, Sweden
Related Publications (2)
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.
PMID: 28224445DERIVEDBerman 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.
PMID: 26693967DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anne H Berman, PhD
Karolinska Institutet
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
February 14, 2014
First Posted
February 17, 2014
Study Start
September 1, 2014
Primary Completion
March 1, 2015
Study Completion
March 1, 2015
Last Updated
September 1, 2015
Record last verified: 2015-08