ISRCTN ISRCTN10007691
DOI https://doi.org/10.1186/ISRCTN10007691
Secondary identifying numbers Swiss National Science Fondation 176295
Submission date
02/12/2019
Registration date
05/12/2019
Last edited
07/02/2025
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
Unhealthy alcohol use is a major morbidity and mortality risk factor among students. Electronic screening and brief interventions have the potential to limit drinking and its consequences by reaching large parts of the population that do not necessarily access care. Computer or internet-based interventions targeting unhealthy alcohol use have shown promising results, but efficacy is limited. Smartphones offer an opportunity for interventions with multiple contacts at the user’s convenience, which may increase interventions’ efficacy. Smartphone applications also allow delivering interventions in context outside of reach of face-to-face or computerized intervention, including in situations in which people are drinking alcohol, for example at parties. Evidence of efficacy of computer or internet-based interventions cannot be extrapolated to smartphone applications: computers and smartphones are used differently, which may change their impact. Research is only starting in this area and efficacy of smartphone applications is largely unknown.
Aim: This project proposes a mixed methods approach to develop and test the efficacy of a smartphone application aimed at decreasing unhealthy alcohol use in students.

Who can participate?
Registered students aged 18 years or older, studying at one of the participating Schools/Universities (French part of Switzerland) who screen positive for unhealthy alcohol use.

What does the study involve?
Participating in 4 assessments over a 12 months period
Participants may be given access to a smartphone app with prevention material

What are the possible benefits and risks of participating?
There may be no direct benefit to participants. Potential benefits to participants include the possibility to reduce alcohol consumption and related problems; participants also may benefit from assessments and monitoring of alcohol use. They might take advantage of study participation to think about their behavior and life values and better know themselves.
The risks of serious adverse consequences as a result of study participation are relatively low. Participants might have concerns about confidentiality of sensitive information reported during the study assessments. The sensitive nature of some of the questions (e.g., alcohol-related) may cause participants discomfort.

Where is the study run from?
Lausanne University Hospital and University of Lausanne, Switzerland

When is the study starting and how long is it expected to run for?
April 2020 to June 2022

Who is funding the study?
Schweizerischer Nationalfonds zur Förderung der Wissenschaftlichen Forschung (Swiss National Science Foundation)

Who is the main contact?
Dr Nicolas Bertholet
Nicolas.Bertholet@chuv.ch

Study website

Contact information

Dr Nicolas Bertholet
Scientific

Lausanne University Hospital
Addiction Medicine
Bugnon 23A
Lausanne
1011
Switzerland

ORCiD logoORCID ID 0000-0001-5064-6377
Phone +41213140327
Email Nicolas.Bertholet@chuv.ch

Study information

Study designInterventional randomized controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Internet/virtual
Study typePrevention
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titleSmartphone-based secondary prevention intervention for students with unhealthy alcohol use: qualitative study and randomized controlled trial
Study acronymESAS
Study objectivesParticipants in the intervention group (experimental condition: secondary prevention intervention delivered via a smartphone application) will report a smaller volume of drinking (measured with the mean number of drinks per week consumed over the past 30 days) at the 6-month follow-up compared to participants in the control group (receiving electronic assessment only).
Ethics approval(s)Approved 25/05/2018, Commission cantonale (VD) d'éthique de la recherche sur l'être humain (CER-VD) (Ethics committee of the Canton de Vaud, Avenue de Chailly 23, 1012 Lausanne, Switzerland; +41 21 316 18 30; secretariat.cer@vd.ch), ref: 2018-00560
Health condition(s) or problem(s) studiedUnhealthy alcohol use
InterventionQualitative study: a member of the target population (i.e. fulfilling the randomized trial inclusion criteria) will be recruited to download and test a prototype of the smartphone-based intervention. After providing written informed consent, participants (n=20) are taking part in two rounds of qualitative assessments (individual semi-structured interviews). The smartphone-based intervention is modified after each round. An interview grid was developed for the project. All interviews are audio-recorded and transcribed verbatim. A conventional content analysis is conducted.

Phase I, development of the smartphone application and qualitative assessment: the piloted smartphone application will be further developed, notably to send messages to participants following pre-specified scenarios based on application usage. Modifications will be done in an iterative process. Two rounds of qualitative assessments (individual semi-structured interviews and focus group) will be conducted among members of the study population. Each round will lead to modifications in the smartphone application.

Phase II, randomized controlled trial: the application’s efficacy will be tested in a two parallel-group randomized controlled trial with a 1:1 allocation ratio with follow-up assessments at 3, 6 and 12 months.
Control (assessment only)
Intervention (assessment + smartphone application).
The entire randomized trial will be conducted electronically. Randomization is embedded within study website with full concealment of allocation. Electronic assessments at follow-up (3, 6, 12 months post baseline)

Intervention: providing access to a secondary prevention intervention targeting unhealthy alcohol use, delivered via a smartphone application
Intervention typeOther
Primary outcome measureMean number of drinks per week over the past 30 days (electronic self-report), measured at 6 months
Secondary outcome measuresAll electronic self-report, measured at 6 months:
1. Number of heavy drinking days over the past 30 days
2. Additional outcomes will be: maximum number of drinks on any day over the past 30 days, alcohol related consequences (measured with the Short Inventory of Problems (SIP-2R), and academic performance
Overall study start date30/03/2017
Completion date12/06/2022

Eligibility

Participant type(s)Learner/student
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants1,696
Total final enrolment1770
Key inclusion criteria1. Registered student at one of the participating Schools/Universities (French part of Switzerland)
2. Age 18 years and over
3. Positive screen for unhealthy alcohol use
4. Smartphone ownership
5. Willingness to complete follow-up assessments
Key exclusion criteria1. Students who participated in the development of the smartphone application
Date of first enrolment26/04/2021
Date of final enrolment28/04/2021

Locations

Countries of recruitment

  • Switzerland

Study participating centre

Lausanne University Hospital and University of Lausanne
Addiction Medicine
Bugnon 23A
Lausanne
1011
Switzerland

Sponsor information

Lausanne University Hospital
Hospital/treatment centre

Addiction Medicine
Lausanne
1011
Switzerland

Phone +41213148400
Email info@chuv.ch
Website http://www.chuv.ch
ROR logo "ROR" https://ror.org/05a353079

Funders

Funder type

Government

Schweizerischer Nationalfonds zur Förderung der Wissenschaftlichen Forschung
Private sector organisation / Trusts, charities, foundations (both public and private)
Alternative name(s)
Schweizerischer Nationalfonds, Swiss National Science Foundation, Fonds National Suisse de la Recherche Scientifique, Fondo Nazionale Svizzero per la Ricerca Scientifica, Fonds National Suisse, Fondo Nazionale Svizzero, Schweizerische Nationalfonds, SNF, SNSF, FNS
Location
Switzerland

Results and Publications

Intention to publish date31/08/2023
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
Publication and dissemination planResults will be presented at international conference and published in peer reviewed journals.
IPD sharing planThe current data sharing plans for this study are unknown and will be available at a later date

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 17/02/2020 24/02/2020 Yes No
Other publications qualitative outcome data on the app development process 07/03/2023 08/03/2023 Yes No
Results article 16/08/2023 17/08/2023 Yes No
Other publications Secondary mediation analysis 06/02/2025 07/02/2025 Yes No

Editorial Notes

07/02/2025: Publication reference added.
17/08/2023: Publication reference added.
25/07/2023: The intention to publish date was changed from 30/06/2022 to 31/08/2023.
08/03/2023: Publication reference added.
15/06/2022: The following changes were made to the trial record:
1. The overall end date was changed from 30/06/2022 to 12/06/2022.
2. The total final enrolment was changed from 1696 to 1770.
28/04/2021: The following changes have been made:
1. The recruitment end date has been changed from 30/06/2021 to 28/04/2021.
2. The total final enrolment number has been added.
30/03/2021: The recruitment start date has been changed from 01/02/2021 to 26/04/2021.
24/11/2020: The recruitment start date was changed from 01/11/2020 to.
31/07/2020: The recruitment start date has been changed from 01/09/2020 to 01/11/2020.
09/04/2020: The recruitment start date has been changed from 01/04/2020 to 01/09/2020.
24/02/2020: Publication reference added.
03/12/2019: Trial’s existence confirmed by Commission cantonale (VD) d'éthique de la recherche sur l'être humain (CER-VD) (Ethics committee of the Canton de Vaud, Switzerland)