Condition category
Mental and Behavioural Disorders
Date applied
02/12/2019
Date assigned
05/12/2019
Last edited
31/07/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

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

Trial website

http://p3.snf.ch/Project-176295#

Contact information

Type

Scientific

Primary contact

Dr Nicolas Bertholet

ORCID ID

http://orcid.org/0000-0001-5064-6377

Contact details

Lausanne University Hospital
Addiction Medicine
Bugnon 23A
Lausanne
1011
Switzerland
+41213140327
Nicolas.Bertholet@chuv.ch

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Swiss National Science Fondation 176295

Study information

Scientific title

Smartphone-based secondary prevention intervention for students with unhealthy alcohol use: qualitative study and randomized controlled trial

Acronym

ESAS

Study hypothesis

Participants 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

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

Study design

Interventional randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Internet

Trial type

Prevention

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Unhealthy alcohol use

Intervention

Qualitative 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 type

Other

Phase

Drug names

Primary outcome measure

Mean number of drinks per week over the past 30 days (electronic self-report), measured at 6 months

Secondary outcome measures

All 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 trial start date

30/03/2017

Overall trial end date

30/06/2022

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Registered student at one of the participating Schools/Universities (French part of Switzerland)
2. Age 18 and over
3. Positive screen for unhealthy alcohol use
4. Smartphone ownership
5. Willingness to complete follow-up assessments

Participant type

Other

Age group

Adult

Gender

Both

Target number of participants

1696

Participant exclusion criteria

1. Students who participated in the development of the smartphone application

Recruitment start date

01/11/2020

Recruitment end date

30/06/2021

Locations

Countries of recruitment

Switzerland

Trial participating centre

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

Sponsor information

Organisation

Lausanne University Hospital

Sponsor details

Addiction Medicine
Lausanne
1011
Switzerland
+41213148400
info@chuv.ch

Sponsor type

Hospital/treatment centre

Website

http://www.chuv.ch

Funders

Funder type

Government

Funder name

Schweizerischer Nationalfonds zur Förderung der Wissenschaftlichen Forschung

Alternative name(s)

Swiss National Science Foundation, Fonds National Suisse de la Recherche Scientifique, Fondo Nazionale Svizzero per la Ricerca Scientifica, Fonds National Suisse, Fondo Nazionale Svizzero, Schweizerischer Nationalfonds, SNF, SNSF, FNS

Funding Body Type

private sector organisation

Funding Body Subtype

Trusts, charities, foundations (both public and private)

Location

Switzerland

Results and Publications

Publication and dissemination plan

Results will be presented at international conference and published in peer reviewed journals.

IPD sharing statement:
The current data sharing plans for this study are unknown and will be available at a later date

Intention to publish date

30/06/2022

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

2020 protocol in https://www.ncbi.nlm.nih.gov/pubmed/32066490 (added 24/02/2020)

Publication citations

Additional files

Editorial Notes

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)