Condition category
Mental and Behavioural Disorders
Date applied
13/12/2007
Date assigned
07/02/2008
Last edited
08/05/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Gerhard Gmel

ORCID ID

Contact details

Mont Paisible 16
Lausanne
1011
Switzerland
gerhard.gmel@chuv.ch

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

FOllow-up and Brief Intervention of Conscripts in Lausanne, Switzerland: a single-centre randomised controlled trial

Acronym

FOBIC

Study hypothesis

Testing the effectiveness of brief interventions on alcohol, tobacco, and cannabis use and related risks outside a clinical setting and delivering it to a large majority of men in the French speaking region of Switzerland. A first phase will concentrate on alcohol use intervention, a second on tobacco, and a third on all substances addressed together.

Research questions are:
1. Are brief interventions among young men effective in reducing hazardous alcohol use and substance use in general?
2. Are booster sessions more effective than single brief intervention sessions?
3. Does a brief intervention in one domain (e.g., alcohol) show cross-effects in another domain (e.g., tobacco)?
4. Are interventions simultaneously provided for multiple risks more effective than an intervention focusing on one risk behaviour at the time?
5. Can simple assessment of problematic use (without brief motivational interviewing [BMI]) be seen as an effective minimal intervention? This can be demonstrated by comparing conscripts of the randomised trial that received
5.1. BMI with those who did not receive BMI but for which substance use was measured during assessment, and
5.2. By comparing the assessment only group with a second control group that received only screening without further assessment and without BMI

As of 13/02/2009 this record was updated to include amended trial dates; the initial trial dates at the time of registration were as follows:
Initial anticipated start date: 30/01/2007
Initial anticipated end date: 31/12/2010

Ethics approval

Added 13/02/09: Ethics Committee for Clinical Research of the Lausanne University Medical School gave approval on the 2nd April 2007 (ref: 15/07)

Study design

Single-centre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Alcohol, tobacco, and cannabis use

Intervention

This trial comprises three separate studies:
1. Study on alcohol use (600 participants)
2. Study on tobacco use (600 participants)
3. Study on the use of alcohol, tobacco and cannabis assessed together (600 participants)

Within each study, the participants will be allocated to one of the following three groups:
Group 1: Screening only (200 participants)
Group 2: Screening + assessment (200 participants)
Group 3: Screening + assessment + BMI (200 participants)

The screening questionnaire takes approximately 5 minutes to complete. The assessment questionnaire takes approximately 15 minutes to complete. BMI is intended to enforce the motivation to change behaviour. Interventions are conducted by experienced psychologists trained in motivational interviewing and in providing brief motivational interventions. Interventions last approximately 30 minutes. The same psychologists provide booster brief motivational intervention sessions 3 months after the first session by telephone. Booster sessions last approximately 20 minutes. Follow-up will be carried out at 6 months.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Alcohol, tobacco and cannabis use 6 months after baseline, measured by the following:
1. Alcohol use:
1.1. Quantity/frequency questionnaires
1.2. Retrospective diary
1.3. Alcohol Use Disorder Identification Test
2. Tobacco use:
2.1. Quantity/frequency questionnaires
2.2. Cigarette Dependence Scale
3. Cannabis use:
3.1. First three questions of the Cannabis Use Disorder Identification Test

Secondary outcome measures

1. Reduction of related risks 6 months after baseline. Related risks are measured using several tests:
1.1. Wechsler Alcohol Consequences
1.2. Questionnaire on dinking and driving
1.3. Attitudes Towards Smoking Scale, or questionnaire for cannabis use consequences
2. Cross-over effects:
2.1. Reduction in at-risk use of tobacco and cannabis use during the alcohol study at 6 months after baseline
2.2. Reduction in at-risk use of alcohol and cannabis use during the tobacco phase at 6 months after baseline.
2.3. Substance use, measured as described above
3. Readiness to change at 6 months after baseline, measured using 10-points Visual Analogue Scale (1 = not ready to change, 10 = extremely ready to change)

Overall trial start date

30/01/2007

Overall trial end date

31/12/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. 19-year old males with a Swiss citizenship enrolling during the mandatory army recruitment process in the French-speaking part of Switzerland
2. Informed consent
3. Provision of a contact address

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

1,800 participants. Target number of recruitment may be increased if additional funding becomes available.

Participant exclusion criteria

Lack of informed consent and provision of contact address.

Recruitment start date

30/01/2007

Recruitment end date

31/12/2010

Locations

Countries of recruitment

Switzerland

Trial participating centre

Mont Paisible 16
Lausanne
1011
Switzerland

Sponsor information

Organisation

Swiss Alcohol Research Foundation (Fondation Suisse De Recherche Sur L'alcool) (Switzerland)

Sponsor details

Case postale 870
Lausanne
1001
Switzerland
+41 21 321 29 59
edomengevieu@sfa-ispa.ch

Sponsor type

Research organisation

Website

Funders

Funder type

Research organisation

Funder name

Swiss Foundation for Alcohol Research (Switzerland) - funding for the alcohol study phase

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Swiss Tobacco Prevention Funds (Switzerland) - funding obtained in 2008 for the tobacco study phase

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Swiss National Science Foundation (Switzerland) - application to be submitted in 2010 for the funding of the multi-substance study phase

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2008 findings of the screening porcedure in http://www.ncbi.nlm.nih.gov/pubmed/18723839
2. 2008 pilot phase results in http://www.saphirdoc.ch/permalien.htm?saphirid=70538
3. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/22931392

Publication citations

  1. Findings of the screening porcedure

    Gmel G, Gaume J, Faouzi M, Kulling JP, Daeppen JB, Who drinks most of the total alcohol in young men--risky single occasion drinking as normative behaviour., Alcohol Alcohol., 43, 6, 692-697, doi: 10.1093/alcalc/agn070.

  2. Results

    Bertholet N, Gaume J, Faouzi M, Gmel G, Daeppen JB, Predictive value of readiness, importance, and confidence in ability to change drinking and smoking., BMC Public Health, 2012, 12, 708, doi: 10.1186/1471-2458-12-708.

Additional files

Editorial Notes