FOllow-up and Brief Intervention of Conscripts in Lausanne, Switzerland

ISRCTN	ISRCTN78822107
DOI	https://doi.org/10.1186/ISRCTN78822107
Protocol serial number	N/A
Sponsor	Swiss Alcohol Research Foundation (Fondation Suisse De Recherche Sur L'alcool) (Switzerland)
Funders	Swiss Foundation for Alcohol Research (Switzerland) - funding for the alcohol study phase, Swiss Tobacco Prevention Funds (Switzerland) - funding obtained in 2008 for the tobacco study phase, Swiss National Science Foundation (Switzerland) - application to be submitted in 2010 for the funding of the multi-substance study phase

Submission date: 13/12/2007
Registration date: 07/02/2008
Last edited: 08/05/2013

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

Not provided at time of registration

Contact information

Dr Gerhard Gmel
Scientific

Mont Paisible 16
Lausanne
1011
Switzerland

Email	gerhard.gmel@chuv.ch

Study information

Primary study design	Interventional
Study design	Single-centre randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	FOllow-up and Brief Intervention of Conscripts in Lausanne, Switzerland: a single-centre randomised controlled trial
Study acronym	FOBIC
Study objectives	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(s)	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)
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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)
Completion date	31/12/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Male
Target sample size at registration	1800
Key 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
Key exclusion criteria	Lack of informed consent and provision of contact address.
Date of first enrolment	30/01/2007
Date of final enrolment	31/12/2010

Locations

Countries of recruitment

Switzerland

Study participating centre

Mont Paisible 16

Lausanne
1011
Switzerland

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	29/08/2012		Yes	No
Other publications	findings of the screening porcedure	01/11/2008		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes