FOllow-up and Brief Intervention of Conscripts in Lausanne, Switzerland
| ISRCTN | ISRCTN78822107 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN78822107 |
| Secondary identifying numbers | N/A |
- 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
Scientific
Mont Paisible 16
Lausanne
1011
Switzerland
| gerhard.gmel@chuv.ch |
Study information
| Study design | Single-centre randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 30/01/2007 |
| Completion date | 31/12/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target number of participants | 1,800 participants. Target number of recruitment may be increased if additional funding becomes available. |
| 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
1011
Switzerland
Sponsor information
Swiss Alcohol Research Foundation (Fondation Suisse De Recherche Sur L'alcool) (Switzerland)
Research organisation
Research organisation
Case postale 870
Lausanne
1001
Switzerland
| Phone | +41 21 321 29 59 |
|---|---|
| edomengevieu@sfa-ispa.ch |
Funders
Funder type
Research organisation
Swiss Foundation for Alcohol Research (Switzerland) - funding for the alcohol study phase
No information available
Swiss Tobacco Prevention Funds (Switzerland) - funding obtained in 2008 for the tobacco study phase
No information available
Swiss National Science Foundation (Switzerland) - application to be submitted in 2010 for the funding of the multi-substance study phase
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other publications | findings of the screening porcedure | 01/11/2008 | Yes | No | |
| Results article | results | 29/08/2012 | Yes | No |
