Clinical trial NCT05565989: Alcohol Consumption, Intention Implementation and Mindfulness Meditation (ADUC-Volet 3 " Prevention ")
Official title: Alcohol Consumption, Intention Implementation and Mindfulness Meditation (ADUC-Volet 3 " Prevention ")
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Binge Drinking
Alcohol Drinking
Keywords: mindfulness
intention implementation
motivationnal interview
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2022-10-04
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1 control condition implying a Motivational Interview (MI)

1 experimental condition implying a Motivational Interview (MI) + Mindfulness-Based Meditation practices (MBM) + Intention Implementation (II)
Primary purpose: PREVENTION

Brief summary: The emergence of new problematic alcohol consumption practices among young people requires new dynamics in prevention strategies. In this context, the ADUC project (Alcohol and Drugs at the University of Caen) aims to develop a better understanding of alcohol consumption, and in particular the practice of binge drinking (BD), in order to develop relevant and adapted prevention tools. The ALCOMEDIIT study (IRESP funding; Agreement 20II31-00 - ADUC part 3) is a randomized controlled trial that focuses on the specific determinant of impulsivity. The main objective of this experiment in social psychology is to validate a program for the prevention of BD practices based on motivational interviewing (MI) associated with intention implementation (II) and mindfulness meditation (MBM) in a student environment.

Detailed description: Context. The emergence of new problematic alcohol consumption practices among young people requires new dynamics in prevention strategies. In this context, the ADUC project (Alcohol and Drugs at the University of Caen) aims to develop a better understanding of alcohol consumption, and in particular the practice of binge drinking (BD), in order to develop relevant and adapted prevention tools. The first step, logistically supported by the University of Caen, consisted in identifying the levels of alcohol consumption of students, the prevalence of binge drinking, and their determinants. Based on more than 7000 participants interviewed, it essentially demonstrated 1) an alarming 22% prevalence of BD among students and 2) four main psychological determinants, namely impulsivity (i.e., the tendency of individuals to act prematurely without fully weighing the consequences of their action), subjective norm (i.e., perception of what is done and/or approved by peers), drinker identity (i.e., how the individual defines him/herself as a drinker), and motivations to drink (social, compliance, enhancement, or coping motivations).

Objective. The ALCOMEDIIT study (IRESP funding; Agreement 20II31-00 - ADUC part 3) is a randomized controlled trial that focuses on the specific determinant of impulsivity. The main objective of this experiment in social psychology is to validate a program for the prevention of BD practices based on motivational interviewing (MI) associated with intention implementation (II) and mindfulness meditation (MBM) in a student environment.

Materials and Methods. This study will include 120 healthy subjects who will be students at the University of Caen Normandy. They will be people who consume alcohol, having a BD score \> 1 in the month preceding the inclusion but not presenting any specific disorder. The trial will be proposed to them by e-mail and the people who meet the inclusion criteria will join either a control group which will benefit from a MI, or an experimental group which will also benefit from a MI but which will be associated with an initiation to MBM with II (initial visit T0). In order to measure the effectiveness of the prevention device in terms of reducing the use of BD, a follow-up at 1 month (T1) as well as a follow-up at 6 months (T6; exploratory) will be proposed to all participants. The total duration of this research protocol is one year.

Hypothesis tested. The aim of this work is to evaluate the interest of associating mindfulness meditation practices, practices implemented to optimize their use, with a motivational interview in a prevention program aiming at reducing alcohol use and the practice of BD in the student population.

Eligibility criteria: Inclusion Criteria:

* aged between 18 and 30 years old,
* of French mother language,
* of both sexes,
* binge drinking score \> 1,
* having signed an informed consent.

Exclusion Criteria:

* Pregnant or breastfeeding students,
* students who declare a history of neurological, neurosurgical, psychiatric, endocrine or infectious diseases.

Primary outcomes:
measure: binge drinking score
timeFrame: 1 month
Secondary outcomes:
measure: craving
timeFrame: 1 month
measure: craving
timeFrame: 6 months
measure: impulsivity
timeFrame: 1 month
measure: impulsivity
timeFrame: 6 months
measure: Readiness to Change Alcohol consumption
timeFrame: 1 month
measure: Readiness to Change Alcohol consumption
timeFrame: 6 months
measure: alcohol use
timeFrame: 6 month
measure: binge drinking score
timeFrame: 6 month
measure: Alcohol use
timeFrame: 1 month
Other outcomes:
Locations:
city: Caen
country: France
facility: University of Caen Normandy
state: Normandie
Study officials:
affiliation: University of Caen Normandy
name: Jessica MANGE, PhD
role: PRINCIPAL_INVESTIGATOR
References: