Alcohol Consumption, Intention Implementation and Mindfulness Meditation (ADUC-Volet 3 " Prevention ")

NCT ID: NCT05565989

Last Updated: 2025-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-03

Study Completion Date

2024-05-28

Brief Summary

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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

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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.

Conditions

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Binge Drinking Alcohol Drinking

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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control (MI)

Motivational Interview

Group Type ACTIVE_COMPARATOR

MI

Intervention Type BEHAVIORAL

A motivational Interview will be conducted with participant.

experimental (MI/MBM/II)

Motivational Interview + mindfulness-bases meditation practice + intention implementation

Group Type EXPERIMENTAL

MBM and II

Intervention Type BEHAVIORAL

An initiation to MBM practice (including 4 exercices) and 2 intention implementation exercices are proposed to participants

MI

Intervention Type BEHAVIORAL

A motivational Interview will be conducted with participant.

Interventions

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MBM and II

An initiation to MBM practice (including 4 exercices) and 2 intention implementation exercices are proposed to participants

Intervention Type BEHAVIORAL

MI

A motivational Interview will be conducted with participant.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Caen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jessica MANGE, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Caen Normandy

Locations

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University of Caen Normandy

Caen, Normandy, France

Site Status

Countries

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France

References

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Mange J, Mauny N, Montcharmont C, Legrand E, Lemercier-Dugarin M, Mortier A, Duvivier M, Leveneur J, Lacherez C, Cabe N, Le Berre AP. A prevention program for binge drinking among students based on mindfulness and implementation intention (ALCOMEDIIT): a randomized controlled trial. Trials. 2024 Jan 2;25(1):1. doi: 10.1186/s13063-023-07887-9.

Reference Type DERIVED
PMID: 38169391 (View on PubMed)

Other Identifiers

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22-0099

Identifier Type: -

Identifier Source: org_study_id

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