Alcohol Consumption, Intention Implementation and Mindfulness Meditation (ADUC-Volet 3 " Prevention ") (ALCOMEDIIT)
Primary Purpose
Binge Drinking, Alcohol Drinking
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
MBM and II
MI
Sponsored by

About this trial
This is an interventional prevention trial for Binge Drinking focused on measuring mindfulness, intention implementation, motivationnal interview
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
control (MI)
experimental (MI/MBM/II)
Arm Description
Motivational Interview
Motivational Interview + mindfulness-bases meditation practice + intention implementation
Outcomes
Primary Outcome Measures
binge drinking score
The BD score (Townshend & Duka, 2005) is calculated on the basis of 3 distinct elements (Q1: "number of average standard drinks per hour (containing about 10g of pure alcohol in France)"; Q2: "number of drunken episodes in the last month" and Q3; "percentage of drunken episodes among the occasions of drinking"). The score results from the following weighting: (4 x Q1) + Q2*6 + (0.2 x Q3). This score considers both the quantity and frequency of drinking, thus integrating the dimension of repeated alcohol withdrawal.
Secondary Outcome Measures
craving
1 item measuring craving
craving
1 item measuring craving
impulsivity
UPPS Scores
impulsivity
UPPS Scores
Readiness to Change Alcohol consumption
This self-assessment based on the transtheoretical model of behaviour change (Prochaska & DiClemente, 1982, DiClemente & Prochaska, 1982) is recognized for its reliability and validity. The RTC-Alcohol has three different scales that correspond to an assessment of the three main stages of behaviour change: the pre-contemplation, contemplation and action stages. Based on the person's score on each of these scales, the experimenter determines which stage of behavior change the person is in.
Readiness to Change Alcohol consumption
This self-assessment based on the transtheoretical model of behaviour change (Prochaska & DiClemente, 1982, DiClemente & Prochaska, 1982) is recognized for its reliability and validity. The RTC-Alcohol has three different scales that correspond to an assessment of the three main stages of behaviour change: the pre-contemplation, contemplation and action stages. Based on the person's score on each of these scales, the experimenter determines which stage of behavior change the person is in.
alcohol use
number of alcoholic drinks
binge drinking score
The BD score (Townshend & Duka, 2005) is calculated on the basis of 3 distinct elements (Q1: "number of average standard drinks per hour (containing about 10g of pure alcohol in France)"; Q2: "number of drunken episodes in the last 6 months" and Q3; "percentage of drunken episodes among the occasions of drinking"). The score results from the following weighting: (4 x Q1) + Q2 + (0.2 x Q3). This score considers both the quantity and frequency of drinking, thus integrating the dimension of repeated alcohol withdrawal.
Alcohol use
Number of alcoholic drinks
Full Information
NCT ID
NCT05565989
First Posted
September 30, 2022
Last Updated
September 30, 2022
Sponsor
University Hospital, Caen
1. Study Identification
Unique Protocol Identification Number
NCT05565989
Brief Title
Alcohol Consumption, Intention Implementation and Mindfulness Meditation (ADUC-Volet 3 " Prevention ")
Acronym
ALCOMEDIIT
Official Title
Alcohol Consumption, Intention Implementation and Mindfulness Meditation (ADUC-Volet 3 " Prevention ")
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 3, 2022 (Anticipated)
Primary Completion Date
November 4, 2022 (Anticipated)
Study Completion Date
October 4, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Caen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Binge Drinking, Alcohol Drinking
Keywords
mindfulness, intention implementation, motivationnal interview
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
170 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
control (MI)
Arm Type
Active Comparator
Arm Description
Motivational Interview
Arm Title
experimental (MI/MBM/II)
Arm Type
Experimental
Arm Description
Motivational Interview + mindfulness-bases meditation practice + intention implementation
Intervention Type
Behavioral
Intervention Name(s)
MBM and II
Intervention Description
An initiation to MBM practice (including 4 exercices) and 2 intention implementation exercices are proposed to participants
Intervention Type
Behavioral
Intervention Name(s)
MI
Intervention Description
A motivational Interview will be conducted with participant.
Primary Outcome Measure Information:
Title
binge drinking score
Description
The BD score (Townshend & Duka, 2005) is calculated on the basis of 3 distinct elements (Q1: "number of average standard drinks per hour (containing about 10g of pure alcohol in France)"; Q2: "number of drunken episodes in the last month" and Q3; "percentage of drunken episodes among the occasions of drinking"). The score results from the following weighting: (4 x Q1) + Q2*6 + (0.2 x Q3). This score considers both the quantity and frequency of drinking, thus integrating the dimension of repeated alcohol withdrawal.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
craving
Description
1 item measuring craving
Time Frame
1 month
Title
craving
Description
1 item measuring craving
Time Frame
6 months
Title
impulsivity
Description
UPPS Scores
Time Frame
1 month
Title
impulsivity
Description
UPPS Scores
Time Frame
6 months
Title
Readiness to Change Alcohol consumption
Description
This self-assessment based on the transtheoretical model of behaviour change (Prochaska & DiClemente, 1982, DiClemente & Prochaska, 1982) is recognized for its reliability and validity. The RTC-Alcohol has three different scales that correspond to an assessment of the three main stages of behaviour change: the pre-contemplation, contemplation and action stages. Based on the person's score on each of these scales, the experimenter determines which stage of behavior change the person is in.
Time Frame
1 month
Title
Readiness to Change Alcohol consumption
Description
This self-assessment based on the transtheoretical model of behaviour change (Prochaska & DiClemente, 1982, DiClemente & Prochaska, 1982) is recognized for its reliability and validity. The RTC-Alcohol has three different scales that correspond to an assessment of the three main stages of behaviour change: the pre-contemplation, contemplation and action stages. Based on the person's score on each of these scales, the experimenter determines which stage of behavior change the person is in.
Time Frame
6 months
Title
alcohol use
Description
number of alcoholic drinks
Time Frame
6 month
Title
binge drinking score
Description
The BD score (Townshend & Duka, 2005) is calculated on the basis of 3 distinct elements (Q1: "number of average standard drinks per hour (containing about 10g of pure alcohol in France)"; Q2: "number of drunken episodes in the last 6 months" and Q3; "percentage of drunken episodes among the occasions of drinking"). The score results from the following weighting: (4 x Q1) + Q2 + (0.2 x Q3). This score considers both the quantity and frequency of drinking, thus integrating the dimension of repeated alcohol withdrawal.
Time Frame
6 month
Title
Alcohol use
Description
Number of alcoholic drinks
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Study protocol and statistical analysis plan will be shared.
Learn more about this trial
Alcohol Consumption, Intention Implementation and Mindfulness Meditation (ADUC-Volet 3 " Prevention ")
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