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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
University Hospital, Caen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Binge Drinking focused on measuring mindfulness, intention implementation, motivationnal interview

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    September 30, 2022
    Last Updated
    September 30, 2022
    Sponsor
    University Hospital, Caen
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    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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