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Impact of a Brief Motivational Intervention Including Counter-marketing Arguments With a Population of Patients With Moderate to Severe Alcohol Use Disorders Who Are Followed up on an Outpatient Basis (Primary Care or Addictology) (DEPREV_Phase 3)

Primary Purpose

Addiction, Alcohol

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Motivational interview
Routine Care
Sponsored by
University Hospital, Brest
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Addiction, Alcohol

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria :

- Patient over 18 years of age

  • Current alcohol consumption (several times a month)
  • Compliance with the criteria for harmful use or dependence according to AUDIT scale greater than or equal to 7 for men or 6 for women
  • Outpatient follow-up in primary care or in addictology in the addictology network of northern Finistère

Exclusion Criteria :

  • Patient under 18 years of age
  • Subject under legal protection, guardianship, or curatorship or deprived of liberty
  • Non comprehension of the French language
  • Acute unstable psychiatric disorders affecting judgment
  • No fixed or cell phone line
  • AUDIT score less than 6 for women and 7 for men
  • Addictology hospitalization history in the last 12 months

Sites / Locations

  • Guillou LandreatRecruiting
  • SIMSON Jean-PierreRecruiting
  • LE GOFF DelphineRecruiting
  • ROZEC PascaleRecruiting
  • LE RESTE Jean-YvesRecruiting
  • BARAIS MarieRecruiting
  • SIMON CatherineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Motivational interview

Routine Care

Arm Description

Patients followed in the primary care network participating in the study and those followed in the addictology network of northern Finistère in the context of their pathology will be offered the opportunity to participate in the study. If the patient was randomized to the intervention group, the patient will receive 2 individual sessions (motivational interview) by telephone within 1 month of inclusion. They will then be assessed at month 1, month 3 and month 6. These assessments will be done by telephone.

Patients followed in the primary care network participating in the study and those followed in the addictology network of northern Finistère in the context of their pathology will be offered the opportunity to participate in the study. If the patient has been randomized to the control group, the patient will be assessed at month 1, month 3 and month 6. These assessments will be done by telephone.

Outcomes

Primary Outcome Measures

Ability of patients to control their own alcohol consumption
The primary outcome is the perceived ability of patients to control their own alcohol consumption measured on a visual analogue scale from 0 to 100 in relation to the question "How much do you estimate your ability to control your alcohol consumption?" with 0 = no ability to control my drinking and 100 = all my ability to control my drinking. This primary outcome is evaluated at 3 month.

Secondary Outcome Measures

Evaluation of quality of life
The quality of life will be evaluated by AQoLS scale whose is a specific quality of life scale to alcohol use disorders. It measures the negative impact of the relationship with alcohol on quality of life through 7 dimensions (Relationships with others, Activities, Negative emotions, Self-esteem, Loss of control, Sleep, Living conditions). Each item corresponds to a score from 0 (not at all) to 3 (very much), the total score being the sum of the 34 items in this self-questionnaire. There is no threshold value, as the patient is his or her own control in his or her own evolution.
Severity of alcohol use disorders
Severity of alcohol use disorders at each visit, as measured by the AUDIT ( (Alcohol Use Disorders Identification Test) score. AUDIT (Alcohol Use Disorders Identification Test) score is a 10-item screening tool to assess alcohol consumption, drinking behaviors, and alcohol-related problems. A score of 8 or more is considered to indicate hazardous or harmful alcohol use.
Evaluation of severity of alcohol use disorders
Severity of alcohol use disorders at each visit, as measured by the number of DSM5 (Diagnostic and Statistical manual of Mental disorders 5) criteria. The DSM5 score is diagnosis of addiction is based on well-defined criteria set out in the Diagnostic and Statistical manual of Mental disorders (DSM), the fifth edition of which was published in 2013. The questionnaire consists of 11 items (diagnostic criteria for substance use disorders from the American Psychiatric Association's DSM V). The presence of 2 to 3 criteria: low addiction / Presence of 4 to 5 criteria: moderate addiction / Presence of 6 or more criteria: severe addiction.
Limitation of alcohol consumption
Ability to implement limiting strategies, as measured by the visual analogue scale from 0 to 100 on the question "How well do you feel you are able to implement strategies to limit/restrict (or avoid) your alcohol consumption" at each visit?
Evaluation of alcohol use
Alcohol consumption measured by the Alcohol Timeline Followback (ATLFB) score at each visit. The ATLFB (Alcohol Timeline FollowBack) is a method for assessing recent drinking behavior. It involves asking clients to retrospectively estimate their daily alcohol consumption over a time period for 30 days prior to the interview. This scale is just an estimate of alcohol consumption on 1 month, there are no minimum or maximum values and so no better or worse outcome.
Craving assessment
The Obsessive Compulsive Drinking Scale (OCDS) is a 14-item questionnaire that measures an individual's alcohol use and his/her attempts to control his/her drinking (each item is scored on a scale from 0 to 4). Obsessive subscale is the summation of items 1-6 / Compulsive subscale is the summation of items 7-14.

Full Information

First Posted
May 3, 2021
Last Updated
July 12, 2023
Sponsor
University Hospital, Brest
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1. Study Identification

Unique Protocol Identification Number
NCT04881500
Brief Title
Impact of a Brief Motivational Intervention Including Counter-marketing Arguments With a Population of Patients With Moderate to Severe Alcohol Use Disorders Who Are Followed up on an Outpatient Basis (Primary Care or Addictology) (DEPREV_Phase 3)
Official Title
Impact of a Brief Motivational Intervention Including Counter-marketing Arguments With a Population of Patients With Moderate to Severe Alcohol Use Disorders Who Are Followed up on an Outpatient Basis (Primary Care or Addictology)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 11, 2022 (Actual)
Primary Completion Date
August 11, 2023 (Anticipated)
Study Completion Date
August 11, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Brest

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Alcohol consumption is the second cause of avoidable death after tobacco. The Evin law was constructed in 1991 with the aim of reducing exposure to alcohol marketing among the youngest. But this law is currently extremely weakened, and in a press release of February 26, 2018, the French Alcohol Society is alarmed by these developments. Studies on the impact of alcohol marketing focus for the most part on young adolescents and the links between marketing exposure and alcohol initiation. But beyond these links, little work has been done on the impact of alcohol marketing on vulnerable subjects with regular alcohol consumption. Alcohol consumption is one of the very first causes of hospitalization in France. The damage is often limited to the notion of risks of dependence, but it can appear as soon as consumption of 1 standard unit/day and mainly concerns the 45-64 year olds. To our knowledge, there are no studies on the impact of alcohol marketing carried out among regular alcohol users with moderate or severe alcohol use disorders. This population is, however, the target of manufacturers, since 10% of the French population consumes 58% of the alcohol sold in France. Moreover, although in the context of tobacco, counter-marketing campaigns and strategies are used to help users develop resistance to the positive marketing stimuli of alcohol, there are no studies that have evaluated this type of intervention with patients with moderate to severe alcohol use disorders. The DEPREV_phase 3 study is a prospective, controlled, randomised, open-label study. Patients followed in the primary care network participating in the study and those followed in the addictology network of northern Finistère in the context of their pathology will be offered the opportunity to participate in the study. Patients agreeing to participate will be randomized in 2 groups (1:1) by the addictology unit: Control group: routine routine follow-up (follow-up in consultations with the attending physician or addictologist) + assessments at Month 1, Month 3 and Month 6. Intervention group: Routine routine follow-up (follow-up in consultation with the attending physician or addictologist) + assessments at Month 1, Month 3 and Month 6 + motivational interview (2 individual sessions, during the first month after inclusion). Patients will then be followed up and evaluated at 1, 3 and 6 months after the inclusion visit.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Addiction, Alcohol

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
142 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Motivational interview
Arm Type
Experimental
Arm Description
Patients followed in the primary care network participating in the study and those followed in the addictology network of northern Finistère in the context of their pathology will be offered the opportunity to participate in the study. If the patient was randomized to the intervention group, the patient will receive 2 individual sessions (motivational interview) by telephone within 1 month of inclusion. They will then be assessed at month 1, month 3 and month 6. These assessments will be done by telephone.
Arm Title
Routine Care
Arm Type
Active Comparator
Arm Description
Patients followed in the primary care network participating in the study and those followed in the addictology network of northern Finistère in the context of their pathology will be offered the opportunity to participate in the study. If the patient has been randomized to the control group, the patient will be assessed at month 1, month 3 and month 6. These assessments will be done by telephone.
Intervention Type
Other
Intervention Name(s)
Motivational interview
Intervention Description
Patients will follow motivational interview (2 individual sessions by phone)
Intervention Type
Other
Intervention Name(s)
Routine Care
Intervention Description
Patients will follow routine care
Primary Outcome Measure Information:
Title
Ability of patients to control their own alcohol consumption
Description
The primary outcome is the perceived ability of patients to control their own alcohol consumption measured on a visual analogue scale from 0 to 100 in relation to the question "How much do you estimate your ability to control your alcohol consumption?" with 0 = no ability to control my drinking and 100 = all my ability to control my drinking. This primary outcome is evaluated at 3 month.
Time Frame
Day 0 to Month 6
Secondary Outcome Measure Information:
Title
Evaluation of quality of life
Description
The quality of life will be evaluated by AQoLS scale whose is a specific quality of life scale to alcohol use disorders. It measures the negative impact of the relationship with alcohol on quality of life through 7 dimensions (Relationships with others, Activities, Negative emotions, Self-esteem, Loss of control, Sleep, Living conditions). Each item corresponds to a score from 0 (not at all) to 3 (very much), the total score being the sum of the 34 items in this self-questionnaire. There is no threshold value, as the patient is his or her own control in his or her own evolution.
Time Frame
Day 0, Month 1, Month 3 and Month 6
Title
Severity of alcohol use disorders
Description
Severity of alcohol use disorders at each visit, as measured by the AUDIT ( (Alcohol Use Disorders Identification Test) score. AUDIT (Alcohol Use Disorders Identification Test) score is a 10-item screening tool to assess alcohol consumption, drinking behaviors, and alcohol-related problems. A score of 8 or more is considered to indicate hazardous or harmful alcohol use.
Time Frame
Day 0, Month 1, Month 3 and Month 6
Title
Evaluation of severity of alcohol use disorders
Description
Severity of alcohol use disorders at each visit, as measured by the number of DSM5 (Diagnostic and Statistical manual of Mental disorders 5) criteria. The DSM5 score is diagnosis of addiction is based on well-defined criteria set out in the Diagnostic and Statistical manual of Mental disorders (DSM), the fifth edition of which was published in 2013. The questionnaire consists of 11 items (diagnostic criteria for substance use disorders from the American Psychiatric Association's DSM V). The presence of 2 to 3 criteria: low addiction / Presence of 4 to 5 criteria: moderate addiction / Presence of 6 or more criteria: severe addiction.
Time Frame
Day 0, Month 1, Month 3 and Month 6
Title
Limitation of alcohol consumption
Description
Ability to implement limiting strategies, as measured by the visual analogue scale from 0 to 100 on the question "How well do you feel you are able to implement strategies to limit/restrict (or avoid) your alcohol consumption" at each visit?
Time Frame
Day 0, Month 1, Month 3 and Month 6
Title
Evaluation of alcohol use
Description
Alcohol consumption measured by the Alcohol Timeline Followback (ATLFB) score at each visit. The ATLFB (Alcohol Timeline FollowBack) is a method for assessing recent drinking behavior. It involves asking clients to retrospectively estimate their daily alcohol consumption over a time period for 30 days prior to the interview. This scale is just an estimate of alcohol consumption on 1 month, there are no minimum or maximum values and so no better or worse outcome.
Time Frame
Day 0, Month 1, Month 3 and Month 6
Title
Craving assessment
Description
The Obsessive Compulsive Drinking Scale (OCDS) is a 14-item questionnaire that measures an individual's alcohol use and his/her attempts to control his/her drinking (each item is scored on a scale from 0 to 4). Obsessive subscale is the summation of items 1-6 / Compulsive subscale is the summation of items 7-14.
Time Frame
Day 0, Month 1, Month 3 and Month 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria : - Patient over 18 years of age Current alcohol consumption (several times a month) Compliance with the criteria for harmful use or dependence according to AUDIT scale greater than or equal to 7 for men or 6 for women Outpatient follow-up in primary care or in addictology in the addictology network of northern Finistère Exclusion Criteria : Patient under 18 years of age Subject under legal protection, guardianship, or curatorship or deprived of liberty Non comprehension of the French language Acute unstable psychiatric disorders affecting judgment No fixed or cell phone line AUDIT score less than 6 for women and 7 for men Addictology hospitalization history in the last 12 months
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Morgane GUILLOU-LANDREAT, Dr
Phone
029822342348
Email
morgane.guillou@chu-brest.fr
Facility Information:
Facility Name
Guillou Landreat
City
Brest
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Morgane GUILLOU LANDREAT, Dr
First Name & Middle Initial & Last Name & Degree
Morgane GUILLOU LANDREAT, Dr
First Name & Middle Initial & Last Name & Degree
Catherine THERENE - MOUDEN, Dr
First Name & Middle Initial & Last Name & Degree
Delphine LEVER, Dr
First Name & Middle Initial & Last Name & Degree
Clémence LE CHAPELAIN
Facility Name
SIMSON Jean-Pierre
City
Brest
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isabelle PICHON
First Name & Middle Initial & Last Name & Degree
Jean-Pierre SIMSON, Dr
Facility Name
LE GOFF Delphine
City
Landerneau
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Delphine Le Goff
First Name & Middle Initial & Last Name & Degree
Delphine LE GOFF, Dr
Facility Name
ROZEC Pascale
City
Landerneau
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pascale ROZEC, Dr
First Name & Middle Initial & Last Name & Degree
Pascale ROZEC, Dr
Facility Name
LE RESTE Jean-Yves
City
Lanmeur
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul AUJOULAT
First Name & Middle Initial & Last Name & Degree
Jean-Yves LE RESTE, Pr
First Name & Middle Initial & Last Name & Degree
Paul AUJOULAT, Dr
Facility Name
BARAIS Marie
City
Lannilis
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie BARAIS, Dr
First Name & Middle Initial & Last Name & Degree
Marie BARAIS, Dr
Facility Name
SIMON Catherine
City
Morlaix
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catherine SIMON, Dr
First Name & Middle Initial & Last Name & Degree
Catherine SIMON, Dr

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All collected data that underlie results in a publication
IPD Sharing Time Frame
Data will be available beginning 19 month and ending 15 years following the final study report completion.
IPD Sharing Access Criteria
Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.

Learn more about this trial

Impact of a Brief Motivational Intervention Including Counter-marketing Arguments With a Population of Patients With Moderate to Severe Alcohol Use Disorders Who Are Followed up on an Outpatient Basis (Primary Care or Addictology) (DEPREV_Phase 3)

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