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)

NCT04881500 | Terminated DMC

• 1 other identifier: 29BRC20.0261
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 6

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.

Conditions

Addiction, Alcohol

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 0 to Month 6

Secondary Outcomes (6)

• Evaluation of quality of life

  Day 0, Month 1, Month 3 and Month 6

• Severity of alcohol use disorders

  Day 0, Month 1, Month 3 and Month 6

• Evaluation of severity of alcohol use disorders

  Day 0, Month 1, Month 3 and Month 6

• Limitation of alcohol consumption

  Day 0, Month 1, Month 3 and Month 6

• Evaluation of alcohol use

  Day 0, Month 1, Month 3 and Month 6

Study Arms (2)

Motivational interview

EXPERIMENTAL

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.

Other: Motivational interview

Routine Care

ACTIVE COMPARATOR

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.

Other: Routine Care

Interventions

Motivational interview OTHER

Patients will follow motivational interview (2 individual sessions by phone)

Motivational interview

Routine Care OTHER

Patients will follow routine care

Routine Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (6)

Guillou Landreat

Brest, France

Location

SIMSON Jean-Pierre

Brest, France

Location

LE GOFF Delphine

Landerneau, France

Location

ROZEC Pascale

Landerneau, France

Location

LE RESTE Jean-Yves

Lanmeur, France

Location

BARAIS Marie

Lannilis, France

Location

MeSH Terms

Conditions

Alcoholism

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2021
• First Posted: May 11, 2021
• Study Start: January 11, 2022
• Primary Completion: March 7, 2024
• Study Completion: March 7, 2024
• Last Updated: July 23, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available beginning 19 month and ending 15 years following the final study report completion.
• 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.

Locations

FR (6)