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)

NCT ID: NCT04881500

Last Updated: 2024-07-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 83 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-11
• Study Completion Date: 2024-03-07

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Motivational interview

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.

Group Type: EXPERIMENTAL

Motivational interview

Intervention Type: OTHER

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

Routine Care

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.

Group Type: ACTIVE_COMPARATOR

Routine Care

Intervention Type: OTHER

Patients will follow routine care

Interventions

Motivational interview

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

Intervention Type: OTHER

Routine Care

Patients will follow routine care

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Brest

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Guillou Landreat

Brest, , France

SIMSON Jean-Pierre

Brest, , France

LE GOFF Delphine

Landerneau, , France

ROZEC Pascale

Landerneau, , France

LE RESTE Jean-Yves

Lanmeur, , France

BARAIS Marie

Lannilis, , France

Countries

France

Other Identifiers

29BRC20.0261

Identifier Type: -

Identifier Source: org_study_id