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)

Addiction, Alcohol Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04881500
• Other study ID #: 29BRC20.0261
• Status: Terminated
• Phase: N/A
• Start date: January 11, 2022
• Est. completion date: March 7, 2024

Study information

• Verified date: March 2024
• Source: University Hospital, Brest
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 83
• Est. completion date: March 7, 2024
• Est. primary completion date: March 7, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Addiction, Alcohol
• Alcoholism

Intervention

Other:
• Motivational interview
Patients will follow motivational interview (2 individual sessions by phone)
• Routine Care
Patients will follow routine care

Locations

Country	Name	City	State
France	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	SIMON Catherine	Morlaix

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Day 0, Month 1, Month 3 and Month 6
Secondary	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.	Day 0, Month 1, Month 3 and Month 6
Secondary	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.	Day 0, Month 1, Month 3 and Month 6
Secondary	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?	Day 0, Month 1, Month 3 and Month 6
Secondary	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.	Day 0, Month 1, Month 3 and Month 6
Secondary	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.	Day 0, Month 1, Month 3 and Month 6