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)
- Conditions
- Addiction, Alcohol
- Interventions
- Other: Routine CareOther: Motivational interview
- Registration Number
- NCT04881500
- Lead Sponsor
- University Hospital, Brest
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 83
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Routine Care 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. Motivational interview 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.
- Primary Outcome Measures
Name Time Method Ability of patients to control their own alcohol consumption Day 0 to Month 6 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
Name Time Method Severity of alcohol use disorders Day 0, Month 1, Month 3 and Month 6 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 quality of life Day 0, Month 1, Month 3 and Month 6 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.
Evaluation of severity of alcohol use disorders Day 0, Month 1, Month 3 and Month 6 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.
Evaluation of alcohol use Day 0, Month 1, Month 3 and Month 6 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 Day 0, Month 1, Month 3 and Month 6 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.
Limitation of alcohol consumption Day 0, Month 1, Month 3 and Month 6 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?
Trial Locations
- Locations (6)
Guillou Landreat
🇫🇷Brest, France
SIMSON Jean-Pierre
🇫🇷Brest, France
LE RESTE Jean-Yves
🇫🇷Lanmeur, France
BARAIS Marie
🇫🇷Lannilis, France
ROZEC Pascale
🇫🇷Landerneau, France
LE GOFF Delphine
🇫🇷Landerneau, France