Motivational Interviews Post Hospitalisation on Maintaining AbstiNence for 1 Year après le Sevrage en Alcool

NCT ID: NCT06618755

Last Updated: 2025-01-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-18
• Study Completion Date: 2026-09-01

Brief Summary

The aim of this clinical study is to evaluate the efficacy of reinforced inpatient aftercare versus usual care on the percentage of days of abstinence during the first year following withdrawal in adults with alcohol use disorders undergoing inpatient withdrawal. The hypothesis is that reinforced post-withdrawal follow-up, of the motivational interview type, during the first 4 months following hospitalisation, in addition to the usual care, would allow :

• Increase the percentage of days of abstinence in the year following withdrawal.
• Reduce the rate of relapse in the year following withdrawal.
• An increase in the cumulative and maximum duration of abstinence, an increase in motivation to maintain the change initiated and a reduction in the use of other substances in the year following withdrawal.
• A reduction in the impact of risk factors involved in the relapse process in the year following withdrawal.

All participants will have assessments to monitor their abstinence and consumption. In addition to their assessments, the experimental group will have motivational talks once every 15 days.

Detailed Description

In Europe, and particularly in France, there is a high level of alcohol consumption per capita (2.51 standard drinks/day/inhabitant in France in 2019). This consumption is not without risk, since 7% of all deaths in France in 2015 were attributable to alcohol, not to mention disabling pathologies and injuries. The treatment of alcohol addiction has many facets (social, neurological, psychological, behavioural, etc.) and involves a number of stages. One aspect that is particularly decisive in the consolidation phase of withdrawal (the phase following withdrawal when the risk of relapse is high) is the motivational dimension, which is widely described in the literature. Motivational Interviewing (MI) is a particularly effective tool for initiating and maintaining change. This tool, provided on a regular basis after discharge from hospital, helps to reinforce and maintain abstinence, a change initiated by users at the time of withdrawal.

Conditions

Alcohol Use Disorder; Addiction; Alcohol Withdrawal; Motivational Interviews; Relapse

Study Design

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

Study Groups

Experimental group : PSH (usual care) with motivational interviewing

People randomised to the experimental group will have scheduled appointments to collect study data (monthly assessment). They will take part in an initial motivational interview to lay the foundations for the work that will be carried out throughout the follow-up period. Then, for 4 and a half months, a motivational interview will be scheduled every 14 days.

Group Type: EXPERIMENTAL

Experimental group : PSH (usual care) with motivational interviewing

Intervention Type: OTHER

The experimental group will begin follow-up after the 1st inclusion visit, during hospitalisation for withdrawal. The first motivational interview will take place 1 to 4 days before discharge from full hospitalisation. The following 10 motivational interviews will be held 2 weeks apart and will follow a framework based on the following objectives: to create a relationship of trust and an effective and lasting therapeutic alliance from the first interview; to create personalised objectives for the user, in line with their addictive pathology; to support the user as they modify, 'fail' and 'succeed' in achieving these objectives; to encourage the emergence and maintenance of the user's desire to change.

Control group : PSH (usual care)

People randomised to the control group will have scheduled appointments for study-related data collection (monthly assessment), in addition to their routine care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Experimental group : PSH (usual care) with motivational interviewing

The experimental group will begin follow-up after the 1st inclusion visit, during hospitalisation for withdrawal. The first motivational interview will take place 1 to 4 days before discharge from full hospitalisation. The following 10 motivational interviews will be held 2 weeks apart and will follow a framework based on the following objectives: to create a relationship of trust and an effective and lasting therapeutic alliance from the first interview; to create personalised objectives for the user, in line with their addictive pathology; to support the user as they modify, 'fail' and 'succeed' in achieving these objectives; to encourage the emergence and maintenance of the user's desire to change.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• With alcohol use disorders defined by at least 2 DSM-V criteria for at least 12 months).
• Being treated for withdrawal in hospital.
• With a goal of complete abstinence.
• With a means of communication (telephone).

Exclusion Criteria

• Lack of understanding (written and spoken) of the French language.
• Breach of HC withdrawal contract, following failure to comply with the rules of the addictology service and somatic complications of addiction.
• Eviction from the department, discharge against medical advice during hospitalisation for withdrawal.
• Proven cognitive problems compromising understanding of the implications of the study and the proposed follow-up. proposed follow-up.
• Serious decompensated somatic pathology.
• Non-membership or non-beneficiaries of a national health insurance scheme.
• Person protected by law, under guardianship or curatorship.
• Not having signed free and informed consent to participate in the research.
• Simultaneous participation in another clinical trial.

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

Sponsors

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Thomas RISDORFER DE ISSDENTZI

Montpellier, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Thomas RISDORFER DE ISSDENTZI

Role: CONTACT

t-risdorferdeissdentzi@chu-montpellier.fr

04 67 33 70 20 ext. +33

Facility Contacts

Thomas RISDORFER DE ISSDENTZI

Role: primary

t-risdorferdeissdentzi@chu-montpellier.fr

04 67 33 70 20

Other Identifiers

RECHMPL22_0564

Identifier Type: -

Identifier Source: org_study_id