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

Official title

IMMANENCE - Intérêt d'un Suivi Sous Forme d'Entretiens Motivationnels spécifiques Post Hospitalisation Sur le Maintien de l'AbstiNENCE Durant l'année Suivant le Sevrage en Alcool

Overview

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.

Interventions

• Other 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 th

Primary outcome measures

• Percentage of days of abstinence over the 12 months following hospitalization for alcohol [Time frame: From inclusion,once a month for 1 year]

Secondary outcome measures (8)

• Relapse rates at 5 and 12 months [Time frame: From inclusion,once a month for 1 year]
• Cumulative duration (in days) and maximum duration of abstinence over 5 and 12 months [Time frame: Assessed 5 months after inclusion and 12 months after inclusion]
• Motivation to maintain abstinence [Time frame: Assessed 0 month, 5 months and 12 months after inclusion]
• Craving felt [Time frame: Assessed 0 month, 5 months and 12 months after inclusion]
• Effectiveness of coping strategies [Time frame: Assessed 0 month, 5 months and 12 months after inclusion]
• Level of anxiety/depression [Time frame: Assessed 0 month, 5 months and 12 months after inclusion]
• Sense of personal effectiveness [Time frame: Assessed 0 month, 5 months and 12 months after inclusion]
• Use of other substances [Time frame: Assessed 0 month, 5 months and 12 months after inclusion]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

France · 1 center

• Thomas RISDORFER DE ISSDENTZI — Montpellier

Identifiers

NCT: NCT06618755 · RECHMPL22_0564

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗