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NCT Number: NCT06618755

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

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.

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Key information

Conditions

Alcohol Use Disorder Addiction Alcohol Withdrawal Alcohol-Related Disorders Alcoholism Behavior Behavior, Addictive Chemically-Induced Disorders Compulsive Behavior Disease Attributes Impulsive Behavior Mental Disorders Motivational Interviews Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Relapse Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Thomas RISDORFER DE ISSDENTZI

Montpellier, 3400, France

Location status: Recruiting

Location contact

Thomas RISDORFER DE ISSDENTZI

CONTACT

[email protected]

04 67 33 70 20

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Experimental group : PSH (usual care) with motivational interviewing

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.

Primary outcomes

  1. Percentage of days of abstinence over the 12 months following hospitalization for alcohol

    Time frame: From inclusion,once a month for 1 year

    The measures used for our main criterion will be declarative and collected on paper and by telephone every month in terms of the number of drinks per day. To facilitate data collection, the Timeline Follow Back method [30], developed by Sobell and also validated by telephone, will be used. This tool enables estimates of daily consumption of standard glasses to be collected retrospectively (for up to 12 months). The advantage of this method is that it reduces recall bias, since the participant can fill in a calendar from day to day and the data are collected every month.

Secondary outcomes

  1. Relapse rates at 5 and 12 months

    Time frame: From inclusion,once a month for 1 year

    Percentage of patients who have relapsed (above WHO recommendations for low-risk drinking) at least once in the 5 and 12 months following hospitalisation for alcohol withdrawal. This relapse rate will be calculated on the basis of the consumption schedule collected using the method presented for the primary endpoint.

    As a reminder, the recommendations for lower-risk drinking are as follows:

    • No more than 10 standard drinks per week
    • No more than 2 standard drinks per day
    • Have days of the week when no alcohol is consumed.

  2. 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

    These cumulative and maximum periods of abstinence will be based on the consumption calendar collected using the Timeline Follow Back method.

  3. Motivation to maintain abstinence

    Time frame: Assessed 0 month, 5 months and 12 months after inclusion

    Assessed using the Stages of Change Readiness and Treatment Eagerness Scale questionnaire

  4. Craving felt

    Time frame: Assessed 0 month, 5 months and 12 months after inclusion

    Assessed using the Obsessive Compulsive Drinking Scale

  5. Effectiveness of coping strategies

    Time frame: Assessed 0 month, 5 months and 12 months after inclusion

    Assessed using the Way og Coping Checklist questionnaire

  6. Level of anxiety/depression

    Time frame: Assessed 0 month, 5 months and 12 months after inclusion

    Assessed using the Hospital Anxiety and Depression scale questionnaire

  7. Sense of personal effectiveness

    Time frame: Assessed 0 month, 5 months and 12 months after inclusion

    Assessed using the Sherer General Self-Efficacy Scale

  8. Use of other substances

    Time frame: Assessed 0 month, 5 months and 12 months after inclusion

    Collection of data declarative data on consumption and quantification in the previous month

Study contacts

Contact information is provided by the study sponsor or research team.

Thomas RISDORFER DE ISSDENTZI

CONTACT

[email protected]

04 67 33 70 20 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study 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

Acronym: IMMANENCE

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Oct 1, 2024
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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