An interventional study of Experimental group : PSH (usual care) with motivational interviewing in Alcohol Use Disorder, Addiction and Alcohol Withdrawal, sponsored by University Hospital, Montpellier. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-18.
Sponsored by University Hospital, Montpellier · Not applicable, Interventional, and Supportive care
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 :
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.
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.
1,674 studies on the registry are indexed under Alcoholism; 331 are open to participants now.
This study's planned enrollment of 104 is above the median of 88 across 1,428 interventional studies indexed under Alcoholism.
Browse Alcoholism studies →University Hospital, Montpellier is the lead sponsor of 1,261 studies on the registry; 224 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: Experimental group : PSH (usual care) with motivational interviewing
People randomised to the control group will have scheduled appointments for study-related data collection (monthly assessment), in addition to their routine care.
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.
Percentage of days of abstinence over the 12 months following hospitalization for alcohol
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.
Time frame: From inclusion,once a month for 1 year
Relapse rates at 5 and 12 months
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.
Time frame: From inclusion,once a month for 1 year
Cumulative duration (in days) and maximum duration of abstinence over 5 and 12 months
These cumulative and maximum periods of abstinence will be based on the consumption calendar collected using the Timeline Follow Back method.
Time frame: Assessed 5 months after inclusion and 12 months after inclusion
Motivation to maintain abstinence
Assessed using the Stages of Change Readiness and Treatment Eagerness Scale questionnaire
Time frame: Assessed 0 month, 5 months and 12 months after inclusion
Craving felt
Assessed using the Obsessive Compulsive Drinking Scale
Time frame: Assessed 0 month, 5 months and 12 months after inclusion
Effectiveness of coping strategies
Assessed using the Way og Coping Checklist questionnaire
Time frame: Assessed 0 month, 5 months and 12 months after inclusion
Level of anxiety/depression
Assessed using the Hospital Anxiety and Depression scale questionnaire
Time frame: Assessed 0 month, 5 months and 12 months after inclusion
Sense of personal effectiveness
Assessed using the Sherer General Self-Efficacy Scale
Time frame: Assessed 0 month, 5 months and 12 months after inclusion
Use of other substances
Collection of data declarative data on consumption and quantification in the previous month
Time frame: Assessed 0 month, 5 months and 12 months after inclusion
Plan to share: Undecided
No publications or documents are linked to this record.
Started Dec 2024 (actual). Primary completion is estimated for Jan 2028, 36 months after the start.
Of 470 non-industry interventional studies with no phase under Alcoholism, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 55. This study's planned 36 months is close to that.
Counting every sponsor, half of 493 studies reached it within 33 months; a quarter within 17 and three quarters within 53.
How these figures are worked out, and which studies are left out of them.
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