Motivational Interviews Post Hospitalisation on Maintaining AbstiNence for 1 Year après le Sevrage en Alcool
IMMANENCE
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
1 other identifier
interventional
104
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 24, 2024
CompletedFirst Posted
Study publicly available on registry
October 1, 2024
CompletedStudy Start
First participant enrolled
December 18, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 13, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 13, 2028
June 18, 2026
June 1, 2026
3.1 years
September 24, 2024
June 17, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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.
From inclusion,once a month for 1 year
Secondary Outcomes (8)
Relapse rates at 5 and 12 months
From inclusion,once a month for 1 year
Cumulative duration (in days) and maximum duration of abstinence over 5 and 12 months
Assessed 5 months after inclusion and 12 months after inclusion
Motivation to maintain abstinence
Assessed 0 month, 5 months and 12 months after inclusion
Craving felt
Assessed 0 month, 5 months and 12 months after inclusion
Effectiveness of coping strategies
Assessed 0 month, 5 months and 12 months after inclusion
- +3 more secondary outcomes
Study Arms (2)
Experimental group : PSH (usual care) with motivational interviewing
EXPERIMENTALPeople 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.
Control group : PSH (usual care)
NO INTERVENTIONPeople randomised to the control group will have scheduled appointments for study-related data collection (monthly assessment), in addition to their routine care.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Thomas RISDORFER DE ISSDENTZI
Montpellier, 3400, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 24, 2024
First Posted
October 1, 2024
Study Start
December 18, 2024
Primary Completion (Estimated)
January 13, 2028
Study Completion (Estimated)
January 13, 2028
Last Updated
June 18, 2026
Record last verified: 2026-06