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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Percentage of days of abstinence over the 12 months following hospitalization for alcohol
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
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.
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.
干预措施: Experimental group : PSH (usual care) with motivational interviewing (Other)
结局指标
主要结局
Percentage of days of abstinence over the 12 months following hospitalization for alcohol
时间窗: 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.
次要结局
- Relapse rates at 5 and 12 months(From inclusion,once a month for 1 year)
- Level of anxiety/depression(Assessed 0 month, 5 months and 12 months after inclusion)
- 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)
- Sense of personal effectiveness(Assessed 0 month, 5 months and 12 months after inclusion)
- Use of other substances(Assessed 0 month, 5 months and 12 months after inclusion)