Can Selfcompassion Training Reduce Alcohol Consumption in Patients With Alcohol Use Disosrder ? Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 152
- 试验地点
- 1
- 主要终点
- Assess the effectiveness of the Mindful Self-Compassion (MSC) program in reducing alcohol consumption in a population with Alcohol Use Disorder (AUD) six months after the intervention
研究概览
简要总结
The objective of this interventional study is to evaluate the effectiveness of the Mindful Self-Compassion (MSC) program in reducing alcohol consumption in a population of individuals with Alcohol Use Disorder (AUD), six months after the intervention. The MSC program was designed to enhance self-compassion skills. It has demonstrated a mediating effect on symptoms of stress, depression, and anxiety, which are known to contribute to the maintenance of AUD.
Outpatients with AUD will be included after providing informed consent and will be randomized into two groups (MSC+TAU vs TAU). The follow-up includes 13 visits over a 9-month period, with group sessions according to allocation. Three follow-up visits are scheduled up to six months after the end of the sessions. Participants will complete several scales and surveys (AUDIT, TLFB, SCS, HAD, SSS-S, TOSCA-3, AQoLS, MAAS, Fagerström, CUDIT-R, EVA craving).
详细描述
Context:
Alcohol Use Disorders (AUD, ICD-10, DSM-5) affect more than 11% of men and 3% of women in France, leading to over 200 diseases and 41,000 deaths annually, primarily due to alcohol-related cancers. The current management of patients with AUD is based on a combination of pharmacological and psychotherapeutic treatments. However, 60% of patients at 6 months and 70% at 1 year fail to significantly reduce their alcohol consumption or maintain abstinence. Therefore, it is crucial to explore new complementary therapeutic strategies.
Self-compassion involves treating oneself with the same kindness, attention, and understanding that we extend to others in times of suffering. Several studies suggest that self-compassion is a key factor in promoting proactive health behaviors and improving adherence in conditions such as diabetes, HIV-related illnesses, and schizophrenia. Individuals with AUD tend to have lower levels of self-compassion compared to the general population, whereas higher levels of self-compassion have shown protective effects against the development and persistence of AUD.
Objectives :
The primary objective is to evaluate the effectiveness of the Mindful Self-Compassion (MSC) program in reducing alcohol consumption among individuals with AUD, measured by the number of heavy drinking days assessed using the Timeline Follow-Back (TLFB) method, six months after treatment completion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 to 75 years.
- •Subjects meeting DSM-5 criteria for Alcohol Use Disorder (AUD).
- •Subjects receiving outpatient care in addiction services, CSAPA, CMP, day hospitals, mental health care institutions, community mental health centers.
- •Subjects affiliated with the social security system.
- •Subjects who have a good understanding of French languague, allowing them to provide informed consent, respond to self-questionnaires, and participate in the MSC program.
排除标准
- •Subjects unable to understand the questionnaires.
- •Subjects presenting moderate or severe suicidal ideation (assessed by the Suicide item of the MINI scale).
- •Subjects with a score <10 on the MoCA version 7.1 test.
- •Subjects admitted to inpatient units (since hospitalization alters alcohol consumption).
- •Subjects unable to provide informed or voluntary consent to participate in the study.
- •Subjects under guardianship or curatorship.
研究组 & 干预措施
Mindful Self-Compassion (MSC) program + Treatment As Usual (TAU)
Participants in this group will attend 9 group sessions of the Mindful Self-Compassion (MSC) program in addition to 9 sessions of Treatment As Usual (TAU), for a total of 18 sessions during the intervention period.
干预措施: Mindful Self-Compassion program (Behavioral)
Mindful Self-Compassion (MSC) program + Treatment As Usual (TAU)
Participants in this group will attend 9 group sessions of the Mindful Self-Compassion (MSC) program in addition to 9 sessions of Treatment As Usual (TAU), for a total of 18 sessions during the intervention period.
干预措施: Treatment As Usual (TAU) program (Behavioral)
Treatment As Usual (TAU)
Participants in this group will attend 18 sessions of Treatment As Usual (TAU) during the intervention period.
干预措施: Treatment As Usual (TAU) program (Behavioral)
结局指标
主要结局
Assess the effectiveness of the Mindful Self-Compassion (MSC) program in reducing alcohol consumption in a population with Alcohol Use Disorder (AUD) six months after the intervention
时间窗: 6 months
The primary outcome measure is the number of heavy drinking days, assessed using the Timeline Follow-Back (TLFB) method, six months after the end of treatment, in both the MSC+Treatment as Usual (TAU) intervention group and the TAU control group
次要结局
- Evaluate the effectiveness of the MSC program on self-compassion levels in a population of individuals with AUD, at one, three, and six months after the intervention.(1 month, 3 month, 6 month)
- Evaluate the effectiveness of the MSC program on self-stigmatization levels in a population of individuals with AUD, at one, three, and six months after the intervention.(1 month, 3 month, 6 month)
- Assess the effectiveness of the MSC program in reducing alcohol consumption in a population of individuals with AUD one and three months after the intervention.(1 months, 3 months)
- Evaluate the effectiveness of the MSC program on craving levels in a population of individuals with AUD, at one, three, and six months after the intervention.(1 month, 3 month, 6 month)
- Assess satisfaction with the MSC program among individuals with AUD.(6 months)
- Assess adherence to the MSC program among individuals with AUD.(6 months)
- Assess the effectiveness of the MSC program in reducing the number of alcohol consumption days in a population of individuals with AUD one, three, and six months after the intervention.(1 months, 3 months, 6 months)
- Evaluate the effectiveness of the MSC program on mean scores for the Alcohol Use Disorders Identification Test (AUDIT) in a population of individuals with AUD one, three, and six months after the intervention.(1 month, 3 month, 6 month)
- Evaluate the effectiveness of the MSC program on depression and anxiety levels in a population of individuals with AUD, at one, three, and six months after the intervention.(1 month, 3 month, 6 month)
- Evaluate the effectiveness of the MSC program on shame and guilt levels in a population of individuals with AUD, at one, three, and six months after the intervention.(1 month, 3 month, 6 month)
- Evaluate the effectiveness of the MSC program on quality of life levels in a population of individuals with AUD, at one, three, and six months after the intervention.(1 month, 3 month, 6 month)
- Evaluate the effectiveness of the MSC program on tobacco use in a population of individuals with AUD, at one, three, and six months after the intervention.(1 month, 3 month, 6 month)
- Assess the effectiveness of the MSC program in reducing alcohol consumption in a population of individuals with AUD one, three, and six months after the intervention.(1 months, 3 months, 6 months])
- Evaluate the effectiveness of the MSC program on mindfulness levels in a population of individuals with AUD, at one, three, and six months after the intervention.(1 month, 3 month, 6 month)
- Evaluate the effectiveness of the MSC program on cannabis use in a population of individuals with AUD, at one, three, and six months after the intervention.(1 month, 3 month, 6 month)
- Assess the effectiveness of the MSC program in reducing alcohol consumption in a population of individuals with AUD one, three, and six months after the intervention.(1 months, 3 months, 6 months)