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).
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. The secondary objectives include evaluating the impact of the MSC program on reducing alcohol consumption by comparing the number of heavy drinking days at one and three months, as well as the total number of drinking days at one, three, and six months between groups using the TLFB method. Biomarkers CDT and GGT will be analyzed at one, three, and six months post-intervention to compare blood values. The program's impact on psychological and behavioral factors will also be assessed using standardized scales at one, three, and six months. Finally, program satisfaction and adherence will be measured using the CSQ-8 scale, session attendance rates, and the percentage of program completion (≥6/8 MSC sessions). Research Hypothesis : Alcohol consumption will be significantly reduced in the group of patients who complete the MSC program compared to the group receiving only standard treatment (Treatment As Usual: TAU). Method : This is a prospective, randomized, controlled, multicenter, single-blind, parallel-group interventional study RIPH2 (French interventional research category). The study follows the CONsolidated Standards of Reporting Trials (CONSORT) 2010 guidelines, updated in 2025. Adult outpatients with AUD (ICD-10 and DSM-5 criteria) will be included after verification of eligibility criteria and the collection of informed consent. Participants will be randomized to one of the following groups: * MSC+TAU group: receiving self-compassion training with the MSC program in addition to standard treatment * TAU group: receiving only standard treatment Each participant will complete 13 visits over 9 months. The MSC+TAU group will attend 9 MSC sessions and 9 TAU sessions (18 sessions in total), while the TAU group will attend 18 TAU sessions. Follow-up assessments will take place at 1, 3, and 6 months after the final session. Participants will exit the study after 245 days (9 months) of follow-up. The study aims to recruit 152 participants over 24 months across three centers (EPS Barthélemy Durand, Paul Brousse University Hospital, EPSM de l'Oise, CHI Montdidier), with an expected start date of October 2025 and a total study duration of 36 months. Expected public health impact : Self-compassion training with the MSC program is expected to significantly reduce alcohol consumption in individuals with AUD. If the results are positive, the MSC program could facilitate alcohol reduction, potentially lowering the risk of alcohol-related disorders, particularly alcohol-induced cancers (e.g., larynx, pharynx, esophagus, breast, liver, bladder, etc.). Perspectives : If effective, the MSC self-compassion training program could be implemented in clinical practice to help patients with AUD who are not yet ready to quit drinking but need a supportive approach to reduce their alcohol consumption.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
152
The MSC self-compassion program will be delivered by instructors trained by the LBCM Organization, certified Qualiopi and affiliated to the ADM (accredited training organization). The MSC program consists of 8 weekly sessions, each 2.5 hours long, plus an additional half-day of supplementary practice .
Current treatment strategies for Alcohol Use Disorders (AUD) rely on a combination of pharmacological and psychotherapeutic treatments (Schuckit, 2009). The three specialized outpatient centers participating in our study provide comprehensive and up-to-date addiction care that meets international and national recommendations (HAS, 2023; SFA, 2023). The services offered, in addition to standard care, include: Brief interventions, Psychoeducation sessions, Motivational interview, Individual and group therapies for patients (cognitive-behavioral therapies, cognitive remediation, relaxation techniques), Individual and group therapies for families, Psychosocial interventions, including social support and strengthening of psychosocial skills, Peer support groups (peer helpers, expert patients, former user groups)
Etablissement Public de Santé Barthélemy Durand
Étampes, France
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
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
Time frame: 6 months
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.
Comparison of the number of heavy drinking days, assessed using the TLFB method, one and three months after the intervention between the MSC+TAU and TAU groups.
Time frame: 1 months, 3 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.
Comparison of the number of alcohol consumption days, assessed using the TLFB method, one, three, and six months after the intervention between the MSC+TAU and TAU groups.
Time frame: 1 months, 3 months, 6 months
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.
Comparison of blood levels of the biological markers Carbohydrate-Deficient Transferrin (CDT), one, three, and six months after the intervention between the MSC+TAU and TAU groups.
Time frame: 1 months, 3 months, 6 months
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.
Comparison of blood levels of the biological marker Gamma-Glutamyl Transferase (GGT), one, three, and six months after the intervention between the MSC+TAU and TAU groups.
Time frame: 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.
Comparison of mean scores obtained on the Alcohol Use Disorders Identification Test (AUDIT, French translation by Gache et al., 2005) at one, three, and six months after the intervention in the MSC+TAU and TAU groups.
Time frame: 1 month, 3 month, 6 month
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.
Comparison of mean scores obtained on the Self-Compassion Scale (SCS, French translation by Kotsou et al., 2016) at one, three, and six months after the intervention between the MSC+TAU and TAU groups.
Time frame: 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.
Comparison of mean scores obtained on the Hospital Anxiety and Depression Scale (HAD, French translation by Lepine et al., 2000) at one, three, and six months after the intervention between the MSC+TAU and TAU groups.
Time frame: 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.
Comparison of mean scores obtained on the Self-Stigma Scale - Short Form (SSS-S, French translation by Golay et al., 2022) at one, three, and six months after the intervention between the MSC+TAU and TAU groups.
Time frame: 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.
Comparison of mean scores obtained on the Test of Self-Conscious Affect evaluating shame and guilt (French-TOSCA-3, French translation by Nugier et al., 2012) at one, three, and six months after the intervention between the MSC+TAU and TAU groups.
Time frame: 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.
Comparison of mean scores obtained on the Alcohol Quality of Life Scale (AQoLS, French translation by Luquiens et al., 2015) at one, three, and six months after the intervention between the MSC+TAU and TAU groups.
Time frame: 1 month, 3 month, 6 month
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.
Comparison of mean scores obtained on the Mindfulness Attention Awareness Scale (MAAS, French translation by Jermann, 2009) at one, three, and six months after the intervention between the MSC+TAU and TAU groups.
Time frame: 1 month, 3 month, 6 month
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.
Comparison of mean scores obtained on the Visual Analog Scale for Craving (EVA, Mottola, 1993) at one, three, and six months after the intervention between the MSC+TAU and TAU groups.
Time frame: 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.
Comparison of mean scores obtained on the Fagerström Test for Nicotine Dependence (Fagerström, French translation by WHO, Etter et al., 1999) at one, three, and six months after the intervention between the MSC+TAU and TAU groups.
Time frame: 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.
Comparison of mean scores obtained on the Test of Cannabis Use Disorders Identification Test - Revised (CUDIT-R, French translation by Luquiens et al., 2021) at one, three, and six months after the intervention between the MSC+TAU and TAU groups.
Time frame: 1 month, 3 month, 6 month
Assess satisfaction with the MSC program among individuals with AUD.
Participant satisfaction, measured using the Client Satisfaction Questionnaire (CSQ-8)
Time frame: 6 months
Assess adherence to the MSC program among individuals with AUD.
Program adherence, assessed by the percentage of sessions attended by each participantn and Percentage of participants who completed the program, defined as attending at least 6 out of 8 sessions
Time frame: 6 months
Manon BAYLE--BERARD, Clinical Research Associate
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