AddictionCOMPALNCT07131124
Can Selfcompassion Training Reduce Alcohol Consumption in Patients With Alcohol Use Disosrder ?
A study testing Mindful Self-Compassion program and Treatment As Usual (TAU) program in people with Addiction and Addiction Disorders, run by Etablissement Public de Santé Barthélemy Durand at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Addiction, Addiction Disorders, Alcohol Use Disorders
- What is being tested?
- Mindful Self-Compassion program and Treatment As Usual (TAU) program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2025to Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Manon BAYLE--BERARD, Clinical Research Associate contact
France1 site
Etablissement Public de Santé Barthélemy Durand
Étampes, 91150
Adélaïde ADUAYI, Project Manager, +33 175021681, Adelaide.Aduayi@eps-etampes.fr
Manon BAYLE--BERARD, Clinical Research Associate, +33 1 69 92 52 52, manon.bayle--berard@eps-etampes.fr
About this study
Official title: Can Selfcompassion Training Reduce Alcohol Consumption in Patients With Alcohol Use Disosrder ? Randomized Controlled Trial
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).
Read the detailed description
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.
- Being tested
- Mindful Self-Compassion program, Treatment As Usual (TAU) program
- Keywords
- Self-compassion, Alcohol Use Disorders
- Medical subject headings
- Behavior, Addictive, Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindful Self-Compassion programBehavioural
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 .
Treatment As Usual (TAU) programBehavioural
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)
| Study group | Role | What they receive |
|---|---|---|
| Mindful Self-Compassion (MSC) program + Treatment As Usual (TAU) | Experimental | 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. Receives: Behavioral: Mindful Self-Compassion program; Behavioral: Treatment As Usual (TAU) program |
| Treatment As Usual (TAU) | Active comparator | Participants in this group will attend 18 sessions of Treatment As Usual (TAU) during the intervention period. Receives: Behavioral: Treatment As Usual (TAU) program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (16)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2025
- Study startOct 2025 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for AddictionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Etablissement Public de Santé Barthélemy Durand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alain DERVAUX, Principal investigator, Etablissement Public de Santé Barthélemy Durand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07131124
- Sponsor's protocol ID
- 23P04
- Other IDs
- 2025-A00584-45
- Acronym
- COMPAL
- Status last verified
- Aug 2025
- First submitted
- 7 Aug 2025
- Last updated
- 20 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chen, G. (2019). The Role of Self-Compassion in Recovery from Substance Use Disorders. Obm Icm, 4, 1-1.
Fond G, Boyer L, Boucekine M, Aden LA, Schurhoff F, Tessier A, Andrianarisoa M, Berna F, Brunel L, Capdevielle D, Chereau I, Mallet J, Denizot H, Dorey JM, Dubertret C, Dubreucq J, Faget C, Gabayet F, Rey R, Richieri R, Passerieux C, Schandrin A, Urbach M, Vidailhet P, Llorca PM, Misdrahi D; FACE-SZ (FondaMental Academic Centers of Expertise for Schizophrenia) group. Validation study of the Medication Adherence Rating Scale. Results from the FACE-SZ national dataset. Schizophr Res. 2017 Apr;182:84-89. doi: 10.1016/j.schres.2016.10.023. Epub 2016 Oct 24.
PubMed 27789187Neff KD, Germer CK. A pilot study and randomized controlled trial of the mindful self-compassion program. J Clin Psychol. 2013 Jan;69(1):28-44. doi: 10.1002/jclp.21923. Epub 2012 Oct 15.
PubMed 23070875Neff KD. Self-Compassion: Theory, Method, Research, and Intervention. Annu Rev Psychol. 2023 Jan 18;74:193-218. doi: 10.1146/annurev-psych-032420-031047. Epub 2022 Aug 12.
PubMed 35961039
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Selfcompassion Training Reduce Alcohol Consumption in Patients With Alcohol Use Disosrder ? Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07131124
- Acronym / sponsor ID
- COMPAL / 23P04
- Keywords
- Self-compassion, Alcohol Use Disorders
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- Etablissement Public de Santé Barthélemy DurandUniversity, hospital or other
- Study start
- Oct 2025 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 20 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindful Self-Compassion (MSC) program + Treatment As Usual (TAU) | Experimental | Behavioral: Mindful Self-Compassion program, Behavioral: Treatment As Usual (TAU) programParticipants 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. |
| Treatment As Usual (TAU) | Active comparator | Behavioral: Treatment As Usual (TAU) programParticipants in this group will attend 18 sessions of Treatment As Usual (TAU) during the intervention period. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindful Self-Compassion programThe 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 . | Behavioural | Mindful Self-Compassion (MSC) program + Treatment As Usual (TAU) |
| Treatment As Usual (TAU) programCurrent 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) | Behavioural | Mindful Self-Compassion (MSC) program + Treatment As Usual (TAU), Treatment As Usual (TAU) |
Primary outcome
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
Time frame: 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
16 secondary outcomes
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Time frame: 1 month, 3 month, 6 month
Assess satisfaction with the MSC program among individuals with AUD.
Time frame: 6 months
Assess adherence to the MSC program among individuals with AUD.
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2025.
- BackgroundChen, G. (2019). The Role of Self-Compassion in Recovery from Substance Use Disorders. Obm Icm, 4, 1-1.
- Background: PubMed 27789187Fond G, Boyer L, Boucekine M, Aden LA, Schurhoff F, Tessier A, Andrianarisoa M, Berna F, Brunel L, Capdevielle D, Chereau I, Mallet J, Denizot H, Dorey JM, Dubertret C, Dubreucq J, Faget C, Gabayet F, Rey R, Richieri R, Passerieux C, Schandrin A, Urbach M, Vidailhet P, Llorca PM, Misdrahi D; FACE-SZ (FondaMental Academic Centers of Expertise for Schizophrenia) group. Validation study of the Medication Adherence Rating Scale. Results from the FACE-SZ national dataset. Schizophr Res. 2017 Apr;182:84-89. doi: 10.1016/j.schres.2016.10.023. Epub 2016 Oct 24.
- Background: PubMed 23070875Neff KD, Germer CK. A pilot study and randomized controlled trial of the mindful self-compassion program. J Clin Psychol. 2013 Jan;69(1):28-44. doi: 10.1002/jclp.21923. Epub 2012 Oct 15.
- Background: PubMed 35961039Neff KD. Self-Compassion: Theory, Method, Research, and Intervention. Annu Rev Psychol. 2023 Jan 18;74:193-218. doi: 10.1146/annurev-psych-032420-031047. Epub 2022 Aug 12.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Manon BAYLE--BERARD, Clinical Research Associate contact
Alain DERVAUX principal investigator
Etablissement Public de Santé Barthélemy Durand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindful Self-Compassion program and Treatment As Usual (TAU) program in people with Addiction and Addiction Disorders, run by Etablissement Public de Santé Barthélemy Durand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Adélaïde ADUAYI, Clinical Project Manager (+33 1 75 02 16 81, adelaide.aduayi@eps-etampes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07131124, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2025.