Can Selfcompassion Training Reduce Alcohol Consumption in Patients With Alcohol Use Disosrder ? (COMPAL)

August 12, 2025 updated by: Etablissement Public de Santé Barthélemy Durand

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
152

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Étampes, France, 91150
        • Etablissement Public de Santé Barthélemy Durand
        • Principal Investigator:
          • Amine Benyamina
        • Principal Investigator:
          • Alain DERVAUX
        • Principal Investigator:
          • Bernard ANGERVILLE
        • Contact:
        • Contact:
        • Principal Investigator:
          • Marie-cécile BRALET
        • Principal Investigator:
          • Marc MOINAS
        • Sub-Investigator:
          • Laura KREMERS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Behavioral: Mindful Self-Compassion program

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 .

Behavioral: Treatment As Usual (TAU) program

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)
Active Comparator: Treatment As Usual (TAU)
Participants in this group will attend 18 sessions of Treatment As Usual (TAU) during the intervention period.
Behavioral: Treatment As Usual (TAU) program

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)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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.
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
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.
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
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.
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]
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
1 month, 3 month, 6 month
Assess satisfaction with the MSC program among individuals with AUD.
Time Frame: 6 months
Participant satisfaction, measured using the Client Satisfaction Questionnaire (CSQ-8)
6 months
Assess adherence to the MSC program among individuals with AUD.
Time Frame: 6 months
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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Etablissement Public de Santé Barthélemy Durand

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Alain DERVAUX, Etablissement Public de Santé Barthélemy Durand

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

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Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 7, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 12, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 20, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 20, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 12, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 23P04
  • 2025-A00584-45 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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