NCT07131124

Brief 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. 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).

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
152

participants targeted

Target at P75+ for not_applicable

Timeline
17mo left

Started Oct 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress30%
Oct 2025Oct 2027

First Submitted

Initial submission to the registry

August 7, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 20, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

August 20, 2025

Status Verified

August 1, 2025

Enrollment Period

1 year

First QC Date

August 7, 2025

Last Update Submit

August 12, 2025

Conditions

Keywords

Self-compassionAlcohol Use Disorders

Outcome Measures

Primary Outcomes (1)

  • 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

    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.

    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.

    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.

    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.

    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

  • +11 more secondary outcomes

Study Arms (2)

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.

Behavioral: Mindful Self-Compassion programBehavioral: 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.

Behavioral: Treatment As Usual (TAU) program

Interventions

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 .

Mindful Self-Compassion (MSC) program + Treatment As Usual (TAU)

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)

Mindful Self-Compassion (MSC) program + Treatment As Usual (TAU)Treatment As Usual (TAU)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Etablissement Public de Santé Barthélemy Durand

Étampes, 91150, France

Location

Related Publications (4)

  • Chen, G. (2019). The Role of Self-Compassion in Recovery from Substance Use Disorders. Obm Icm, 4, 1-1.

    BACKGROUND
  • 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.

    PMID: 27789187BACKGROUND
  • Neff 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.

    PMID: 23070875BACKGROUND
  • Neff 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.

    PMID: 35961039BACKGROUND

MeSH Terms

Conditions

Behavior, AddictiveAlcoholism

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Compulsive BehaviorImpulsive BehaviorBehaviorAlcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Alain DERVAUX

    Etablissement Public de Santé Barthélemy Durand

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Adélaïde ADUAYI, Clinical Project Manager

CONTACT

Manon BAYLE--BERARD, Clinical Research Associate

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2025

First Posted

August 20, 2025

Study Start

October 1, 2025

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2027

Last Updated

August 20, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations