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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorEtablissement Public de Santé Barthélemy Durand

About this 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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Mindful Self-Compassion program

    Behavioral

    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) program

    Behavioral

    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)

Treatment groups

152 Participants
are divided into 2 treatment groups
Group A: Mindful Self-Compassion (MSC) program + Treatment As Usual (TAU)Experimental treatment 2 interventions
Group B: Treatment As Usual (TAU)Active comparator 1 intervention

Trial outcomes

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

Time frame
6 months

Secondary outcomes

1

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
2

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
3

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
4

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]

Other outcomes

Sponsors and contacts

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