Comparison of the Effectiveness of Two Psycho-physical Interventions: Mindfulness Based Relapse Prevention (MBRP) and Unguided Meditative Relaxation in Patients With Alcohol Use Disorder

NCT04598399 | Recruiting

• 1 other identifier: PHRCN/2018/AL-01
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 7

Brief Summary

Alcohol use disorder (AUD) is the second highest preventable cause of death in France. Only 3% of patients are prescribed approved drugs for reducing alcohol consumption or maintenance of abstinence. Increasing evidence supports the efficacy of psychotherapies such as cognitive and behavioral therapies (CBT) in AUD. However, some patients are resistant to CBT and the positive effects of CBT could wane over time, resulting in mid- and long-term relapses. Mindfulness practice is increasingly widespread in the United States and its efficacy in various fields appears very promising. The study investigators hypothesize that the Mindfulness Based Relapse Prevention (MBRP) program will be more efficient than a relaxation/meditation without guidance control program in AUD.

Conditions

Alcohol Use Disorder (AUD)

Outcome Measures

Primary Outcomes (1)

• Reduction in number of heavy drinking days (HDD) over previous 4 weeks, between the last drinking period at inclusion and 6 months.

  Alcohol Time Line Follow Back (TLFB) where a HDD = consummation of 4+ (for women) or 5+ (for men) drinks per day.

  6 months

Secondary Outcomes (40)

• Change in number of heavy drinking days (HDD) during the last 4 weeks, between the last drinking period at inclusion and 3 months between groups

  3 months

• Change in number of heavy drinking days (HDD) during the last 4 weeks, between the last drinking period at inclusion and 12 months between groups

  12 months

• Change in 4-week total alcohol consumption since baseline

  3 months

• Change in 4-week total alcohol consumption since baseline

  12 months

• Change in frequency of craving since baseline

  3 months

Study Arms (2)

MBRP program:

EXPERIMENTAL

Behavioral: Mindfulness Based Relapse Prevention

Standard care

ACTIVE COMPARATOR

Behavioral: Relaxation/ meditation

Interventions

Mindfulness Based Relapse Prevention BEHAVIORAL

7 x 60-120 minute sessions with different themes: Automatic pilot/triggers/relapse/high-risk situations/ mindfulness in daily life. There will be a welcoming time, with a focus on at-home practice and difficulties, a theoretical presentation of new concepts, practical meditation exercises and a debriefing.

MBRP program:

Relaxation/ meditation BEHAVIORAL

7 x 60-120 minute sessions each with a different sound from nature with unguided, closed relaxation group with a maximum of 12 participants

Standard care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Having a moderate to severe alcohol use disorder according to DSM 5 criteria.

You may not qualify if:

• Severe depression (Beck Depression Inventory\> 30)
• Schizophrenic disorder,
• Current maniac or hypomaniac episode,
• Patient with dementia or severe cognitive impairment that would prevent him/her from following the course of a session, as judged by the clinician.
• Insufficient French understanding to complete the questionnaires
• Pregnant or breastfeeding woman
• Absence of social security regimen
• Other mindfulness-based structured therapies
• Refusal to sign the written consent. • The patient is under safeguard of justice or state guardianship

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (7)

Ssra Les Eumenides

Angers, 49100, France

RECRUITING

Hôpital Corentin-Celton

Issy-les-Moulineaux, France

NOT YET RECRUITING

CHU de Nantes

Nantes, France

RECRUITING

CHU de Nimes

Nîmes, France

RECRUITING

Hopital Fernand Widal

Paris, 75010, France

NOT YET RECRUITING

Hopital Des 4 Villes

Sèvres, 92310, France

NOT YET RECRUITING

Hopital Paul Brousse

Villejuif, France

NOT YET RECRUITING

MeSH Terms

Conditions

Alcoholism

Interventions

Meditation

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Relaxation Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Amandine Luquiens

  CHU Nimes

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amandine Luquiens

CONTACT

04.66.68.69.98; Amandine.luquiens@chu-nimes.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: In order to limit measurement and attrition biases, the patient will be kept unaware of the hypotheses concerning the details of the evaluated programs (MBRP or control) and the program expected to be superior
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2020
• First Posted: October 22, 2020
• Study Start: October 20, 2021
• Primary Completion: January 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: August 21, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (7)