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ClinicalTrials.gov ID

NCT04598399

Lead Sponsor

Centre Hospitalier Universitaire de NīmesOTHER

Overall Status

Recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

168Estimated

Last Update Posted

Aug 21, 2025Actual

Start Date

Oct 20, 2021Actual

Primary Completion Date

Jan 2026Estimated

Completion Date

Jan 2027Estimated

Official Title

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

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.

• Alcohol Use Disorder (AUD)

• Mindfulness Based Relapse Prevention
• Relaxation/ meditation

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

• Having a moderate to severe alcohol use disorder according to DSM 5 criteria.
• The last drink must have been consumed at most in the last 60 days before the pre-inclusion visit. The patient must have had at least 1 HDD during the last drinking period

Exclusion Criteria:

• 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

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Single

Lead Sponsor

Centre Hospitalier Universitaire de NīmesOTHER

marie.bronnec@chu-nantes.fr02.40.84.61.16

drc@chu-nimes.fr04.66.68.42.36