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Clinical Trials in France / NCT04598399
Recruiting Not applicable

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 · tracked via the Priya Life Science France tracker
Sponsor
Centre Hospitalier Universitaire de Nīmes
Phase
Not applicable
Started
2021-10-20
Last updated
2025-08-21

Condition(s) studied

Alcohol Use Disorder (AUD)

Investigational drug(s) / intervention(s)

Mindfulness Based Relapse PreventionRelaxation/ meditation

Mindfulness Based Relapse Prevention: 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.

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 outcome measure(s)

  • Reduction in number of heavy drinking days (HDD) over previous 4 weeks, between the last drinking period at inclusion and 6 months. — 6 months
    Alcohol Time Line Follow Back (TLFB) where a HDD = consummation of 4+ (for women) or 5+ (for men) drinks per day.

Trial sites (7)

FacilityCityRegionStatus
Ssra Les Eumenides Angers 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 France Not Yet Recruiting
Hopital Des 4 Villes Sèvres France Not Yet Recruiting
Hopital Paul Brousse Villejuif France Not Yet Recruiting

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A Radiomic MRI Predictive Model for Response to Concomitant Chemoradiotherapy in Locally Advanced Cervical Cancer Recruiting
Resistance Exercise With Blood Flow Restriction by Vascular Occlusion on Myocardial Function in Heart Failure With Reduced Ejection Fraction Recruiting

Other trials for the same condition

Evaluation of a Virtual Reality-based Version of the Multiple Errands Test in Alcohol Use Disorder Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04598399 on ClinicalTrials.gov ↗ ← All trials in France