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

NCT ID: NCT04598399

Last Updated: 2025-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

168 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-20

Study Completion Date

2027-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Alcohol Use Disorder (AUD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
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

Study Groups

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MBRP program:

Group Type EXPERIMENTAL

Mindfulness Based Relapse Prevention

Intervention Type 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.

Standard care

Group Type ACTIVE_COMPARATOR

Relaxation/ meditation

Intervention Type 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

Interventions

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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.

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Amandine Luquiens

Role: PRINCIPAL_INVESTIGATOR

CHU Nimes

Locations

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Ssra Les Eumenides

Angers, , France

Site Status RECRUITING

Hôpital Corentin-Celton

Issy-les-Moulineaux, , France

Site Status NOT_YET_RECRUITING

CHU de Nantes

Nantes, , France

Site Status RECRUITING

CHU de Nimes

Nîmes, , France

Site Status RECRUITING

Hopital Fernand Widal

Paris, , France

Site Status NOT_YET_RECRUITING

Hopital Des 4 Villes

Sèvres, , France

Site Status NOT_YET_RECRUITING

Hopital Paul Brousse

Villejuif, , France

Site Status NOT_YET_RECRUITING

Countries

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France

Central Contacts

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Amandine Luquiens

Role: CONTACT

04.66.68.69.98

Facility Contacts

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CORINNE DANO

Role: primary

0241353485

Patrice Louvillle

Role: primary

01 58 00 44 25

Marie Grall-Bronnec

Role: primary

02.40.84.61.16

Anissa Megzari

Role: primary

04.66.68.42.36

FLORENCE VORSPAN

Role: primary

0141525676

NICOLAS THIERCELIN

Role: primary

0177707940

Amine Benyamina

Role: primary

01 45 59 69 78

Other Identifiers

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PHRCN/2018/AL-01

Identifier Type: -

Identifier Source: org_study_id

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