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

August 19, 2025 updated by: Centre Hospitalier Universitaire de Nīmes
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
168

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Angers, France, 49100
        • Recruiting
        • Ssra Les Eumenides
        • Contact:
      • Issy-les-Moulineaux, France
        • Not yet recruiting
        • Hôpital Corentin-Celton
        • Contact:
        • Principal Investigator:
          • Patrice Louvillle
      • Nantes, France
        • Recruiting
        • CHU de Nantes
        • Principal Investigator:
          • Marie Grall-Bronnec
        • Contact:
      • Nîmes, France
        • Recruiting
        • CHU de Nîmes
        • Contact:
        • Principal Investigator:
          • Amandine Luquiens
      • Paris, France, 75010
        • Not yet recruiting
        • Hopital Fernand Widal
        • Contact:
      • Sèvres, France, 92310
        • Not yet recruiting
        • Hopital Des 4 Villes
        • Contact:
      • Villejuif, France
        • Not yet recruiting
        • Hôpital Paul Brousse
        • Principal Investigator:
          • Amine Benyamina
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Standard care
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
Experimental: MBRP program:
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Reduction in number of heavy drinking days (HDD) over previous 4 weeks, between the last drinking period at inclusion and 6 months.
Time Frame: 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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Time Frame: 3 months
Alcohol Time Line Follow Back (TLFB) where a HDD = consummation of 4+ (for women) or 5+ (for men) drinks per day.
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
Time Frame: 12 months
Alcohol Time Line Follow Back (TLFB) where a HDD = consummation of 4+ (for women) or 5+ (for men) drinks per day.
12 months
Change in 4-week total alcohol consumption since baseline
Time Frame: 3 months
number of drinks (1 glass = 1 unit according to grams alcohol)
3 months
Change in 4-week total alcohol consumption since baseline
Time Frame: 12 months
number of drinks (1 glass = 1 unit according to grams alcohol)
12 months
Change in frequency of craving since baseline
Time Frame: 3 months
version F of craving experience questionnaire (CEQ-F)
3 months
Change in frequency of craving since baseline
Time Frame: 6 months
version F of craving experience questionnaire (CEQ-F)
6 months
Change in frequency of craving since baseline
Time Frame: 12 months
version F of craving experience questionnaire (CEQ-F)
12 months
Change in strength of craving since baseline
Time Frame: 3 months
version S of craving experience questionnaire (CEQ-S)
3 months
Change in strength of craving since baseline
Time Frame: 6 months
version S of craving experience questionnaire (CEQ-S)
6 months
Change in strength of craving since baseline
Time Frame: 12 months
version S of craving experience questionnaire (CEQ-S)
12 months
Anxiety at baseline
Time Frame: Baseline
Beck Anxiety Inventory depression (BAI): 21-item self-assessment scale assessing anxiety
Baseline
Change in anxiety since baseline
Time Frame: 3 months
Beck Anxiety Inventory depression (BAI): 21-item self-assessment scale assessing anxiety
3 months
Change in anxiety since baseline
Time Frame: 6 months
Beck Anxiety Inventory depression (BAI): 21-item self-assessment scale assessing anxiety
6 months
Change in anxiety since baseline
Time Frame: 12 months
Beck Anxiety Inventory depression (BAI): 21-item self-assessment scale assessing anxiety
12 months
Depression at baseline
Time Frame: Baseline
Beck Depression Inventory (BDI): 21 items assessing the presence and severity of depressive symptoms
Baseline
Change in depression since baseline
Time Frame: 3 months
Beck Depression Inventory (BDI): 21 items assessing the presence and severity of depressive symptoms
3 months
Change in depression since baseline
Time Frame: 6 months
Beck Depression Inventory (BDI): 21 items assessing the presence and severity of depressive symptoms
6 months
Change in depression since baseline
Time Frame: 12 months
Beck Depression Inventory (BDI): 21 items assessing the presence and severity of depressive symptoms
12 months
Change in quality of life since baseline
Time Frame: 3 months
Alcohol Quality of Life Scale (AQoLS): 34-item patient-reported questionnaire
3 months
Change in quality of life since baseline
Time Frame: 6 months
Alcohol Quality of Life Scale (AQoLS): 34-item patient-reported questionnaire
6 months
Change in quality of life since baseline
Time Frame: 12 months
Alcohol Quality of Life Scale (AQoLS): 34-item patient-reported questionnaire
12 months
Emotion regulation at baseline
Time Frame: Baseline
Emotion Regulation Questionnaire (ERQ): 10-item scale designed to assessing Cognitive Reappraisal and Expressive Suppression on a 7-point Likert-type scale ranging from 1 (strongly disagree) to 7 (strongly agree).
Baseline
Change in emotion regulation since baseline
Time Frame: 3 months
Emotion Regulation Questionnaire (ERQ): 10-item scale designed to assessing Cognitive Reappraisal and Expressive Suppression on a 7-point Likert-type scale ranging from 1 (strongly disagree) to 7 (strongly agree).
3 months
Change in emotion regulation since baseline
Time Frame: 6 months
Emotion Regulation Questionnaire (ERQ): 10-item scale designed to assessing Cognitive Reappraisal and Expressive Suppression on a 7-point Likert-type scale ranging from 1 (strongly disagree) to 7 (strongly agree).
6 months
Change in emotion regulation since baseline
Time Frame: 12 months
Emotion Regulation Questionnaire (ERQ): 10-item scale designed to assessing Cognitive Reappraisal and Expressive Suppression on a 7-point Likert-type scale ranging from 1 (strongly disagree) to 7 (strongly agree).
12 months
Difficulties regulating emotion at baseline
Time Frame: Baseline
Difficulties in Emotion Regulation scale (DERS -Impulse): items 3, 14, 19, 24R, 27, 32 from DERS
Baseline
Changes in difficulties regulating emotion since baseline
Time Frame: 3 months
Difficulties in Emotion Regulation scale (DERS -Impulse): items 3, 14, 19, 24R, 27, 32 from DERS
3 months
Changes in difficulties regulating emotion since baseline
Time Frame: 6 months
Difficulties in Emotion Regulation scale (DERS -Impulse): items 3, 14, 19, 24R, 27, 32 from DERS
6 months
Changes in difficulties regulating emotion since baseline
Time Frame: 12 months
Difficulties in Emotion Regulation scale (DERS -Impulse): items 3, 14, 19, 24R, 27, 32 from DERS
12 months
Changes in impulsivity since baseline
Time Frame: 3 months
Impulsive behavior scale (UPPS-P): 20-item self-assessment scale
3 months
Impulsivity at baseline
Time Frame: Baseline
Impulsive behavior scale (UPPS-P): 20-item self-assessment scale
Baseline
Changes in impulsivity since baseline
Time Frame: 6 months
Impulsive behavior scale (UPPS-P): 20-item self-assessment scale
6 months
Changes in impulsivity since baseline
Time Frame: 12 months
Impulsive behavior scale (UPPS-P): 20-item self-assessment scale
12 months
Changes in coping mechanism
Time Frame: 3 months
brief COPE questionnaire: 14 scales including 2 items (28 items in total)
3 months
Coping mechanism at baseline
Time Frame: Baseline
brief COPE questionnaire: 14 scales including 2 items (28 items in total)
Baseline
Changes in coping mechanism
Time Frame: 6 months
brief COPE questionnaire: 14 scales including 2 items (28 items in total)
6 months
Changes in coping mechanism
Time Frame: 12 months
brief COPE questionnaire: 14 scales including 2 items (28 items in total)
12 months
Cognitive impairment
Time Frame: Baseline
Montreal Cognitive Assessment (MoCA)
Baseline
Initial mindfulness
Time Frame: Baseline
Five Facets Mindfulness Questionnaire (FFMQ): 39-item self-assessment tool measuring 5 factors of mindfulness
Baseline
Number of meditation sessions per week over the last 4 weeks
Time Frame: Month 6
Month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Universitaire de Nīmes

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Amandine Luquiens, CHU Nîmes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 20, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 16, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 16, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 22, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 21, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 19, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PHRCN/2018/AL-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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