Study of Mindfulness Practice Efficacy in Alcoholic Relapse Prevention (Mindfulness)

May 10, 2017 updated by: University Hospital, Clermont-Ferrand

Among behavioral cognitive psychotherapies, new "Mindfulness" interventions allow patient to identify, pay attention and accept external (sensory stimuli) and internal (cognition and emotions) phenomena. This "to do with" training has yielded promising results in stress management, prevention of depressive relapse, management of craving and an increase in self-efficacy. Few studies (none in France) have attempted to measure the efficacy of this technique on alcohol relapse, in particular by comparing it with a usual management strategy (conventional relapse prevention therapy).

The main objective of this study is to compare the efficacy on alcoholic relapse (measured in the "first glass" consumed), from a Mindfulness therapeutic program to a conventional Relapse Prevention program. Secondary objectives are to demonstrate the efficacy of this program on craving, self-efficacy, and secondary endpoints of relapse (massive alcoholism, number of alcoholisation days).

Study Overview

Status

Status

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

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.

Detailed Description

Each patient will perform 12 psychotherapeutic sessions (Mindfulness or Relapse Prevention) over a period of 6 weeks. Patients will be evaluated by a practitioner different from the practitioner who makes the psychotherapeutic management.

Patients will be assessed at inclusion (Initial visit), after the 12 sessions of management (M0), 1 month (M1), 2 month (M2), 3 month (M3), 4 month (M4), 5 month (M5), 6 month (M6), after initial visit as follows

Initial Visit

  • Signature of an informed consent form.
  • Demographic characteristics (gender, age, family status, professional status, level of education …)
  • Clinical data (patient status, ongoing pharmacological treatment, withdrawal, previous CBT ...)
  • Criteria and severity of alcohol dependence (DSM 5)
  • Evaluation of depressive symptomatology and severity (HAM-D)
  • Level of pre-intervention alcohol consumption (AUDIT-C)
  • "Binge drinking" consumption
  • Craving before alcohol withdrawal (EVA craving)
  • Mindfulness Skills (KIMS)
  • Self-efficacy to remain abstinent (QAE-Alcohol)
  • Drinking habits (QHPBA)

After the 12 sessions (M0)

  • Data on treatments in progress or change in treatment
  • Depressive symptomatology and severity (HAM-D)
  • Level of alcohol consumption in post-intervention (AUDIT-C)
  • "Binge drinking" consumption
  • Craving after alcohol withdrawal (EVA craving)
  • Mindfulness Skills (KIMS)
  • Self-efficacy to remain abstinent (QAE-Alcohol)
  • Distribution of the 1st Daily Alcohol Logbook (TLFB)

At 1 month (M1)

  • Return of the 1st Daily Alcohol Logbook (TLFB)
  • Data on treatments in progress or change in treatment
  • Mindfulness Skills (KIMS)
  • "Binge drinking" consumption
  • Self-efficacy to remain abstinent (QAE-Alcohol)
  • Distribution of the 2nd Daily Alcohol Logbook (TLFB)

At 2 month (M2)

  • Return of the 2nd Daily Alcohol Logbook (TLFB)
  • Data on treatments in progress or change in treatment
  • Mindfulness Skills (KIMS)
  • "Binge drinking" consumption
  • Self-efficacy to remain abstinent (QAE-Alcohol)
  • Distribution of the 3th Daily Alcohol Logbook (TLFB)

At 3 month (M3)

  • Return of the 3th Daily Alcohol Logbook (TLFB)
  • Data on treatments in progress or change in treatment
  • Mindfulness Skills (KIMS)
  • "Binge drinking" consumption
  • Self-efficacy to remain abstinent (QAE-Alcohol)
  • Distribution of the 4th Daily Alcohol Logbook (TLFB)

At 4 month (M4)

  • Return of the 4th Daily Alcohol Logbook (TLFB)
  • Data on treatments in progress or change in treatment
  • Mindfulness Skills (KIMS)
  • "Binge drinking" consumption
  • Self-efficacy to remain abstinent (QAE-Alcohol)
  • Distribution of the 5th Daily Alcohol Logbook (TLFB)

At 5 month (M5)

  • Return of the 5th Daily Alcohol Logbook (TLFB)
  • Data on treatments in progress or change in treatment
  • Mindfulness Skills (KIMS)
  • "Binge drinking" consumption
  • Self-efficacy to remain abstinent (QAE-Alcohol)
  • Distribution of the 6th Daily Alcohol Logbook (TLFB)

At 6 month (M6)

  • Return of the 6th Daily Alcohol Logbook (TLFB)
  • Data on treatments in progress or change in treatment
  • Mindfulness Skills (KIMS)
  • "Binge drinking" consumption
  • Self-efficacy to remain abstinent (QAE-Alcohol)

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 (Anticipated)

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.
200

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

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

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female aged 18 to 75 (including landmarks)
  • Patients in withdrawal for alcohol dependence according to DSM IV criteria (1994); hospital or outpatient withdrawal of more than 10 days and less than 10 weeks.

Exclusion Criteria:

  • Psychiatric comorbidity (dipsomaniac alcoholism, anteriority of one or more hypomanic or manic episodes, psychoses, severe depression, severe suicidal risk)
  • Other addiction syndrome than tobacco and alcohol
  • Problems that impede participation in a group, such as severe borderline personality disorder; antisocial personality; tendency to dissociation; phobias of interceptive type (panic attacks and hypochondria ...)
  • Problems preventing the completion of questionnaires, such as cognitive dysfunctions, dysfunctions of attention and concentration skills, or a language barrier
  • Severe recurring pathology
  • Need for individual weekly follow-up

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: None (Open Label)

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.
Experimental: Relapse Prevention
Each patient will perform 12 classic psychotherapeutic sessions over a period of 6 weeks.
Behavioral: Relapse prevention
It's a conventional relapse prevention program which allow to measure the alcoholic relapse in the first glass consumed.
Experimental: Mindfulness Practice
Each patient will perform 12 mindfulness psychotherapeutic sessions over a period of 6 weeks.
Behavioral: Mindfulness practice
Mindfulness interventions are behavioral cognitive psychotherapies which allow patient to identify, pay attention and accept external (sensory stimuli) and internal (cognition and emotions) phenomena.

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
Number of alcoholic relapses
Time Frame: 6 month
Proportion of patients with an alcohol consumption of at least one glass of alcohol
6 month

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
Alcohol relapse time
Time Frame: 6 month
Measurement : Number of days elapsed between the end of treatment and the first relapse compare between the two interventions (classic or "mindfulness")
6 month
Delay in "heavy drinking" relapse
Time Frame: 6 month
Measurement : Number of days elapsed between the end of treatment and the first heavy drinking (≥4 glasses of alcohol for women and ≥6 glasses of alcohol for men) compare between the two interventions (classic or "mindfulness")
6 month
Frequency of consumption
Time Frame: 6 month
Measurement : Number of consumption days during 6 month compare between the two interventions (classic or "mindfulness")
6 month
Daily quantities consumed
Time Frame: 6 month
Measurement : Number of standard glasses consumed per day during 6 month compare between the two interventions (classic or "mindfulness")
6 month
Degree of mindfulness skills
Time Frame: 6 month
Measurement : Score at the KIMS Scale (Kentucky Inventory of Mindfulness Skills) evaluated each month, compare before and after intervention (classic or "mindfulness")
6 month
Severity of alcohol craving
Time Frame: 6 month
Measurement: Assessed daily on a VAS craving (Visual analogue scale) in the daily observation book, compare before and after intervention (classic or "mindfulness")
6 month
Level of self-efficacy
Time Frame: 6 month
Measurement: Assessed daily on a VAS self-efficacy (Visual analogue scale) in the daily observation book, compare before and after intervention (classic or "mindfulness")
6 month

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.
University Hospital, Clermont-Ferrand

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Lundbeck SAS 37-45

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.
January 21, 2017

Primary Completion (Anticipated)

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.
December 1, 2017

Study Completion (Anticipated)

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.
September 1, 2018

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).
May 4, 2017

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.
May 10, 2017

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.
May 12, 2017

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.
May 12, 2017

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.
May 10, 2017

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.
May 1, 2017

More Information

Terms related to this study

Keywords

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.
  • CHU-321
  • 2016-A00048-43 (Other Identifier: 2016-A00048-43)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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