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

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

200

Phase

  • 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 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

Ages Eligible for Study

16 years to 73 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
Intervention / Treatment
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

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

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

University Hospital, Clermont-Ferrand

Collaborators

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)

January 21, 2017

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

September 1, 2018

Study Registration Dates

First Submitted

May 4, 2017

First Submitted That Met QC Criteria

May 10, 2017

First Posted (Actual)

May 12, 2017

Study Record Updates

Last Update Posted (Actual)

May 12, 2017

Last Update Submitted That Met QC Criteria

May 10, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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