NCT03150550

Brief Summary

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 21, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 4, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 12, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

May 12, 2017

Status Verified

May 1, 2017

Enrollment Period

10 months

First QC Date

May 4, 2017

Last Update Submit

May 10, 2017

Conditions

Alcohol Use Disorder

Keywords

MindfulnessAlcoholAlcohol Use DisorderRelapseRelapse PreventionCognitive-behavioral therapy

Outcome Measures

Primary Outcomes (1)

  • Number of alcoholic relapses

    Proportion of patients with an alcohol consumption of at least one glass of alcohol

    6 month

Secondary Outcomes (7)

  • Alcohol relapse time

    6 month

  • Delay in "heavy drinking" relapse

    6 month

  • Frequency of consumption

    6 month

  • Daily quantities consumed

    6 month

  • Degree of mindfulness skills

    6 month

  • +2 more secondary outcomes

Study Arms (2)

Relapse Prevention

EXPERIMENTAL

Each patient will perform 12 classic psychotherapeutic sessions over a period of 6 weeks.

Behavioral: Relapse prevention

Mindfulness Practice

EXPERIMENTAL

Each patient will perform 12 mindfulness psychotherapeutic sessions over a period of 6 weeks.

Behavioral: Mindfulness practice

Interventions

Mindfulness practiceBEHAVIORAL

Mindfulness interventions are behavioral cognitive psychotherapies which allow patient to identify, pay attention and accept external (sensory stimuli) and internal (cognition and emotions) phenomena.

Mindfulness Practice
Relapse preventionBEHAVIORAL

It's a conventional relapse prevention program which allow to measure the alcoholic relapse in the first glass consumed.

Relapse Prevention

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand

France, 63003, France

RECRUITING

MeSH Terms

Conditions

AlcoholismRecurrence

Interventions

Secondary Prevention

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TherapeuticsPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPublic Health PracticePublic HealthEnvironment and Public Health

Central Study Contacts

Patrick LACARIN

CONTACT

04 73 75 11 95placarin@chu-clermontferrand.fr

Julie GENESTE

CONTACT

04 73 75 47 84j_geneste@chu-clermontferrand.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Simple Blind
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2017

First Posted

May 12, 2017

Study Start

January 21, 2017

Primary Completion

December 1, 2017

Study Completion

September 1, 2018

Last Updated

May 12, 2017

Record last verified: 2017-05

Locations

FR(1)