Study of Mindfulness Practice Efficacy in Alcoholic Relapse Prevention

Alcohol Use Disorder Clinical Trial

— Mindfulness  

Official title:

Study of Mindfulness Practice Efficacy in Alcoholic Relapse Prevention

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03150550
• Other study ID #: CHU-321
• Secondary ID: 2016-A00048-43
• Status: Recruiting
• Phase: N/A
• First received: May 4, 2017
• Last updated: May 10, 2017
• Start date: January 21, 2017
• Est. completion date: September 2018

Study information

• Verified date: May 2017
• Source: University Hospital, Clermont-Ferrand
• Contact: Patrick LACARIN
• Phone: 04 73 75 11 95
• Email: placarin[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: September 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Disorder
• Recurrence

Intervention

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

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	France

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	Lundbeck SAS 37-45

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of alcoholic relapses	Proportion of patients with an alcohol consumption of at least one glass of alcohol	6 month
Secondary	Alcohol relapse time	Measurement : Number of days elapsed between the end of treatment and the first relapse compare between the two interventions (classic or "mindfulness")	6 month
Secondary	Delay in "heavy drinking" relapse	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
Secondary	Frequency of consumption	Measurement : Number of consumption days during 6 month compare between the two interventions (classic or "mindfulness")	6 month
Secondary	Daily quantities consumed	Measurement : Number of standard glasses consumed per day during 6 month compare between the two interventions (classic or "mindfulness")	6 month
Secondary	Degree of mindfulness skills	Measurement : Score at the KIMS Scale (Kentucky Inventory of Mindfulness Skills) evaluated each month, compare before and after intervention (classic or "mindfulness")	6 month
Secondary	Severity of alcohol craving	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
Secondary	Level of self-efficacy	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