Clinical trial NCT03150550: Study of Mindfulness Practice Efficacy in Alcoholic Relapse Prevention
Official title: Study of Mindfulness Practice Efficacy in Alcoholic Relapse Prevention
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alcohol Use Disorder
Keywords: Mindfulness
Alcohol
Alcohol Use Disorder
Relapse
Relapse Prevention
Cognitive-behavioral therapy
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: Lundbeck SAS 37-45
First posted: 2017-05-12
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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)

Eligibility criteria: 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

Primary outcomes:
measure: Number of alcoholic relapses
timeFrame: 6 month
Secondary outcomes:
measure: Alcohol relapse time
timeFrame: 6 month
measure: Delay in "heavy drinking" relapse
timeFrame: 6 month
measure: Frequency of consumption
timeFrame: 6 month
measure: Daily quantities consumed
timeFrame: 6 month
measure: Degree of mindfulness skills
timeFrame: 6 month
measure: Severity of alcohol craving
timeFrame: 6 month
measure: Level of self-efficacy
timeFrame: 6 month
Other outcomes:
Locations:
city: France
country: France
facility: CHU Clermont-Ferrand
Study officials:
References: