Study of Mindfulness Practice Efficacy in Alcoholic Relapse Prevention
NCT ID: NCT03150550
Last Updated: 2017-05-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
200 participants
INTERVENTIONAL
2017-01-21
2018-09-30
Brief Summary
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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).
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Detailed Description
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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)
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Relapse Prevention
Each patient will perform 12 classic psychotherapeutic sessions over a period of 6 weeks.
Relapse prevention
It's a conventional relapse prevention program which allow to measure the alcoholic relapse in the first glass consumed.
Mindfulness Practice
Each patient will perform 12 mindfulness psychotherapeutic sessions over a period of 6 weeks.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Lundbeck SAS 37-45
UNKNOWN
University Hospital, Clermont-Ferrand
OTHER
Responsible Party
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Locations
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CHU Clermont-Ferrand
France, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2016-A00048-43
Identifier Type: OTHER
Identifier Source: secondary_id
CHU-321
Identifier Type: -
Identifier Source: org_study_id
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