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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-A00048-43 | Other Identifier | 2016-A00048-43 |
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| Name | Class |
|---|---|
| Lundbeck SAS 37-45 | UNKNOWN |
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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).
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
After the 12 sessions (M0)
At 1 month (M1)
At 2 month (M2)
At 3 month (M3)
At 4 month (M4)
At 5 month (M5)
At 6 month (M6)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Relapse Prevention | Experimental | Each patient will perform 12 classic psychotherapeutic sessions over a period of 6 weeks. |
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| Mindfulness Practice | Experimental | Each patient will perform 12 mindfulness psychotherapeutic sessions over a period of 6 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness practice | Behavioral | Mindfulness interventions are behavioral cognitive psychotherapies which allow patient to identify, pay attention and accept external (sensory stimuli) and internal (cognition and emotions) phenomena. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of alcoholic relapses | Proportion of patients with an alcohol consumption of at least one glass of alcohol | 6 month |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Delay in "heavy drinking" relapse |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Patrick LACARIN | Contact | 04 73 75 11 95 | placarin@chu-clermontferrand.fr | |
| Julie GENESTE | Contact | 04 73 75 47 84 | j_geneste@chu-clermontferrand.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Clermont-Ferrand | Recruiting | France | 63003 | France |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D055502 | Secondary Prevention |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D011314 | Preventive Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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Simple Blind
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| Relapse prevention | Behavioral | It's a conventional relapse prevention program which allow to measure the alcoholic relapse in the first glass consumed. |
|
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 | Measurement : Number of consumption days during 6 month compare between the two interventions (classic or "mindfulness") | 6 month |
| Daily quantities consumed | 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 | 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 | 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 | 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 |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015980 | Public Health Practice |
| D011634 | Public Health |
| D004778 | Environment and Public Health |