Comparison of the Effectiveness of Two Psycho-physical Interventions: Mindfulness Based Relapse Prevention (MBRP) and Unguided Meditative Relaxation in Patients With Alcohol Use Disorder

Centre Hospitalier Universitaire de Nīmes168 enrolled

Overview

Alcohol use disorder (AUD) is the second highest preventable cause of death in France. Only 3% of patients are prescribed approved drugs for reducing alcohol consumption or maintenance of abstinence. Increasing evidence supports the efficacy of psychotherapies such as cognitive and behavioral therapies (CBT) in AUD. However, some patients are resistant to CBT and the positive effects of CBT could wane over time, resulting in mid- and long-term relapses. Mindfulness practice is increasingly widespread in the United States and its efficacy in various fields appears very promising. The study investigators hypothesize that the Mindfulness Based Relapse Prevention (MBRP) program will be more efficient than a relaxation/meditation without guidance control program in AUD.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

168

Conditions

Alcohol Use Disorder (AUD)

Interventions

7 x 60-120 minute sessions with different themes: Automatic pilot/triggers/relapse/high-risk situations/ mindfulness in daily life. There will be a welcoming time, with a focus on at-home practice and difficulties, a theoretical presentation of new concepts, practical meditation exercises and a debriefing.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Having a moderate to severe alcohol use disorder according to DSM 5 criteria. * The last drink must have been consumed at most in the last 60 days before the pre-inclusion visit. The patient must have had at least 1 HDD during the last drinking period Exclusion Criteria: * Severe depression (Beck Depression Inventory\> 30) * Schizophrenic disorder, * Current maniac or hypomaniac episode, * Patient with dementia or severe cognitive impairment that would prevent him/her from following the course of a session, as judged by the clinician. * Insufficient French understanding to complete the questionnaires * Pregnant or breastfeeding woman * Absence of social security regimen * Other mindfulness-based structured therapies * Refusal to sign the written consent. • The patient is under safeguard of justice or state guardianship

Locations (7)

Ssra Les Eumenides

Angers, France

RECRUITING

Hôpital Corentin-Celton

Issy-les-Moulineaux, France

NOT_YET_RECRUITING

CHU de Nantes

Nantes, France

RECRUITING

CHU de Nimes

Nîmes, France

RECRUITING

Hopital Fernand Widal

Paris, France

NOT_YET_RECRUITING

Hopital Des 4 Villes

Sèvres, France

NOT_YET_RECRUITING

Hopital Paul Brousse

Villejuif, France

NOT_YET_RECRUITING

Outcomes

Primary Outcomes

Reduction in number of heavy drinking days (HDD) over previous 4 weeks, between the last drinking period at inclusion and 6 months.

Alcohol Time Line Follow Back (TLFB) where a HDD = consummation of 4+ (for women) or 5+ (for men) drinks per day.

Time frame: 6 months

Secondary Outcomes

Change in number of heavy drinking days (HDD) during the last 4 weeks, between the last drinking period at inclusion and 3 months between groups

Alcohol Time Line Follow Back (TLFB) where a HDD = consummation of 4+ (for women) or 5+ (for men) drinks per day.

Time frame: 3 months

Change in number of heavy drinking days (HDD) during the last 4 weeks, between the last drinking period at inclusion and 12 months between groups

Alcohol Time Line Follow Back (TLFB) where a HDD = consummation of 4+ (for women) or 5+ (for men) drinks per day.

Time frame: 12 months

Change in 4-week total alcohol consumption since baseline

number of drinks (1 glass = 1 unit according to grams alcohol)

Time frame: 3 months

Change in 4-week total alcohol consumption since baseline

number of drinks (1 glass = 1 unit according to grams alcohol)

Time frame: 12 months

Change in frequency of craving since baseline

version F of craving experience questionnaire (CEQ-F)

Time frame: 3 months

Change in frequency of craving since baseline

version F of craving experience questionnaire (CEQ-F)

Time frame: 6 months

Change in frequency of craving since baseline

version F of craving experience questionnaire (CEQ-F)

Time frame: 12 months

Change in strength of craving since baseline

version S of craving experience questionnaire (CEQ-S)

Time frame: 3 months

Change in strength of craving since baseline

version S of craving experience questionnaire (CEQ-S)

Time frame: 6 months

Change in strength of craving since baseline

version S of craving experience questionnaire (CEQ-S)

Time frame: 12 months

Anxiety at baseline

Beck Anxiety Inventory depression (BAI): 21-item self-assessment scale assessing anxiety

Time frame: Baseline

Change in anxiety since baseline

Beck Anxiety Inventory depression (BAI): 21-item self-assessment scale assessing anxiety

Time frame: 3 months

Change in anxiety since baseline

Beck Anxiety Inventory depression (BAI): 21-item self-assessment scale assessing anxiety

Time frame: 6 months

Change in anxiety since baseline

Beck Anxiety Inventory depression (BAI): 21-item self-assessment scale assessing anxiety

Time frame: 12 months

Depression at baseline

Beck Depression Inventory (BDI): 21 items assessing the presence and severity of depressive symptoms

Time frame: Baseline

Change in depression since baseline

Beck Depression Inventory (BDI): 21 items assessing the presence and severity of depressive symptoms

Time frame: 3 months

Change in depression since baseline

Beck Depression Inventory (BDI): 21 items assessing the presence and severity of depressive symptoms

Time frame: 6 months

Change in depression since baseline

Beck Depression Inventory (BDI): 21 items assessing the presence and severity of depressive symptoms

Time frame: 12 months

Change in quality of life since baseline

Alcohol Quality of Life Scale (AQoLS): 34-item patient-reported questionnaire

Time frame: 3 months

Change in quality of life since baseline

Alcohol Quality of Life Scale (AQoLS): 34-item patient-reported questionnaire

Time frame: 6 months

Change in quality of life since baseline

Alcohol Quality of Life Scale (AQoLS): 34-item patient-reported questionnaire

Time frame: 12 months

Emotion regulation at baseline

Emotion Regulation Questionnaire (ERQ): 10-item scale designed to assessing Cognitive Reappraisal and Expressive Suppression on a 7-point Likert-type scale ranging from 1 (strongly disagree) to 7 (strongly agree).

Time frame: Baseline

Change in emotion regulation since baseline

Time frame: 3 months

Change in emotion regulation since baseline

Time frame: 6 months

Change in emotion regulation since baseline

Time frame: 12 months

Difficulties regulating emotion at baseline

Difficulties in Emotion Regulation scale (DERS -Impulse): items 3, 14, 19, 24R, 27, 32 from DERS

Time frame: Baseline

Changes in difficulties regulating emotion since baseline

Difficulties in Emotion Regulation scale (DERS -Impulse): items 3, 14, 19, 24R, 27, 32 from DERS

Time frame: 3 months

Changes in difficulties regulating emotion since baseline

Difficulties in Emotion Regulation scale (DERS -Impulse): items 3, 14, 19, 24R, 27, 32 from DERS

Time frame: 6 months

Changes in difficulties regulating emotion since baseline

Difficulties in Emotion Regulation scale (DERS -Impulse): items 3, 14, 19, 24R, 27, 32 from DERS

Time frame: 12 months

Changes in impulsivity since baseline

Impulsive behavior scale (UPPS-P): 20-item self-assessment scale

Time frame: 3 months

Impulsivity at baseline

Impulsive behavior scale (UPPS-P): 20-item self-assessment scale

Time frame: Baseline

Changes in impulsivity since baseline

Impulsive behavior scale (UPPS-P): 20-item self-assessment scale

Time frame: 6 months

Changes in impulsivity since baseline

Impulsive behavior scale (UPPS-P): 20-item self-assessment scale

Time frame: 12 months

Changes in coping mechanism

brief COPE questionnaire: 14 scales including 2 items (28 items in total)

Time frame: 3 months

Coping mechanism at baseline

brief COPE questionnaire: 14 scales including 2 items (28 items in total)

Time frame: Baseline

Changes in coping mechanism

brief COPE questionnaire: 14 scales including 2 items (28 items in total)

Time frame: 6 months

Changes in coping mechanism

brief COPE questionnaire: 14 scales including 2 items (28 items in total)

Time frame: 12 months

Cognitive impairment

Montreal Cognitive Assessment (MoCA)

Time frame: Baseline

Initial mindfulness

Five Facets Mindfulness Questionnaire (FFMQ): 39-item self-assessment tool measuring 5 factors of mindfulness

Time frame: Baseline

Number of meditation sessions per week over the last 4 weeks

Time frame: Month 6

Comparison of the Effectiveness of Two Psycho-physical Interventions: Mindfulness Based Relapse Prevention (MBRP) and Unguided Meditative Relaxation in Patients With Alcohol Use Disorder

Overview

Conditions

Interventions

Eligibility

Locations (7)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts