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

Study Overview
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Brief Summary
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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.

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

Conditions
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Alcohol Use Disorder (AUD)

Intervention / Treatment
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* Behavioral: Mindfulness Based Relapse Prevention
* Behavioral: Relaxation/ meditation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MBRP program:<br> | Behavioral: Mindfulness Based Relapse Prevention<br>* 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.<br>|
| Active Comparator: Standard care<br> | Behavioral: Relaxation/ meditation<br>* 7 x 60-120 minute sessions each with a different sound from nature with unguided, closed relaxation group with a maximum of 12 participants<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 12 months | 
| Change in 4-week total alcohol consumption since baseline | number of drinks (1 glass = 1 unit according to grams alcohol) | 3 months | 
| Change in 4-week total alcohol consumption since baseline | number of drinks (1 glass = 1 unit according to grams alcohol) | 12 months | 
| Change in frequency of craving since baseline | version F of craving experience questionnaire (CEQ-F) | 3 months | 
| Change in frequency of craving since baseline | version F of craving experience questionnaire (CEQ-F) | 6 months | 
| Change in frequency of craving since baseline | version F of craving experience questionnaire (CEQ-F) | 12 months | 
| Change in strength of craving since baseline | version S of craving experience questionnaire (CEQ-S) | 3 months | 
| Change in strength of craving since baseline | version S of craving experience questionnaire (CEQ-S) | 6 months | 
| Change in strength of craving since baseline | version S of craving experience questionnaire (CEQ-S) | 12 months | 
| Anxiety at baseline | Beck Anxiety Inventory depression (BAI): 21-item self-assessment scale assessing anxiety | Baseline | 
| Change in anxiety since baseline | Beck Anxiety Inventory depression (BAI): 21-item self-assessment scale assessing anxiety | 3 months | 
| Change in anxiety since baseline | Beck Anxiety Inventory depression (BAI): 21-item self-assessment scale assessing anxiety | 6 months | 
| Change in anxiety since baseline | Beck Anxiety Inventory depression (BAI): 21-item self-assessment scale assessing anxiety | 12 months | 
| Depression at baseline | Beck Depression Inventory (BDI): 21 items assessing the presence and severity of depressive symptoms | Baseline | 
| Change in depression since baseline | Beck Depression Inventory (BDI): 21 items assessing the presence and severity of depressive symptoms | 3 months | 
| Change in depression since baseline | Beck Depression Inventory (BDI): 21 items assessing the presence and severity of depressive symptoms | 6 months | 
| Change in depression since baseline | Beck Depression Inventory (BDI): 21 items assessing the presence and severity of depressive symptoms | 12 months | 
| Change in quality of life since baseline | Alcohol Quality of Life Scale (AQoLS): 34-item patient-reported questionnaire | 3 months | 
| Change in quality of life since baseline | Alcohol Quality of Life Scale (AQoLS): 34-item patient-reported questionnaire | 6 months | 
| Change in quality of life since baseline | Alcohol Quality of Life Scale (AQoLS): 34-item patient-reported questionnaire | 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). | Baseline | 
| Change in emotion regulation since 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). | 3 months | 
| Change in emotion regulation since 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). | 6 months | 
| Change in emotion regulation since 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). | 12 months | 
| Difficulties regulating emotion at baseline | Difficulties in Emotion Regulation scale (DERS -Impulse): items 3, 14, 19, 24R, 27, 32 from DERS | Baseline | 
| Changes in difficulties regulating emotion since baseline | Difficulties in Emotion Regulation scale (DERS -Impulse): items 3, 14, 19, 24R, 27, 32 from DERS | 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 | 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 | 12 months | 
| Changes in impulsivity since baseline | Impulsive behavior scale (UPPS-P): 20-item self-assessment scale | 3 months | 
| Impulsivity at baseline | Impulsive behavior scale (UPPS-P): 20-item self-assessment scale | Baseline | 
| Changes in impulsivity since baseline | Impulsive behavior scale (UPPS-P): 20-item self-assessment scale | 6 months | 
| Changes in impulsivity since baseline | Impulsive behavior scale (UPPS-P): 20-item self-assessment scale | 12 months | 
| Changes in coping mechanism | brief COPE questionnaire: 14 scales including 2 items (28 items in total) | 3 months | 
| Coping mechanism at baseline | brief COPE questionnaire: 14 scales including 2 items (28 items in total) | Baseline | 
| Changes in coping mechanism | brief COPE questionnaire: 14 scales including 2 items (28 items in total) | 6 months | 
| Changes in coping mechanism | brief COPE questionnaire: 14 scales including 2 items (28 items in total) | 12 months | 
| Cognitive impairment | Montreal Cognitive Assessment (MoCA) | Baseline | 
| Initial mindfulness | Five Facets Mindfulness Questionnaire (FFMQ): 39-item self-assessment tool measuring 5 factors of mindfulness | Baseline | 
| Number of meditation sessions per week over the last 4 weeks |  | Month 6 |