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
- Alcohol Use Disorder (AUD)
- Interventions
- Behavioral: Relaxation/ meditationBehavioral: Mindfulness Based Relapse Prevention
- Registration Number
- NCT04598399
- Lead Sponsor
- Centre Hospitalier Universitaire de Nīmes
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 168
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard care Relaxation/ meditation - MBRP program: Mindfulness Based Relapse Prevention -
- Primary Outcome Measures
Name Time Method Reduction in number of heavy drinking days (HDD) over previous 4 weeks, between the last drinking period at inclusion and 6 months. 6 months Alcohol Time Line Follow Back (TLFB) where a HDD = consummation of 4+ (for women) or 5+ (for men) drinks per day.
- Secondary Outcome Measures
Name Time Method Change in frequency of craving since baseline 12 months version F of craving experience questionnaire (CEQ-F)
Coping mechanism at baseline Baseline brief COPE questionnaire: 14 scales including 2 items (28 items in total)
Cognitive impairment Baseline Montreal Cognitive Assessment (MoCA)
Number of meditation sessions per week over the last 4 weeks Month 6 Change in 4-week total alcohol consumption since baseline 12 months number of drinks (1 glass = 1 unit according to grams alcohol)
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 3 months Alcohol Time Line Follow Back (TLFB) where a HDD = consummation of 4+ (for women) or 5+ (for men) drinks per day.
Anxiety at baseline Baseline Beck Anxiety Inventory depression (BAI): 21-item self-assessment scale assessing anxiety
Difficulties regulating emotion at baseline Baseline Difficulties in Emotion Regulation scale (DERS -Impulse): items 3, 14, 19, 24R, 27, 32 from DERS
Impulsivity at baseline Baseline Impulsive behavior scale (UPPS-P): 20-item self-assessment scale
Initial mindfulness Baseline Five Facets Mindfulness Questionnaire (FFMQ): 39-item self-assessment tool measuring 5 factors of mindfulness
Change in strength of craving since baseline 12 months version S of craving experience questionnaire (CEQ-S)
Change in depression since baseline 12 months Beck Depression Inventory (BDI): 21 items assessing the presence and severity of depressive symptoms
Emotion regulation at baseline 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).
Change in emotion regulation since baseline 12 months 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).
Changes in coping mechanism 12 months brief COPE questionnaire: 14 scales including 2 items (28 items in total)
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 12 months Alcohol Time Line Follow Back (TLFB) where a HDD = consummation of 4+ (for women) or 5+ (for men) drinks per day.
Change in anxiety since baseline 12 months Beck Anxiety Inventory depression (BAI): 21-item self-assessment scale assessing anxiety
Depression at baseline Baseline Beck Depression Inventory (BDI): 21 items assessing the presence and severity of depressive symptoms
Change in quality of life since baseline 12 months Alcohol Quality of Life Scale (AQoLS): 34-item patient-reported questionnaire
Changes in difficulties regulating emotion since baseline 12 months Difficulties in Emotion Regulation scale (DERS -Impulse): items 3, 14, 19, 24R, 27, 32 from DERS
Changes in impulsivity since baseline 12 months Impulsive behavior scale (UPPS-P): 20-item self-assessment scale
Trial Locations
- Locations (7)
Ssra Les Eumenides
🇫🇷Angers, France
CHU de Nantes
🇫🇷Nantes, France
Hôpital Corentin-Celton
🇫🇷Issy-les-Moulineaux, France
CHU de Nimes
🇫🇷Nîmes, France
Hopital Fernand Widal
🇫🇷Paris, France
Hopital Des 4 Villes
🇫🇷Sèvres, France
Hopital Paul Brousse
🇫🇷Villejuif, France