Clinical trial NCT04598399: Comparison of the Effectiveness of Two Psycho-physical Interventions: Mindfulness Based Relapse Prevention (MBRP) and Unguided Meditative Relaxation in Patients With Alcohol Use Disorder
Official title: 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 type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alcohol Use Disorder (AUD)
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2020-10-22
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Reduction in number of heavy drinking days (HDD) over previous 4 weeks, between the last drinking period at inclusion and 6 months.
timeFrame: 6 months
Secondary outcomes:
measure: 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
timeFrame: 3 months
measure: 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
timeFrame: 12 months
measure: Change in 4-week total alcohol consumption since baseline
timeFrame: 3 months
measure: Change in 4-week total alcohol consumption since baseline
timeFrame: 12 months
measure: Change in frequency of craving since baseline
timeFrame: 3 months
measure: Change in frequency of craving since baseline
timeFrame: 6 months
measure: Change in frequency of craving since baseline
timeFrame: 12 months
measure: Change in strength of craving since baseline
timeFrame: 3 months
measure: Change in strength of craving since baseline
timeFrame: 6 months
measure: Change in strength of craving since baseline
timeFrame: 12 months
measure: Anxiety at baseline
timeFrame: Baseline
measure: Change in anxiety since baseline
timeFrame: 3 months
measure: Change in anxiety since baseline
timeFrame: 6 months
measure: Change in anxiety since baseline
timeFrame: 12 months
measure: Depression at baseline
timeFrame: Baseline
measure: Change in depression since baseline
timeFrame: 3 months
measure: Change in depression since baseline
timeFrame: 6 months
measure: Change in depression since baseline
timeFrame: 12 months
measure: Change in quality of life since baseline
timeFrame: 3 months
measure: Change in quality of life since baseline
timeFrame: 6 months
measure: Change in quality of life since baseline
timeFrame: 12 months
measure: Emotion regulation at baseline
timeFrame: Baseline
measure: Change in emotion regulation since baseline
timeFrame: 3 months
measure: Change in emotion regulation since baseline
timeFrame: 6 months
measure: Change in emotion regulation since baseline
timeFrame: 12 months
measure: Difficulties regulating emotion at baseline
timeFrame: Baseline
measure: Changes in difficulties regulating emotion since baseline
timeFrame: 3 months
measure: Changes in difficulties regulating emotion since baseline
timeFrame: 6 months
measure: Changes in difficulties regulating emotion since baseline
timeFrame: 12 months
measure: Changes in impulsivity since baseline
timeFrame: 3 months
measure: Impulsivity at baseline
timeFrame: Baseline
measure: Changes in impulsivity since baseline
timeFrame: 6 months
measure: Changes in impulsivity since baseline
timeFrame: 12 months
measure: Changes in coping mechanism
timeFrame: 3 months
measure: Coping mechanism at baseline
timeFrame: Baseline
measure: Changes in coping mechanism
timeFrame: 6 months
measure: Changes in coping mechanism
timeFrame: 12 months
measure: Cognitive impairment
timeFrame: Baseline
measure: Initial mindfulness
timeFrame: Baseline
measure: Number of meditation sessions per week over the last 4 weeks
timeFrame: Month 6
Other outcomes:
Locations:
city: Angers
country: France
facility: Ssra Les Eumenides
city: Issy-les-Moulineaux
country: France
facility: Hôpital Corentin-Celton
city: Nantes
country: France
facility: CHU de Nantes
city: Nîmes
country: France
facility: CHU de Nimes
city: Paris
country: France
facility: Hopital Fernand Widal
city: Sèvres
country: France
facility: Hopital Des 4 Villes
city: Villejuif
country: France
facility: Hopital Paul Brousse
Study officials:
affiliation: CHU Nimes
name: Amandine Luquiens
role: PRINCIPAL_INVESTIGATOR
References: