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 Nīmes

Status: Enrolling

Conditions: Alcohol Use Disorder (AUD)

Treatments: Behavioral: Mindfulness Based Relapse Prevention; Behavioral: Relaxation/ meditation

Study type: Interventional

Funder types: Other

Identifiers

NCT04598399

PHRCN/2018/AL-01

Details and patient eligibility

About

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.

Enrollment: 168 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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168 participants in 2 patient groups

MBRP program:

Experimental group

Treatment:

Behavioral: Mindfulness Based Relapse Prevention

Standard care

Active Comparator group

Treatment:

Behavioral: Relaxation/ meditation