Actively Recruiting
Comparison of the Effectiveness of Two Psycho-physical Interventions: Mindfulness Based Relapse Prevention and Unguided Meditative Relaxation in Patients With Alcohol Use Disorder
Led by Centre Hospitalier Universitaire de Nīmes · Updated on 2025-08-21
168
Participants Needed
7
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating two psycho-physical interventions for people with moderate to severe alcohol use disorder (AUD) to reduce heavy drinking days and prevent relapse. The study compares Mindfulness Based Relapse Prevention (MBRP), a structured program involving mindfulness practice, with an unguided meditative relaxation program. This research addresses the need for effective therapies in AUD, as only a small percentage of patients receive approved drugs, and some patients are resistant to cognitive behavioral therapies. Participants will be randomly assigned to either the MBRP group or a relaxation/meditation control group. MBRP involves seven sessions lasting 60 to 120 minutes each, covering topics such as triggers, relapse prevention, and mindfulness in daily life, including meditation exercises and discussions on at-home practice. The relaxation group attends seven sessions of unguided relaxation with nature sounds, accommodating up to 12 participants per group. Throughout the study, participants will be monitored for changes in heavy drinking days, alcohol consumption, craving frequency and strength, anxiety, depression, quality of life, emotion regulation, impulsivity, coping mechanisms, and cognitive impairment over 3, 6, and 12 months. Researchers will track the number of meditation sessions and assess mental health and behavioral changes. The primary outcome is the reduction in heavy drinking days six months after inclusion, with continued evaluations up to one year.
CONDITIONS
Brief 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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 heavy drinking day during the last drinking period.
You will not qualify if you...
- Severe depression (Beck Depression Inventory > 30).
- Schizophrenic disorder.
- Current maniac or hypomaniac episode.
- Dementia or severe cognitive impairment that would prevent following the course of a session.
- 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.
- Patient under safeguard of justice or state guardianship.
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 7 sessions over several weeks
Participants attend 7 sessions of either Mindfulness Based Relapse Prevention or unguided meditative relaxation, each session lasting 60 to 120 minutes with various themes or sounds focused on relapse prevention and relaxation.
7 weekly sessions (in-person or group)
Duration - Up to 12 months
Participants are monitored for changes in heavy drinking days, craving, anxiety, depression, quality of life, emotion regulation, impulsivity, coping mechanisms, and other outcomes up to 12 months after treatment.
Follow-up assessments at 3, 6, and 12 months
Trial Site Locations
Total: 7 locations
1
Ssra Les Eumenides
Angers, France, 49100
Actively Recruiting
2
Hôpital Corentin-Celton
Issy-les-Moulineaux, France
Not Yet Recruiting
3
CHU de Nantes
Nantes, France
Actively Recruiting
4
CHU de Nimes
Nîmes, France
Actively Recruiting
5
Hopital Fernand Widal
Paris, France, 75010
Not Yet Recruiting
6
Hopital Des 4 Villes
Sèvres, France, 92310
Not Yet Recruiting
7
Hopital Paul Brousse
Villejuif, France
Not Yet Recruiting
Research Team
A
Amandine Luquiens
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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