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Recruiting 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

No phase Interventional Alcohol Use Disorder (AUD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Mindfulness Based Relapse Prevention, Relaxation/ meditation.
Who it may be relevant to
Registry conditions: Alcohol Use Disorder (AUD). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Behavioral Mindfulness Based Relapse Prevention
    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.
  • Behavioral Relaxation/ meditation
    7 x 60-120 minute sessions each with a different sound from nature with unguided, closed relaxation group with a maximum of 12 participants

Primary outcome measures

  • Reduction in number of heavy drinking days (HDD) over previous 4 weeks, between the last drinking period at inclusion and 6 months. [Time frame: 6 months]
Secondary outcome measures (12)
  • 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 [Time frame: 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 [Time frame: 12 months]
  • Change in 4-week total alcohol consumption since baseline [Time frame: 3 months]
  • Change in 4-week total alcohol consumption since baseline [Time frame: 12 months]
  • Change in frequency of craving since baseline [Time frame: 3 months]
  • Change in frequency of craving since baseline [Time frame: 6 months]
  • Change in frequency of craving since baseline [Time frame: 12 months]
  • Change in strength of craving since baseline [Time frame: 3 months]
  • Change in strength of craving since baseline [Time frame: 6 months]
  • Change in strength of craving since baseline [Time frame: 12 months]
  • Anxiety at baseline [Time frame: Baseline]
  • Change in anxiety since baseline [Time frame: 3 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

France · 7 centers
  • Ssra Les Eumenides — Angers
  • Hôpital Corentin-Celton — Issy-les-Moulineaux
  • CHU de Nantes — Nantes
  • CHU de Nimes — Nîmes
  • Hopital Fernand Widal — Paris
  • Hopital Des 4 Villes — Sèvres
  • Hopital Paul Brousse — Villejuif

Identifiers

NCT: NCT04598399 · PHRCN/2018/AL-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗