Comparison of the Effectiveness of Two Psycho-physical Interventions: Mindfulness Based Relapse Prevention (MBRP) and Unguided Meditative Relaxation in Patients With Alcohol Use Disorder

Обзор

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.

Вмешательства

• Поведенческое 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.
• Поведенческое 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

Первичные конечные точки

• Reduction in number of heavy drinking days (HDD) over previous 4 weeks, between the last drinking period at inclusion and 6 months. [Срок оценки: 6 months]

Вторичные конечные точки (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 [Срок оценки: 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 [Срок оценки: 12 months]
• Change in 4-week total alcohol consumption since baseline [Срок оценки: 3 months]
• Change in 4-week total alcohol consumption since baseline [Срок оценки: 12 months]
• Change in frequency of craving since baseline [Срок оценки: 3 months]
• Change in frequency of craving since baseline [Срок оценки: 6 months]
• Change in frequency of craving since baseline [Срок оценки: 12 months]
• Change in strength of craving since baseline [Срок оценки: 3 months]
• Change in strength of craving since baseline [Срок оценки: 6 months]
• Change in strength of craving since baseline [Срок оценки: 12 months]
• Anxiety at baseline [Срок оценки: Baseline]
• Change in anxiety since baseline [Срок оценки: 3 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Франция · 7 центров

• 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

Идентификаторы

NCT: NCT04598399 · PHRCN/2018/AL-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗