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NCT Number: 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

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.

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Key information

Conditions

Alcohol Use Disorder (AUD) Alcohol-Related Disorders Alcoholism Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ssra Les Eumenides, Angers, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mindfulness Based Relapse Prevention

Behavioral

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.

Relaxation/ meditation

Behavioral

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 outcomes

  1. 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

    Alcohol Time Line Follow Back (TLFB) where a HDD = consummation of 4+ (for women) or 5+ (for men) drinks per day.

Secondary outcomes

  1. 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

    Alcohol Time Line Follow Back (TLFB) where a HDD = consummation of 4+ (for women) or 5+ (for men) drinks per day.

  2. 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

    Alcohol Time Line Follow Back (TLFB) where a HDD = consummation of 4+ (for women) or 5+ (for men) drinks per day.

  3. Change in 4-week total alcohol consumption since baseline

    Time frame: 3 months

    number of drinks (1 glass = 1 unit according to grams alcohol)

  4. Change in 4-week total alcohol consumption since baseline

    Time frame: 12 months

    number of drinks (1 glass = 1 unit according to grams alcohol)

  5. Change in frequency of craving since baseline

    Time frame: 3 months

    version F of craving experience questionnaire (CEQ-F)

  6. Change in frequency of craving since baseline

    Time frame: 6 months

    version F of craving experience questionnaire (CEQ-F)

  7. Change in frequency of craving since baseline

    Time frame: 12 months

    version F of craving experience questionnaire (CEQ-F)

  8. Change in strength of craving since baseline

    Time frame: 3 months

    version S of craving experience questionnaire (CEQ-S)

  9. Change in strength of craving since baseline

    Time frame: 6 months

    version S of craving experience questionnaire (CEQ-S)

  10. Change in strength of craving since baseline

    Time frame: 12 months

    version S of craving experience questionnaire (CEQ-S)

  11. Anxiety at baseline

    Time frame: Baseline

    Beck Anxiety Inventory depression (BAI): 21-item self-assessment scale assessing anxiety

  12. Change in anxiety since baseline

    Time frame: 3 months

    Beck Anxiety Inventory depression (BAI): 21-item self-assessment scale assessing anxiety

  13. Change in anxiety since baseline

    Time frame: 6 months

    Beck Anxiety Inventory depression (BAI): 21-item self-assessment scale assessing anxiety

  14. Change in anxiety since baseline

    Time frame: 12 months

    Beck Anxiety Inventory depression (BAI): 21-item self-assessment scale assessing anxiety

  15. Depression at baseline

    Time frame: Baseline

    Beck Depression Inventory (BDI): 21 items assessing the presence and severity of depressive symptoms

  16. Change in depression since baseline

    Time frame: 3 months

    Beck Depression Inventory (BDI): 21 items assessing the presence and severity of depressive symptoms

  17. Change in depression since baseline

    Time frame: 6 months

    Beck Depression Inventory (BDI): 21 items assessing the presence and severity of depressive symptoms

  18. Change in depression since baseline

    Time frame: 12 months

    Beck Depression Inventory (BDI): 21 items assessing the presence and severity of depressive symptoms

  19. Change in quality of life since baseline

    Time frame: 3 months

    Alcohol Quality of Life Scale (AQoLS): 34-item patient-reported questionnaire

  20. Change in quality of life since baseline

    Time frame: 6 months

    Alcohol Quality of Life Scale (AQoLS): 34-item patient-reported questionnaire

  21. Change in quality of life since baseline

    Time frame: 12 months

    Alcohol Quality of Life Scale (AQoLS): 34-item patient-reported questionnaire

  22. Emotion regulation at baseline

    Time frame: Baseline

    Emotion Regulation Questionnaire (ERQ): 10-item scale designed to assessing Cognitive Reappraisal and Expressive Suppression on a 7-point Likert-type scale ranging from 1 (strongly disagree) to 7 (strongly agree).

  23. Change in emotion regulation since baseline

    Time frame: 3 months

    Emotion Regulation Questionnaire (ERQ): 10-item scale designed to assessing Cognitive Reappraisal and Expressive Suppression on a 7-point Likert-type scale ranging from 1 (strongly disagree) to 7 (strongly agree).

  24. Change in emotion regulation since baseline

    Time frame: 6 months

    Emotion Regulation Questionnaire (ERQ): 10-item scale designed to assessing Cognitive Reappraisal and Expressive Suppression on a 7-point Likert-type scale ranging from 1 (strongly disagree) to 7 (strongly agree).

  25. Change in emotion regulation since baseline

    Time frame: 12 months

    Emotion Regulation Questionnaire (ERQ): 10-item scale designed to assessing Cognitive Reappraisal and Expressive Suppression on a 7-point Likert-type scale ranging from 1 (strongly disagree) to 7 (strongly agree).

  26. Difficulties regulating emotion at baseline

    Time frame: Baseline

    Difficulties in Emotion Regulation scale (DERS -Impulse): items 3, 14, 19, 24R, 27, 32 from DERS

  27. Changes in difficulties regulating emotion since baseline

    Time frame: 3 months

    Difficulties in Emotion Regulation scale (DERS -Impulse): items 3, 14, 19, 24R, 27, 32 from DERS

  28. Changes in difficulties regulating emotion since baseline

    Time frame: 6 months

    Difficulties in Emotion Regulation scale (DERS -Impulse): items 3, 14, 19, 24R, 27, 32 from DERS

  29. Changes in difficulties regulating emotion since baseline

    Time frame: 12 months

    Difficulties in Emotion Regulation scale (DERS -Impulse): items 3, 14, 19, 24R, 27, 32 from DERS

  30. Changes in impulsivity since baseline

    Time frame: 3 months

    Impulsive behavior scale (UPPS-P): 20-item self-assessment scale

  31. Impulsivity at baseline

    Time frame: Baseline

    Impulsive behavior scale (UPPS-P): 20-item self-assessment scale

  32. Changes in impulsivity since baseline

    Time frame: 6 months

    Impulsive behavior scale (UPPS-P): 20-item self-assessment scale

  33. Changes in impulsivity since baseline

    Time frame: 12 months

    Impulsive behavior scale (UPPS-P): 20-item self-assessment scale

  34. Changes in coping mechanism

    Time frame: 3 months

    brief COPE questionnaire: 14 scales including 2 items (28 items in total)

  35. Coping mechanism at baseline

    Time frame: Baseline

    brief COPE questionnaire: 14 scales including 2 items (28 items in total)

  36. Changes in coping mechanism

    Time frame: 6 months

    brief COPE questionnaire: 14 scales including 2 items (28 items in total)

  37. Changes in coping mechanism

    Time frame: 12 months

    brief COPE questionnaire: 14 scales including 2 items (28 items in total)

  38. Cognitive impairment

    Time frame: Baseline

    Montreal Cognitive Assessment (MoCA)

  39. Initial mindfulness

    Time frame: Baseline

    Five Facets Mindfulness Questionnaire (FFMQ): 39-item self-assessment tool measuring 5 factors of mindfulness

  40. Number of meditation sessions per week over the last 4 weeks

    Time frame: Month 6

Study contacts

Contact information is provided by the study sponsor or research team.

Amandine Luquiens

CONTACT

[email protected]

04.66.68.69.98

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Acronym: MBRP

Important dates

Study start
2021
Primary completion
2026
Study completion
2027
First posted
Oct 22, 2020
Registry last updated
Aug 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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