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

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ClinicalTrials.gov Identifier: NCT04598399
Recruitment Status : Not yet recruiting
First Posted : October 22, 2020
Last Update Posted : August 5, 2021
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Alcohol Use Disorder (AUD) Behavioral: Mindfulness Based Relapse Prevention Behavioral: Relaxation/ meditation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 168 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: In order to limit measurement and attrition biases, the patient will be kept unaware of the hypotheses concerning the details of the evaluated programs (MBRP or control) and the program expected to be superior
Primary Purpose: Treatment
Official 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
Estimated Study Start Date : October 2021
Estimated Primary Completion Date : April 2025
Estimated Study Completion Date : November 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol

Arms and Interventions
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Arm Intervention/treatment
Experimental: MBRP program: 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.
Active Comparator: Standard care 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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 30 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04598399


Contacts
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Contact: Amandine Luquiens 04.66.68.69.98 Amandine.luquiens@chu-nimes.fr

Locations
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France
Hôpital Corentin-Celton
Issy-les-Moulineaux, France
Contact: Patrice Louvillle    01 58 00 44 25    patrice.louvillle@aphp.fr   
Principal Investigator: Patrice Louvillle         
CHU de Nantes
Nantes, France
Contact: Marie Grall-Bronnec    02.40.84.61.16    marie.bronnec@chu-nantes.fr   
Principal Investigator: Marie Grall-Bronnec         
CHU de Nimes
Nîmes, France
Contact: Anissa Megzari    04.66.68.42.36    drc@chu-nimes.fr   
Principal Investigator: Amandine Luquiens         
Clinique Des Epinettes
Paris, France
Contact: Marion Groppi    01 84 82 42 42    m.groppi@cliniquedesepinettes.com   
Principal Investigator: Marion Groppi         
Sub-Investigator: Arnaud Plat         
Hopital Pitié-Salpétriere
Paris, France
Contact: Yves Edel    01 45 59 69 78    yves.edel@aphp.fr   
Principal Investigator: Yves Edel         
Le CSAPA - Association Charonne
Paris, France
Contact: Pascale Bouthillon-Heizmann    01 45 83 22 22    pascale.bouthillon@charonne.asso.fr   
Principal Investigator: Pascale Bouthillon-Heizmann         
Hopital Paul Brousse
Villejuif, France
Contact: Amine Benyamina    01 45 59 69 78    secretariat.addictologie.pbr@aphp.fr   
Principal Investigator: Amine Benyamina         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
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Principal Investigator: Amandine Luquiens CHU Nimes
More Information
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Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT04598399    
Other Study ID Numbers: PHRCN/2018/AL-01
First Posted: October 22, 2020    Key Record Dates
Last Update Posted: August 5, 2021
Last Verified: August 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alcoholism
Alcohol Drinking
Drinking Behavior
Alcohol-Related Disorders
 Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders