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)

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.

Study Overview

• Status: Recruiting
• Conditions: Alcohol Use Disorder (AUD)
• Intervention / Treatment: Behavioral: Mindfulness Based Relapse Prevention; Behavioral: Relaxation/ meditation

• Study Type: Interventional
• Enrollment (Estimated): 168
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Amandine Luquiens; Phone Number: 04.66.68.69.98; Email: amandine.luquiens@chu-nimes.fr

Study Locations

• France
  • Angers, France, 49100
    • Recruiting
    • Ssra Les Eumenides
    • Contact: CORINNE DANO; Phone Number: 0241353485; Email: codano@chu-angers.fr
  • Issy-les-Moulineaux, France
    • Not yet recruiting
    • Hôpital Corentin-Celton
    • Contact: Patrice Louvillle; Phone Number: 01 58 00 44 25; Email: patrice.louvillle@aphp.fr
    • Principal Investigator: Patrice Louvillle
  • Nantes, France
    • Recruiting
    • CHU de Nantes
    • Principal Investigator: Marie Grall-Bronnec
    • Contact: Marie Grall-Bronnec; Phone Number: 02.40.84.61.16; Email: marie.bronnec@chu-nantes.fr
  • Nîmes, France
    • Recruiting
    • CHU de Nîmes
    • Contact: Anissa Megzari; Phone Number: 04.66.68.42.36; Email: drc@chu-nimes.fr
    • Principal Investigator: Amandine Luquiens
  • Paris, France, 75010
    • Not yet recruiting
    • Hopital Fernand Widal
    • Contact: FLORENCE VORSPAN; Phone Number: 0141525676; Email: florence.vorspan@aphp.fr
  • Sèvres, France, 92310
    • Not yet recruiting
    • Hopital Des 4 Villes
    • Contact: NICOLAS THIERCELIN; Phone Number: 0177707940; Email: n.thiercelin@ch4v.fr
  • Villejuif, France
    • Not yet recruiting
    • Hopital Paul Brousse
    • Principal Investigator: Amine Benyamina
    • Contact: Amine Benyamina; Phone Number: 01 45 59 69 78; Email: secretariat.addictologie.pbr@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in number of heavy drinking days (HDD) over previous 4 weeks, between the last drinking period at inclusion and 6 months.	Alcohol Time Line Follow Back (TLFB) where a HDD = consummation of 4+ (for women) or 5+ (for men) drinks per day.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Alcohol Time Line Follow Back (TLFB) where a HDD = consummation of 4+ (for women) or 5+ (for men) drinks per day.	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	Alcohol Time Line Follow Back (TLFB) where a HDD = consummation of 4+ (for women) or 5+ (for men) drinks per day.	12 months
Change in 4-week total alcohol consumption since baseline	number of drinks (1 glass = 1 unit according to grams alcohol)	3 months
Change in 4-week total alcohol consumption since baseline	number of drinks (1 glass = 1 unit according to grams alcohol)	12 months
Change in frequency of craving since baseline	version F of craving experience questionnaire (CEQ-F)	3 months
Change in frequency of craving since baseline	version F of craving experience questionnaire (CEQ-F)	6 months
Change in frequency of craving since baseline	version F of craving experience questionnaire (CEQ-F)	12 months
Change in strength of craving since baseline	version S of craving experience questionnaire (CEQ-S)	3 months
Change in strength of craving since baseline	version S of craving experience questionnaire (CEQ-S)	6 months
Change in strength of craving since baseline	version S of craving experience questionnaire (CEQ-S)	12 months
Anxiety at baseline	Beck Anxiety Inventory depression (BAI): 21-item self-assessment scale assessing anxiety	Baseline
Change in anxiety since baseline	Beck Anxiety Inventory depression (BAI): 21-item self-assessment scale assessing anxiety	3 months
Change in anxiety since baseline	Beck Anxiety Inventory depression (BAI): 21-item self-assessment scale assessing anxiety	6 months
Change in anxiety since baseline	Beck Anxiety Inventory depression (BAI): 21-item self-assessment scale assessing anxiety	12 months
Depression at baseline	Beck Depression Inventory (BDI): 21 items assessing the presence and severity of depressive symptoms	Baseline
Change in depression since baseline	Beck Depression Inventory (BDI): 21 items assessing the presence and severity of depressive symptoms	3 months
Change in depression since baseline	Beck Depression Inventory (BDI): 21 items assessing the presence and severity of depressive symptoms	6 months
Change in depression since baseline	Beck Depression Inventory (BDI): 21 items assessing the presence and severity of depressive symptoms	12 months
Change in quality of life since baseline	Alcohol Quality of Life Scale (AQoLS): 34-item patient-reported questionnaire	3 months
Change in quality of life since baseline	Alcohol Quality of Life Scale (AQoLS): 34-item patient-reported questionnaire	6 months
Change in quality of life since baseline	Alcohol Quality of Life Scale (AQoLS): 34-item patient-reported questionnaire	12 months
Emotion regulation at 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).	Baseline
Change in emotion regulation since 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).	3 months
Change in emotion regulation since 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).	6 months
Change in emotion regulation since 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).	12 months
Difficulties regulating emotion at baseline	Difficulties in Emotion Regulation scale (DERS -Impulse): items 3, 14, 19, 24R, 27, 32 from DERS	Baseline
Changes in difficulties regulating emotion since baseline	Difficulties in Emotion Regulation scale (DERS -Impulse): items 3, 14, 19, 24R, 27, 32 from DERS	3 months
Changes in difficulties regulating emotion since baseline	Difficulties in Emotion Regulation scale (DERS -Impulse): items 3, 14, 19, 24R, 27, 32 from DERS	6 months
Changes in difficulties regulating emotion since baseline	Difficulties in Emotion Regulation scale (DERS -Impulse): items 3, 14, 19, 24R, 27, 32 from DERS	12 months
Changes in impulsivity since baseline	Impulsive behavior scale (UPPS-P): 20-item self-assessment scale	3 months
Impulsivity at baseline	Impulsive behavior scale (UPPS-P): 20-item self-assessment scale	Baseline
Changes in impulsivity since baseline	Impulsive behavior scale (UPPS-P): 20-item self-assessment scale	6 months
Changes in impulsivity since baseline	Impulsive behavior scale (UPPS-P): 20-item self-assessment scale	12 months
Changes in coping mechanism	brief COPE questionnaire: 14 scales including 2 items (28 items in total)	3 months
Coping mechanism at baseline	brief COPE questionnaire: 14 scales including 2 items (28 items in total)	Baseline
Changes in coping mechanism	brief COPE questionnaire: 14 scales including 2 items (28 items in total)	6 months
Changes in coping mechanism	brief COPE questionnaire: 14 scales including 2 items (28 items in total)	12 months
Cognitive impairment	Montreal Cognitive Assessment (MoCA)	Baseline
Initial mindfulness	Five Facets Mindfulness Questionnaire (FFMQ): 39-item self-assessment tool measuring 5 factors of mindfulness	Baseline
Number of meditation sessions per week over the last 4 weeks		Month 6

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Amandine Luquiens, CHU Nimes

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2021
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): November 1, 2025

Study Registration Dates

• First Submitted: October 16, 2020
• First Submitted That Met QC Criteria: October 16, 2020
• First Posted (Actual): October 22, 2020

Study Record Updates

• Last Update Posted (Actual): January 26, 2024
• Last Update Submitted That Met QC Criteria: January 25, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Drinking Behavior; Alcohol-Related Disorders; Substance-Related Disorders; Alcohol Drinking; Alcoholism
• Other Study ID Numbers: PHRCN/2018/AL-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No