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) Clinical Trial

— MBRP  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04598399
• Other study ID #: PHRCN/2018/AL-01
• Status: Recruiting
• Phase: N/A
• Start date: October 20, 2021
• Est. completion date: November 2025

Study information

• Verified date: January 2024
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: Amandine Luquiens
• Phone: 04.66.68.69.98
• Email: Amandine.luquiens[@]chu-nimes.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 168
• Est. completion date: November 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Disorder (AUD)
• Alcoholism

Intervention

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.
• 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

Locations

Country	Name	City	State
France	Ssra Les Eumenides	Angers
France	Hôpital Corentin-Celton	Issy-les-Moulineaux
France	CHU de Nantes	Nantes
France	CHU de Nimes	Nîmes
France	Hopital Fernand Widal	Paris
France	Hopital Des 4 Villes	Sèvres
France	Hopital Paul Brousse	Villejuif

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

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