search
Back to results

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)

Primary Purpose

Alcohol Use Disorder (AUD)

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Mindfulness Based Relapse Prevention
Relaxation/ meditation
Sponsored by
Centre Hospitalier Universitaire de Nīmes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Use Disorder (AUD)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ssra Les Eumenides
  • Hôpital Corentin-Celton
  • CHU de NantesRecruiting
  • CHU de Nimes
  • Le CSAPA - Association Charonne
  • Hopital Paul Brousse

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MBRP program:

Standard care

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
October 16, 2020
Last Updated
April 11, 2023
Sponsor
Centre Hospitalier Universitaire de Nīmes
search

1. Study Identification

Unique Protocol Identification Number
NCT04598399
Brief 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
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 20, 2021 (Actual)
Primary Completion Date
April 2025 (Anticipated)
Study Completion Date
November 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder (AUD)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
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
Allocation
Randomized
Enrollment
168 (Anticipated)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amandine Luquiens
Phone
04.66.68.69.98
Email
Amandine.luquiens@chu-nimes.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amandine Luquiens
Organizational Affiliation
CHU Nimes
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ssra Les Eumenides
City
Angers
ZIP/Postal Code
49100
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
CORINNE DANO
Phone
0241353485
Email
codano@chu-angers.fr
Facility Name
Hôpital Corentin-Celton
City
Issy-les-Moulineaux
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrice Louvillle
Phone
01 58 00 44 25
Email
patrice.louvillle@aphp.fr
First Name & Middle Initial & Last Name & Degree
Patrice Louvillle
Facility Name
CHU de Nantes
City
Nantes
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie Grall-Bronnec
Phone
02.40.84.61.16
Email
marie.bronnec@chu-nantes.fr
First Name & Middle Initial & Last Name & Degree
Marie Grall-Bronnec
Facility Name
CHU de Nimes
City
Nîmes
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anissa Megzari
Phone
04.66.68.42.36
Email
drc@chu-nimes.fr
First Name & Middle Initial & Last Name & Degree
Amandine Luquiens
Facility Name
Le CSAPA - Association Charonne
City
Paris
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pascale Bouthillon-Heizmann
Phone
01 45 83 22 22
Email
pascale.bouthillon@charonne.asso.fr
First Name & Middle Initial & Last Name & Degree
Pascale Bouthillon-Heizmann
Facility Name
Hopital Paul Brousse
City
Villejuif
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amine Benyamina
Phone
01 45 59 69 78
Email
secretariat.addictologie.pbr@aphp.fr
First Name & Middle Initial & Last Name & Degree
Amine Benyamina

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs