Alcohol Use DisorderMindfulnessNCT03150550
Study of Mindfulness Practice Efficacy in Alcoholic Relapse Prevention
A study testing Mindfulness practice and Relapse prevention in people with Alcohol Use Disorder, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Among behavioral cognitive psychotherapies, new "Mindfulness" interventions allow patient to identify, pay attention and accept external (sensory stimuli) and internal (cognition and emotions) phenomena. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- Mindfulness practice and Relapse prevention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 21 Jan 2017to Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged 18 to 75 (including landmarks)
- Patients in withdrawal for alcohol dependence according to DSM IV criteria (1994); hospital or outpatient withdrawal of more than 10 days and less than 10 weeks.
Who cannot join
- Psychiatric comorbidity (dipsomaniac alcoholism, anteriority of one or more hypomanic or manic episodes, psychoses, severe depression, severe suicidal risk)
- Other addiction syndrome than tobacco and alcohol
- Problems that impede participation in a group, such as severe borderline personality disorder; antisocial personality; tendency to dissociation; phobias of interceptive type (panic attacks and hypochondria ...)
- Problems preventing the completion of questionnaires, such as cognitive dysfunctions, dysfunctions of attention and concentration skills, or a language barrier
- Severe recurring pathology
- Need for individual weekly follow-up
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Clermont-Ferrand
France, 63003
Patrick LACARIN, 04 73 75 11 95, placarin@chu-clermontferrand.fr
Julie GENESTE, 04 73 75 47 84, j_geneste@chu-clermontferrand.fr
About this study
Among behavioral cognitive psychotherapies, new "Mindfulness" interventions allow patient to identify, pay attention and accept external (sensory stimuli) and internal (cognition and emotions) phenomena. This "to do with" training has yielded promising results in stress management, prevention of depressive relapse, management of craving and an increase in self-efficacy. Few studies (none in France) have attempted to measure the efficacy of this technique on alcohol relapse, in particular by comparing it with a usual management strategy (conventional relapse prevention therapy).
The main objective of this study is to compare the efficacy on alcoholic relapse (measured in the "first glass" consumed), from a Mindfulness therapeutic program to a conventional Relapse Prevention program. Secondary objectives are to demonstrate the efficacy of this program on craving, self-efficacy, and secondary endpoints of relapse (massive alcoholism, number of alcoholisation days).
Read the detailed description
Each patient will perform 12 psychotherapeutic sessions (Mindfulness or Relapse Prevention) over a period of 6 weeks. Patients will be evaluated by a practitioner different from the practitioner who makes the psychotherapeutic management.
Patients will be assessed at inclusion (Initial visit), after the 12 sessions of management (M0), 1 month (M1), 2 month (M2), 3 month (M3), 4 month (M4), 5 month (M5), 6 month (M6), after initial visit as follows
Initial Visit
- Signature of an informed consent form.
- Demographic characteristics (gender, age, family status, professional status, level of education …)
- Clinical data (patient status, ongoing pharmacological treatment, withdrawal, previous CBT ...)
- Criteria and severity of alcohol dependence (DSM 5)
- Evaluation of depressive symptomatology and severity (HAM-D)
- Level of pre-intervention alcohol consumption (AUDIT-C)
- "Binge drinking" consumption
- Craving before alcohol withdrawal (EVA craving)
- Mindfulness Skills (KIMS)
- Self-efficacy to remain abstinent (QAE-Alcohol)
- Drinking habits (QHPBA)
After the 12 sessions (M0)
- Data on treatments in progress or change in treatment
- Depressive symptomatology and severity (HAM-D)
- Level of alcohol consumption in post-intervention (AUDIT-C)
- "Binge drinking" consumption
- Craving after alcohol withdrawal (EVA craving)
- Mindfulness Skills (KIMS)
- Self-efficacy to remain abstinent (QAE-Alcohol)
- Distribution of the 1st Daily Alcohol Logbook (TLFB)
At 1 month (M1)
- Return of the 1st Daily Alcohol Logbook (TLFB)
- Data on treatments in progress or change in treatment
- Mindfulness Skills (KIMS)
- "Binge drinking" consumption
- Self-efficacy to remain abstinent (QAE-Alcohol)
- Distribution of the 2nd Daily Alcohol Logbook (TLFB)
At 2 month (M2)
- Return of the 2nd Daily Alcohol Logbook (TLFB)
- Data on treatments in progress or change in treatment
- Mindfulness Skills (KIMS)
- "Binge drinking" consumption
- Self-efficacy to remain abstinent (QAE-Alcohol)
- Distribution of the 3th Daily Alcohol Logbook (TLFB)
At 3 month (M3)
- Return of the 3th Daily Alcohol Logbook (TLFB)
- Data on treatments in progress or change in treatment
- Mindfulness Skills (KIMS)
- "Binge drinking" consumption
- Self-efficacy to remain abstinent (QAE-Alcohol)
- Distribution of the 4th Daily Alcohol Logbook (TLFB)
At 4 month (M4)
- Return of the 4th Daily Alcohol Logbook (TLFB)
- Data on treatments in progress or change in treatment
- Mindfulness Skills (KIMS)
- "Binge drinking" consumption
- Self-efficacy to remain abstinent (QAE-Alcohol)
- Distribution of the 5th Daily Alcohol Logbook (TLFB)
At 5 month (M5)
- Return of the 5th Daily Alcohol Logbook (TLFB)
- Data on treatments in progress or change in treatment
- Mindfulness Skills (KIMS)
- "Binge drinking" consumption
- Self-efficacy to remain abstinent (QAE-Alcohol)
- Distribution of the 6th Daily Alcohol Logbook (TLFB)
At 6 month (M6)
- Return of the 6th Daily Alcohol Logbook (TLFB)
- Data on treatments in progress or change in treatment
- Mindfulness Skills (KIMS)
- "Binge drinking" consumption
- Self-efficacy to remain abstinent (QAE-Alcohol)
- Conditions
- Alcohol Use Disorder
- Being tested
- Mindfulness practice, Relapse prevention
- Keywords
- Mindfulness, Alcohol, Alcohol Use Disorder, Relapse, Relapse Prevention, Cognitive-behavioral therapy
- Medical subject headings
- Alcoholism, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness practiceBehavioural
Mindfulness interventions are behavioral cognitive psychotherapies which allow patient to identify, pay attention and accept external (sensory stimuli) and internal (cognition and emotions) phenomena.
Relapse preventionBehavioural
It's a conventional relapse prevention program which allow to measure the alcoholic relapse in the first glass consumed.
| Study group | Role | What they receive |
|---|---|---|
| Relapse Prevention | Experimental | Each patient will perform 12 classic psychotherapeutic sessions over a period of 6 weeks. Receives: Behavioral: Relapse prevention |
| Mindfulness Practice | Experimental | Each patient will perform 12 mindfulness psychotherapeutic sessions over a period of 6 weeks. Receives: Behavioral: Mindfulness practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of alcoholic relapses
Proportion of patients with an alcohol consumption of at least one glass of alcohol
Measured: 6 month
Secondary outcomes (7)
Alcohol relapse time
Measurement : Number of days elapsed between the end of treatment and the first relapse compare between the two interventions (classic or "mindfulness")
Measured: 6 month
Delay in "heavy drinking" relapse
Measurement : Number of days elapsed between the end of treatment and the first heavy drinking (≥4 glasses of alcohol for women and ≥6 glasses of alcohol for men) compare between the two interventions (classic or "mindfulness")
Measured: 6 month
Frequency of consumption
Measurement : Number of consumption days during 6 month compare between the two interventions (classic or "mindfulness")
Measured: 6 month
Daily quantities consumed
Measurement : Number of standard glasses consumed per day during 6 month compare between the two interventions (classic or "mindfulness")
Measured: 6 month
Degree of mindfulness skills
Measurement : Score at the KIMS Scale (Kentucky Inventory of Mindfulness Skills) evaluated each month, compare before and after intervention (classic or "mindfulness")
Measured: 6 month
Severity of alcohol craving
Measurement: Assessed daily on a VAS craving (Visual analogue scale) in the daily observation book, compare before and after intervention (classic or "mindfulness")
Measured: 6 month
Level of self-efficacy
Measurement: Assessed daily on a VAS self-efficacy (Visual analogue scale) in the daily observation book, compare before and after intervention (classic or "mindfulness")
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2017
- Study start21 Jan 2017
- Primary completionDec 2017 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Lundbeck SAS 37-45
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03150550
- Sponsor's protocol ID
- CHU-321
- Other IDs
- 2016-A00048-43
- Acronym
- Mindfulness
- Status last verified
- May 2017
- First submitted
- 4 May 2017
- Last updated
- 12 May 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Mindfulness Practice Efficacy in Alcoholic Relapse Prevention
- ClinicalTrials.gov ID
- NCT03150550
- Acronym / sponsor ID
- Mindfulness / CHU-321
- Conditions
- Alcohol Use Disorder
- Keywords
- Mindfulness, Alcohol, Alcohol Use Disorder, Relapse, Relapse Prevention, Cognitive-behavioral therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Lundbeck SAS 37-45
- Study start
- 21 Jan 2017 (actual)
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 12 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Among behavioral cognitive psychotherapies, new "Mindfulness" interventions allow patient to identify, pay attention and accept external (sensory stimuli) and internal (cognition and emotions) phenomena. This "to do with" training has yielded promising results in stress management, prevention of depressive relapse, management of craving and an increase in self-efficacy. Few studies (none in France) have attempted to measure the efficacy of this technique on alcohol relapse, in particular by comparing it with a usual management strategy (conventional relapse prevention therapy).
The main objective of this study is to compare the efficacy on alcoholic relapse (measured in the "first glass" consumed), from a Mindfulness therapeutic program to a conventional Relapse Prevention program. Secondary objectives are to demonstrate the efficacy of this program on craving, self-efficacy, and secondary endpoints of relapse (massive alcoholism, number of alcoholisation days).
Detailed description
Each patient will perform 12 psychotherapeutic sessions (Mindfulness or Relapse Prevention) over a period of 6 weeks. Patients will be evaluated by a practitioner different from the practitioner who makes the psychotherapeutic management.
Patients will be assessed at inclusion (Initial visit), after the 12 sessions of management (M0), 1 month (M1), 2 month (M2), 3 month (M3), 4 month (M4), 5 month (M5), 6 month (M6), after initial visit as follows
Initial Visit
- Signature of an informed consent form.
- Demographic characteristics (gender, age, family status, professional status, level of education …)
- Clinical data (patient status, ongoing pharmacological treatment, withdrawal, previous CBT ...)
- Criteria and severity of alcohol dependence (DSM 5)
- Evaluation of depressive symptomatology and severity (HAM-D)
- Level of pre-intervention alcohol consumption (AUDIT-C)
- "Binge drinking" consumption
- Craving before alcohol withdrawal (EVA craving)
- Mindfulness Skills (KIMS)
- Self-efficacy to remain abstinent (QAE-Alcohol)
- Drinking habits (QHPBA)
After the 12 sessions (M0)
- Data on treatments in progress or change in treatment
- Depressive symptomatology and severity (HAM-D)
- Level of alcohol consumption in post-intervention (AUDIT-C)
- "Binge drinking" consumption
- Craving after alcohol withdrawal (EVA craving)
- Mindfulness Skills (KIMS)
- Self-efficacy to remain abstinent (QAE-Alcohol)
- Distribution of the 1st Daily Alcohol Logbook (TLFB)
At 1 month (M1)
- Return of the 1st Daily Alcohol Logbook (TLFB)
- Data on treatments in progress or change in treatment
- Mindfulness Skills (KIMS)
- "Binge drinking" consumption
- Self-efficacy to remain abstinent (QAE-Alcohol)
- Distribution of the 2nd Daily Alcohol Logbook (TLFB)
At 2 month (M2)
- Return of the 2nd Daily Alcohol Logbook (TLFB)
- Data on treatments in progress or change in treatment
- Mindfulness Skills (KIMS)
- "Binge drinking" consumption
- Self-efficacy to remain abstinent (QAE-Alcohol)
- Distribution of the 3th Daily Alcohol Logbook (TLFB)
At 3 month (M3)
- Return of the 3th Daily Alcohol Logbook (TLFB)
- Data on treatments in progress or change in treatment
- Mindfulness Skills (KIMS)
- "Binge drinking" consumption
- Self-efficacy to remain abstinent (QAE-Alcohol)
- Distribution of the 4th Daily Alcohol Logbook (TLFB)
At 4 month (M4)
- Return of the 4th Daily Alcohol Logbook (TLFB)
- Data on treatments in progress or change in treatment
- Mindfulness Skills (KIMS)
- "Binge drinking" consumption
- Self-efficacy to remain abstinent (QAE-Alcohol)
- Distribution of the 5th Daily Alcohol Logbook (TLFB)
At 5 month (M5)
- Return of the 5th Daily Alcohol Logbook (TLFB)
- Data on treatments in progress or change in treatment
- Mindfulness Skills (KIMS)
- "Binge drinking" consumption
- Self-efficacy to remain abstinent (QAE-Alcohol)
- Distribution of the 6th Daily Alcohol Logbook (TLFB)
At 6 month (M6)
- Return of the 6th Daily Alcohol Logbook (TLFB)
- Data on treatments in progress or change in treatment
- Mindfulness Skills (KIMS)
- "Binge drinking" consumption
- Self-efficacy to remain abstinent (QAE-Alcohol)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Relapse Prevention | Experimental | Behavioral: Relapse preventionEach patient will perform 12 classic psychotherapeutic sessions over a period of 6 weeks. |
| Mindfulness Practice | Experimental | Behavioral: Mindfulness practiceEach patient will perform 12 mindfulness psychotherapeutic sessions over a period of 6 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or female aged 18 to 75 (including landmarks)
- Patients in withdrawal for alcohol dependence according to DSM IV criteria (1994); hospital or outpatient withdrawal of more than 10 days and less than 10 weeks.
Key exclusion criteria (6 listed)
- Psychiatric comorbidity (dipsomaniac alcoholism, anteriority of one or more hypomanic or manic episodes, psychoses, severe depression, severe suicidal risk)
- Other addiction syndrome than tobacco and alcohol
- Problems that impede participation in a group, such as severe borderline personality disorder; antisocial personality; tendency to dissociation; phobias of interceptive type (panic attacks and hypochondria ...)
- Problems preventing the completion of questionnaires, such as cognitive dysfunctions, dysfunctions of attention and concentration skills, or a language barrier
- Severe recurring pathology
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness practiceMindfulness interventions are behavioral cognitive psychotherapies which allow patient to identify, pay attention and accept external (sensory stimuli) and internal (cognition and emotions) phenomena. | Behavioural | Mindfulness Practice |
| Relapse preventionIt's a conventional relapse prevention program which allow to measure the alcoholic relapse in the first glass consumed. | Behavioural | Relapse Prevention |
Primary outcome
Number of alcoholic relapses
Time frame: 6 month
Proportion of patients with an alcohol consumption of at least one glass of alcohol
7 secondary outcomes
Alcohol relapse time
Time frame: 6 month
Delay in "heavy drinking" relapse
Time frame: 6 month
Frequency of consumption
Time frame: 6 month
Daily quantities consumed
Time frame: 6 month
Degree of mindfulness skills
Time frame: 6 month
Severity of alcohol craving
Time frame: 6 month
Level of self-efficacy
Time frame: 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness practice and Relapse prevention in people with Alcohol Use Disorder, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick LACARIN (04 73 75 11 95, placarin@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of alcoholic relapses (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2017.