Back to resultsCognitive Remediation in Alcohol Disorders (ALCOSTIM)
Primary Purpose
Alcohol Disorders
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
cognitive remediation
Sponsored by
About this trial
This is an interventional treatment trial for Alcohol Disorders
Eligibility Criteria
Inclusion Criteria:
- Patient male or female aged 18 to 60, French speaking and affiliated to the social security system
- Patient with TUAL (DSM-5) at the forefront of alcohol use disorders at the time of inclusion
- Patient with neuropsychological disorders objectified on BEARNI (BEARNI for Brief Evaluation of Alcohol-Related Neuropsychological Evaluation, Ritz et al., 2015 cut-off cognitive score = 13, adding a point for patients with bachelor level or lower) and confirmed at the neuropsychological checkup showing pathological performance (at least two free or total recalls of RL / RI 16 <-1.65 and / or RBMT IGM <-1.65 OR number of persecutory or deficit errors at MCST <-1.65 and / or at least two BADS subtests with a score of <or = 2 (except temporal judgment)). Evaluation (BEARNI) at least 48h after stopping benzodiazepines
- Patient weaned of alcohol, that is to say between 5 and 21 days after stopping alcohol, after disappearing signs of withdrawal (Cushman score <2) and stopping benzodiazepines
- First hospitalization type day hospital (not necessarily first weaning)
- Patient having been informed of the study and being able to give written informed consent.
Exclusion Criteria:
- Patient with severe and long-lasting neurological complications related to alcohol (Korsakoff syndrome, fetal alcohol syndrome, ...)
- Patient with a disorder of severe use of another psychoactive substance according to DSM-5, except tobacco
- Patient with motor or sensory deficit making cognitive remediation impossible
- Patient previously included or already included in another biomedical research
- Homeless patient
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
cognitive remediation
usual care
Arm Description
The innovative nature of this cognitive remediation program is that it integrates both neuropsychological psychoeducation, the principles of reeducation of altered cognitive functions and the setting in addictological context benefiting from the interactions of the group situation. Thus, during the three months of REMED management, six modules corresponding to six altered cognitive domains. The REMED group will benefit from cognitive remediation of episodic memory disorders, executive and attentional functions, and the theory of the mind integrating psychoeducation, training and systematic situations related to an alcoholic context.
Outcomes
Primary Outcome Measures
total quantity of alcohol consumed in 3 months (measured in units of pure alcohol, 1 unit = 10g of alcohol).
using TimeLine-Follow-Back tracking method (TLFB)
Secondary Outcome Measures
Full Information
NCT ID
NCT03335215
First Posted
November 3, 2017
Last Updated
November 3, 2017
Sponsor
University Hospital, Caen
1. Study Identification
Unique Protocol Identification Number
NCT03335215
Brief Title
Cognitive Remediation in Alcohol Disorders
Acronym
ALCOSTIM
Official Title
Interest of Cognitive Remediation for the Reduction of Consumption in Alcohol Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2018 (Anticipated)
Primary Completion Date
August 1, 2019 (Anticipated)
Study Completion Date
February 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Caen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The individual and societal cost of alcohol use disorders (TUAL), present in 10% of the population in France, is considerable. Despite psychotherapeutic and drug addiction treatment, the relapse rate remains very high, partly because of their very frequent cognitive disorders. In fact, more than 75% of TUAL patients present to varying degrees neuropsychological alterations that are only rarely detected and never treated. However, these cognitive disorders limit the benefit of psychotherapeutic care, reduce compliance with pharmacological treatments and hinder the patient's ability to change his behavior with respect to alcohol. An innovative way to promote the maintenance of the therapeutic contract, and therefore to reduce alcohol consumption in these patients, would be to improve their cognitive functioning. The objective of this study is to measure the efficacy of a non-drug treatment, based on a specific and personalized cognitive remediation program, compared to a standard treatment in Day Hospitalization, in order to reduce the rate of relapse very high in TUAL. It is a randomized, single-blind study with two parallel groups of patients with post-weaning neuropsychological disorders: REMED (cognitive remediation) and CONTROL (usual care).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
cognitive remediation
Arm Type
Experimental
Arm Description
The innovative nature of this cognitive remediation program is that it integrates both neuropsychological psychoeducation, the principles of reeducation of altered cognitive functions and the setting in addictological context benefiting from the interactions of the group situation. Thus, during the three months of REMED management, six modules corresponding to six altered cognitive domains. The REMED group will benefit from cognitive remediation of episodic memory disorders, executive and attentional functions, and the theory of the mind integrating psychoeducation, training and systematic situations related to an alcoholic context.
Arm Title
usual care
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
cognitive remediation
Intervention Description
The innovative nature of this program is that it integrates both neuropsychological psychoeducation, the principles of reeducation of altered cognitive functions and the setting in addictological context benefiting from the interactions of the group situation. Thus, during the three months of REMED management, six modules corresponding to six altered cognitive domains that may have an impact on the maintenance of the therapeutic contract will be offered to patients. The REMED group will benefit from cognitive remediation of episodic memory disorders, executive and attentional functions, and the theory of the mind integrating psychoeducation, training and systematic situations related to an alcoholic context. The different procedures of neuropsychological management (facilitation, use of preserved capacities and compensation) will help to integrate the concepts and addictological strategies necessary to maintain the therapeutic contract taking into account cognitive impairments.
Primary Outcome Measure Information:
Title
total quantity of alcohol consumed in 3 months (measured in units of pure alcohol, 1 unit = 10g of alcohol).
Description
using TimeLine-Follow-Back tracking method (TLFB)
Time Frame
baseline until 3 month of intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient male or female aged 18 to 60, French speaking and affiliated to the social security system
Patient with TUAL (DSM-5) at the forefront of alcohol use disorders at the time of inclusion
Patient with neuropsychological disorders objectified on BEARNI (BEARNI for Brief Evaluation of Alcohol-Related Neuropsychological Evaluation, Ritz et al., 2015 cut-off cognitive score = 13, adding a point for patients with bachelor level or lower) and confirmed at the neuropsychological checkup showing pathological performance (at least two free or total recalls of RL / RI 16 <-1.65 and / or RBMT IGM <-1.65 OR number of persecutory or deficit errors at MCST <-1.65 and / or at least two BADS subtests with a score of <or = 2 (except temporal judgment)). Evaluation (BEARNI) at least 48h after stopping benzodiazepines
Patient weaned of alcohol, that is to say between 5 and 21 days after stopping alcohol, after disappearing signs of withdrawal (Cushman score <2) and stopping benzodiazepines
First hospitalization type day hospital (not necessarily first weaning)
Patient having been informed of the study and being able to give written informed consent.
Exclusion Criteria:
Patient with severe and long-lasting neurological complications related to alcohol (Korsakoff syndrome, fetal alcohol syndrome, ...)
Patient with a disorder of severe use of another psychoactive substance according to DSM-5, except tobacco
Patient with motor or sensory deficit making cognitive remediation impossible
Patient previously included or already included in another biomedical research
Homeless patient
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Cognitive Remediation in Alcohol Disorders
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