Cognitive Remediation in Alcohol Disorders (ALCOSTIM)

Interest of Cognitive Remediation for the Reduction of Consumption in Alcohol Disorders

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).

Study Overview

• Status: Unknown
• Conditions: Alcohol Disorders
• Intervention / Treatment: Other: cognitive remediation

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: usual care
Experimental: cognitive remediation; 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.	Other: cognitive remediation; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	baseline until 3 month of intervention

Collaborators and Investigators

• Sponsor: University Hospital, Caen

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2018
• Primary Completion (Anticipated): August 1, 2019
• Study Completion (Anticipated): February 1, 2020

Study Registration Dates

• First Submitted: November 3, 2017
• First Submitted That Met QC Criteria: November 3, 2017
• First Posted (Actual): November 7, 2017

Study Record Updates

• Last Update Posted (Actual): November 7, 2017
• Last Update Submitted That Met QC Criteria: November 3, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Alcohol-Related Disorders
• Other Study ID Numbers: 17-123

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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