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ClinicalTrials.gov ID

NCT07390877

Lead Sponsor

Nantes University HospitalOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

130Estimated

Last Update Posted

Feb 19, 2026Actual

Start Date

Feb 28, 2026Estimated

Primary Completion Date

Jan 15, 2028Estimated

Completion Date

Jan 15, 2029Estimated

Official Title

Cognitive and Metacognitive Remediation in Addiction Treatment: Randomized Controlled Trial of Efficacy in Parallel Arms

Brief Summary

Cognitive and metacognitive remediation in addiction treatment: Value of Adding a cognitive remediation program to improve overall self-efficacy in patients with alcohol use disorder.

Detailed Description

Alcohol use disorder (AUD) is the third leading risk factor for morbidity worldwide and represents a major public health issue. It is associated with numerous somatic and psychological harms, as well as cognitive impairments that lead to a deterioration in quality of life and continued AUD. It is therefore essential that cognitive disorders be targeted for treatment, along with craving, emotional dysregulation, and erroneous beliefs. Similarly, strengthening the sense of self-efficacy plays a crucial role in the recovery of patients with AUD and helps consolidate their ability to cope with the challenges of daily life. Several studies have demonstrated the benefits of cognitive remediation, and the need to offer this type of care more systematically has been widely advocated in several literature reviews. Based on data from the literature and validated cognitive remediation programs, the R'COMET program was designed for patients with SUD. It combines cognitive remediation, emotion perception, and metacognition. The aim of this program is to improve cognitive and metacognitive functions and to enhance the sense of self-efficacy, which is a major determinant of recovery in addictive disorders.

The objective of the R'COMET study is to evaluate the effectiveness of this program on overall self-efficacy, cognitive and metacognitive performance, alcohol consumption, and quality of life in patients with AUD, at the end of the program and at 3 months.

• Alcohol Use Disorder

• cognitive remediation group
• Relaxation control program

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

• Aged between 18 and 65 (inclusive).
• Native French speaker or educated in French.
• Primary diagnosis of AUD according to DSM-5, with or without comorbid SUD.
• Currently in withdrawal: abstinent for at least 7 days and no more than 30 days.
• At least mild cognitive impairment, as measured by the BEARNI scale (mild impairment on the global scale or score below the threshold on at least one of the subtests).

Exclusion Criteria:

• Guardianship.
• Simultaneous participation in a cognitive rehabilitation group, an ETP programme or a mindfulness meditation group.
• Presence of unstabilised psychiatric or addictive comorbidity. The notion of instability is assessed over the past month and is defined by: (i) the need to introduce a new psychotropic treatment, (ii) the need to increase the dosage of an existing psychotropic treatment, (iii) the need for hospitalisation. Given the profile of the patients sought, the start of psychotropic treatment or hospitalisation to support alcohol withdrawal will not be considered exclusion criteria.
• Presence of neurodegenerative disease, Korsakoff's syndrome, mental retardation, or any other condition that may significantly interfere with the completion of assessments, as determined by the clinician.

Primary Purpose

Other

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Single

Lead Sponsor

Nantes University HospitalOTHER

jennyfer.cholet@ch-gdaumezon.fr02 51 82 93 00

morgane.guillou@chu-brest.fr06 23 18 42 62

gilles2.thomas@intradef.gouv.fr02 98 43 72 26

leslie.hureau@chu-nantes.fr02 40 84 61 16

sbillard@epsm-quimper.fr02 98 98 66 00