Cognitive and Metacognitive Remediation in Addiction Treatment.

NCT07390877 | Not Yet Recruiting

• 1 other identifier: RC25_0044
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 6

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.

Conditions

Alcohol Use Disorder

Keywords

Alcohol use disorder; Cognitive remediation; Self-efficacity

Outcome Measures

Primary Outcomes (1)

• Change in General Self-Efficacy (SGSES-fr)

  The primary outcome measure will be the change in the overall score on the SGSES-fr scale between the pre-treatment assessment (V1) and the immediate post-treatment assessment (V2). The advantage of this scale over other self-efficacy scales is that it is not linked to specific situations or behaviors, but represents a general measure. The minimum value is 10 and the maximum value is 40. 10 is a high outcome 40 is a low outcome It is expected that this score will increase between V1 and V2.

  6 months

Study Arms (2)

R'COMET treatment program (cognitive remediation program)

EXPERIMENTAL

The program will include 10 weekly sessions in an open group format to facilitate the patient's engagement in the treatment program (the patient may join the group at any time). The sessions will last 2 hours, ideally with 4-5 patients per session. Each session will include group and/or individual cognitive exercises to encourage interaction and the sharing of experiences, while also providing individualized and tailored support for each participant. Every cognitive exercise will be approached from a motivational perspective. The exercises offered during the sessions will be combined with systematic verbalization of strategies and emotional states, as well as psychoeducational, body-based, non-verbal communication, and cognitive-behavioral techniques. The proposed strategies will draw on both retrieval and compensatory approaches depending on the individual profiles. A progress booklet will be given to the patient.

Behavioral: cognitive remediation group

Relaxation control program

ACTIVE COMPARATOR

The relaxation program consists of 10 weekly sessions lasting 2 hours, held in open groups of 4 to 5 participants. Each session follows a flexible structure with several phases: a welcome moment where participants identify and express their feelings, a musical listening period to help them settle into the session, and a self-massage activity to promote bodily awareness. This is followed by a guided relaxation phase-either passive or active-to encourage physical and mental release. At the end of the session, a different breathing exercise is introduced each week so participants can discover which technique suits them best. The session concludes with a verbalization period, allowing everyone to share their sensations and impressions in a supportive, non-judgmental environment. Participants are encouraged to practice the exercises independently as well .

Behavioral: Relaxation control program

Interventions

cognitive remediation group BEHAVIORAL

The program will include 10 weekly sessions in an open group format to facilitate the patient's engagement in the treatment program (the patient may join the group at any time). The sessions will last 2 hours, ideally with 4-5 patients per session. Each session will include group and/or individual cognitive exercises to encourage interaction and the sharing of experiences, while also providing individualized and tailored support for each participant. Every cognitive exercise will be approached from a motivational perspective. The exercises offered during the sessions will be combined with systematic verbalization of strategies and emotional states, as well as psychoeducational, body-based, non-verbal communication, and cognitive-behavioral techniques. The proposed strategies will draw on both retrieval and compensatory approaches depending on the individual profiles.

R'COMET treatment program (cognitive remediation program)

Relaxation control program BEHAVIORAL

The relaxation program consists of 10 weekly sessions lasting 2 hours, held in open groups of 4 to 5 participants. Each session follows a flexible structure with several phases: a welcome moment where participants identify and express their feelings, a musical listening period to help them settle into the session, and a self-massage activity to promote bodily awareness. This is followed by a guided relaxation phase-either passive or active-to encourage physical and mental release. At the end of the session, a different breathing exercise is introduced each week so participants can discover which technique suits them best. The session concludes with a verbalization period, allowing everyone to share their sensations and impressions in a supportive, non-judgmental environment. Participants are encouraged to practice the exercises independently as well .

Relaxation control program

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Guardianship.
• Simultaneous participation in a cognitive rehabilitation group, an ETP programme or a mindfulness meditation group.
• 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.

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (6)

EPSM Epsylan

Blain, France

Location

EPSM Georges Daumézon

Bouguenais, France

Location

CHRU Brest

Brest, France

Location

HIA

Brest, France

Location

CHU de Nantes

Nantes, France

Location

EPSM du Finistère Sud

Quimper, France

Location

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Leslie TOUATI-HUREAU

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leslie TOUATI-HUREAU

CONTACT

+33 2 40 84 61 16; leslie.hureau@chu-nantes.fr

Gaëlle CHALLET

CONTACT

gaelle.bouju@chu-nantes.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a controlled study in which participants are randomized into two parallel groups: cognitive remediation group (R'COMET) or relaxation group (comparator).

Study Record Dates

• First Submitted: December 5, 2025
• First Posted: February 5, 2026
• Study Start: February 28, 2026
• Primary Completion (Estimated): January 15, 2028
• Study Completion (Estimated): January 15, 2029
• Last Updated: February 19, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (6)