Menu
Not yet recruiting NCT07390877

Cognitive and Metacognitive Remediation in Addiction Treatment.

No phase Interventional Alcohol Use Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: cognitive remediation group, Relaxation control program.
Who it may be relevant to
Registry conditions: Alcohol Use Disorder. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Behavioral cognitive remediation group
    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
  • Behavioral Relaxation control program
    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

Primary outcome measures

  • Change in General Self-Efficacy (SGSES-fr) [Time frame: 6 months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Other

Study locations

France · 6 centers
  • EPSM Epsylan — Blain
  • EPSM Georges Daumézon — Bouguenais
  • CHRU Brest — Brest
  • HIA — Brest
  • CHU de Nantes — Nantes
  • EPSM du Finistère Sud — Quimper

Identifiers

NCT: NCT07390877 · RC25_0044

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗