Alcohol Use DisorderR'COMETNCT07390877
Cognitive and Metacognitive Remediation in Addiction Treatment.
A study testing cognitive remediation group in people with Alcohol Use Disorder, run by Nantes University Hospital at 6 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- cognitive remediation group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 6 sitesFrance
- Study dates
- 28 Feb 2026to 15 Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Gaëlle CHALLET contact
6 sites in 1 country
France6 sites
EPSM Epsylan
Blain
Léa BLUTEAU, MD, 02 40 51 52 80, lea.bluteau@ch-epsylan.fr
Léa BLUTEAU, MD
EPSM Georges Daumézon
Bouguenais
Jennyfer CHOLET, MD, 02 51 82 93 00, jennyfer.cholet@ch-gdaumezon.fr
Jennyfer CHOLET, MD
CHRU Brest
Brest
Morgane GUILLOU-LANDREART, MD, 06 23 18 42 62, morgane.guillou@chu-brest.fr
Morgane GUILLOU-LANDREART, MD
HIA
Brest
Gilles THOMAS, MD, 02 98 43 72 26, gilles2.thomas@intradef.gouv.fr
Gilles THOMAS, MD
CHU de Nantes
Nantes
Leslie TOUATI-HUREAU, 02 40 84 61 16, leslie.hureau@chu-nantes.fr
Leslie TOUATI-HUREAU
EPSM du Finistère Sud
Quimper
Stéphane BILLARD, MD, 02 98 98 66 00, sbillard@epsm-quimper.fr
Stéphane BILLARD, MD
About this study
Official title: Cognitive and Metacognitive Remediation in Addiction Treatment: Randomized Controlled Trial of Efficacy in Parallel Arms
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.
Read the 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.
- Conditions
- Alcohol Use Disorder
- Being tested
- cognitive remediation group, Relaxation control program
- Keywords
- Alcohol use disorder, Cognitive remediation, Self-efficacity
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive remediation groupBehavioural
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.
Relaxation control programBehavioural
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 .
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 . Receives: Behavioral: Relaxation control program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start28 Feb 2026 (estimated)
- Primary completion15 Jan 2028 (estimated)
- Study completion15 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a controlled study in which participants are randomized into two parallel groups: cognitive remediation group (R'COMET) or relaxation group (comparator).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leslie TOUATI-HUREAU, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07390877
- Sponsor's protocol ID
- RC25_0044
- Acronym
- R'COMET
- Status last verified
- Dec 2025
- First submitted
- 5 Dec 2025
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive and Metacognitive Remediation in Addiction Treatment: Randomized Controlled Trial of Efficacy in Parallel Arms
- ClinicalTrials.gov ID
- NCT07390877
- Acronym / sponsor ID
- R'COMET / RC25_0044
- Conditions
- Alcohol Use Disorder
- Keywords
- Alcohol use disorder, Cognitive remediation, Self-efficacity
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 28 Feb 2026 (estimated)
- Primary completion
- 15 Jan 2028 (estimated)
- Study completion
- 15 Jan 2029 (estimated)
- First posted
- 5 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This is a controlled study in which participants are randomized into two parallel groups: cognitive remediation group (R'COMET) or relaxation group (comparator).
| Arm | Type | Receives |
|---|---|---|
| R'COMET treatment program (cognitive remediation program) | Experimental | Behavioral: cognitive remediation groupThe 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. |
| Relaxation control program | Active comparator | Behavioral: Relaxation control programThe 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 . |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cognitive remediation groupThe 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. | Behavioural | R'COMET treatment program (cognitive remediation program) |
| Relaxation control programThe 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 . | Behavioural | Relaxation control program |
Primary outcome
Change in General Self-Efficacy (SGSES-fr)
Time frame: 6 months
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gaëlle CHALLET contact
Leslie TOUATI-HUREAU principal investigator
Nantes University Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cognitive remediation group in people with Alcohol Use Disorder, run by Nantes University Hospital at 6 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Leslie TOUATI-HUREAU (+33 2 40 84 61 16, leslie.hureau@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in General Self-Efficacy (SGSES-fr) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026.