MEthylphenidate in ADHD - Addiction(s) Comorbidity: Value of Adding a Cognitive Remediation Program to Improve Short- and Medium-term Therapeutic Response

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

248 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-11

Study Completion Date

2029-12-11

Brief Summary

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MEthylphenidate in ADHD - Addiction(s) comorbidity: benefit of adding a cognitive remediation program to improve short- and medium-term therapeutic response

Detailed Description

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It seems essential to optimize the therapeutic management of patients suffering from ADHD/addiction(s) comorbidity by specifically targeting their neuropsychological deficits, in addition to the pharmacological and psychosocial approaches currently recommended. By intensively training deficient functions on the one hand, and promoting the development of compensatory strategies on the other, cognitive remediation could thus be a therapeutic tool of choice, producing beneficial effects that persist over time and translate into objectifiable changes in daily life. Cognitive training programs have been successfully proposed to patients with ADHD, but these were mainly programs designed for children, and very few studies have been carried out in adults, a fortiori in adults with ADHD-addiction(s) comorbidity.

The main aim of the study was to evaluate the effectiveness of cognitive remediation compared with the control program in addition to MPH treatment in reducing the functional impact of ADHD in patients with other addictive comorbidities, at the end of treatment.

Conditions

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ADHD-add

Keywords

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Methylphenidate Cognitive remediation Functional improvement

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Cognitive remediation program

The cognitive remediation program under study (experimental treatment) consists of cognitive exercises performed on computers, in 30-45 minute sessions. The cognitive exercises target the deficits commonly observed in ADHD, a fortiori when it is associated with addictive disorders (working memory, inhibitory control, cognitive flexibility, attention, planning). The proposed program will be based on a software solution for cognitive rehabilitation, developed and validated for the treatment of attention and memory disorders and neurodegenerative, neurotraumatic and neuropsychiatric pathologies (PRESCO® software, marketed by HappyNeuron).

Group Type EXPERIMENTAL

Cognitive remediation program, with the PRESCO® software

Intervention Type BEHAVIORAL

The program runs for 12 weeks, with two sessions per week, one with a neuropsychologist. In the first 4 weeks, the patient will have weekly sessions at the center and complete the other session at home using the app provided for the study. For the next 8 weeks, sessions with the neuropsychologist will be every other week, with the other session at home. The neuropsychologist will track progress through the software history and follow up by phone if needed.

The proposed program will be based on a software solution for cognitive rehabilitation, developed and validated for the treatment of attention and memory disorders and neurodegenerative, neurotraumatic and neuropsychiatric pathologies (PRESCO® software, marketed by HappyNeuron).

Control program

For the control program (comparator), we will use a software solution from the same company, but dedicated to stimulating and training auditory functions (AUDITICO® software). The advantage of this solution is that, like PRESCO®, it offers training exercises that are not aimed at re-educating cognitive functions. These include, for example, sound identification and discrimination activities. This tool can also be used by anyone, and is accessible for follow-up by the practitioner. It also offers levels of increasing difficulty, making it stimulating for users.

Group Type ACTIVE_COMPARATOR

Control program, with the AUDITICO® software

Intervention Type BEHAVIORAL

Control program, with the same functional characteristics but without the targeted cognitive functions.

For the control program (comparator), we will use a software solution from the same company, but dedicated to stimulating and training auditory functions (AUDITICO® software). The advantage of this solution is that, like PRESCO®, it offers training exercises that are not aimed at re-educating cognitive functions. These include, for example, sound identification and discrimination activities. This tool can also be used by anyone, and is accessible for follow-up by the practitioner. It also offers levels of increasing difficulty, making it stimulating for users.

Interventions

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Cognitive remediation program, with the PRESCO® software

The program runs for 12 weeks, with two sessions per week, one with a neuropsychologist. In the first 4 weeks, the patient will have weekly sessions at the center and complete the other session at home using the app provided for the study. For the next 8 weeks, sessions with the neuropsychologist will be every other week, with the other session at home. The neuropsychologist will track progress through the software history and follow up by phone if needed.

The proposed program will be based on a software solution for cognitive rehabilitation, developed and validated for the treatment of attention and memory disorders and neurodegenerative, neurotraumatic and neuropsychiatric pathologies (PRESCO® software, marketed by HappyNeuron).

Intervention Type BEHAVIORAL

Control program, with the AUDITICO® software

Control program, with the same functional characteristics but without the targeted cognitive functions.

For the control program (comparator), we will use a software solution from the same company, but dedicated to stimulating and training auditory functions (AUDITICO® software). The advantage of this solution is that, like PRESCO®, it offers training exercises that are not aimed at re-educating cognitive functions. These include, for example, sound identification and discrimination activities. This tool can also be used by anyone, and is accessible for follow-up by the practitioner. It also offers levels of increasing difficulty, making it stimulating for users.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Age over 15 (patients treated in the "adult" stream);
* Diagnosis of ADHD confirmed by DIVA-5 interview (for patients over 18) or Young DIVA-5 (for patients between 15 and 17) following a specialized ADHD-addiction(s) consultation;
* Indication for MPH treatment according to European recommendations (J. J. S. Kooij et al., 2019) and absence of contraindications (particularly cardiological);
* Presence of at least one comorbid addictive disorder (TUS and/or AC);
* Having given their consent to take part in the study;
* Being affiliated to the French social security system or benefiting from such a system.

Exclusion Criteria

* Presence of disorders of the higher functions or difficulties in reading or writing the French language making it impossible to collect data;
* Pregnant or breast-feeding woman;
* Person deprived of liberty;
* Person under compulsory psychiatric care;
* Participation in another interventional research protocol involving another psychotherapeutic or pharmacological intervention that may have an impact on clinical outcome;
* Guardianship or safeguard of justice.

Minimum Eligible Age

15 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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