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

Nantes University Hospital (NUH)

Status: Enrolling

Conditions: ADHD-add

Treatments: Behavioral: Control program, with the AUDITICO® software; Behavioral: Cognitive remediation program, with the PRESCO® software

Study type: Interventional

Funder types: Other

Identifiers

NCT06906328

RC23_0506

Details and patient eligibility

About

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

Full description

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.

Enrollment: 248 estimated patients

Sex: All

Ages: 15 to 99 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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248 participants in 2 patient groups

Cognitive remediation program

Experimental group

Description:

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).

Treatment:

Behavioral: Cognitive remediation program, with the PRESCO® software

Control program

Active Comparator group

Description:

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.

Treatment:

Behavioral: Control program, with the AUDITICO® software