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

Обзор

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

Подробное описание

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.

Вмешательства

• Поведенческое Cognitive remediation program, with the PRESCO® software
  The program runs for 16 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
• Поведенческое 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.

Первичные конечные точки

• Immediate ADHD functional improvement, at the end of the CRT (Cognitive remediation therapy) program [Срок оценки: 9 month]

Вторичные конечные точки (7)

• Sustained ADHD functional improvement, 6 months after the end of CRT. [Срок оценки: 9 month]
• Immediate and sustained ADHD symptom improvement, both at the end of CRT and 6 months later. [Срок оценки: 9 month]
• Immediate and sustained improvement of neuropsychological deficits, both at the end of CRT and 6 months later. [Срок оценки: 9 month]
• Immediate and sustained improvement of the severity of comorbid addictive disorders, both at the end of CRT and 6 months later. [Срок оценки: 9 month]
• Immediate and sustained improvement of the psychopathological characteristics associated with ADHD-addiction(s) comorbidity, both at the end of CRT and 6 months later. [Срок оценки: 9 month]
• Immediate and sustained improvement of adherence to MPH treatment, both at the end of CRT and 6 months later. [Срок оценки: 9 month]
• Immediate and sustained ADHD functional improvement, both at the end of CRT and 6 months later, compared between ADHD subtypes (predominantly inattentive, predominantly impulsive/hyperactive, or combined type) [Срок оценки: 9 month]

Критерии участия

Критерии включения

• Age over 18;
• Diagnosis of ADHD confirmed by DIVA-5 interview 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 (SUD and/or BA);
• Having given their consent to take part in the study;
• Being affiliated to the French social security system or benefiting from such a system.

Критерии исключения

• 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.
• Patients who consumned psychoactive substances within 12 hours prior to their visit.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Франция · 6 центров

• CHRU Brest — Brest
• EPSM du Finistère Sud — Quimper
• EPSM Georges Daumézon (Fleury-les-Aubrais, Loiret) — Fleury-les-Aubrais
• CHRU de Tours — Tours
• CH Georges Daumézon - Bouguenais — Bouguenais
• CHU Nantes — Nantes

Публикации

• Cabelguen C, Challet-Bouju G, Thiabaud E, Donnio Y, Lefebvre L, Hardouin JB, Grall-Bronnec M. Randomised controlled trial on the efficacy of adding cognitive remediation therapy to methylphenidate in adult patients with attention deficit hyperactivity disorder and addictive disorders (META): CRT in ADHD and addiction - META study protocol. BMJ Open. 2026 Mar 31;16(3):e111698. doi: 10.1136/bmjopen- PMID 41916643

Идентификаторы

NCT: NCT06906328 · RC23_0506

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗