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

ConditionADHD-add
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorNantes University Hospital

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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);

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Cognitive remediation program, with the PRESCO® software

    Behavioral

    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 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, with the AUDITICO® software

    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.

Treatment groups

248 Participants
are divided into 2 treatment groups
Group A: Cognitive remediation programExperimental treatment 1 intervention
Group B: Control programActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Immediate ADHD functional improvement, at the end of the CRT (Cognitive remediation therapy) program

Evaluate the effectiveness of cognitive remediation versus the control program, alongside MPH treatment, in reducing the functional impact of ADHD in patients with addictive comorbidities at the end of treatment Functional improvement can be defined as an improvement of at least 30% in the functional impact score between post- and pre-treatment assessment. In our study, the functional outcome score used will be the global score of the WFIRS (Weiss Functional Impairment Rating Scale, A score of more than 1.5 points is considered to be representative of an impairment in the area concerned. Higher scores mean a worse outcome, the minimum and maximum values for each score are 0 and 3 respectively) questionnaire. The primary endpoint will therefore be the proportion of patients achieving functional improvement (at least 30% improvement in WFIRS score) in each group, estimated at the end of treatment.

Time frame
9 month

Secondary outcomes

1

Sustained ADHD functional improvement, 6 months after the end of CRT.

To evaluate the efficacy 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, 6 months after the end of treatment The endpoint will be the proportion of patients achieving functional improvement (at least 30% improvement in WFIRS score (Weiss Functional Impairment Rating Scale, A score of more than 1.5 points is considered to be representative of an impairment in the area concerned. Higher scores mean a worse outcome, the minimum and maximum values for each score are 0 and 3 respectively)) in each group, estimated 6 months after the end of treatment.

Time frame
9 month
2

Immediate and sustained ADHD symptom improvement, both at the end of CRT and 6 months later.

To evaluate the efficacy of cognitive remediation versus the control program, alongside MPH treatment, in reducing ADHD symptoms in patients with comorbid addictions, at the end of treatment and 6 months post-treatment The evaluation criterion will be the proportion of patients who achieved symptom improvement (at least 30% improvement in the ASRS score (Adult ADHD Self-Report Scale Symptom Checklist, higher scores mean a worse outcome, the minimum and maximum values for each score are 0 and 36 respectively) for the dominant ADHD subtype, or either in case of combined type) in each group, estimated at treatment end or 6 months later.

Time frame
9 month
3

Immediate and sustained improvement of neuropsychological deficits, both at the end of CRT and 6 months later.

To compare the efficacy of cognitive remediation versus the control program in addition to MPH treatment, at the end of treatment and 6 months after the end of treatment, in improving neuropsychological deficits. Neuropsychological deficits will be evaluated using performance scores on a series of neurocognitive tasks assessing key cognitive functions (all performance scores will be standardized to be comparable, i.e. Z-scores): * D2-R (selective attention), * Digit memory test (short-term memory and working memory), * Stroop test (inhibition), * Verbal fluency test (spontaneous flexibility) * Zoo test (planning)

Time frame
9 month
4

Immediate and sustained improvement of the severity of comorbid addictive disorders, both at the end of CRT and 6 months later.

To compare the efficacy of cognitive remediation versus the control program in addition to MPH treatment, at the end of treatment and 6 months after the end of treatment, in reducing the severity of comorbid addictive disorders The severity of comorbid addictive disorders will be assessed based on the number of diagnostic criteria met in the diagnostic interviews, including: * MINI-S (alcohol and substance use disorders), * NODS (gambling disorder), * Diagnostic interview adapted from NODS for sexual addiction, * Diagnostic interview adapted from NODS for gaming disorder, * YFAS for food addiction, * Mc Elroy for compulsive buying.

Time frame
9 month

Other outcomes

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