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Clinical Trials in France / NCT06858527
Recruiting Not applicable

Deficit Hyperactivity Disorder / Substance Use Disorder Comorbidity in Integrated Treatment

NCT06858527 · tracked via the Priya Life Science France tracker
Sponsor
Assistance Publique - Hôpitaux de Paris
Phase
Not applicable
Started
2025-04-01
Last updated
2025-06-26

Condition(s) studied

Attention Deficit Hyperactivity Disorder (ADHD)Substance-related Disorder

Investigational drug(s) / intervention(s)

TAU+integrated group CBT

TAU+integrated group CBT: TAU+integrated group CBT : participants receive a group psychotherapeutic intervention of Integrated CBT lasting eight weekly two-hour sessions, in parallel with their usual individual care. The sessions are led by a psychologist trained and certified in the practice of CBT and a psychiatrist specialized in addiction medicine. The psychotherapeutic intervention follows a fixed structure and is inspired by the CBT manual for the management of ADHD associated with SUDs published by Matthys et al. (2018). This intervention includes modules on planning and organization, time and distraction management, emotional regulation, work on impulsive behaviors and social skills, cognitive work, as well as substance use management and relapse prevention. The sessions will be punctuated by regular breaks to ensure participants' comfort and the integration of the skills worked on during the sessions. TAU : participants receive their usual care, in exception of group psychotherapeutic interventions.

Study summary

Attention Deficit Hyperactivity Disorder (ADHD) and Substance Use Disorders (SUDs) is a highly common comorbid condition associated with serious medical and psychosocial consequences. However, and despite the international consensus recommending integrated treatment for this comorbidity, few studies tested the efficacy of specific psychotherapeutic treatment for this comorbidity.

The aim of this study is to test the efficacy of a specific group Cognitive and Behavioral Therapy (CBT) for the treatment of adults with this comorbidity.

This is a longitudinal, randomized controlled intervention study utilizing a crossover design between the intervention and treatment-as-usual (TAU) waitlist condition, aimed at testing the effectiveness of an integrated psychotherapeutic group treatment for adults with comorbid Attention Deficit Hyperactivity Disorder (ADHD) and Substance Use Disorders (SUDs).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Age 18 or older ; * Suffer from at least one moderate to severe SUD regarding the DSM-5 (tobacco excluded) ; * Being currently treated for a SUD by a physician of a psychologist ; * Being diagnosed with an ADHD according to the DIVA 2.0 of DIVA-5 ; * Being affiliated to a health insurance ; * Understanding and being able to express himselves in French * Signed consent Exclusion Criteria: * Age under 18; * Pregnant or breastfeeding women; * Not having sign the consent form; * Major difficulties in understanding and/or expressing themselves in french; * Severe cognitive impairment; * Acute medical condition making assessment impossible and/or contraindicating participation in group intervention; * Substance use disorder in a protected environment, currentlu or in the last 15 days, or expected during the study; * No substance use disorder other than tobacco use disorder; * Persons under guardianship; * Participant deprived of liberty or under penal care orders; * Participation in another group psychotherapeutic intervention throughout the duration of the intervention

Primary outcome measure(s)

  • Emotion dysregulation — Week 1 ; Week 9 ; Week 18 ; Week 31
    Emotion dysregulation subscale of the Adult Self Report Scale for ADHD ( ASRS-31). The scale score ranges from 0 (low dysregulation) to 16 (high dysregulation).

Trial sites (1)

FacilityCityRegionStatus
Hôpital Fernand Widal, Assistance-Publique - Hôpitaux de Paris Paris France Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06858527 on ClinicalTrials.gov ↗ ← All trials in France