Clinical trial NCT06858527: Deficit Hyperactivity Disorder / Substance Use Disorder Comorbidity in Integrated Treatment
Official title: Adults with Attention Deficit Hyperactivity Disorder / Substance Use Disorder Comorbidity in Integrated Treatment: Effectiveness and Feasibility
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder (ADHD)
Substance-related Disorder
Keywords: Attention Deficit Hyperactivity Disorder
Substance-Related Disorders
Cognitive Behavioral Therapy
Dual Diagnosis
Randomized Controlled Trial
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2025-03-05
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: All 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.
Primary purpose: TREATMENT

Brief 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).

Detailed description: Substance Use Disorders (SUDs) affect between 0.5% and 15% of the general population and are responsible for a huge morbidity, mortality and social costs (Aldridge et al., 2018; Peterson et al., 2021). Among existing psychotherapeutic approaches, Cognitive and Behavioural Therapy (CBT) is one of the most widely validated, particularly in the addictive population (Hampel et al., 2020; Kabisa et al., 2021; Knapp et al., 2021; Marlatt \& Donovan, 2005; Ray et al., 2020). Psychiatric comorbidities are very often associated with SUD (Toftdahl et al., 2016). Among these, Attention Deficit Hyperactivity Disorder (ADHD) is one of the most common, occurring in more than 20% of adults with SUDs (Rohner et al., 2023; van Emmerik-van Oortmerssen et al., 2012) compared with 2.6% in the general population (Song et al., 2021).

The diagnosis and management of adult ADHD are difficult (Cortese et al., 2018; Lopez et al., 2018), particularly when ADHD is comorbid with SUD (Fatséas et al., 2016; Icick et al., 2020; Young et al., 2015). No specific treatment has been yet validated for this comorbidity. It is noteworthy that recognition of adult ADHD has grown considerably in France over the last years.

In this field, the international consensus on the screening, diagnosis and management of this comorbidity recommends integrated treatments (targeting the different disorders at the same time), combining pharmacotherapy with psychotherapy, emphasing the relevance of CBT in this field (Crunelle et al., 2018; Özgen et al., 2020). Despite these immense unmet needs, only one specific ADHD-SUDs psychotherapeutic program has been evaluated to date (van Emmerik-van Oortmerssen et al., 2019)

This protocol aims to test the efficacity of an integrated group Cognitive Behavioral Therapy (CBT) treatment for adults with comorbid Attention Deficit Hyperactivity Disorder (ADHD) and Substance Use Disorders (SUDs) on emotional dysregulation at the primary outcome. Addiction and ADHD symptoms, quality of life, self-esteem, and transdiagnostic constructs (impulsivity, perseverative thinking) are considered as secondary outcomes.

This study corresponds to a longitudinal intervention study using a cross-over design between the group intervention and treatment-as-usual (TAU) waiting condition.

Participants corresponding to inclusion criteria and consenting to participate are enrolled to the study and undergo a first interview assessing clinical and sociodemographic variables and self-rated questionnaires for primary and secondary outcomes. Then they are computer-randomised, controlling for duration of pharmacological treatment in two arms: (1) Treatment-Waiting and (2) Waiting-Treatment. In each condition (Waiting or Treatment) participant conserve their usual treatment for SUD and ADHD, excluding psychotherapeutic group interventions.

The first sequence consists in eight weeks of treatment (TAU for the Waiting-Intervention arm, and TAU+integrated group CBT for the Intervention-Waiting arm). The integrated group CBT consists in weekly two hours groups sessions. At the end of the first sequence and before the second sequence, participants undergo again self-report questionnaires for primary and secondary outcomes.

For the second sequence, participants switch the intervention condition for eight weeks (TAU+integrated group CBT for the Waiting-Intervention arm, and TAU for the Intervention-Waiting arm). At the end of this sequence, participants undergo again self-report questionnaires for primary and secondary outcomes, representing (1) post-intervention data for the Waiting-Intervention arm and (2) a two moths follow-up for the Intervention-Waiting arm.

The third sequence (follow-up) consists in three months of TAU condition, without any exclusion criteria for psychotherapeutic group interventions, ending with a last completion of a shortened battery of questionnaires for primary and secondary outcomes (if needed, questionnaires could be assessed by phone).

Eligibility criteria: 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 outcomes:
measure: Emotion dysregulation
timeFrame: Week 1 ; Week 9 ; Week 18 ; Week 31
Secondary outcomes:
measure: Substance use
timeFrame: Week 1 ; Week 9 ; Week 18 ; Week 31
measure: Self-confidence in abstinence
timeFrame: Week 1 ; Week 9 ; Week 18 ; Week 31
measure: Craving
timeFrame: Week 1 ; Week 9 ; Week 18
measure: Nicotine dependence
timeFrame: Week 1 ; Week 9 ; Week 18 ; Week 31
measure: ADHD symptoms
timeFrame: Week 1 ; Week 9 ; Week 18
measure: Impulsivity
timeFrame: Week 1 ; Week 9 ; Week 18
measure: Perseverative thinking
timeFrame: Week 1 ; Week 9 ; Week 18
measure: Global Quality of life
timeFrame: Week 1 ; Week 9 ; Week 18 ; Week 31
measure: Physical Quality of life
timeFrame: Week 1 ; Week 9 ; Week 18 ; Week 31
measure: Psychological Quality of life
timeFrame: Week 1 ; Week 9 ; Week 18 ; Week 31
measure: Self Esteem
timeFrame: Week 1 ; Week 9 ; Week 18
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Fernand Widal, Assistance-Publique - Hôpitaux de Paris
Study officials:
affiliation: Paris-Nanterre University, UR-4430 CLIPSYD ; Paris-Cité University, UMR-S-1144 INSERM; Fernand-Widal Hospital AP-HP
name: Norman Therribout, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Paris-Cité University, UMR-S-1144 INSERM; Fernand-Widal Hospital AP-HP
name: Romain Icick, MD, PhD
role: STUDY_DIRECTOR
affiliation: Paris-Nanterre University, UR-4430 CLIPSYD
name: Lucia Romo, MD, PhD
role: STUDY_DIRECTOR
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