Deficit Hyperactivity Disorder / Substance Use Disorder Comorbidity in Integrated Treatment

Not Applicable

Not yet recruiting

• Conditions: Attention Deficit Hyperactivity Disorder (ADHD); Substance-related Disorder

• Registration Number: NCT06858527
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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).

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-27
• Study First Submitted QC: 2025-02-27
• Study Start: 2025-03
• Study First Posted: 2025-03-05
• Last Update Submitted: 2025-03-13
• Last Update Posted: 2025-03-18
• Primary Completion: 2029-10
• Study Completion: 2029-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 132

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
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).

Secondary Outcome Measures

Name	Time	Method
Substance use	Week 1 ; Week 9 ; Week 18 ; Week 31	Description: Frequency and quantity of substance in the last 15 days, assessed with the Timeline Follow-Back Questionnaire (TLFB)
Self-confidence in abstinence	Week 1 ; Week 9 ; Week 18 ; Week 31	Description: Self-confidence in the capacity to not use substance in several tempting contexts, assessed with the Brief Situational Confidence Questionnaire (BSCQ). The scale score ranges from 0% (low self-confidence) to 16 (high self-confidence).
Craving	Week 1 ; Week 9 ; Week 18	Craving frequency and intensity measured with the Craving Experience Questionnaire (CEQ).The frequency scale ranges from 11 (very infrequent) to 110 (always) and the intensity scale ranges from 11 (low) to 110 (extreme).
Nicotine dependence	Week 1 ; Week 9 ; Week 18 ; Week 31	Nicotine dependence assessed with the Heaviness of Smoking Index (HSI).The total score ranges from 0 (no dependence) to 6 (severe dependence).
ADHD symptoms	Week 1 ; Week 9 ; Week 18	ADHD symptoms are assessed with the total score of Adult Self Report Scale for ADHD (ASRS-32) and the four subscales (Inattention, Hyperactivity-Impulsivity, emotion dysregulation and executive functions deficit). ). The total score ranges from 0 (low ADHD severity) to 124 (high ADHD severity). The Inattention subscale ranges from 0 (low inattentive symptoms) to 36 (high inattentive symptoms). The Hyperactive-Impulsive subscale ranges from 0 (low hyperactive-impulsive symptoms) to 36 (high hyperactive-impulsive symptoms). The emotion dysregulation subscale ranges from 0 (low dysregulation) to 16 (high dysregulation). The executive function deficit subscale ranges from 0 (low deficit) to 36 (severe deficit).
Impulsivity	Week 1 ; Week 9 ; Week 18	Impulsivity is measured with the UPPS-P self-report scale. The UPPS-P total score ranges from 20 (low impulsivity) to 80 (high impulsivity).
Perseverative thinking	Week 1 ; Week 9 ; Week 18	Ruminations are assessed with the Perseverative Thinking Questionnaire (PTQ), a self-report scale. The total score ranges from 0 (no ruminations) to 40 (severe rumination).
Global Quality of life	Week 1 ; Week 9 ; Week 18 ; Week 31	Global Quality of life is assessed with a visual analogue scale from 0 (very poor quality) to 100 (very good quality)
Physical Quality of life	Week 1 ; Week 9 ; Week 18 ; Week 31	Physical quality of life is assessed with a visual analogue scale from 0 (very poor quality) to 100 (very good quality)
Psychological Quality of life	Week 1 ; Week 9 ; Week 18 ; Week 31	Psychological quality of life is assessed with a visual analogue scale from 0 (very poor quality) to 100 (very good quality)
Self Esteem	Week 1 ; Week 9 ; Week 18	Self-esteem is measured with a single self-report item : the Self Esteem Single Index (SISE)

Trial Locations

Locations (1)

Hôpital Fernand Widal, Assistance-Publique - Hôpitaux de Paris; 🇫🇷 Paris, France