Adults With Attention Deficit Hyperactivity Disorder / Substance Use Disorder Comorbidity in Integrated Treatment: Effectiveness and Feasibility
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- Emotion dysregulation
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Treatment-Waiting
For this arm, participants receive eight weekly sessions of CBT integrated group treatment in addition to TAU, and then eight weeks of TAU.
Then, 3 months follow-up, receiving TAU.
干预措施: TAU+integrated group CBT (Other)
Waiting-Treatment
For this arm, participants receive eight weeks of TAU, and then eight weekly sessions of CBT integrated group treatment in addition to TAU Then, 3 months follow-up, receiving TAU.
干预措施: TAU+integrated group CBT (Other)
结局指标
主要结局
Emotion dysregulation
时间窗: 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).
次要结局
- Self-confidence in abstinence(Week 1 ; Week 9 ; Week 18 ; Week 31)
- Craving(Week 1 ; Week 9 ; Week 18)
- Nicotine dependence(Week 1 ; Week 9 ; Week 18 ; Week 31)
- Substance use(Week 1 ; Week 9 ; Week 18 ; Week 31)
- ADHD symptoms(Week 1 ; Week 9 ; Week 18)
- Impulsivity(Week 1 ; Week 9 ; Week 18)
- Perseverative thinking(Week 1 ; Week 9 ; Week 18)
- Global Quality of life(Week 1 ; Week 9 ; Week 18 ; Week 31)
- Physical Quality of life(Week 1 ; Week 9 ; Week 18 ; Week 31)
- Psychological Quality of life(Week 1 ; Week 9 ; Week 18 ; Week 31)
- Self Esteem(Week 1 ; Week 9 ; Week 18)