Feasibility and Efficacy of Cognitive-Behavioral Therapy for Patients With ADHD/Behavioral Addiction Comorbidity

Официальное название

Feasibility and Efficacy of Cognitive-Behavioral Therapy for Patients With ADHD/Behavioral Addiction Comorbidity: a Pilot Randomized Controlled Trial (ADHDDICT)

Обзор

The main objective of this pilot study is to assess preliminary data on the feasibility of CBT and its evaluation in a randomised trial in patients with co-occurring ADHD and behavioural addiction: Evaluation and comparison of the 12-week retention rate of patients randomised to CBT compared with patients in the 'treatment as usual' control arm. In order to meet the objective, the patient will take part in a standardized assessment, followed by a therapeutic intervention and a new standardized assessment after the intervention. The standardized assessment consists as follows : * firstly, 7 self-questionnaires to be completed by the patient, lasting around 45 min, aimed at assessing his or her socio-demographic data; current symptoms, quality of life and functional impact related to ADHD; impulsivity, emotion regulation and assessment of possible anxiety-depressive disorders. * Then the patient will follow the 10 session of cognitivo behavioural psychotherapy. * At 12-weeks post-inclusion, an assessment visit is carried out during which a battery of tests will be administered. This is followed by a research interview with a professional, aimed at gathering his or her experiences.

Вмешательства

• Поведенческое Cognitive behavioral therapy
  Session 1: Functional analysis, motivational approach and psycho-education (advantages/disadvantages of consumption ; effect of addiction on mental disorders and interaction ADHD/behavioral addiction) Session 2: Follow-up to psycho-education session 1, treatment plan Session 3: ADHD: compensation strategies; reducing distractibility distractibility Session 4: ADHD: calendar and organization worksheet Session 5: ADHD: mood disorders and emotions Session 6: Recognizing and managing emotions Sessio

Первичные конечные точки

• Retention rate [Срок оценки: At the 12-week]
• Adhesion [Срок оценки: Between baseline and 12 weeks]
• Adhesion [Срок оценки: between baseline and 12 weeks]

Вторичные конечные точки (12)

• Quantitative evaluation of acceptance percentage [Срок оценки: At 14 weeks]
• Satisfaction of participants in the Cognitive-behavioural therapy group [Срок оценки: At 14 weeks]
• Perceived benefits [Срок оценки: At 14 weeks]
• Collection of difficulties during the therapy [Срок оценки: At 14 weeks]
• Assessment of barriers and levers to psychotherapy and cognitive behavioral disorder therapy [Срок оценки: At 14 weeks]
• Assessment of patients' perceived needs in terms of psychotherapy [Срок оценки: At 14 weeks]
• ADHD symptoms [Срок оценки: From baseline up to 12 weeks]
• Quality of life specific to attention-deficit disorder (ADHD) [Срок оценки: From baseline up to 12 weeks]
• Functional impact of attention deficit hyperactivity disorder (ADHD) [Срок оценки: From baseline up to 12 weeks]
• Craving [Срок оценки: From baseline up to 12 weeks]
• Impulsivity [Срок оценки: From baseline up to 12 weeks]
• Emotional dysregulation [Срок оценки: From baseline up to 12 weeks]

Критерии участия

Критерии включения

• Patient over 18 (age ≥ 18 years)
• Patient treated in an outpatient addictology department at the CHU of Brest, Nantes or Tours and presenting an ADHD/behavioral addiction comorbidity
• Patient affiliated to a social security scheme
• For patients treated with methylphenidate: no change in treatment dosage during the previous three months.
• For patients not treated with methylphenidate: no introduction of methylphenidate within the next three months.

Критерии исключения

• Patients with psychotic disorders (assessed by clinician)
• Pregnant or breast-feeding women
• Patients under protective supervision (guardianship or curatorship)
• Persons under court protection
• Persons deprived of their liberty
• Patients who do not meet the eligibility criteria for CBT (e.g., cognitive impairment, hearing impairment).
• Physical inability to participate in CBT sessions (e.g., lack of telephone, foreseeable unavailability).
• Difficulty understanding self-questionnaires, including illiteracy.
• Participation in another interventional research protocol involving another psychotherapeutic or pharmacological intervention that may have an impact on clinical outcome.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Франция · 3 центра

• CHU La Cavale Blanche — Brest
• Centre Hospitalier Saint Jacques — Nantes
• CHRU De Tours — Tours

Идентификаторы

NCT: NCT06797726 · DR240076

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗