Feasibility and Efficacy of Cognitive-Behavioral Therapy for Patients With ADHD/Behavioral Addiction Comorbidity
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cognitive behavioral therapy.
- Who it may be relevant to
- Registry conditions: ADHD, Behavioral Addiction. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Feasibility and Efficacy of Cognitive-Behavioral Therapy for Patients With ADHD/Behavioral Addiction Comorbidity: a Pilot Randomized Controlled Trial (ADHDDICT)
Overview
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.
Interventions
- Behavioral 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
Primary outcome measures
- Retention rate [Time frame: At the 12-week]
- Adhesion [Time frame: Between baseline and 12 weeks]
- Adhesion [Time frame: between baseline and 12 weeks]
Secondary outcome measures (12)
- Quantitative evaluation of acceptance percentage [Time frame: At 14 weeks]
- Satisfaction of participants in the Cognitive-behavioural therapy group [Time frame: At 14 weeks]
- Perceived benefits [Time frame: At 14 weeks]
- Collection of difficulties during the therapy [Time frame: At 14 weeks]
- Assessment of barriers and levers to psychotherapy and cognitive behavioral disorder therapy [Time frame: At 14 weeks]
- Assessment of patients' perceived needs in terms of psychotherapy [Time frame: At 14 weeks]
- ADHD symptoms [Time frame: From baseline up to 12 weeks]
- Quality of life specific to attention-deficit disorder (ADHD) [Time frame: From baseline up to 12 weeks]
- Functional impact of attention deficit hyperactivity disorder (ADHD) [Time frame: From baseline up to 12 weeks]
- Craving [Time frame: From baseline up to 12 weeks]
- Impulsivity [Time frame: From baseline up to 12 weeks]
- Emotional dysregulation [Time frame: From baseline up to 12 weeks]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
France · 3 centers
- CHU La Cavale Blanche — Brest
- Centre Hospitalier Saint Jacques — Nantes
- CHRU De Tours — Tours
Identifiers
NCT: NCT06797726 · DR240076