Clinical trial NCT06797726: Feasibility and Efficacy of Cognitive-Behavioral Therapy for Patients with ADHD/behavioral Addiction Comorbidity
Official title: Feasibility and Efficacy of Cognitive-Behavioral Therapy for Patients with ADHD/behavioral Addiction Comorbidity: a Pilot Randomized Controlled Trial (ADHDDICT)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: ADHD
Behavioral Addiction
Keywords: CBT
Cognitive behavioral therapy
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
Collaborators: name: Nantes University Hospital
name: University Hospital, Brest
First posted: 2025-01-28
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


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.

Primary outcomes:
measure: Retention rate
timeFrame: At the 12-week
measure: Adhesion
timeFrame: Between baseline and 12 weeks
measure: Adhesion
timeFrame: between baseline and 12 weeks
Secondary outcomes:
measure: Quantitative evaluation of acceptance percentage
timeFrame: At 14 weeks
measure: Satisfaction
timeFrame: At 14 weeks
measure: Perceived benefits
timeFrame: At 14 weeks
measure: Collection of difficulties during the therapy
timeFrame: At 14 weeks
measure: Assessment of barriers and levers to psychotherapy and cognitive behavioral disorder therapy
timeFrame: At 14 weeks
measure: Assessment of patients' perceived needs in terms of psychotherapy
timeFrame: At 14 weeks
measure: ADHD symptoms
timeFrame: From baseline up to 12 weeks
measure: Quality of life specific to attention-deficit disorder (ADHD)
timeFrame: From baseline up to 12 weeks
measure: Functional impact of attention deficit hyperactivity disorder (ADHD)
timeFrame: From baseline up to 12 weeks
measure: Craving
timeFrame: From baseline up to 12 weeks
measure: Impulsivity
timeFrame: From baseline up to 12 weeks
measure: Emotional dysregulation
timeFrame: From baseline up to 12 weeks
measure: Anxiety symptoms
timeFrame: From baseline up to 12 weeks
measure: Evolution of psychiatric disorders
timeFrame: At 12 weeks
measure: Severity of addictive disorders
timeFrame: At 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: CHRU de Tours
name: Servane BARRAULT, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Nantes University Hospital
name: Clémence CABLEGUEN, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Brest
name: Morgane GUILLOU, Dr
role: PRINCIPAL_INVESTIGATOR
References: