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

R

Regional University Hospital Center (CHRU)

Status

Enrolling

Conditions

ADHD
Behavioral Addiction

Treatments

Behavioral: Cognitive behavioral therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT06797726
DR240076

Details and patient eligibility

About

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.

Enrollment

54 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

54 participants in 2 patient groups

CBT group
Experimental group
Description:
10 sessions of Cognitive Behavioral Therapy (CBT) Behavioral and Cognitive Therapy (CBT) adapted to comorbidity ADHD/behavioral addiction in remote format (teleconsultation) + routine care (care provided according to the protocols of each center).
Treatment:
Behavioral: Cognitive behavioral therapy
Control group
No Intervention group
Description:
routine care (care performed according to protocols of each center)

Trial contacts and locations

3

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Central trial contact

Servane BARRAULT, Dr; Amélie Delage

Data sourced from clinicaltrials.gov

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