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

NCT06797726 | Recruiting

• 1 other identifier: DR240076
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 3

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.

Conditions

ADHD; Behavioral Addiction

Keywords

CBT; Cognitive behavioral therapy

Outcome Measures

Primary Outcomes (3)

• Retention rate

  Proportion of randomized present at the 12-week visit

  At the 12-week

• Adhesion

  Number of sessions performed between baseline and 12 weeks,

  Between baseline and 12 weeks

• Adhesion

  percentage of patients who attended at least 70% of sessions

  between baseline and 12 weeks

Secondary Outcomes (15)

• Quantitative evaluation of acceptance percentage

  At 14 weeks

• Satisfaction of participants in the Cognitive-behavioural therapy group

  At 14 weeks

• Perceived benefits

  At 14 weeks

• Collection of difficulties during the therapy

  At 14 weeks

• Assessment of barriers and levers to psychotherapy and cognitive behavioral disorder therapy

  At 14 weeks

Study Arms (2)

CBT group

EXPERIMENTAL

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).

Behavioral: Cognitive behavioral therapy

Control group

NO INTERVENTION

routine care (care performed according to protocols of each center)

Interventions

Cognitive behavioral therapy BEHAVIORAL

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 Session 7: Analysis of functional elements in addictive disorder addictive disorders in patients with ADHD Session 8: Risk situations, psycho-education (emotions) Session 9: Managing craving; analysis of the functional elements of of addiction Session 10: Relapse and relapse prevention, problem solving and social pressure

CBT group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Tours: lead
• Nantes University Hospital: collaborator
• University Hospital, Brest: collaborator

Study Sites (3)

CHU La Cavale Blanche

Brest, France

NOT YET RECRUITING

Centre Hospitalier Saint Jacques

Nantes, France

ACTIVE NOT RECRUITING

CHRU De Tours

Tours, France

RECRUITING

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Servane BARRAULT, Dr

  CHRU de Tours

  PRINCIPAL INVESTIGATOR

• Clémence CABLEGUEN, Dr

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

• Morgane GUILLOU, Dr

  CHU Brest

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Servane BARRAULT, Dr

CONTACT

(+33)2.47.47.91.91; s.barrault@chu-tours.fr

Amélie Delage

CONTACT

0247473933; a.delage@chu-tours.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: January 28, 2025
• Study Start: May 13, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: June 25, 2025

Record last verified: 2025-06

Locations

FR (3)