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

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

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.

Study Overview

• Status: Recruiting
• Conditions: ADHD; Behavioral Addiction
• Intervention / Treatment: Behavioral: Cognitive behavioral therapy

• Study Type: Interventional
• Enrollment (Estimated): 54
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Servane BARRAULT, Dr; Phone Number: (+33)2.47.47.91.91; Email: s.barrault@chu-tours.fr
• Study Contact Backup: Name: Amélie DELAGE; Phone Number: 0247473933; Email: a.delage@chu-tours.fr

Study Locations

• France
  • Brest, France
    • Not yet recruiting
    • CHU La Cavale Blanche
    • Contact: Morgane Guillou, Dr
  • Nantes, France
    • Active, not recruiting
    • Centre Hospitalier Saint Jacques
  • Tours, France
    • Recruiting
    • Chru De Tours
    • Contact: Servane BARRAULT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CBT group; 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; 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
No Intervention: Control group; routine care (care performed according to protocols of each center)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantitative evaluation of acceptance percentage	Number of randomized patients / number of eligible patients eligible patients	At 14 weeks
Perceived benefits	only assessed in Cognitive-behavioural therapy group, assessed during an interview with a psychologist	At 14 weeks
Collection of difficulties during the therapy	only assessed in Cognitive-behavioural therapy group, assessed during an interview with a psychologist	At 14 weeks
Assessment of barriers and levers to psychotherapy and cognitive behavioral disorder therapy	Evaluated only for the control group, assessed during an interview with a psychologist	At 14 weeks
Assessment of patients' perceived needs in terms of psychotherapy	Evaluated only for the control group, assessed during an interview with a psychologist	At 14 weeks
ADHD symptoms	Evaluation will be based on the ASRS-18 (Adult Self-Report Scale) total score. This self-administered questionnaire comprises eighteen questions, six of which are considered to be the most representative of the symptoms associated with ADHD. These six questions, in Part A of the questionnaire, form the core of the ASRS v1.1 screening. Part B contains the remaining twelve questions. The impact of symptoms on different areas of the patient's life is also assessed. Screening is positive when the patient presents at least 4 symptoms with a significant impact among the first 6 items . Each item is rated from 0 to 4, giving a total ASRS-18 score ranging from 0 to 72, with sub-scores for inattention (0 to 36), motor hyperactivity/impulsivity (0 to 20) and verbal hyperactivity/impulsivity (0 to 16).	From baseline up to 12 weeks
Quality of life specific to attention-deficit disorder (ADHD)	The Adult ADHD Quality of Life scale (AAQOL) will be used during the assessment phases. This tool has good psychometric qualities and assesses four dimensions of quality of life: productivity in daily life, psychological health, relationships and outlook on life. The AAQOL provides a total quality of life score, as well as 4 sub-scores for each dimension. The total score is between 0 and 100, the sub-dimension scores between 0 and 100 (transformed from responses to each of the responses to each of the 29 items ranging from 1 to 5). The higher the score (total and sub-score), the higher, the better the quality of life	From baseline up to 12 weeks
Functional impact of attention deficit hyperactivity disorder (ADHD)	The Weiss Functional Impairment Rating Scale-Self-Report (WFIRS-S) will be used during the assessment phases. This tool, with good psychometric qualities, assesses the impacts of ADHD in seven domains: family, work life, school life, life skills, self-image, social life and risk-taking. Any item rated "2" or "3" is two standard deviations outside the clinical norms for ADHD and is considered impaired. A conservative threshold for defining impairment in any domain is either two items scored '2', or one item scored '3'. The average item score for most domains is '1', with the exception of 'at-risk activities', which is '0.5'. The average score for each of the 7 dimensions is between 0 and 3.	From baseline up to 12 weeks
Craving	A visual analog scale (VAS) to assess craving will be used. In the absence of a validated tool to measure craving in a homogeneous way in behavioral addictions, we will ask participants to rate the intensity of craving on a scale from 0 to 10 (0 corresponding to no craving and 10 to maximum craving) and to evaluate the frequency of craving as well as its duration. This type of craving measurement is frequently used in the literature and in addiction research protocols.	From baseline up to 12 weeks
Impulsivity	The Impulsive Behavior Scale (UPPS-P) will be used during the assessment phases to measure impulsivity. This tool has good psychometric qualities and measures the following sub-dimensions of impulsivity: positive urgency, negative urgency, lack of premeditation, lack of perseverance and sensation seeking. The score for each dimension ranges from 4 to 16; there is no total score. The higher the score (subscales), the higher the impulsivity.	From baseline up to 12 weeks
Emotional dysregulation	The Difficulties in Emotion Regulation Scale (DERS 36) will be used (during the assessment phases) to evaluate emotional dysregulation. With good psychometric qualities, this scale measures 6 dimensions: unacceptance of negative emotions, difficulty engaging in goal-directed behaviors in the presence of negative emotions, difficulty controlling impulsive behaviors in the presence of negative emotions, restricted access to emotion regulation strategies perceived as effective, emotional awareness and lack of understanding of one's emotions, defined as a lack of emotional clarity. The total score ranges from 36 to 180, with sub-dimensions scores ranging from 6 to 30. The higher the score (total scale and subscales), the greater the emotional dysregulation.	From baseline up to 12 weeks
Anxiety symptoms	The Hospital Anxiety and Depression scale (HAD) will be used to assess the presence of anxiety and depressive symptoms in participants. This is a variable we wish to control for, in order to verify that anxiety and depressive symptoms are not potential confounding factors in the assessment results. This scale has good psychometric qualities and can be used to assess two dimensions: anxiety symptoms and depressive symptoms. The total score ranges from 0 to 21 for each dimension. For each dimension, the following interpretation can be proposed: - 7 or less: no symptoms - 8 to 10: moderate score - 11 to 14: average score 15 to 21: severe score. In practice, a threshold score ≥ 11 for each subscale is retained for a significant anxiety or depression score.	From baseline up to 12 weeks
Evolution of psychiatric disorders	Evaluation will be based on MINI-S interview (mini international neuropsychiatric interview, simplified )	At 12 weeks
Severity of addictive disorders	Evaluation will be based on Clinical Global Impression. The CGI includes two complementary single-item measures that assess the following: (a) severity of psychopathology on a scale of 1 to 7 and (b) change from baseline on a similar treatment on a similar seven-point scale. Following a assessment, the CGI can be completed in less than a minute by an experienced experienced assessor. The CGI is used to gather clinical impressions and track clinical clinical progress over time	At 12 weeks
Satisfaction of participants in the Cognitive-behavioural therapy group	only assessed in Cognitive-behavioural therapy group, assessed during an interview with a psychologist (qualitative evaluation)	At 14 weeks

Collaborators and Investigators

• Sponsor: University Hospital, Tours
• Collaborators: University Hospital, Brest; Nantes University Hospital
• Investigators: Principal Investigator: Servane BARRAULT, Dr, Chru De Tours; Principal Investigator: Clémence CABLEGUEN, Dr, Nantes University Hospital; Principal Investigator: Morgane GUILLOU, Dr, CHU Brest

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: November 26, 2024
• First Submitted That Met QC Criteria: January 27, 2025
• First Posted (Actual): January 28, 2025

Study Record Updates

• Last Update Posted (Estimated): June 25, 2025
• Last Update Submitted That Met QC Criteria: June 18, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Cognitive behavioral therapy; CBT
• Additional Relevant MeSH Terms: Compulsive Behavior; Impulsive Behavior; Behavior, Addictive
• Other Study ID Numbers: DR240076

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No