ADHDADHDDICTNCT06797726
Feasibility and Efficacy of Cognitive-Behavioral Therapy for Patients With ADHD/Behavioral Addiction Comorbidity
A study testing Cognitive behavioral therapy in people with ADHD and Behavioral Addiction, run by University Hospital, Tours at 3 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ADHD, Behavioral Addiction
- What is being tested?
- Cognitive behavioral therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 3 sitesFrance
- Study dates
- 13 May 2025to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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 locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites, 2 recruiting
- Not yet recruiting
CHU La Cavale Blanche
Brest
Morgane Guillou, Dr
- Active, not recruiting
Centre Hospitalier Saint Jacques
Nantes
- Recruiting
CHRU De Tours
Tours
Servane BARRAULT
About this study
Official title: 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.
- Conditions
- ADHD, Behavioral Addiction
- Being tested
- Cognitive behavioral therapy
- Keywords
- CBT, Cognitive behavioral therapy
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavioral therapyBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: Cognitive behavioral therapy |
| Control group | No intervention | routine care (care performed according to protocols of each center) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention rate
Proportion of randomized present at the 12-week visit
Measured: At the 12-week
Adhesion
Number of sessions performed between baseline and 12 weeks,
Measured: Between baseline and 12 weeks
Adhesion
percentage of patients who attended at least 70% of sessions
Measured: between baseline and 12 weeks
Secondary outcomes (15)
Quantitative evaluation of acceptance percentage
Number of randomized patients / number of eligible patients eligible patients
Measured: At 14 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)
Measured: At 14 weeks
Perceived benefits
only assessed in Cognitive-behavioural therapy group, assessed during an interview with a psychologist
Measured: At 14 weeks
Collection of difficulties during the therapy
only assessed in Cognitive-behavioural therapy group, assessed during an interview with a psychologist
Measured: 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
Measured: 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
Measured: 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).
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From baseline up to 12 weeks
Evolution of psychiatric disorders
Evaluation will be based on MINI-S interview (mini international neuropsychiatric interview, simplified )
Measured: 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
Measured: At 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study start13 May 2025
- Primary completionAug 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Collaborators
- Nantes University Hospital, University Hospital, Brest
- Responsible party
- Sponsor
- Investigators
- Servane BARRAULT, Dr, Principal investigator, CHRU de ToursClémence CABLEGUEN, Dr, Principal investigator, Nantes University HospitalMorgane GUILLOU, Dr, Principal investigator, CHU Brest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06797726
- Sponsor's protocol ID
- DR240076
- Acronym
- ADHDDICT
- Status last verified
- Jun 2025
- First submitted
- 26 Nov 2024
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Efficacy of Cognitive-Behavioral Therapy for Patients With ADHD/Behavioral Addiction Comorbidity: a Pilot Randomized Controlled Trial (ADHDDICT)
- ClinicalTrials.gov ID
- NCT06797726
- Acronym / sponsor ID
- ADHDDICT / DR240076
- Conditions
- ADHD, Behavioral Addiction
- Keywords
- CBT, Cognitive behavioral therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Collaborators
- Nantes University Hospital, University Hospital, Brest
- Study start
- 13 May 2025 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 28 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBT group | Experimental | Behavioral: Cognitive behavioral therapy10 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). |
| Control group | No intervention | –routine care (care performed according to protocols of each center) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive behavioral therapySession 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 | Behavioural | CBT group |
Primary outcome
Retention rate
Time frame: At the 12-week
Proportion of randomized present at the 12-week visit
Adhesion
Time frame: Between baseline and 12 weeks
Number of sessions performed between baseline and 12 weeks,
Adhesion
Time frame: between baseline and 12 weeks
percentage of patients who attended at least 70% of sessions
15 secondary outcomes
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
Anxiety symptoms
Time frame: From baseline up to 12 weeks
Evolution of psychiatric disorders
Time frame: At 12 weeks
Severity of addictive disorders
Time frame: At 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Servane BARRAULT, Dr principal investigator
CHRU de Tours
Clémence CABLEGUEN, Dr principal investigator
Nantes University Hospital
Morgane GUILLOU, Dr principal investigator
CHU Brest
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive behavioral therapy in people with ADHD and Behavioral Addiction, run by University Hospital, Tours at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Servane BARRAULT, Dr ((+33)2.47.47.91.91, s.barrault@chu-tours.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention rate (time frame: At the 12-week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2025.