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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
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).
Show all 9Show fewer
  • 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.

Servane BARRAULT, Dr contact

(+33)2.47.47.91.91

s.barrault@chu-tours.fr

Amélie Delage contact

0247473933

a.delage@chu-tours.fr

France3 sites, 2 recruiting
  • CHU La Cavale Blanche

    Brest

    Morgane Guillou, Dr

    Not yet recruiting
  • Centre Hospitalier Saint Jacques

    Nantes

    Active, not recruiting
  • CHRU De Tours

    Tours

    Servane BARRAULT

    Recruiting

Other trials in France

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.
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 groups in NCT06797726
Study groupRoleWhat they receive
CBT groupExperimental10 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 groupNo interventionroutine 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.

  1. Retention rate

    Proportion of randomized present at the 12-week visit

    Measured: At the 12-week

  2. Adhesion

    Number of sessions performed between baseline and 12 weeks,

    Measured: Between baseline and 12 weeks

  3. Adhesion

    percentage of patients who attended at least 70% of sessions

    Measured: between baseline and 12 weeks

Secondary outcomes (15)
  1. Quantitative evaluation of acceptance percentage

    Number of randomized patients / number of eligible patients eligible patients

    Measured: At 14 weeks

  2. 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

  3. Perceived benefits

    only assessed in Cognitive-behavioural therapy group, assessed during an interview with a psychologist

    Measured: At 14 weeks

  4. Collection of difficulties during the therapy

    only assessed in Cognitive-behavioural therapy group, assessed during an interview with a psychologist

    Measured: At 14 weeks

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. Evolution of psychiatric disorders

    Evaluation will be based on MINI-S interview (mini international neuropsychiatric interview, simplified )

    Measured: At 12 weeks

  15. 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.

  1. First posted28 Jan 2025
  2. Study start13 May 2025
  3. Primary completionAug 2026 (estimated)
  4. Study completionOct 2026 (estimated)

Resources

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)
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

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.

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