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

ConditionsADHDBehavioral Addiction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Tours

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Patients with psychotic disorders (assessed by clinician)

Pregnant or breast-feeding women

Patients under protective supervision (guardianship or curatorship)

Persons under court protection

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

54 Participants
are divided into 2 treatment groups
Group A: CBT groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Retention rate

Proportion of randomized present at the 12-week visit

Time frame
At the 12-week
2

Adhesion

Number of sessions performed between baseline and 12 weeks,

Time frame
Between baseline and 12 weeks
3

Adhesion

percentage of patients who attended at least 70% of sessions

Time frame
between baseline and 12 weeks

Secondary outcomes

1

Quantitative evaluation of acceptance percentage

Number of randomized patients / number of eligible patients eligible patients

Time frame
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)

Time frame
At 14 weeks
3

Perceived benefits

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

Time frame
At 14 weeks
4

Collection of difficulties during the therapy

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

Time frame
At 14 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Tours

Lead sponsor

Nantes University Hospital

Collaborator

University Hospital, Brest

Collaborator

Source ClinicalTrials.gov
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