Clinical trial NCT03967418: Behavioral Addictions and Related NeuroCOgnitive Aspects
Official title: Study BANCO2: Behavioral Addictions and Related NeuroCOgnitive Aspects : Monocentric, Prospective, Controlled, Open-label Study Conducted with a Sample of Patients with Behavioural Addiction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Behavioral Addiction
Keywords: Behavioral addiction
neurocognition
neuropsychology
sexual addiction
eating disorders
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2019-05-30
Enrollment: 120
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Improving knowledge about behavioural addictions is a real public health issue. The etiopathogenic model of behavioural addictions is multifactorial, with various risk and vulnerability factors, involved in the initiation and maintenance of the disorders. Among these factors, neurocognitive alterations associated with behavioural addictions has recently aroused interest among researchers.

To our knowledge, there is no work wich compared several behavioural addictions with each other on a neurocognitive level. Moreover, neurocognitive data concerning certain behavioural addictions (such as sexual addiction) is almost non-existent. However, understanding the neurocognitive profiles of these patients would allow the investigators, on the one hand, to reinforce the existing literature and improve our understanding of the global process of addiction, and on the other hand, to propose alternative approaches to its management, taking into account the neurocognitive difficulties of the patients.

The investigators therefore propose to explore the neurocognitive alterations of patients suffering from several behavioural addiction (sexual addiction and eating disorders with bulimia episodes), by comparing them with each other, to matched healthy control groups and to a recognized behavioural addiction (gambling disorder; data from the BANCO study - NCT03202290).


Eligibility criteria: Inclusion Criteria for all participants:

* More than 15 years and 3 months old
* Mastering the French language
* Social Security Affiliates
* Having given consent
* Correct level of vision allowing the reading of instructions, the distinction of shapes and colours and the understanding of shapes and images presented in cognitive tasks (subjectively attested by the patient)
* Correct hearing level, allowing a good understanding of the sounds presented (subjectively attested by the patient and the assessor at the first contact for eligibility)

Inclusion criteria for patients:

* Suffering from one of the behavioural addiction explored
* Beginning treatment in the Addictology department of the University Hospital of Nantes

Inclusion criteria for healthy volunteers:

- Free from the explored behavioural addictions

Exclusion Criteria for all participants:

* Current and not stabilized psychiatric and addictive disorders (mood disorders, anxiety disorders and substance-use disorders except nicotine, lifetime psychotic syndrome), diagnosed by the MINI and after consultation with the clinician,
* Non stabilized endocrine disorders
* Neurological disorders (such as head trauma, neurodegenerative diseases, unbalanced epilepsy, mental retardation, etc.),
* Taking a psychotropic treatment wich is not stabilized for at least 2 weeks,
* Consumption of a psychoactive substance - other than nicotine - within the 12 hours prior to the assessment,
* Color blindness
* Cardiac problems self-reported by the patient, in order to avoid bias in the measurement of cardiac parameters,
* Electrical implants as declared by the participant (to avoid measurement artifacts)
* Having benefited from current or past cognitive remediation program
* Reporting being pregnant or breastfeeding
* Current participation or in the past month in a pharmacological research protocol
* Presenting difficulties for reading or writing French
* Being under guardianship
* With significant cognitive impairment not compatible with de cognitive assessment

Exclusion criteria for healthy volunteers :

- Suffering from one of the behavioural addiction explored

Primary outcomes:
measure: Scores obtained at the various neurocognitive tests used
timeFrame: 4 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Nantes
country: France
facility: CHU de Nantes
Study officials:
affiliation: Nantes University Hospital
name: Marie GRALL BRONNEC, Pr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hurel E, Grall-Bronnec M, Thiabaud E, Saillard A, Hardouin JB, Challet-Bouju G. A Case-Control Study on Behavioral Addictions and Neurocognition: Description of the BANCO and BANCO2 Protocols. Neuropsychiatr Dis Treat. 2021 Jul 20;17:2369-2386. doi: 10.2147/NDT.S292490. eCollection 2021.