BANCO2: Behavioral Addictions and Related NeuroCOgnitive Aspects

Sponsor

Nantes University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT03967418

Collaborator

(none)

180

Enrollment

Location

Arms

35.1

Anticipated Duration (Months)

5.1

Patients Per Site Per Month

Study Details

Study Description

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, excessive use of video games 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).

Condition or Disease	Intervention/Treatment	Phase
Behavioral Addiction	Behavioral: Cognitive and clinical assessment	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

180 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

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

Actual Study Start Date :

Oct 28, 2019

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Oct 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Other: Patients with behavioral addictions Patients suffering from behavioural addiction (sexual addiction, excessive use of video games and eating disorders with bulimia episodes) will be recruited	Behavioral: Cognitive and clinical assessment The content of the assessment will be the same for all subjects and will consist of a cognitive assessment (neurocognition, social cognition, metacognition, emotional reactivity) and a clinical assessment (impulsivity, personality, psychiatric and addictive comorbidities)
Other: Healthy volunteers Healthy volunteers will be matched on gender, age and education level to patients	Behavioral: Cognitive and clinical assessment The content of the assessment will be the same for all subjects and will consist of a cognitive assessment (neurocognition, social cognition, metacognition, emotional reactivity) and a clinical assessment (impulsivity, personality, psychiatric and addictive comorbidities)

Arm

Intervention/Treatment

Other: Patients with behavioral addictions

Patients suffering from behavioural addiction (sexual addiction, excessive use of video games and eating disorders with bulimia episodes) will be recruited

Behavioral: Cognitive and clinical assessment

The content of the assessment will be the same for all subjects and will consist of a cognitive assessment (neurocognition, social cognition, metacognition, emotional reactivity) and a clinical assessment (impulsivity, personality, psychiatric and addictive comorbidities)

Other: Healthy volunteers

Healthy volunteers will be matched on gender, age and education level to patients

Behavioral: Cognitive and clinical assessment

Outcome Measures

Primary Outcome Measures

Scores obtained at the various neurocognitive tests used [4 hours]
A composite score will be created to reflect the overall level of cognitive performance of individuals with behavioral addictions, compared to healthy controls

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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