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Behavioral Addictions and Related NeuroCOgnitive Aspects (BANCO2)

Primary Purpose

Behavioral Addiction

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Cognitive and clinical assessment
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Behavioral Addiction focused on measuring Behavioral addiction, neurocognition, neuropsychology, sexual addiction, internet gaming disorder, eating disorders

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • CHU de NantesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Patients with behavioral addictions

Healthy volunteers

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 27, 2019
Last Updated
September 14, 2020
Sponsor
Nantes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03967418
Brief Title
Behavioral Addictions and Related NeuroCOgnitive Aspects
Acronym
BANCO2
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

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 28, 2019 (Actual)
Primary Completion Date
October 2022 (Anticipated)
Study Completion Date
October 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Behavioral Addiction
Keywords
Behavioral addiction, neurocognition, neuropsychology, sexual addiction, internet gaming disorder, eating disorders

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients with behavioral addictions
Arm Type
Other
Arm Description
Patients suffering from behavioural addiction (sexual addiction, excessive use of video games and eating disorders with bulimia episodes) will be recruited
Arm Title
Healthy volunteers
Arm Type
Other
Arm Description
Healthy volunteers will be matched on gender, age and education level to patients
Intervention Type
Behavioral
Intervention Name(s)
Cognitive and clinical assessment
Intervention Description
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)
Primary Outcome Measure Information:
Title
Scores obtained at the various neurocognitive tests used
Description
A composite score will be created to reflect the overall level of cognitive performance of individuals with behavioral addictions, compared to healthy controls
Time Frame
4 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marie GRALL BRONNEC, Pr
Phone
02 40 84 76 20
Email
marie.bronnec@chu-nantes.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Gaëlle CHALLET-BOUJU, PhD
Phone
02 40 84 76 20
Email
gaelle.bouju@chu-nantes.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie GRALL BRONNEC, Pr
Organizational Affiliation
Nantes University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Nantes
City
Nantes
ZIP/Postal Code
44093
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie GRALL BRONNEC, Pr
First Name & Middle Initial & Last Name & Degree
Marie GRALL BRONNEC, Pr

12. IPD Sharing Statement

Citations:
PubMed Identifier
34321880
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.
Results Reference
derived

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Behavioral Addictions and Related NeuroCOgnitive Aspects

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