Behavioral Addictions and Related NeuroCOgnitive Aspects (BANCO2)

September 14, 2020 updated by: Nantes University Hospital

Study BANCO2: Behavioral Addictions and Related NeuroCOgnitive Aspects : Monocentric, Prospective, Controlled, Open-label Study Conducted With a Sample of Patients With Behavioural Addiction

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Nantes, France, 44093
        • Recruiting
        • CHU de Nantes
        • Contact:
          • Marie GRALL BRONNEC, Pr
        • Principal Investigator:
          • Marie GRALL BRONNEC, Pr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Scores obtained at the various neurocognitive tests used
Time Frame: 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
4 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Investigators

  • Principal Investigator: Marie GRALL BRONNEC, Pr, CHU de Nantes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 28, 2019

Primary Completion (Anticipated)

October 1, 2022

Study Completion (Anticipated)

October 1, 2022

Study Registration Dates

First Submitted

May 27, 2019

First Submitted That Met QC Criteria

May 27, 2019

First Posted (Actual)

May 30, 2019

Study Record Updates

Last Update Posted (Actual)

September 16, 2020

Last Update Submitted That Met QC Criteria

September 14, 2020

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC19_0177

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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