NCT03967418

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
116

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 27, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 30, 2019

Completed
5 months until next milestone

Study Start

First participant enrolled

October 28, 2019

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 26, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 26, 2025

Completed
Last Updated

July 4, 2025

Status Verified

July 1, 2025

Enrollment Period

5.7 years

First QC Date

May 27, 2019

Last Update Submit

July 1, 2025

Conditions

Keywords

Behavioral addictionneurocognitionneuropsychologysexual addictioneating disorders

Outcome Measures

Primary Outcomes (1)

  • 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

    4 hours

Study Arms (2)

Patients with behavioral addictions

OTHER

Patients suffering from behavioural addiction (sexual addiction and eating disorders with bulimia episodes) will be recruited

Behavioral: Cognitive and clinical assessment

Healthy volunteers

OTHER

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

Behavioral: Cognitive and clinical assessment

Interventions

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)

Healthy volunteersPatients with behavioral addictions

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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)
  • Suffering from one of the behavioural addiction explored
  • Beginning treatment in the Addictology department of the University Hospital of Nantes
  • \- Free from the explored behavioural addictions

You may not qualify if:

  • 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
  • \- Suffering from one of the behavioural addiction explored

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Nantes

Nantes, 44093, France

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Compulsive Sexual Behavior DisorderFeeding and Eating Disorders

Condition Hierarchy (Ancestors)

Behavior, AddictiveCompulsive BehaviorImpulsive BehaviorBehaviorSexual and Gender DisordersSexual Dysfunctions, PsychologicalMental DisordersSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Marie GRALL BRONNEC, Pr

    Nantes University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2019

First Posted

May 30, 2019

Study Start

October 28, 2019

Primary Completion

June 26, 2025

Study Completion

June 26, 2025

Last Updated

July 4, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations