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Study protocol for an online randomised controlled trial among non-treatment seeking problem gamblers: training inhibition in online problem gambling (TRAIN-online) trial

Authors :
Pascal Perney
Cédric Lemogne
Ruben Miranda
Yann LeStrat
Amine Benyamina
Antoine Santiago
Amandine Luquiens
Arnaud Carré
Centre de recherche en épidémiologie et santé des populations (CESP)
Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Saclay
Service Addictologie [CHU Nîmes] (Pôle ICAGNE)
Hôpital Universitaire de Réadaptation, de Rééducation et d'Addictologie du CHU de Nîmes [Grau-du-Roi] (CHU Nîmes)
Centre Hospitalier Universitaire de Nîmes (CHU Nîmes)-Centre Hospitalier Universitaire de Nîmes (CHU Nîmes)
Laboratoire Inter-universitaire de Psychologie : Personnalité, Cognition, Changement Social (LIP-PC2S)
Université Savoie Mont Blanc (USMB [Université de Savoie] [Université de Chambéry])-Université Grenoble Alpes (UGA)
Service de psychiatrie adulte [CHU Pitié-Salpêtière]
CHU Pitié-Salpêtrière [AP-HP]
Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)
Hôpital Européen Georges Pompidou [APHP] (HEGP)
Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)
Institut de psychiatrie et neurosciences de Paris (IPNP - U1266 Inserm)
Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Paris (UP)
Hôpital Louis Mourier - AP-HP [Colombes]
Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)
Service de Psychiatrie Adulte [CHU Pitié-Salpêtière]
Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)
Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité)
Université de Montpellier (UM)
Gestionnaire, Hal Sorbonne Université
Source :
BMJ Open, BMJ Open, BMJ Publishing Group, 2021, 11 (11), pp.e051641. ⟨10.1136/bmjopen-2021-051641⟩, BMJ Open, 2021, 11 (11), pp.e051641. ⟨10.1136/bmjopen-2021-051641⟩, BMJ Open, Vol 11, Iss 11 (2021)
Publication Year :
2021
Publisher :
BMJ Publishing Group, 2021.

Abstract

IntroductionDevelopment of fully internet-based programs could provide a new avenue to improve access to healthcare for problem gamblers. In this project, we aim to assess the efficacy of a web-based cognitive intervention targeting inhibitory control among problem gamblers, using a randomised controlled design. As impaired inhibitory control is involved in self-regulation difficulties in behavioural addictions, it represents a particularly relevant cognitive process to target for an online psychological intervention.Methods and analysisThis will be a single-blinded, randomised, comparative therapeutic web-based, controlled trial. Up to 200 non-treatment seeking adult problem gamblers with a Problem Gambling Severity Index-recent (PGSI-recent) score ≥5 will be included. The intervention will be a computerised cognitive training program targeting inhibitory skills. The comparator, an active control, will be a computerised neutral sensorial program. Both programs will be carried out under similar conditions: biweekly online training for 6 weeks and optional telephone support will be offered to patients for debriefing. The main objective of the study is to assess the clinical efficacy of the online cognitive training program at 6 weeks, measured with the PGSI-recent. The secondary objectives are to assess the efficacy on the gambling behaviour assessed by the account-based gambling data, on the self-reported gambling practice, and on the inhibition performance at the neuropsychological level at 6, 14 and 52 weeks. We will also assess the acceptability of this program and the preferred level of guidance. Data analysis will be in intention-to-treat.Ethics and disseminationThis randomized controlled trial will be executed in compliance with the Helsinki Declaration, and was approved by the local ethics boards (Comité de Protection des Personnes) in October 2017. The findings will be published in peer-reviewed journals.Trial registration numberNCT03673800.

Details

Language :
English
ISSN :
20446055
Volume :
11
Issue :
11
Database :
OpenAIRE
Journal :
BMJ Open
Accession number :
edsair.doi.dedup.....e396e4427f858970c1a01257c35d460e