Addiction Team, CESP, Villejuif, Île-de-France, France
Department of Addictology, Nîmes University Hospital, Nimes, Languedoc-Roussillon, France.
BMJ Open. 2021 Nov 30;11(11):e051641. doi: 10.1136/bmjopen-2021-051641.
Development 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.
This 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.
This 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.
NCT03673800.
完全基于互联网的项目开发可以为改善问题赌徒的医疗保健提供新途径。在本项目中，我们旨在使用随机对照设计评估针对问题赌徒抑制控制的基于网络的认知干预的效果。由于抑制控制受损涉及行为成瘾的自我调节困难，因此它是针对在线心理干预的一个特别相关的认知过程。
这将是一项单盲、随机、对照的基于互联网的、治疗性的临床试验。将纳入 200 名非治疗寻求的成年问题赌徒，他们的近期问题赌博严重程度指数（PGSI-recent）得分≥5。干预措施将是针对抑制技能的计算机化认知训练计划。对照组为计算机化中性感觉程序，为活性对照。这两个程序将在相似的条件下进行：6 周内每两周进行一次在线培训，并为患者提供电话支持，以便进行汇报。该研究的主要目的是在 6 周时评估在线认知训练计划的临床效果，使用近期 PGSI-recent 进行评估。次要目标是评估基于账户的赌博数据评估的赌博行为、自我报告的赌博实践以及 6、14 和 52 周时神经心理水平的抑制表现的疗效。我们还将评估该计划的可接受性和首选指导水平。数据分析将采用意向治疗。
这项随机对照试验将遵守赫尔辛基宣言进行，已于 2017 年 10 月获得当地伦理委员会（Comité de Protection des Personnes）的批准。研究结果将发表在同行评议的期刊上。
NCT03673800。
