跳至主要内容
临床试验/NCT03673800
NCT03673800进行中(未招募)不适用

Cognitive Control Training in Online Problem Gambling: an Online Randomized Controlled Trial Among Non-treatment Seeking Problem Gamblers

Assistance Publique - Hôpitaux de Paris2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2019年2月18日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
200
试验地点
2
主要终点
The change over 6 weeks in Problem gambling severity index (PGSI)-recent total score, collected by internet

研究概览

简要总结

An online single blinding, randomized, comparative therapeutic web-based, controlled trial. The main objective of the study is to assess the clinical efficacy of an online computerized cognitive training program targeted on cognitive control, namely on inhibition, measured with the PGSI-recent, a modified version of Problem Gambling Severity Index (PGSI) with a 30 days recall period in patients with problem gambling, at 6 weeks, as compared to a control program with a similar setting.

详细描述

Cognitive training is currently used in brain damaged patients and in some psychiatric conditions, like schizophrenia or depression. Very few cognitive training programs have been published and tested in addictive disorders.

Training online is currently proposed in standard care, and is listed as recommended activities in daily hospitalization in addiction specialized out-settings in France.

The purpose of this research is to test the efficacy of an online intervention in gambling addiction through cognitive training targeting cognitive control inhibition.

The experimental Intervention (Cognitive Training) is a computerized cognitive training targeting inhibitory control of motor response (Scientific Brain Training®).The tasks included in the program have been selected and modified to target inhibition.

Control intervention is a sensorial program with a similar format targeting visual acuity. This is not a cognitive program, and can be considered as neutral in the addiction field.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

The change over 6 weeks in Problem gambling severity index (PGSI)-recent total score, collected by internet

时间窗: Change from baseline at 6 weeks

PGSI-recent, a modified version of Problem Gambling Severity Index (PGSI) with a 30 days recall period in patients with problem gambling, at 6 weeks

次要结局

  • Gambling time slot(In last 4 weeks before baseline (T0) , 6 weeks (T1), 14 weeks (T2) and 52 weeks (T3))
  • EuroQol five dimensions questionnaire (EQ-5D)(Between baseline (T0) , 6 weeks (T1) and 14 weeks (T2))
  • Number of sessions (all games)(In last 4 weeks before baseline (T0) , 6 weeks (T1), 14 weeks (T2) and 52 weeks (T3))
  • Short form of Urgency, Premeditation, Perseverance, Sensation seeking, and Positive urgency (UPPS-P) Impulsive behavior scale(Between baseline (T0) , 6 weeks (T1) and 14 weeks (T2))
  • Gambling Quality of Life Scale (GQoLS)(Between baseline (T0) , 6 weeks (T1) and 14 weeks (T2))
  • Total loss by game(In last 4 weeks before baseline (T0) , 6 weeks (T1), 14 weeks (T2) and 52 weeks (T3))
  • Session duration (poker only)(In last 4 weeks before baseline (T0) , 6 weeks (T1), 14 weeks (T2) and 52 weeks (T3))
  • Acceptability of the online program assessed by the number of training session(At 6 week (T1))
  • Level of guidance assessed by the number of phone session(At 6 week (T1))
  • Acceptability of the online program assessed by the length of training session(At 6 week (T1))
  • Time Line Follow Back (TLFB) -gambling(Between baseline (T0) , 6 weeks (T1) and 14 weeks (T2))
  • Total stake by game(In last 4 weeks before baseline (T0) , 6 weeks (T1), 14 weeks (T2) and 52 weeks (T3))
  • Compulsivity(In last 4 weeks before baseline (T0) , 6 weeks (T1), 14 weeks (T2) and 52 weeks (T3))
  • Number of deposit in the hour following a stake(In last 4 weeks before baseline (T0) , 6 weeks (T1), 14 weeks (T2) and 52 weeks (T3))
  • Problem gambling severity index - recent (PGSI)(Between baseline (T0) , and 14 weeks (T2))
  • Neuropsychological assessment: Stop Signal Task (SST)(Between baseline (T0) , 6 weeks (T1) and 14 weeks (T2))
  • Total Deposit(In last 4 weeks before baseline (T0) , 6 weeks (T1), 14 weeks (T2) and 52 weeks (T3))
  • Level of guidance assessed by the length of phone session(At 6 week (T1))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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