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Clinical Trials/NCT03673800
NCT03673800
Active, not recruiting
Not Applicable

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

Assistance Publique - Hôpitaux de Paris1 site in 1 country200 target enrollmentFebruary 18, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pathological Gambling
Sponsor
Assistance Publique - Hôpitaux de Paris
Enrollment
200
Locations
1
Primary Endpoint
The change over 6 weeks in Problem gambling severity index (PGSI)-recent total score, collected by internet
Status
Active, not recruiting
Last Updated
2 years ago

Overview

Brief Summary

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.

Detailed Description

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. An optional guidance by phone performed by a trained neuropsychologist is proposed to the included subjects in both groups, up to15 minutes twice a week. Study design: A therapeutic web-based, comparative, randomized controlled trial, 2 arms, single blinding, with 52 weeks follow-up: * a 14 weeks patient follow up (6 weeks for efficacy assessment and maintenance at 14 weeks). * 52 weeks gambling account based data extracted from the ARJEL database in last 4 weeks before baseline, week 6, week 14 and week 52. Population of study participants : Problem gamblers who will contact the responsible of the study. Schedule for the study : * Duration of inclusion period: 8 months * Duration of patient participation: 52 weeks (12 months) including 14 weeks of active gambler participation and up to 52 weeks for the collection of gambler data from the ARJEL database. * Total research duration: 20 months Main objective : 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. Secondary objectives of the study are: * to assess the efficacy on the evolution of the gambling behaviour assessed by the account player based gambling data, at 6, 14and 52 weeks. * to assess the efficacy on the evolution of the self-reported gambling practice, and of quality of life at 0, 6 and 14 weeks. * to assess the efficacy on the evolution of inhibition performance at the neuropsychological level at 0, 6 and 14, weeks. * We will also assess the acceptability of this program and the preferred level of guidance of the non-treatment seeking problem gamblers as factor of response. Statistical analysis:The change in PGSI-recent total score over 6 weeks will be compared with the student's t-test. If the test application conditions are not met, a Wilcoxon test will be applied.

Registry
clinicaltrials.gov
Start Date
February 18, 2019
End Date
March 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

Time Frame: 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

Secondary Outcomes

  • 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))

Study Sites (1)

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