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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-A01666-47 | Other Identifier | IDRCB |
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| Name | Class |
|---|---|
| ARJEL (Autorité de Régulation des Jeux En Ligne) | OTHER |
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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.
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:
Population of study participants : Problem gamblers who will contact the responsible of the study.
Schedule for the study :
Secondary objectives of the study are:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive Training | Experimental | Online Cognitive training on the Scientific Brain Training® (SBT®) platform with optional guidance by phone |
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| Online sensorial program | Sham Comparator | Online sensorial program on the Scientific Brain Training® (SBT®) platform with optional guidance by phone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental Group | Other | Cognitive web-based training : 2 up to 30 minutes sessions a week during 6 weeks. Optional debriefing by a neuropsychologist up to 15 minutes twice a week |
| Measure | Description | Time Frame |
|---|---|---|
| The change over 6 weeks in Problem gambling severity index (PGSI)-recent total score, collected by internet | 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 | Change from baseline at 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Problem gambling severity index - recent (PGSI) | Between baseline (T0) , and 14 weeks (T2) | |
| Short form of Urgency, Premeditation, Perseverance, Sensation seeking, and Positive urgency (UPPS-P) Impulsive behavior scale | Impulsivity scale |
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Inclusion criteria
Non-inclusion criteria
1. Gamblers cannot speak or understand French
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| Name | Affiliation | Role |
|---|---|---|
| Amandine LUQUIENS, MD, PhD, HDR | Assistance Publique Hoptiaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Paul Brousse Hospital | Villejuif | 94800 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34848517 | Derived | Santiago A, Carre A, Miranda R, Lemogne C, LeStrat Y, Benyamina A, Perney P, Luquiens A. Study protocol for an online randomised controlled trial among non-treatment seeking problem gamblers: training inhibition in online problem gambling (TRAIN-online) trial. BMJ Open. 2021 Nov 30;11(11):e051641. doi: 10.1136/bmjopen-2021-051641. |
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| ID | Term |
|---|---|
| D005715 | Gambling |
| D016739 | Behavior, Addictive |
| ID | Term |
|---|---|
| D012309 | Risk-Taking |
| D001519 | Behavior |
| D007174 | Disruptive, Impulse Control, and Conduct Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000091942 | Cognitive Training |
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D000066530 | Neurological Rehabilitation |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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| Control Group | Other | Sensorial web-based training : 2 up to 30 minutes sessions a week during 6 weeks. Optional debriefing by a neuropsychologist up to 15 minutes twice a week |
|
| Between baseline (T0) , 6 weeks (T1) and 14 weeks (T2) |
| Time Line Follow Back (TLFB) -gambling | Money and time spent gambling including offline gambling | Between baseline (T0) , 6 weeks (T1) and 14 weeks (T2) |
| EuroQol five dimensions questionnaire (EQ-5D) | Health related quality of life self-questionnaire | Between baseline (T0) , 6 weeks (T1) and 14 weeks (T2) |
| Gambling Quality of Life Scale (GQoLS) | Health related quality of life self-questionnaire specific to gambling disorder | Between baseline (T0) , 6 weeks (T1) and 14 weeks (T2) |
| Neuropsychological assessment: Stop Signal Task (SST) | Cognitive task assessing inhibition | Between baseline (T0) , 6 weeks (T1) and 14 weeks (T2) |
| Total Deposit | Total Deposit assessed by the account player based gambling data (ARJEL database) | In last 4 weeks before baseline (T0) , 6 weeks (T1), 14 weeks (T2) and 52 weeks (T3) |
| Total stake by game | Total stake by game assessed by the account player based gambling data (ARJEL database) | In last 4 weeks before baseline (T0) , 6 weeks (T1), 14 weeks (T2) and 52 weeks (T3) |
| Compulsivity | Compulsivity (as defined by three consecutive deposits in a 12-hour period of time) assessed by the account player based gambling data (ARJEL database) | 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 | Number of deposit in the hour following a stake assessed by the account player based gambling data (ARJEL database) | In last 4 weeks before baseline (T0) , 6 weeks (T1), 14 weeks (T2) and 52 weeks (T3) |
| Total loss by game | Total loss by game assessed by the account player based gambling data (ARJEL database) | In last 4 weeks before baseline (T0) , 6 weeks (T1), 14 weeks (T2) and 52 weeks (T3) |
| Number of sessions (all games) | Number of sessions (all games) in a clinical meaning assessed by the account player based gambling data (ARJEL database) Session is defined as gambling behaviour in itself; we'll consider the beginning of a session when a gambling action occurs after no gambling action since at least 30 minutes, and the end of the gambling session a gambling action followed by no gambling action during 30 minutes. | In last 4 weeks before baseline (T0) , 6 weeks (T1), 14 weeks (T2) and 52 weeks (T3) |
| Session duration (poker only) | Session duration (poker only) assessed by the account player based gambling data (ARJEL database) | In last 4 weeks before baseline (T0) , 6 weeks (T1), 14 weeks (T2) and 52 weeks (T3) |
| Gambling time slot | Gambling time slot assessed by the account player based gambling data (ARJEL database). The time slots are divided as follows:
| 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) |
| Acceptability of the online program assessed by the length of training session | At 6 week (T1) |
| Level of guidance assessed by the number of phone session | Number of debriefing by phone sessions | At 6 week (T1) |
| Level of guidance assessed by the length of phone session | Length of debriefing by phone sessions | At 6 week (T1) |
| D003192 | Compulsive Behavior |
| D007175 | Impulsive Behavior |
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |