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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-A03558-45 | Other Identifier | ANSM |
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More and more studies aim to improve neurocognitive functioning in alcohol use disorder, but very few studies have focused on training-inhibitory-control efficacy on alcohol intake. Our program relies on a comprehensive model of addiction considering inhibition deficit as the hallmark of addiction. Our program proposes inhibition training on a task which does not refer to alcohol, combined with a debriefing promoting transferability of the enhanced skill and psychoeducation. In this perspective of aiming to retrain deficits involved in addiction in itself and not only due to alcohol toxicity. We propose an add-on single-blinded randomized controlled trial, in alcohol use disorder, assessing the efficacy of a computerized cognitive training program targeting inhibition as compared to treatment as usual.
Our hypothesis is that a computerized program aiming to retrain deficits involved in addiction in itself and not only due to alcohol toxicity i.e.inhibition training on tasks which do not refer to alcohol, combined with a debriefing promoting transferability of the enhanced skills, in addition to treatment as usual, is more effective than a control condition in addition to treatment as usual.
The program 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 processes. The tasks are "find your way", "Don't fall in the trap", "Under pressure", "gulf-stream", "catch the ladybird" and an additional task: "Color and word Stroop test".
The program must be dispensed twice a week with at least in the week one session on site, the other either on site or at home via an application to download, during 6 weeks.
The duration for one session is 45 minutes, including:
Control condition: A sensorial program with similar conditions (45 minutes sessions twice a week), but targeting visual acuity, considered as neutral in the addiction field.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive training | Experimental | Computerized cognitive training program targeting inhibitory control |
|
| Control Training | Sham Comparator | A sensorial program with similar conditions, but targeting visual acuity, considered as neutral in the addiction field |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive training | Other | Computerized cognitive training targeting inhibitory control of motor response used during 45 minutes sessions twice a week for 6 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| The reduction in number of heavy drinking days between the last drinking 4-week period and 6 weeks, assessed with the Time Line Follow Back (TLFB). | The number of heavy drinking days (HDD) is defined as a day with an alcohol consumption ≥60 g for men and ≥40 g for women. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in total alcohol consumption (g/day) between T1 and - T2, -T3 assessed with the TLFB | 12 weeks | |
| Change in number of heavy drinking days between T1 and -T3 assessed with the TLFB | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
Will not be included patients:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Paul Brousse Hospital | Villejuif | 94800 | France |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000091942 | Cognitive Training |
| ID | Term |
|---|---|
| D000066530 | Neurological Rehabilitation |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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| Control training | Other | Fictitious computerized training used during 45 minutes sessions twice a week for 6 weeks |
|
| Change in Alcohol Quality of life scale between T1 and -T2, -T3 | 12 weeks |
| Change in Clinical Global Impression scale (CGI) severity between T1 and -T2, -T3 | 12 weeks |
| Change in Difficulties in Emotion Regulation Scale-Impulse (DERS-IMPULSE ) between T1 and -T2, -T3 | 12 weeks |
| Change in Stop Signal Reaction Time (SSRT) between T1 and -T2, T3 | 12 weeks |
| Change in Stop-signal delay (SSD) from the Stop Signal Task (SST) between T1 and -T2, T3 | 12 weeks |
| Change in Wechsler Adult Intelligence Scale (WAIS) between T1 and -T2, -T3 | 12 weeks |
| Change in Corsi test between T1 and -T2, -T3 | 12 weeks |
| Change in Brixton test between T1 and -T2, -T3 | 12 weeks |
| Change in Trail Making Test (TMT) between T1 and -T2, -T3 | 12 weeks |
| Change in Verbal fluencies test between T1 and -T2, -T3 | 12 weeks |
| Description of the influence of catechol-O-methyltransferase (COMT) variant on efficacy | Genotyping of catechol-O-methyltransferase (COMT) | one day |
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |