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| Name | Class |
|---|---|
| Instituto São João de Deus | UNKNOWN |
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Cognitive dysfunction is one of the different consequences of excessive alcohol consumption, affecting many domains associated with prefrontal and temporal lobes, such as attention, verbal fluency, and memory.
This study will explore the clinical impact of two cognitive rehabilitation tools to promote cognitive improvements of AUD individuals.
Excessive consumption of alcohol affects many functions associated with the prefrontal and temporal lobes, including different executive functions, memory, and complex motor control. Among several treatments, the Transtheoretical Model, a multidisciplinary approach, is one of the most standardized. However, it lacks effective and innovative cognitive rehabilitation tools. In this study, two cognitive rehabilitation tools, already clinically validated for stroke patients, will be implemented to promote cognitive recovery of Alcohol Use Disorder (AUD) individuals under treatment in the Alcoholic Rehabilitation Center S. Ricardo Pampuri from Casa de Saúde S. João de Deus (Madeira, Portugal). Within a randomized controlled trial with 60 participants, this study intend to assess and compare the clinical effectiveness of both a paper-and-pencil tasks training and content equivalent virtual reality (VR) simulation of activities of daily living with time-matched standard treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Virtual Reality | Experimental | Standard treatment protocol and 12 sessions (30 minutes each) of personalized cognitive activities in a virtual city environment (Reh@City). |
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| Paper and Pencil | Experimental | Standard treatment protocol and 12 sessions (30 minutes each) of personalized paper-and-pencil cognitive activities,using the Task Generator tool. |
|
| Control Group | Active Comparator | The standard treatment protocol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual Reality | Procedure | The Virtual Reality group will be involved in the Standard treatment protocol and will perform personalized activities of daily living in a virtual city environment (Reh@City). |
| Measure | Description | Time Frame |
|---|---|---|
| Montreal Cognitive Assessment (Cognitive Screening). | Change from baseline in the Montreal Cognitive Assessment | Baseline, Post-intervention (4 weeks), 6-month and 12-month follow-up |
| Frontal Assessment Battery (FAB- Executive functioning). | Change from baseline in the Frontal Assessment Battery. | Baseline, Post-intervention (4 weeks), 6-month and 12-month follow-up |
| SF-36 Medical Outcomes Study 36 - Item Short - Form Health Survey | Change from baseline in the SF-36 | Baseline, Post-intervention (4 weeks), 6-month and 12-month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Toulouse-Pieron (Attention). | Change from baseline in the Toulouse-Pieron Cancellation Test. | Baseline, Post-intervention (4 weeks), 6-month and 12-month follow-up |
| Verbal Paired Associates (WMS-III) (Memory). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto São João de Deus- CSSJD Funchal | Funchal | 9020-126 | Portugal |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_ICF | Yes | No | Yes | Study Protocol and Informed Consent Form | Nov 10, 2020 |
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| Paper and Pencil | Procedure | The paper and Pencil group will be involved in the Standard treatment protocol and will perform personalized cognitive paper-and-pencil tasks, using the Task Generator tool. |
|
| Control Group | Procedure | The standard treatment protocol. |
|
Change from baseline in the Verbal Paired Associates (WMS-III)
| Baseline, Post-intervention (4 weeks), 6-month and 12-month follow-up |
| Rey Complex Figure (Visuospatial skills and visual memory). | Change from baseline in the Rey Complex Figure. | Baseline, Post-intervention (4 weeks), 6-month and 12-month follow-up |
| Symbol Search and Coding (WAIS III). | Change from baseline in the Symbol Search and Coding (WAIS III) | Baseline, Post-intervention (4 weeks), 6-month and 12-month follow-up] |
| Letter-number sequencing (WAIS-III)- Working Memory | Change from baseline in the Letter-number sequencing (WAIS III) | Baseline, Post-intervention (4 weeks), 6-month and 12-month follow-up] |
| Nov 16, 2020 |
| Prot_ICF_000.pdf |
| 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 |
|---|---|
| D010209 | Paper |
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
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