Psychiatric Disorder Clinical Trial
Official title:
Efficacy of Kinect-based Versus Tablet-based Cognitive Training Through Simulations of Instrumental Activities of Daily Living: a Pilot Study With Chronic Psychiatric Patients
NCT number | NCT05100849 |
Other study ID # | 1/2021 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 1, 2020 |
Est. completion date | October 30, 2021 |
Verified date | May 2022 |
Source | Universidade da Madeira |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study aims to analyze which cognitive training experimental condition - Tablet versus Kinect - results in greater cognitive, mood, quality of life, and functional gains in a sample of chronic psychiatric patients.
Status | Completed |
Enrollment | 18 |
Est. completion date | October 30, 2021 |
Est. primary completion date | December 31, 2020 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A to 75 Years |
Eligibility | Inclusion Criteria: - Psychiatric diagnosis; - Maximum age: 75 years old; - Relatively preserved language abilities (expressive and receptive language); - Being able to read and write; - Having no motor limitations; - Having no medical history of neurological conditions (e.g., stroke, traumatic brain injury, multiple sclerosis, etc.) - Preserved visual and auditory acuity; Exclusion Criteria: - Experiencing an acute psychiatric episode. |
Country | Name | City | State |
---|---|---|---|
Portugal | Casa de Saúde Câmara Pestana | Funchal | São Gonçalo |
Lead Sponsor | Collaborator |
---|---|
Universidade da Madeira | Casa de Saúde Câmara Pestana |
Portugal,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Montreal Cognitive Assessment (MoCA) (Cognitive screening) | Change from baseline in the Montreal Cognitive Assessment (MoCA); Min score=0; Max score=30; Higher scores mean a better outcome | Baseline (1 week before the beginning of the intervention), post-intervention (7 weeks) and follow-up (3-months) | |
Primary | Frontal Assessment Battery (FAB) (Executive functions screening) | Change from baseline in the Frontal Assessment Battery (FAB). Min score=0; Max score=18; Higher scores mean a better outcome. | Baseline (1 week before the beginning of the intervention), post-intervention (7 weeks) and follow-up (3-months) | |
Primary | Toulouse-Piéron Cancellation Test (TP) (Sustained and selective attention) | Change from baseline in the Toulouse-PiĆ©ron Cancellation Test (TP); Min score=0; Max score=dependent on patients' performance during a 10-min time frame; A higher work efficiency index means a better outcome, whereas a higher dispersion index means a worse outcome. | Baseline (1 week before the beginning of the intervention), post-intervention (7 weeks) and follow-up (3-months) | |
Primary | Rey Complex Figure Test (RCFT) (Visuospatial skills and visual memory) | Change from baseline in the Rey Complex Figure Test (RCFT); Min score=0; Max score=36; Higher scores mean a better outcome. | Baseline (1 week before the beginning of the intervention), post-intervention (7 weeks) and follow-up (3-months) | |
Primary | Symbol Search and Coding (WAIS-III) (Processing speed) | Change from baseline in the Symbol Search and Coding (WAIS-III); Min score=0; Max score dependent on patients' performance in a 120 seconds time frame. Higher scores in both subtests mean a better outcome. | Baseline (1 week before the beginning of the intervention), post-intervention (7 weeks) and follow-up (3-months) | |
Primary | Verbal Fluency Tests (semantic and phonemic) (Executive Functions) | Change from baseline in the Verbal Fluency Tests (semantic and phonemic); Min score=0; Max score dependent on patients' performance during a 1-minute time frame. Higher scores on both verbal fluency tests mean a better outcome. | Baseline (1 week before the beginning of the intervention), post-intervention (7 weeks) and follow-up (3-months) | |
Primary | Free and Cued Selective Reminding Test (FCSRT) (Verbal Memory) | Change from baseline in the Free and Cued Selective Reminding Test (FCSRT); Min score immediate recall trials=0; Max score immediate recall trials=48; Min score Delayed recall trials=0; Max score delayed recall trials=16. Higher scores on both trials mean a better outcome. | Baseline (1 week before the beginning of the intervention), post-intervention (7 weeks) and follow-up (3-months) | |
Secondary | Beck Depression Inventory II (BDI-II) (Depressive symptomatology) | Change from baseline in the BDI-II; Min score=0; Max score=63; Higher scores mean a worse outcome. | Baseline (1 week before the beginning of the intervention), post-intervention (7 weeks) and follow-up (3-months) | |
Secondary | World Health Organization Quality of Life - Bref (WHOQOL-Bref) (Quality of life) | Change from baseline in the World Health Organization Quality of life-Bref (WHOQOL-Bref); Min score=0; Max score=100; Higher scores mean a better outcome. | Baseline (1 week before the beginning of the intervention), post-intervention (7 weeks) and follow-up (3-months) | |
Secondary | Adults and Older Adults Functional Assessment Inventory (IAFAI) | Change from baseline in the Adults and Older Adults Functional Assessment Inventory; (IAFAI). Min score=0; Max score=100; Higher scores mean a worse outcome. | Baseline (1 week before the beginning of the intervention), post-intervention (7 weeks) and follow-up (3-months) |
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