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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date May 2022
Source Universidade da Madeira
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

Cognitive deficits are a nuclear feature of several psychiatric disorders, leading to a decrease in functional abilities and quality of life. Besides facilitating the inclusion of more ecologically valid stimuli and training tasks, technology-based cognitive training methods allow more dynamic interactions with the cognitive training content, which can result in an enhancement of patients' motivation and engagement in the therapeutic process. The modality of interaction with the cognitive training content may influence patients' response to cognitive training interventions. For instance, cognitive training through the tablet requires essentially hand movements (e.g., interaction with the training tasks by touching the correct stimuli), while cognitive training through the Kinect involves the performance of wide range movements (e.g., interaction with the training tasks by making specific "body" movements to select the correct stimuli). 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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Kinect-based cognitive training
The Kinect-based group will be involved in the standard treatment protocol and will perform a 14-sessions cognitive training program that consists of instrumental activities of daily living simulations. The cognitive training content will be projected onto a wall and patients will interact with the content, i.e., the selection of the appropriate response, through movement (kinect).
Tablet-based cognitive training
The Tablet-based group will be involved in the standard treatment protocol and will perform a 14-sessions cognitive training program that consists of instrumental activities of daily living simulations. Patients will interact with the cognitive training content through a tablet.

Locations

Country Name City State
Portugal Casa de Saúde Câmara Pestana Funchal São Gonçalo

Sponsors (2)

Lead Sponsor Collaborator
Universidade da Madeira Casa de Saúde Câmara Pestana

Country where clinical trial is conducted

Portugal, 

Outcome

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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