- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05100849
Kinect-based Versus Tablet-based Cognitive Training: a Pilot Study With Psychiatric Patients
May 17, 2022 updated by: Sergi Bermúdez i Badia, Universidade da Madeira
Efficacy of Kinect-based Versus Tablet-based Cognitive Training Through Simulations of Instrumental Activities of Daily Living: a Pilot Study With Chronic Psychiatric Patients
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
18
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
São Gonçalo
-
Funchal, São Gonçalo, Portugal, 9060-378
- Casa de Saúde Câmara Pestana
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 75 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Kinect-based cognitive training
Standard treatment protocol and 14 sessions (biweekly during 30 minutes) of Kinect-based cognitive training inspired by instrumental activities of daily living.
|
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).
|
|
Experimental: Tablet-based cognitive training
Standard treatment protocol and 14 sessions (biweekly during 30 minutes) of Tablet-based cognitive training inspired by instrumental activities of daily living.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Montreal Cognitive Assessment (MoCA) (Cognitive screening)
Time Frame: Baseline (1 week before the beginning of the intervention), post-intervention (7 weeks) and follow-up (3-months)
|
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)
|
|
Frontal Assessment Battery (FAB) (Executive functions screening)
Time Frame: Baseline (1 week before the beginning of the intervention), post-intervention (7 weeks) and follow-up (3-months)
|
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)
|
|
Toulouse-Piéron Cancellation Test (TP) (Sustained and selective attention)
Time Frame: Baseline (1 week before the beginning of the intervention), post-intervention (7 weeks) and follow-up (3-months)
|
Change from baseline in the Toulouse-Piéron 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)
|
|
Rey Complex Figure Test (RCFT) (Visuospatial skills and visual memory)
Time Frame: Baseline (1 week before the beginning of the intervention), post-intervention (7 weeks) and follow-up (3-months)
|
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)
|
|
Symbol Search and Coding (WAIS-III) (Processing speed)
Time Frame: Baseline (1 week before the beginning of the intervention), post-intervention (7 weeks) and follow-up (3-months)
|
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)
|
|
Verbal Fluency Tests (semantic and phonemic) (Executive Functions)
Time Frame: Baseline (1 week before the beginning of the intervention), post-intervention (7 weeks) and follow-up (3-months)
|
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)
|
|
Free and Cued Selective Reminding Test (FCSRT) (Verbal Memory)
Time Frame: Baseline (1 week before the beginning of the intervention), post-intervention (7 weeks) and follow-up (3-months)
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Beck Depression Inventory II (BDI-II) (Depressive symptomatology)
Time Frame: Baseline (1 week before the beginning of the intervention), post-intervention (7 weeks) and follow-up (3-months)
|
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)
|
|
World Health Organization Quality of Life - Bref (WHOQOL-Bref) (Quality of life)
Time Frame: Baseline (1 week before the beginning of the intervention), post-intervention (7 weeks) and follow-up (3-months)
|
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)
|
|
Adults and Older Adults Functional Assessment Inventory (IAFAI)
Time Frame: Baseline (1 week before the beginning of the intervention), post-intervention (7 weeks) and follow-up (3-months)
|
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)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2020
Primary Completion (Actual)
December 31, 2020
Study Completion (Actual)
October 30, 2021
Study Registration Dates
First Submitted
May 27, 2021
First Submitted That Met QC Criteria
October 19, 2021
First Posted (Actual)
October 29, 2021
Study Record Updates
Last Update Posted (Actual)
May 18, 2022
Last Update Submitted That Met QC Criteria
May 17, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1/2021
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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