Kinect-based Versus Tablet-based Cognitive Training: a Pilot Study With Psychiatric Patients
Primary Purpose
Psychiatric Disorder
Status
Completed
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Kinect-based cognitive training
Tablet-based cognitive training
Sponsored by
About this trial
This is an interventional treatment trial for Psychiatric Disorder focused on measuring Cognitive training, Simulations of instrumental activities of daily living, Tablet-based cognitive training, Kinect-based cognitive training, Psychiatric disorders
Eligibility Criteria
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.
Sites / Locations
- Casa de Saúde Câmara Pestana
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Kinect-based cognitive training
Tablet-based cognitive training
Arm Description
Standard treatment protocol and 14 sessions (biweekly during 30 minutes) of Kinect-based cognitive training inspired by instrumental activities of daily living.
Standard treatment protocol and 14 sessions (biweekly during 30 minutes) of Tablet-based cognitive training inspired by instrumental activities of daily living.
Outcomes
Primary Outcome Measures
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
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.
Toulouse-Piéron Cancellation Test (TP) (Sustained and selective attention)
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.
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.
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.
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.
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT05100849
First Posted
May 27, 2021
Last Updated
May 17, 2022
Sponsor
Universidade da Madeira
Collaborators
Casa de Saúde Câmara Pestana
1. Study Identification
Unique Protocol Identification Number
NCT05100849
Brief Title
Kinect-based Versus Tablet-based Cognitive Training: a Pilot Study With Psychiatric Patients
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
October 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade da Madeira
Collaborators
Casa de Saúde Câmara Pestana
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychiatric Disorder
Keywords
Cognitive training, Simulations of instrumental activities of daily living, Tablet-based cognitive training, Kinect-based cognitive training, Psychiatric disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Kinect-based cognitive training
Arm Type
Experimental
Arm Description
Standard treatment protocol and 14 sessions (biweekly during 30 minutes) of Kinect-based cognitive training inspired by instrumental activities of daily living.
Arm Title
Tablet-based cognitive training
Arm Type
Experimental
Arm Description
Standard treatment protocol and 14 sessions (biweekly during 30 minutes) of Tablet-based cognitive training inspired by instrumental activities of daily living.
Intervention Type
Procedure
Intervention Name(s)
Kinect-based cognitive training
Intervention Description
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).
Intervention Type
Procedure
Intervention Name(s)
Tablet-based cognitive training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Montreal Cognitive Assessment (MoCA) (Cognitive screening)
Description
Change from baseline in the Montreal Cognitive Assessment (MoCA); Min score=0; Max score=30; Higher scores mean a better outcome
Time Frame
Baseline (1 week before the beginning of the intervention), post-intervention (7 weeks) and follow-up (3-months)
Title
Frontal Assessment Battery (FAB) (Executive functions screening)
Description
Change from baseline in the Frontal Assessment Battery (FAB). Min score=0; Max score=18; Higher scores mean a better outcome.
Time Frame
Baseline (1 week before the beginning of the intervention), post-intervention (7 weeks) and follow-up (3-months)
Title
Toulouse-Piéron Cancellation Test (TP) (Sustained and selective attention)
Description
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.
Time Frame
Baseline (1 week before the beginning of the intervention), post-intervention (7 weeks) and follow-up (3-months)
Title
Rey Complex Figure Test (RCFT) (Visuospatial skills and visual memory)
Description
Change from baseline in the Rey Complex Figure Test (RCFT); Min score=0; Max score=36; Higher scores mean a better outcome.
Time Frame
Baseline (1 week before the beginning of the intervention), post-intervention (7 weeks) and follow-up (3-months)
Title
Symbol Search and Coding (WAIS-III) (Processing speed)
Description
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.
Time Frame
Baseline (1 week before the beginning of the intervention), post-intervention (7 weeks) and follow-up (3-months)
Title
Verbal Fluency Tests (semantic and phonemic) (Executive Functions)
Description
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.
Time Frame
Baseline (1 week before the beginning of the intervention), post-intervention (7 weeks) and follow-up (3-months)
Title
Free and Cued Selective Reminding Test (FCSRT) (Verbal Memory)
Description
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.
Time Frame
Baseline (1 week before the beginning of the intervention), post-intervention (7 weeks) and follow-up (3-months)
Secondary Outcome Measure Information:
Title
Beck Depression Inventory II (BDI-II) (Depressive symptomatology)
Description
Change from baseline in the BDI-II; Min score=0; Max score=63; Higher scores mean a worse outcome.
Time Frame
Baseline (1 week before the beginning of the intervention), post-intervention (7 weeks) and follow-up (3-months)
Title
World Health Organization Quality of Life - Bref (WHOQOL-Bref) (Quality of life)
Description
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.
Time Frame
Baseline (1 week before the beginning of the intervention), post-intervention (7 weeks) and follow-up (3-months)
Title
Adults and Older Adults Functional Assessment Inventory (IAFAI)
Description
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.
Time Frame
Baseline (1 week before the beginning of the intervention), post-intervention (7 weeks) and follow-up (3-months)
10. Eligibility
Sex
Female
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Casa de Saúde Câmara Pestana
City
Funchal
State/Province
São Gonçalo
ZIP/Postal Code
9060-378
Country
Portugal
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
36251861
Citation
Camara J, Ferreira L, Faria AL, Vilar M, Bermudez I Badia S. Feasibility, Acceptability, and Preliminary Impact of Full-Body Interaction on Computerized Cognitive Training Based on Instrumental Activities of Daily Living: A Pilot Randomized Controlled Trial with Chronic Psychiatric Inpatients. Games Health J. 2022 Oct 11. doi: 10.1089/g4h.2021.0228. Online ahead of print.
Results Reference
derived
Learn more about this trial
Kinect-based Versus Tablet-based Cognitive Training: a Pilot Study With Psychiatric Patients
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