Kinect-based Versus Tablet-based Cognitive Training: a Pilot Study With Psychiatric Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy of Kinect-based Versus Tablet-based Cognitive Training Through Simulations of Instrumental Activities of Daily Living: a Pilot Study With Chronic Psychiatric Patients

Conditions
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Psychiatric Disorder

Intervention / Treatment
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* Procedure: Kinect-based cognitive training
* Procedure: Tablet-based cognitive training


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Kinect-based cognitive training<br>Standard treatment protocol and 14 sessions (biweekly during 30 minutes) of Kinect-based cognitive training inspired by instrumental activities of daily living. | Procedure: Kinect-based cognitive training<br>* 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).<br>|
| Experimental: Tablet-based cognitive training<br>Standard treatment protocol and 14 sessions (biweekly during 30 minutes) of Tablet-based cognitive training inspired by instrumental activities of daily living. | Procedure: Tablet-based cognitive training<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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. | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognitive training, Simulations of instrumental activities of daily living, Tablet-based cognitive training, Kinect-based cognitive training, Psychiatric disorders