Psychiatric DisorderNCT05100849
Kinect-based Versus Tablet-based Cognitive Training: a Pilot Study With Psychiatric Patients
A study testing Kinect-based cognitive training and Tablet-based cognitive training in people with Psychiatric Disorder, run by Universidade da Madeira at 1 site in Portugal.
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. Read more about this study
- Who is it for?
- Ages Up to 75 years, women only
- Conditions the study is for
- Psychiatric Disorder
- What is being tested?
- Kinect-based cognitive training and Tablet-based cognitive training
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Jul 2020to 30 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 75 years
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- Experiencing an acute psychiatric episode.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Psychiatric Disorder
- Being tested
- Kinect-based cognitive training, Tablet-based cognitive training
- Keywords
- Cognitive training, Simulations of instrumental activities of daily living, Tablet-based cognitive training, Kinect-based cognitive training, Psychiatric disorders
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinect-based cognitive trainingProcedure or surgery
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 trainingProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Kinect-based cognitive training | Experimental | Standard treatment protocol and 14 sessions (biweekly during 30 minutes) of Kinect-based cognitive training inspired by instrumental activities of daily living. Receives: Procedure: Kinect-based cognitive training |
| Tablet-based cognitive training | Experimental | Standard treatment protocol and 14 sessions (biweekly during 30 minutes) of Tablet-based cognitive training inspired by instrumental activities of daily living. Receives: Procedure: Tablet-based cognitive training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (1 week before the beginning of the intervention), post-intervention (7 weeks) and follow-up (3-months)
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Baseline (1 week before the beginning of the intervention), post-intervention (7 weeks) and follow-up (3-months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2021
- Study start1 Jul 2020
- Primary completion31 Dec 2020
- Study completion30 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Psychiatric DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade da Madeira
- Sponsor type
- University, hospital or other
- Collaborators
- Casa de Saúde Câmara Pestana
- Responsible party
- Principal investigator, Sergi Bermúdez i Badia, Universidade da Madeira
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05100849
- Sponsor's protocol ID
- 1/2021
- Status last verified
- May 2022
- First submitted
- 27 May 2021
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36251861
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05100849
- Acronym / sponsor ID
- 1/2021
- Conditions
- Psychiatric Disorder
- Keywords
- Cognitive training, Simulations of instrumental activities of daily living, Tablet-based cognitive training, Kinect-based cognitive training, Psychiatric disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Universidade da MadeiraUniversity, hospital or other
- Collaborators
- Casa de Saúde Câmara Pestana
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 30 Oct 2021 (actual)
- First posted
- 29 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kinect-based cognitive training | Experimental | Procedure: Kinect-based cognitive trainingStandard treatment protocol and 14 sessions (biweekly during 30 minutes) of Kinect-based cognitive training inspired by instrumental activities of daily living. |
| Tablet-based cognitive training | Experimental | Procedure: Tablet-based cognitive trainingStandard treatment protocol and 14 sessions (biweekly during 30 minutes) of Tablet-based cognitive training inspired by instrumental activities of daily living. |
Who may qualify
- Ages
- Up to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (1 listed)
- Experiencing an acute psychiatric episode.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kinect-based cognitive trainingThe 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). | Procedure or surgery | Kinect-based cognitive training |
| Tablet-based cognitive trainingThe 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. | Procedure or surgery | Tablet-based cognitive training |
Primary outcome
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
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.
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.
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.
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.
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.
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.
3 secondary outcomes
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
- Derived from this study: PubMed 36251861Camara 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kinect-based cognitive training and Tablet-based cognitive training in people with Psychiatric Disorder, run by Universidade da Madeira at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05100849, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2022.