NCT05100849

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 27, 2021

Completed
5 months until next milestone

First Posted

Study publicly available on registry

October 29, 2021

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2021

Completed
Last Updated

May 18, 2022

Status Verified

May 1, 2022

Enrollment Period

6 months

First QC Date

May 27, 2021

Last Update Submit

May 17, 2022

Conditions

Keywords

Cognitive trainingSimulations of instrumental activities of daily livingTablet-based cognitive trainingKinect-based cognitive trainingPsychiatric disorders

Outcome Measures

Primary Outcomes (7)

  • 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 Outcomes (3)

  • Beck Depression Inventory II (BDI-II) (Depressive symptomatology)

    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)

    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)

    Baseline (1 week before the beginning of the intervention), post-intervention (7 weeks) and follow-up (3-months)

Study Arms (2)

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.

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.

Procedure: Tablet-based cognitive training

Interventions

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).

Kinect-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.

Tablet-based cognitive training

Eligibility Criteria

AgeUp to 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • Experiencing an acute psychiatric episode.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Casa de Saúde Câmara Pestana

Funchal, São Gonçalo, 9060-378, Portugal

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Mental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor at the University of Madeira and Senior Researcher at NOVA LINCS

Study Record Dates

First Submitted

May 27, 2021

First Posted

October 29, 2021

Study Start

July 1, 2020

Primary Completion

December 31, 2020

Study Completion

October 30, 2021

Last Updated

May 18, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations